Accutane pills

Posted on May 10, 2011 by Bergen
Accutane Pills

Accutane Pills

What is Accutane?

Accutane is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Accutane pills are used to minimize the acne on the face. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms. This treatment is highly effective, because it decreases the production of oils from the sebaceous glands found on the skin, as well as the size of these glands. Although incredibly effective, Accutane acne treatment does come with some risks that will be discussed later.

Roche Pharmaceuticals a famous drug company patented this drug. There are several names for this drug in different parts of the world. For instance, in the USA it is known as Isotretinoin, in other countries it is usually called Roaccutane. Isotretinoin is the generic name of accutane drug. Accutane for Acne helps by reducing the production of oil in the oil glands, so the appearance of acne is noticeably reduced.

The reason that Accutane is seen as the ‘last resort’ acne treatment option is because of is potency. After four to five months of regular use, Accutane therapy usually results in a noticeable clearing of acne. Because of its potency, only moderate or severe cases of acne are treated with Accutane.

Once the treatment is over, rest assured that the side effect associated with accutane will subside. Result often speaks for themselves and for those patients that undergone the cystic acne accutane treatment it is worth the time and effort.

There are two types of acne pills: Prescription Acne Pills and Herbal Acne Pills.

The prescription acne pills are expensive but popular pills and mainly contain accutane (accutane simply reduces the amount of oil produced by your skin) the popular but dangerous acne drug especially for pregnant woman.

The herbal one is made of herbal ingredients and should contain some of the following: DMAE, Dandelion Root, Aloe Vera Leaf, Witch Hazel Leaf, White Willow Bark, Milk Thistle, and Alpha Lipoic Acid.

How acne treatment works?

These acne pills contain antioxidants and herbal extracts which helps in eliminating the bacteria that are dangerous to your skin and promote infections. They also helps in reducing the redness of your skin and heal damaged skin These pills balances the hormonal and chemical imbalances in the body that lead to acne flare-ups and the more severe form, cystic acne. These acne pills would give you improvement on your skin texture and prevent formation of new zits or pimples.

What are the efficacy rates of Accutane?

Accutane for Acne has a pretty good success rate, with approximately 35 to 38% of patients experiencing complete remission after one course of Accutane. In more stubborn acne cases, your dermatologist may choose to give you more than one course of the medication. After one course of treatment, approximately 70% of all patients experience remission from symptoms.

As with many drugs, Accutane acne treatment does come with some potential risks. The most common side effects of Accutane are related directly to the decreased production of sebum in the skin. Such side effects are dryness of skin and lips, itch, rash, peeling skin, and fragile skin. There are also some side effects that are related to the decreased production of sebum in the eyes, such as conjunctivitis, dry eyes, and a reduced tolerance for contact lenses. Also, because fats and albumin are used to transport the isotretinoin molecule found in Accutane, these levels may be slightly raised. Less frequently occurring side effects can include severe acne flares, mood swings, or fatigue.

Notable drug interactions include vitamin A supplements, as well as a certain drug that used in fighting cancer and autoimmune diseases, known as methotrexate.

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Acne outcome

Posted on December 12, 2011 by Bergen

Data from the literature were used to construct a database that included patient demographics, elements of study design (e.g. randomized or nonrandomized treatment), acne severity, sample size, drug, drug class, dose, SER and one or more measures of acne condition. Patients’ data were excluded if acne was rated as severe, as only oral retinoid therapy is effective in these cases. Therefore, studies with patients diagnosed with mild, mild to moderate, moderate or moderate to severe acne were included. If the acne was not defined in terms of severity but noted as antibiotic treatment resistant, or if patients were enrolled based on severity of seborrhoea, these study results were also included in the database. Studies were required to have both sebum excretion and acne measure(s) determined in the same patients for inclusion.

Sebum excretion was measured by various methods across studies. The earliest studies from the 1980s determined SER using a gravimetric technique, while another study in the following decade measured sustainable SER using a similar type of procedure. Studies conducted recently used more technically advanced methods icluding a Sebumeter or Sebutape to measure sebum production. Sebum excretion was expressed as the weight of sebum produced in a defined area of the skin per unit time. One study measured total sebum lipids by gas chromatography–mass spectrometry. Another study did not indicate the method of sebum measurement, and reported only the percentage reduction in sebum production.

Acne measures included total lesion count, inflammatory lesion count and acne severity grade, as these parameters were the most commonly reported measures of acne outcome. Both lesion count and an ordinal global assessment scale are currently recommended by the U.S. Food and Drug Administration (FDA) as coprimary endpoints in the development of drugs for the treatment of acne vulgaris. However, the FDA acknowledges that many methods exist for the assessment of acne severity and the dif?culty involved in developing a standardized ordinal scale. Indeed, the acne severity grading systems used in the studies considered here included the Leeds technique (three studies), the method of Allen and Smith (one study), an investigator global evaluation scale of 1–5 (one study), an acne severity scale of 1–10 (one study) and a rating scale that was undefined (one study).

Data were collected at all time points reported in each study. The duration of treatment generally ranged from 4 to 6 months for studies with isotretinoin, four to 13 cycles for oral contraceptives, and 3 months for zileuton, a 5-lipoxygenase inhibitor. Only 3- and 4-month data were selected and pooled for this analysis, when reduction of sebum appeared to reach its maximum effect and measurable improvement was noted in acne.

As the data of interest were often expressed in different units across studies, all values were converted to percentage reduction from baseline values. Data were evaluated graphically and visually inspected for evidence of a relationship between reduction in sebum excretion and reduction in acne measure. Where a correlation was apparent, a statistical model was used to describe the relationship. Graphics were performed using S-Plus 6.2 or SigmaPlot 9.1.

The correlation between sebum and acne appears to be consistent over the range of conditions under which these parameters have been studied, both in acne patients not receiving treatment and also following treatment with various medications. Specifically, it illustrates the lack of influence of various study characteristics on the relationship between SER and lesion count reduction. Thus, the model was considered to be adequate across multiple drug classes, 3- and 4-month endpoints, a range of acne severity and from both randomized and nonrandomized treatments.

Estimates of sebum reduction required for acne improvement are consistent with an early prediction by Cunliffe that ‘sebum reduction of 35% or more is probablyneeded to produce a satisfactory clinical response’. While the definition of satisfactory response may be debatable, 50% improvement in acne severity was used as a target for estimating the sebum reduction associated with meaningful clinical outcome.

Studies reported in the literature included acne outcomes at various time intervals post-treatment, including 2, 3, 4, 6, 9 and 12 months. Individual studies generally reported outcomes at 2, 4 and 6 months, or 3, 6 and 9 months. With isotretinoin and antiandrogen therapies, sebum reduction appears to reach its maximum level by 4 months and remains stable thereafter. Oral contraceptive medication showed a plateau in sebum reduction in the 3–9 month range. In all cases, acne outcome continued to improve beyond the time in which sebum reduction had stabilized, and may require up to a year of treatment to reach a plateau. In this analysis, onlythe 3- or 4-month time-point data were used. Therefore, the association of sebum reduction with improvement in acne measure is being evaluated at one snapshot in time, recognizing that disequilibrium exists in the relationship between these two parameters. A more complex model is currently being developed to characterize the individual time courses of each parameter and the relationship between them. This will potentially allow the prediction of acne measures at various durations of treatment which may provide a useful tool in the design of acne clinical trials where sebum reduction is the target mechanism of action.

It has been demonstrated in numerous studies, both individually in the literature reports and collectively, that not only is sebum excretion a determinant of acne severity, but it can also be modulated to improve acne. The results shown here suggest that the collective data across multiple studies may provide a useful generalization ofthe association of sebum reduction and acne outcome. Because the relationship apparently remains consistent regardless of the treatment, it can be inferred that extrapolation to novel exploratory treatments may be valid. In addition, it could also be inferred that the efficacy of acne therapies as diverse in mechanism as oral contraceptives and isotretinoin may be attributable solely or principally to their activity in reducing sebum production.

In conclusion, in answer to the question ‘Can sebum reduction predict acne outcome?’, evidence in the literature supports the answer of ‘Yes’. Acne outcome appears to be highly dependent on sebum reduction not only within individual studies, but also across studies and multiple drug classes. Further work is ongoing to develop a statistical model to characterize this relationship more fully and project acne outcomes at later stages of treatment.

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Various Acne Treatments

Posted on December 12, 2011 by Bergen

Sebum excretion has generally been accepted as an important factor in the development of acne vulgaris. However, the relationship of sebum excretion and acneoutcome has not yet been clearly demonstrated quantitatively. The objective of this analysis was to explore the correlation of sebum and acne by combining datafrom studies of various acne treatments that have demonstrated effects on both sebum excretion and acne outcome. Acne measures included total lesion count,inflammatory lesion count and acne severity grade. For each acne measure, data were pooled and analysed at the 3- and 4-month endpoints, when sebum reduction has generally equilibrated and efficacy in acne is approaching the maximum effect for most treatments. A linear model was used to describe the percentage reduction in each acne measure as a function of percentage reduction in sebum excretion. Slope values were similar for the three acne parameters and all were significantly different from zero (P < 0?025), suggesting a significant correlation of sebum and acne. The projected sebum reduction required to achieve 50% reduction in acne measures ranged from 30% to 50%. The results shown here suggest that the collective data across multiple studies may provide a useful generalization of the association of sebum reduction and acne outcome. As the relationship apparently remains consistent regardless of the treatment, it can be inferred that extrapolation to novel exploratory treatments may be valid.

Many researchers have observed that a correlation exists between sebum excretion and acne severity. In fact, this relationship has been clearly demonstrated in numerous studies over the past four decades. While the mechanism of acne lesion formation is multifactorial, sebum excretion plays an important role. Higher rates of sebum excretion are associated with more severe acne. Further, acne severity can be modulated by various medications that reduce sebum, and these parameters appear to be related at least in a qualitative fashion. We have attempted to look across multiple studies reported in the dermatology literature to determine if the sebum–acne relationship can be quantified and subsequently generalized to predict acne outcome from sebum reduction.

There are broadly two major classes of acne treatment that reduce sebum: systemic retinoids and hormones. The mechanisms of action by which these drugs improve acne are actually more complex, but they each reduce sebum secretion.

Retinoid therapy, specifically oral isotretinoin, provides the most effective acne treatment for moderate to severe inflammatory acne. However, because of its teratogenicity and adverse event profile, cautious use of this medication is required. Isotretinoin acts on multiple factors involved in acne pathogenesis, by normalizing follicular keratinization, indirectly inhibiting Propionibacterium acnes growth, decreasing inflammation, reducing sebaceous gland size and reducing sebum excretion. However, the exact mechanism(s) of action is not known. Among all acne medications, it has the greatest effect on sebum reduction reaching values of approximately 90%. Interestingly, topical isotretinoin does not appear to affect sebum excretion and has only moderate ef?cacy in the treatment of acne.

While hormone therapy modulates sebum excretion to a lesser extent than systemic isotretinoin, it is an effective treatment for many women with acne. Several progestins, such as cyproterone acetate (CPA), demonstrate notable antiandrogenic properties and apparently have a direct effect on sebum excretion. Increased androgen activity, either systemic or local, is associated with sebaceous gland proliferation and elevated sebum excretion, and consequently has been linked to severity of acne. High doses of oestrogens are also linked to reduction in sebum production although the mechanism by which oestrogen affects sebum, apart from its antagonist effects on androgens, is not clear. With combination therapy of an oestrogen and CPA, sebum reduction of up to 75% has been reported.

The correlation of sebum and acne was explored across the spectrum of antiacne activity combining data from the various drug classes. Further, an attempt was made to model the relationship of sebum reduction with improvement in acne.

Methods

A Medline search was conducted to identify studies in which sebum excretion was measured in patients with acne with and without acne treatment. Key words included sebum, sebum excretion, sebaceous gland, sebumeter, sebutape, acne lesions, inflammatory acne, acne grade and acne severity.

No treatment

Data were collected from several studies that reported sebum excretion rates in patients with varying degrees of acne who were not receiving treatment. Of the six studies that were included, four used a gravimetric method and two used a Sebumeter to determine the sebum excretion rate (SER). Sebum production was determined as the weight of sebum measured per area of skin per unit time. Four of the studies used a subjective investigator rating scale for acne severity and two classified individuals as either with or without acne.

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A tratment of infantile acne

Posted on December 12, 2011 by Bergen

Infantile acne is a rare occurrence. It Is more common in boys and predominately occurs on the cheeks in infants between the ages of 1 and 16 months. Clinically, the lesions range from comedones to inflammatory papulopustules to cysts. Successful therapies include topical tretinoin, benzoyi peroxide and topical and oral erythromycin. For more serious cases, oral isotretinoin (Accutane) has been reported to successfully treat recalcitrant infantile cystic acne. We describe two additional patients with infantile cystic acne treated successfully with oral isotretinoin.The dose of isotretinoin used ranged from 0.2 mg/kg/day to 1.5 mg/kg/day. The treatment duration varied from 5 to 14 months. Careful monthly monitoring is recommended because of the many side effects reported with isotretinoin. Practical tips for the administration of oral isotretinoin in infants are reviewed.

Infiinlile acne is often misdiagnosed because of its rare occurrence. Boys are more commonly affected, with ihe central cheeks being the most common localion. It typically begins after 3 months of age and resolves by age 4 or 5. generally without treatment. In infants requiting ireatnient. this usually consists of topical betizoyl peroxide, topical tretinoin, or topical or oral erythromycin. Infantile acne may be severe enough to lead to persistent nodules, cysts, and scarring. In severe cases, hormonal evaluation may be necessary lo rule out an underlying endocrinopathy and hyperandrogenism.

Oral isotretinoin has been used with success to treat resistant occurrences of infantile acne causing severe scarring and cosmetic sequelae (5-H). We report two young girls with severe nodulocystic acne treated successfully with oral isotretinoin.

Case Reports

Patient 1

A healthy 6-month-old girl presented with an acneifonn facial eruption consisting of several Infantile Acne 1 hundred open and closed comedones and a few inllammatory papules and small cysts. The comedonal component had been present since the age of I month and had been treated unsuccessfully with Neosporin and 1% hydrocortisone cream. The patient was prescribed oral erythromycin suspension 2OOmg/5 ml. 2 ml three times a day. She was also given tretinoin (Retin A Micro) gel 0.1% to be applied every other night and benzoyl peroxide 4% cream every morning. No improvement was noted after 9 months of conservative therapy. On follow-up she continued to worsen despite treatment, requiring repeated incision and drainage of several purulent, infected facial abscesses. General physical examination did not lind any overt signs of hypcrandrogenism, specifically because she was at Tanner stage 1 with no clitoromegaly or breast tissue and absent signs of secondary sexual characteristics. On cutaneous examination, she had severe papules, pustules, nodules and cysts with scarring. The patieni was sent for an endocrine work-up and was found to have nomial levels of free and total testosterone, androstenedione, sex honiione binding globulin and dehydroepiandrosterone sulfate (DHEAS).

Al 14 months of age she was started on oral isotretinoin at 0.2 mg/kg/day and was slowly increased to 1.5 mg/kg/day. She remained on isotretinoin for a totalof 14 months and received a total cumulative dose of 315 nig/kg. She had no major side effects, was monitored monthly, with a complete blood count, triglycerides.cholesterol, and liver function tests. Her triglycerides ranged from 117 to 2S6 mg/dl during treatment, while all other parameters remained nonnal. Her acne improvedgradually with this regimen. At age 5 she continues to have some comedones and infiammatory papules but is controlled on topical tretinoin.

Patient 2

A healthy 7-month-old girl presented to dermatology with an acneifomi eruption on her Infantile Acne 2 face. Her mother staled that she had erythematous papules since birth and had been tried on 1% hydrocortisone and 12% lactic acid lotion without relief. On her first visit she was noted to have open and closed comedones and inflammatory papules with yellow crusts. She had no signs of androgen excess or precocious puberty. She was prescribed tretinoin gel 0.1%. benzoyl peroxide wash4%, and cephelexin 125 mg/5 ml, I teaspoon three times a day for 2 weeks with no improvement. The patient continued on the topical tretinoin gel and was started onbenzoyl peroxide/erythromycin gel. Despite continuation of this regimen for 2 months, she progressed to have a nodulocytic component. Her endocrine work-up hadnormal findings. She was placed on erythromycin EES 200 mg/kg. 4 ml twice a day for I montb and continued tretinoin gel and benzoyl peroxide/erythromycin gelwithout improvement.

At 13 months of age she was begun on oral isotretinoin. She weighed 21 pounds and was placed on 10 mg every other day. She was monitored monthly for 5 months and continued on the same dose of oral isotretinoin without any major side effects. Her laboratory mnnitoring was all within normal limits. She had considerable improvement in her acneiform eruption, and the isotretinoin was discontinued after a 5-month course with a total cumulative dose of 90 mg/kg.

Acne is generally thought to be a disease of adolescence, affecting 90% of teenagers. However, acne is seen in neonates, infants, and small children. Acne rieonatorum is defined as acne present at birth or occurring during the lirsl four weeks of life. It has been esliniated that 20% of newboms can be affected. Most of these occurrences consist of mild, inflammatory, facial lesions that run a selflimited course. Boys are more likely to be affected, and the cheeks are the most prominently involved area.

The most widely accepled cause of acne neonatorum is hyperactive sebaceous glands stimulated by neonatal androgens. The differential diagnosis consists ofmiliaria, transienl neonatal pustular melanosis, erythema toxicum neonatomm, neonatal sebaceous ghuid hyperpiasia, cephalic pustulosis, acneform drug eruptions, and infections caused by viruses, bacteria, or fungus.

Some confusion exists as to vv-hether neonatal acne truly exists or if the term neonatal cephalic pustulosis is a more accurate description. Neonatal acne has beendeiined as inllanimatory papules and pustules scattered over the cheeks without comedones. Many studies and reports have claimed that neonatal acne is an  inflammatory response to Fityrosporiim species, it is probable, however, that some of what is termed neonatal acne is an early presentation of comedonal acne (as inpatient 1) and not a response to Maiassczia. More studies are needed to define the clinical characteri.stics and pathogenesis of both neonatal cephalic pustuiosis andneonatal acne.

Infantile acne is much less common and is defined as acne with an onset occurring from 1 to 16 months of age. It is also more common in boys and the cheeks arethe most predominant area affected. Clinically, inflammatory papules, pustules, and comedones are typically seen. In severe cases, cysts can occur, and may lead tosubsequent scarring.

Lisunily, both acne neonatorum and infantile acne arc miki and have a self-limited course. If treatment is needed, topical benzoyl peroxide creams and washes,topical irelinoin. and topical and oral erythromycin are commonly used. Isotretinoin has been used with success in recalcitrant infantile cystic acne. Four published patients were treated successfully with doses of isotretinoin ranging from 0.5 to 2 mg/kg/day for 4 to 6 months. No major side effects were describetl.

Isotretinoin is FDA approved for children 12 years and older for the treatment of nodulocystic acne. The dosing regimen is typically 0.5-1.0 mg/kg/day for a period of 20 weeks. Some clinicians prefer to prescribe isotretinoin until a cumulative dose of 120 mg/kg is reached. Total doses lower then this have been associated with higher relapse rates. The ideal cumulative isotretinoin dose for infantile acne is not known. Our palients required 315 mg/kg and 90 mg/kg, respeciiveiy, for clearance of their acne.

Adverse skeletal effects reported with oral retinoids are numerous and include calcitication of ligaments and tendons, cortical hyperostosis, periosteal thickening,premature epiphyseal closure, and possible osteoporosis. These side effects are extremely rare at lypical doses used for acne treatment. On the other hand, longterm high dose (2-5 mg/kg/day) retinoid treatment of ichthyosis or xerodeniia pigmentosum may pose a greater risk for bony and mu.sculoskeletal changes.

Caution should be used when treating infantile acne so that the average dose of isotretinoin ranges between 0.5 iuid 1.5 mg/kg/day. The recommended dosing schedule for isotretinoin is iwice daily and with food or milk to enhance oral absorption. Administration in young children and infants is complicated by the fact thai this drug is not available in a liquid suspension, and is highly light and oxygen labile. Isotretinoin is available in 10, 20, and 40 mg soft gelatin capsules. In order to administer dosages inthe 0.3-2 mg/kg/day range, it may be necessary to split capsules in half. Unfortunately, isotrelinoin is extremely sensitive to light and oxygen and will degrade shortly after exposure.

Roche Pharmaceuticals recommends piercing Accutane capsules with a large bore needle and squeezing the contenis of the capsule into soft food like cottage cheese,ice cream, pudding, oatmeal, or butter. This leads to drug wastage and concern over stability ofthe drug alter exposure to light and oxygen. The soft gelatin capsuleis filled wiih a mixture of an unpalatable, oily inactive vehicle and active drug. We found this method of delivery inadequate because of the taste of the oily vehicle (even when concealed in food), concerns over the amount of drug versus vehicle delivered as a result of incomplete evacuation of the capsule, and drug instability followingexposure to light and oxygen.

An alternative method of drug delivery involves freezing the isotretinoin capsules to a solid consistency. This allows one to cut the capsule in half or in quarters to deliver the desired dose. The capsule can then be concealed in a palatable food such as a candy biir. This method prevents wasting of the drug, tninimizes exposure ofthe active ingredient to lighl and oxygen atid masks the poor taste of the vehicle.

Our two young patients further demonstrate that oral isotretinoin can be used safely and is quite effeclive in infants with severe nodulocystic acne that is unresponsive to conventional therapies.

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Accutane for acne drug treatment

Posted on December 11, 2011 by Bergen

Considered the biggest breakthrough in acne drug treatment over the last 20 years, Accutane is the only drug that has the potential to clear severe acne permanently after one course of treatment. One course, which is typically five months, results in prolonged remission of acne in up to 85 percent of patients. A member of a class of drugs known as retinoids, Accutane is highly effective. But it doesn’t work for everyone, and some patients need more than one course of treatment.

No other acne medicine works as well for severe acne. Patients generally have to keep using other medications because they only suppress acne temporarily. But as powerful as Accutane can be in improving patients’ lives, its adverse effects can be just as powerful. The drug is known to cause miscarriage and severe birth defects. Patients taking Accutane may develop potentially serious problems affecting a number of organs, including the liver, intestines, eyes, ears, and skeletal system. And some patients taking Accutane have developed serious psychiatric problems, including depression. More rarely, patients have developed suicidal behavior and killed themselves.

Because it is a high-risk drug, Accutane should be reserved for cases of “severe recalcitrant nodular acne,” according to the product’s labeling. This type of acne is resistant to standard acne treatment, including oral antibiotics, and is characterized by many nodules or cysts–inflammatory lesions filled with pus and lodged deep within the skin. These lesions can cause pain, permanent scarring, and negative psychological effects.

FDA approved Accutane in 1982, and since then, about 5 million people in the United States and 12 million worldwide have been treated with it, according to its manufacturer, Hoffmann-La Roche of Nutley, N.J. The number of patients taking the drug has increased, and half are females, most of whom are in their childbearing years (age 15-44). Because of concern about the drug’s risks, FDA continues to evaluate Accutane and work with the manufacturer to maximize safe use of the drug.

Warning about Pregnancy Risks

When FDA approved Accutane, the drug was known to be teratogenic–able to cause birth defects. It was designated as Category X, meaning that it must be avoided under all circumstances during pregnancy. Nursing mothers also should not use Accutane.Though not every fetus exposed to Accutane becomes deformed, the risk of birth defects among pregnant women is extremely high. These defects include hydrocephaly (enlargement of the fluid-filled spaces of the brain) and microcephaly (small head), heart defects, facial deformities such as cleft lip and missing ears, and mental retardation.

Reports in the literature suggest that about 25 to 35 percent of babies will suffer a malformation after exposure, and that doesn’t account for other defects, such as learning disabilities, that aren’t detectable at birth. Miscarriages and premature births have also been reported.

Possible Psychiatric Link

Many patients say they feel better about themselves after receiving successful treatment for acne. Evelyn Germanakos, of Los Angeles, Calif., struggled with acne as an adult, and says she felt like her old self after Accutane cleared up lumpy blemishes in 1997. “I had gotten to the point where I didn’t even want to go outside or be with people, let alone look in the mirror,” she says. But while Accutane may help lift psychosocial distress such as embarrassment, evidence suggests that it may actually cause serious psychiatric disorders in some people.

The relationship between Accutane and depression remains unproven, but some patients have reported that their depression subsided when they stopped the medication and came back when they resumed taking it. And some who have reported problems with depression while taking Accutane had no previous psychiatric history. FDA considers the number of reports of serious depression associated with Accutane high compared to other drugs in its database.

From 1982 to May 2000, FDA received reports of 37 U.S. Accutane patients who committed suicide, 24 while on the drug and 13 after stopping the drug. In addition to suicides, FDA received reports of 110 U.S. Accutane users hospitalized for depression, suicidal ideation, and suicide attempt during the same time period. As of May 2000, FDA had received reports of 284 Accutane users with non-hospitalized depression.Several factors make it hard to definitively link depression with Accutane. Depression is a common problem, and some patients may be suffering from it before starting Accutane therapy. Additionally, some patients who reported depression with Accutane had previous courses of the drug without depression. Even so, it is recommended that doctors act as if Accutane could have psychiatric effects until there is more information, says FDA’s Wilkin.

More common side effects of Accutane include lip inflammation and drying of the skin and mucous membranes.

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Isotretinoin side effects

Posted on December 11, 2011 by Bergen

The United States has ramped up efforts to mitigate the risk of birth defects associated with isotretinoin (Accutane) by requiring physicians and patients to register before they can prescribe or take the drug.
The response in Canada has been markedly less stringent, despite recommendations last year from a federal government expert advisory committee.
Isotretinoin, used to treat recalcitrant nodular acne, is known to have serious side effects, including birth defects, severe depression and, potentially, vascular incidents.
On Mar. 1, the US Food and Drug Administration (FDA) made iPLEDGE, its risk management program aimed at preventing use of the drug during pregnancy, compulsory (www.ipledge-progam.com). To obtain the drug, patients must register with iPLEDGE, complete an informed consent form and obtain counseling about the risks.Women of childbearing age must take 2 pregnancy tests and be on 2 forms of birth control or abstain from sex. Physicians must also register with iPLEDGE prior to prescribing isotretinoin. In Canada, an estimated 224 600 prescriptions for isotretinoin were filled in the past year, according to IMS Health (retail value of $32 million). The manufacturer reports an average of 3.6 pregnancy exposures per year between 1996 and 2003. Between January 1983 and December 2004, Health Canada identified only 3 “fetal disorders” as “possibly due to Accutane exposure.”
Health Canada recently stated that although FDA information suggests a “signficant rate” of pregnancy exposures “Health Canada’s pharmacovigilance program… has shown no evidenc e  of   a   compa r abl e   s i tua t ion  in Canada.” (CMAJ 2005;172:15).
However, the Motherisk Program at the Toronto Hospital for Sick Children receives an average of 10 to 20 pregnancy exposure reports annually. Not all cases are reported, says Motherisk Director Dr. Gideon Koren, because Health Canada doesn’t have a comprehensive monitoring system. Health Canada discontinued the development of Mothernet, which would have captured such cases, several years ago.
“Unfortunately pregnant women are not a priority for Health Canada,” says Koren.
Health Canada requires that women taking isotretinoin give written informe dconsent, receive education about the teratogenicity of the drug, and agree to use 2 contraceptive methods while on the drug. Similar measures in the US were ruled by the FDA to be insufficient to protect fetuses.
Rather than an iPLEDGE-type registry, Motherisk suggests a mandatory Web-based training program and certification of physicians as a condition for prescribing isotretinoin. A similar program exists for methadone.
In May 2005, Health Canada’s Scientific Advisory Panel on isotretinoin unanimously rejecting the idea of an i-PLEDGE type registry for Canada, but otherwise its recommendations were strikingly similar to those measures being taken in the US, including introducing an expanded physicians’ checklist, a consent form, a toll-free information number, a web site, an education program for family doctors and pharmacists, and pregnancy testing.
Dr. Jack Toole, chair of the panel says “There is absolutely no question that pregnancy exposure on isotretinoin must be prevented and that we must do all that we possibly can to do that.”
The panel’s recommendations have not  be en  a c t ed on.  He a l th Canada spokesperson, Christopher Williams, says the government expects to convene a working group by September to “analyze the best way of putting them into effect. However, it is unlikely that any implementation will take place in 2006.”
In April, Health Canada released another advisory about the drug, asking doctors to report any cases of myocardial infarction, cerebrovascular and thromboembolic disorders suspected of being associated with isotretinoin (CMAJ 2006;174:1211). Since 1983 there have been 29 reported incidents of vascular disorders. Williams said that “no causal link between this type of side effect and the drug has been established.”
The drug ranks in the top 10 of the US FDA’s database of drugs associated with reports of depression and suicide attempts. In Canada, 25% of adverse responses reported since isotretinoin was introduced relate to psychiatric events. A warning of the possible link was issued in 2001.
Although it is intended as a drug of last resort for extreme cases of acne, isotretinoin is increasingly being used for milder cases, as well as for psoriasis rosacea and other conditions. — Margot Andresen, Gatineau, Quebec US abortion bans: South Dakota banned abortion in February, and 11 other states are poised to consider similar action.
“People are afraid here,” Dr. Marivin Buehner told the St. Louis Post-Dispatch. Buehner’s Rapid City office was picketed after he spoke on TV against the ban.“The whole environment of intimidation that is the legacy of the anti-abortion movement has a stronghold here in South Dakota. That’s how the ban got through the Legislature without a challenge from the South Dakota Medical Association.” The law is slated to come into effect July 1, but Planned Parenthood has vowed to block it through a federal lawsuit. Opponents of the law are also collecting signatures calling for a plebiscite on the ban in November. Similar laws are being considered by governments in Alabama, Georgia, Indiana, Kentucky, Ohio, Mississippi, Missouri, Rhode Island, South Carolina, Tennessee and We s t  Virginia. In related news, theGuttmacher Institute, a not-for-profit corporation for reproductive research, policy analysis and public education, reports that 33 states have made it more difficult or more expensive for poor women and teenagers to obtain contraceptives and related medical services.

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AAccutane to treat severe acne

Posted on December 11, 2011 by Bergen

Accutane (Isotretinoin) is a prescription oral medication approved by the Food and Drug Administration (FDA) to treat severe, recalcitrant nodular acne. It is also a known human teratogen that can cause multiple major malformations. Embryopathy associated with the mother’s exposure to isotretinoin during the first trimester of pregnancy includes craniofacial, cardiac, thymic, and central nervous system malformations. In response to FDA recommendations, the manufacturer began a pregnancy-prevention program in 1988 that included educational materials for physicians and patients and offered women reimbursement for contraceptive counseling by a physician. The pregnancy-prevention program coordinators asked reproductive-aged women being treated with isotretinoin to enroll voluntarily in the Boston University Accutane Survey (BUAS). The total number of reproductive-aged women taking isotretinoin in the United States is unknown; however, 454,273 women enrolled in the BUAS from 1989 to October 1999. BUAS has estimated that 38%-40% of reproductive-aged women taking isotretinoin chose to enroll in the survey (BUAS, unpublished data, 1999). Although isotretinoin is contraindicated in pregnancy and has a package label warning users to avoid pregnancy while taking it, exposed pregnancies occur. Approximately 900 pregnancies occurred among BUAS enrollees during 1989-1998 (BUAS, unpublished data, 1999). Roche Laboratories began direct-to-consumer print advertisements in 1996, added television and radio advertisements to selected cities in 1997, and expanded the campaign to the entire United States in 1998.

During March 1999, CDC interviewed women who had had recent isotretinoin-exposed pregnancies. The objective of the study was to draw attention to the continued occurrence of isotretinoin-exposed pregnancies 11 years after the inception of the PPP and to learn more about why these exposed pregnancies happened. California was selected as the study site because of its large population and the availability of referrals from the California Teratogen Information Service and Clinical Research Center (CTIS). This report summarizes the results of the study, which suggest that some isotretinoin-exposed pregnancies can be prevented. The case reports describe the experiences of three study respondents.

Summary of Interviews

Eligible women resided in California, used isotretinoin while pregnant, had their last menstrual period after January 1, 1997, and reported their pregnancy to the BUAS or to the CTIS. Twenty-three women met these criteria; 14 consented to be interviewed. The nine eligible women who did not respond or declined to participate were enrolled in the BUAS. Two of the 14 respondents had pregnancies reported to both the BUAS and the CTIS. Nine respondents were interviewed in person and five by telephone. The interview included questions on indications for and use of isotretinoin, contraceptive history, pregnancy history, procedures used in the initial prescription of isotretinoin, and recall of advertisements for prescription acne medication.

The 14 respondents were aged 15-39 years at the time of the exposed pregnancy (median age: 25.5 years); 10 (71%) were aged 21-39 years. Eight (57%) reported having at least one instance of sexual intercourse without using contraception at the time of the exposed pregnancy; 13 (93%) did not use two forms of contraception as recommended in the pregnancy-prevention program procedures. Ten had pregnancy tests before starting isotretinoin; however, three whose pregnancy test results were negative were pregnant when they began taking isotretinoin. Two respondents reported that their exposed pregnancies occurred while using leftover isotretinoin from earlier prescriptions, and one received and filled the isotretinoin prescription in Mexico.

Seven (50%) respondents reported viewing an advertisement for prescription acne treatment before taking isotretinoin. Four of the seven reported that the advertisement contributed to their decision to seek acne treatment and to ask their physician about isotretinoin. Four live-born infants with no major malformations resulted from these 14 pregnancies. One live-born infant had major malformations. The other pregnancy outcomes were four spontaneous abortions and five induced abortions. No information was available on the presence of malformations in the aborted fetuses.

Although all 14 respondents knew that isotretinoin should not be used during pregnancy, none reported seeing all components of the pregnancy-prevention program, and four had not seen any component other than the information available on the isotretinoin packet. None of the women reported being referred for contraceptive counseling or being told that they would not have to pay for the counseling.

Case Reports

Case 1. After taking isotretinoin for I month, a 25-year-old woman was notified by her dermatologist that her pregnancy test was positive, despite negative results on a pregnancy test before beginning isotretinoin. She had been using two forms of contraception but did not wait for menstruation before starting isotretinoin therapy as recommended by the PPP. Her infant was born with multiple anomalies including complex congenital heart disease consisting of double outlet right ventricle with dextrocardia and aortic atresia, hydrocephalus, and facial dysmorphism. After extensive medical treatment and cardiac surgery, the infant died at age 9 weeks.

Case 2. A 35-year-old woman who had been taking isotretinoin for approximately 6 months tested positive on a home pregnancy test. She was 12 weeks pregnant when she discontinued isotretinoin use. Since 1989, she had had three isotretinoin-exposed pregnancies; only the third pregnancy resulted in a live birth. The first course of isotretinoin was prescribed by a dermatologist; she obtained the other prescriptions from a friend who was a health-care worker. The outcome of the third exposed pregnancy was a full-term infant with no apparent malformations.

Case 3. A 35-year-old woman who was using an intrauterine device tested positive on a home pregnancy test. She had been taking isotretinoin for approximately 3 years before this pregnancy and had taken two doses of isotretinoin since her last menstrual period. She did not have acne. She took isotretinoin for approximately 1 week each month before menstruation to prevent oily skin. She was a health-care provider and received the prescription from a colleague who did not ask about or recommend contraception. She elected to terminate the pregnancy because of the exposure. Reported by: CD Chambers, MPH, KL Jones, MD, Dept of Pediatrics, Div of Dysmorphology and Teratology, Univ of California, San Diego, La Jolla; EJ Lammer, MD, Children’s Hospital, Oakland, California. CM Van Bennekom, MPH, AA Mitchell, MD, Slone Epidemiology Unit, Boston Univ, Boston, Massachusetts. Birth Defects and Pediatric Genetics Br, Div of Birth Defects, Child Development, and Disability and Health (proposed), National Center for Environmental Health, CDC.

Editorial Note: These cases identified challenges to preventing isotretinoin-exposed pregnancies; 13 of the 14 respondents did not use two forms of effective contraception, and eight had used no contraception when the exposed pregnancy occurred. The study also illustrated problems with acquiring a prescription outside a clinical setting, using leftover medication, purchasing the medication outside the United States, failing to perform pregnancy testing before therapy, and failing to wait 3 days after menstruation before beginning treatment.

Although the 14 respondents did not represent all women taking isotretinoin or all women with isotretinoin-exposed pregnancies, they were similar to others enrolled in the BUAS (e.g., the average age of the respondents was similar to the women enrolled in the BUAS [median: 26 years]); however, respondents included more women aged >30 years than in previous studies of isotretinoin-exposed pregnancies. Seventy-one percent had some type of pregnancy test before starting isotretinoin, which is similar to the 60% reported for all women enrolled in the BUAS. The highest percentage of pregnancies in the BUAS occurred among women using oral contraceptives; nevertheless, more than half the 14 respondents reported at least one instance of sexual intercourse when contraception was not used, indicating that failure to use contraception may be as important as contraceptive failure.

The warning label on isotretinoin packaging states that it should not be used by women of childbearing potential unless the patient meets such conditions as having “severe, disfiguring nodular acne that is recalcitrant to standard therapies”. At least half of the 14 respondents reported that they did not meet this definition. Recent reports suggest that some dermatologists view isotretinoin as an effective method for treating conditions other than cystic acne. More widespread use of isotretinoin may result in more isotretinoin-exposed pregnancies.

The findings in this study are subject to at least two limitations. First, these cases were a convenience sample of 14 women from California, and they may not represent all isotretinoin-exposed pregnancies. Second, the findings cannot be generalized to evaluate the overall effectiveness of the pregnancy-prevention program or other prevention programs.Despite the increased demand that may be generated by Accutane advertising, physicians should limit use of the drug in women of childbearing potential to those who meet the criteria on the package insert. When isotretinoin treatment is necessary, physicians should provide precautions, contraindications, and all pregnancy-prevention program elements; care should be taken by women and their physicians to ensure that contraceptive recommendations are understood and followed. In addition, women of childbearing potential should not use isotretinoin unless they are under the care of a physician familiar with isotretinoin use.

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Acne vulgaris and Accutane (Isotretinoin)

Posted on December 11, 2011 by Bergen

Acne vulgaris is common and can lead to long-lasting physical and emotional scars. Accutane (Isotretinoin) is effective for severe forms of the disease. Prescriptions ofisotretinoin have more than doubled in the last decade, and apart from Accutane’s well-publicized teratogenic effects, the drug’s potential psychiatric adverse effectshave caused concern.
The drug ranks in the top 10 of the US Food and Drug Administration’s (FDA’s) database of drugs associated with reports of depression and suicide attempts. In Canada, of the 222 cases of adverse events reported to Health Canada since the drug was first marketed in 1983, 56 (25%) involved psychiatric adverse events, including depression and suicidal ideation (Ryan Baker, Health Canada: personal communication, Nov. 22, 2002). A warning of a possible link with depression and suicide was issued in 2001. Recently, the FDA warned that people taking Accutane may also experience aggressive and violent behaviours.
The drug: Isotretinoin, a vitamin A derivative, is approved for patients with severe acne not responding to standard therapy, including systemic antibiotic therapy. The drug may act through retinoic acid receptors to cause a variety of effects, including a reversal of androgenic effects on sebaceous glands. Common adverse effects include inflammation of the lips (cheilitis), dry and brittle skin, hair loss and ophthalmologic effects (e.g., dry eyes, corneal opacifications and night blindness).
The drug is highly teratogenic, and sexually active women should use at least 2 reliable forms of contraception beginning a month before starting the drug and continuing for a month after stopping it. Myalgias, headache, fatigue and bone changes (hyperostosis) occasionally occur, and cases in which patients experience persistent headaches, nausea, vomiting or blurred vision should be investigated for pseudotumour cerebri. Hypertriglyceridemia is common, and patients also need to be monitoredfor hepatotoxic effects.
Isotretinoin’s link to psychiatric adverse events is controversial. Depressive disorders are common in the population, and up to 5.6% of patients with mild to moderate acne may have preexisting suicidal ideations. Furthermore, improvement of a person’s acne can often reduce symptoms of anxiety and depression, and in one study, involving 20 895 acne patients registered in databases in Saskatchewan and the United Kingdom, isotretinoin users were no more likely than those taking antibiotics for their condition to have depression or commit suicide.
Most acne can be effectively managed with topical agents, oral antibiotic therapy or oral contraceptive therapy. Isotretinoin should be reserved for more severe, recalcitrant, scarring acne. It is not yet clear whether previous psychiatric symptoms increase a patient’s risk of psychiatric adverse events while taking isotretinoin, but the patient’s mental state should be regularly monitored before and during treatment.
Patients should be warned that, while taking the drug, they may experience symptoms of depression, aggression or suicidal ideation and that they should report these to their physician immediately if they occur. Although discontinuation of the drug may reverse some psychiatric adverse effects, further psychiatric intervention is sometimes required.

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Isotretinoin for treatment of severe acne

Posted on December 11, 2011 by Bergen

The debate about the safety of isotretinoin (Accutane) parallels the debate about the safety of antidepressant drugs — huge benefits versus what some think are serious risks.

A chemical derivative of vitamin A (retinol), isotretinoin is a wonder drug for the treatment of severe acne. It cuts the output of the sebaceous glands, source of the oils that contribute to acne lesions. It changes the cells that line hair follicles, so they become less likely to block the follicle openings and permit a lesion to develop. And it reduces inflammation (redness and pain). For those with the most severe form of acne, about 90% improve substantially during the 20-week course of treatment. If acne returns, it is usually mild enough to be treated by more conservative methods.

Isotretinoin has some serious side effects. It dries the skin and nasal passages, and it can cause peeling skin, thinning hair, and brittle nails. Joint pain, high blood lipid levels, weakened night vision, headache, and liver inflammation can also occur. And the drug is so dangerous to a fetus that, to receive a prescription, women must understand the dangers, have two negative pregnancy tests, and use two forms of effective contraception to avoid becoming pregnant.

Then there is the issue of neuropsychiatric effects. High doses of vitamin A can cause headache, depression, fatigue, irritability, aggression, even personality change and psychosis — a syndrome called hypervitaminosis A. So it’s no surprise that isotretinoin is suspected of causing intolerable or deadly psychiatric effects.

Clinical trials have been reassuring. For example, this year, researchers in St. Louis reported a study in which they treated 101 teens and preteens for acne over four months, half of them with isotretinoin. They found no difference in depressive symptoms between the two groups, and no suicidal thoughts in patients who took psotretinoin.

Suicide, thankfully, is rare, so it would not be expected to occur in a study this small. In large surveys, though, it is also hard to find increased depression or suicide risk. One review found that suicide reports to the FDA following isotretinoin use are one-fifth the number expected by looking at rates in the general population. Other surveys of thousands of patients have found no increase in depression, suicide, or antidepressant drug use in patients taking isotretinoin. But critics point out that depression and suicide are probably under-reported and that some of the authors of these reports had links to the drug’s manufacturer, Hoffmann-La Roche.

Individual case reports do link isotretinoin to depression—especially patients who say they became depressed for the first time after taking isotretinoin, recovered when they stopped, and became depressed again after restarting. Also, when compared to other drugs, isotretinoin has a relatively high frequency of FDA case reports of depression and suicide.
And now there is scientific evidence that isotretinoin acts on the brain. Using brain scans, researchers at Emory University showed this year that the drug reduces activity in the orbitofrontal cortex; so does depression. Patients whose orbitofrontal activity slowed the most were not more likely to become depressed, but they were more likely to have headaches. And another recent report suggests a connection between headache and depressive symptoms in isotretinoin users.

This new evidence and the troubling case reports, should be enough to keep dermatologists and their patients alert. Patients taking isotretinoin should let their physicians know about any depressive symptoms, self-destructive thoughts, or other mood changes, and maybe about headaches as well. But depressed persons need  not avoid isotretinoin. Severe acne itself often lowers mood and damages self-esteem, so effective treatment can improve emotional health. As long as they stay informed and attentive, patients and physicians should be able to negotiate this medical treatment safely.

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Acne scarring

Posted on October 28, 2011 by Bergen

Acne scarring Cystic acne treatment is important as it has the tendency of persisting beyond the age of 20 and often leads to permanent scarring. The cysts or nodules are actually the blockages of the oil glands, which burst open forming pus in the surrounding tissue.

Acne is a common skin affliction in the US. 85% of the youth between the ages of 12 and 24 seem to develop acne.

Factors influencing Acne

The growth of bacteria on the skin, over production of keratin and sebum and the inflammatory response are the factors which influence acne. The male hormone Androgen also affects the production of sebum and influences acne.

Cystic Acne

Cystic acne is the large and irritating bumps with pustules often hidden deep under the surface of the skin. They are more painful than the normal zits and are caused due to the shifts of hormones, which results in the over-production of oil in your skin glands.Eventually, the gland swells and bursts with the sebum hardening into a clump which is too large for escaping through skin pores.

Dermatological Treatments

The process of getting rid of cystic acne requires a lot of time, as the infection waste is not discharged. Most cases of acne are successfully cured with the help of the dermatologist.
A dermatologist should be consulted if you find the acne products available in the markets to be ineffective or if your acne is causing you to be distressed. If you suffer from acne with big and painful bumps or if you are worried by the scars caused by acne, then you need to see a dermatologist immediately. The medication prescribed by the dermatologist is often a product named Accutane. Accutane sometimes have side-effects that can cause depression in patients.

Isotretinoin, prescribed by the dermatologists is helpful but pregnant women should avoid consuming isotretinoin as it can cause birth defects for the baby to be born.
Another treatment is by injecting each cyst with dilute cortisone solution, which provide fast relief to the inflammations.

You can also opt for acne surgery. It speeds the clearance of acne. The surgery should only be conducted under the guidance of a dermatologist.

If you have severe form of acne covering your body and face, you need treatments immediately. Any ignorance on your part could leave you scarred forever.

Blue and Red Light Therapy

This phototherapy is a new, approved and natural method for treating acne. Blue light destroys acne bacteria and red lights quicken the skin’s healing process.

Prevention of Acne

Cures are possible in case of cystic acne; however prevention is the best method. A daily multivitamin gives you the essential nutrients your body requires to metabolize oil as it is necessary to counter the hormone shifts by targeting your oil glands.

Acne patients should cleanse their skin twice daily and must not attempt to squeeze or touch the affected parts.

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Acne drug Accutane

Posted on October 28, 2011 by Bergen

Acne drug Accutane An Accutane Recall has occurred in 2009 for the popular acne drug Accutane in response to the million greenback lawsuits that resulted from the in depth aspect effects caused by this drug. Manufacturer Hoffmann-La Roche mainly for the treatment of nodular or cystic acne developed a brand name for isotretinoin called Accutane. Also found below the name Clarais, Amnesteem, Roaccutane and Sotret, Accutane may be a retinoid drug that’s a Vitamin A synthetic form.

The United States Food and Drug Administration approved this medication within the year 1982. Off-label uses additionally included gentle to moderate acne treatments.Accutane could be a vastly common medication that has a lot of than the usual share of public scrutiny and an in depth dangerous side effects history. This can be mainly due to the myriad aspect effects that include suicidal tendencies, irritable bowel syndrome, blurred vision and skin sensitivity.As a result of of this, Accutane manufacturer Roche prescription drugs pulled the drug out from the USA market and eleven other countries in the year 2009. The reason for the Accutane recall was that the manufacturer failed to clearly state the side effects of the drug on the label, and therefore was discontinued. Before the Accutane recall, a lot of than thirteen million patients were prescribed with Accutane. For that reason, the FDA or the Food and Drug Administration of the US was severely criticized for not doing their share of warnings concerning the side effects of Accutane.

It occasionally happens that several drugs have complications. A few of them happen to be somewhat unimportant and some can be extremely dangerous. Accutane is amongst the prescription drugs that brings about dangerous side effects. It is actually applied to start treating acne pimples. In contrast to other related prescription drugs that use antibacterial substances, Accutane triggers epidermis alters. It leads to human skin to get a smaller amount oil, and thus it causes treatment as well as decrease of acne. Whilst Accutane is really beneficial and also powerful it can certainly bring about quite a few serious side-effects. People that take this substance should be aware of this particular point. Additionally, if you use Accutane erroneously it can harm you.

Well-known dangerous side effects of Accutane include itchy epidermis, hair loss, and also other disorders. These negative effects tend to be moderate and will be conveniently taken care of. After you get acquainted with substantial complications of Accutane you’re going to be shocked. For example, expectant women should in no case make use of Accutane because it might cause delivery defects. Some other negative effects consist of conditions of the urinary and also intestinal tract systems, joint pain and others. Hence, you need to be capable to deal with health problems whenever taking Accutane, although this medication is basically effective in treating pimples.

 

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