The latest verdict against Accutane

Last month, a New Jersey jury awarded a Utah woman named Kamie Kendall $10.5 million for damage done by the acne drug Accutane, one of a series of recent successful lawsuits against the drug’s maker, Hoffman-LaRoche, Inc. The court found that Hoffman-LaRoche did not adequately warn consumers of the drug’s risks and side effects. A lawyer on the winning side states:

It’s a very dangerous drug – it causes birth defects, it causes psychosis, it causes IBD. When you’ve got a drug like this you shouldn’t mince words at all, which is at the heart of the case. No question that’s been our point, and in three cases, we’ve won $2.5 million, then just over $7 million, then now almost $11 million. That’s closing in on $20 million in three verdicts.

You can read more on these cases at Drug Injury Watch.

Accutane is the brand name for oral isotretinoin, a drug generally used for the treatment of severe acne. Claravis is a leading generic brand of the drug. does not list Accutane or oral isotretinoin in our drug search engine database.

In terms of efficacy, the drugs are basically identical, but also come with unavoidable — and sometimes severe — side effects. Unless your acne has failed to respond to other treatments (such as antibiotics), most doctors recommend exhausting your other options first.

The most dangerous potential side effect is for unborn children. To ensure that female patients don’t start on isotretinoin while pregnant (or while having the potential to become pregnant), a Web-based program called iPLEDGE was launched in 2006. Mandated by the FDA, the site requires dermatologists to register their patients before prescribing the drug, and pharmacists are required to check the site before dispensing.

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Part of the purpose of the FDA program has been to discourage patients from buying isotretinoin online, because the FDA believes there is an increased chance of women ordering the drug without knowing the pregnancy risks. (As users of our site know, the online pharmacies within the database all require a doctor’s prescription. Canadian pharmacies, however, are not part of the iPLEDGE system.)

So what’s the lesson in all this?

We can’t depend on drug marketers to tell us of their drugs’ risks. Unfortunately, too often we can’t depend on the FDA, either. So protect yourself with knowledge before filling a doctor’s prescription for Accutane or any other drug.

About Cary Byrd

eDrugSearch founder, Cary Byrd, has been called an “e-health innovator” by MarketIntellNow, interviewed by top pharmaceutical industry journalists, invited to Matthew Holt’s Health 2.0 Conference and a Consumer Report's health summit, and highlighted on numerous health blogs. - Search. Compare. Save.

0 thoughts on “The latest verdict against Accutane

  • This is a powerful drug – when my husband took it shortly after it was FDA cleared in the early 1980s it curled his otherwise straight hair. Now 30 years later it has just been prescribed for our son because all other things tried have failed. I understand how powerful and dangerous it is, but the costs associated with monthly MD visits and blood tests – not to mention the cost of the drug itself – are outrageous, even for a family with insurance. If there is a way to get it cheaper I am all for it.

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