Accutane

Accutane (isotretinoin capsules) is a medication that has been prescribed to treat severe cystic acne vulgaris since it was approved by the U.S. Food & Drug Administration (FDA) in 1982. According to Accutane?s manufacturer, the Swiss pharmaceutical company Hoffmann-La Roche, more than five million people in the United States and twelve million people worldwide have been treated with the drug since its introduction.

In February 2002, Roche?s patents for isotretinoin expired, allowing other companies to sell less expensive generic versions of the drug. Today, generic forms of Accutane are sold under the brand names Accure (manufactured by Alphapharm), Aknenormin (Hermal), Amnesteem (Mylan), Ciscutan (Pelpharma), Claravis (Barr), Isohexal (Hexal), Isotroin (Cipla), Oratan (Douglas Pharmaceuticals), and Sotret (Ranbaxy).

Since Accutane?s beginning, however, it has been linked to an assortment of dangerous side-effects such as birth defects, psychiatric disorders and suicide, and most recently, inflammatory bowel disease (IBD).

How does Accutane work?

Accutane is a retinoic acid derivative- in other words, it is derived from vitamin A, which is a natural substance found in small quantities in the body. Accutane?s exact mechanism of action is still unknown, but the drug shrinks the sebaceous glands found in the skin which secrete sebum (an oily substance composed of fat and dead fat-producing cells). The drug is also believed to stabilize keratinization- the shedding of skin cells. Both an over-production of sebum and excess of keratinized cells can cause the pores of the skin to become blocked. When a pore is blocked, bacteria called propionbacteria that are naturally found on the skin and thrive on sebum, become too abundant for the size of the pore. The bacteria then secrete chemicals that break down the wall of the pore, spilling bacteria onto the skin, forming what is generally known as an acne lesion.

Severe cases of acne surpass the stage of common acne (acne vulgaris), and often exhibit deep red cysts and nodes when the sebaceous gland becomes blocked. Accutane?s ability to shrink the sebaceous glands (thus minimizing propionbacteria) and stabilize keratinization of epidermal cells makes the skin much less likely to break out, even in severe cases of acne.

Accutane is a powerful medication and is intended to be prescribed only after other acne treatments have failed. Acne treatment typically begins with topical medications (e.g. over the counter benzoyl peroxide treatments), followed or combined with oral antibiotics. In severe cases of acne that do not respond to such traditional treatments, accutane may be prescribed, but only under very regulated and monitored conditions.

What is iPLEDGE?

In a hope to prevent some of the dangerous side-effects associated by Accutane, in August 2005 the FDA mandated a system to monitor and restrict the dispensing of Accutane. Since the system went into effect on March 1, 2006, dematologists have been required to register their Accutane patients on the FDA?s iPLEDGE website before prescribing the drug. A physician is prohibited from prescribing more than a 30-day supply of the drug and restricted from writing a new prescription for at least 30 days. If the patient is a female, she must pledge to use two forms of birth control pill while taking Accutane. Pharmacies must follow similar time-limited prescription rules under the system. Additionally, before a pharmacist dispenses Accutane to the patient, the pharmacist is required to check the website to confirm that the patient has been registered on the iPLEDGE system. The pharmacist must interview a female patient to confirm that she is using two forms of birth-control before the pharmacist dispenses the drug to the patient. The patient may then receive a 30-day supply of Accutane only if an iPLEDGE identification card to the pharmacist and the patient is picking up the medication within seven days from the date the prescription was written.

What are Accutane's side-effects?

During its development, Roche learned that Accutane can cause serious birth defects if a woman uses the drug while she is pregnant. Since its approval, the FDA has required explicit warnings on Accutane packaging relaying to physicians and users of the drug as to the dangers of Accutane causing birth defects and that the drug should not be used by women who are pregnant or are likely to become pregnant. The birth defect warnings have been made more prominent in recent years, as is evident by the FDA?s mandatory iPLEDGE program.

Since 1985, Roche has listed depression as a side-effect of Accutane. In the past decade, much controversy and publicity has developed over Accutane?s capability of causing severe psychiatric disorders, including violent and aggressive behavior, as well as suicide.

More recently, Accutane has been linked to increased levels of cholesterol and digestive disorders, particularly inflammatory bowel disease (IBD.)

Have you used Accutane?

If you or a relative has experienced severe side-effects during use of Accutane and you would like to speak to a professional to discuss your rights, please fill out the short form below and a member of Seeger Weiss?s experienced legal staff will contact you. Initial consultations are free of charge and do not create a legal relationship. Seeger Weiss LLP has offices located in both New York and New Jersey and its attorneys are available to practice throughout the country.