According to the notice posted on the iPledge website, name brand Accutane is no longer available for sale in the United States. Roche Laboratories, Inc. has decided to discontinue this isotretinoin acne drug. As of September 2010, the last lot of this medication reached its expiration date. Roche claims that the decision to stop distributing the drug is not because of its potentially harmful side effects (such as irritable bowel syndrome). So, this is not actually a product recall. However it is unlikely that Roche will reintroduce the drug in the U.S. market in its current form. What does this discontinuation of the original version of Accutane mean for patients who still need treatment for adult acne that doesn’t respond to other commonly prescribed therapies?
Buying “Black Market” Accutane Is Hazardous
First, it’s important to note that many websites still claim to sell Accutane. It is possible that some pharmaceutical suppliers do have batches of expired pills still on hand. Or, these sites may be selling generic medications that are not really “name brand” Accutane. Either way, this medication has a history of serious health risks and requires careful monitoring during treatment. Buying this drug without a prescription and using it outside the supervision of a certified dermatologist or other experienced physician is very dangerous. Women who take this type of medication without being properly educated about the risks are exposing pregnancies with tragic consequences that could have been avoided.
Other Acne Drugs Are Still Legally Available
Patients who are desperate for an effective treatment for their cystic acne do not have to turn to bootlegged versions of Accutane for relief of adult acne. There are other drug companies that make their own version of this oral isotretinoin medication. All of these capsules contain the same active ingredient as Accutane and are used to treat severe cystic/nodular adult acne. These are marketed under the brand names Amnesteem, and Claravis. They carry a similar risk of side effects and complications as Accutane.
Patient Education and Compliance a Must for Safety
Registration with the iPledge program is required for all patients taking these drugs. Monthly confirmation of responsible birth control usage is also a must for women who have any possibility of becoming pregnant during treatment. Most female patients are instructed to use two birth control methods starting one month before taking their first isotretinoin dose, consistently throughout the treatment phase, and for one month afterward. Each birth control method must be approved by a physician. This is because isotretinoin may interfere with the effectiveness of some hormonal medications such as the progestin only “mini-pill”.
For more information on isotretinoin (Accutane), click here.