A New Jersey man won a $25 million verdict after he alleged that Roche (RHHBY.PK)'s acne drug Accutane gave him an inflamatory bowel disorder that required the removal of his colon.
The verdict raises a question: If Accutane (generic name isotretinoin) has such dramatic side effects, why is it still on the market? The question is not trivial. Taking Accutane can kill you. Or, if you get pregnant, it can kill your baby. Literally. That graphic on the right is not me being sarcastic. It's the actual graphic used on the top of the FDA's official patient information sheet for this drug.
Here is an incomplete list of its side effects:
- miscarriages (patients must be on birth control when using it)
- birth defects (facial and nervous system deformities, mental retardation)
- increased internal skull pressure
- bone mineral density
- aggressive or violent behaviors
- acute pancreatitis
- "unknown" cardiovascular consequences
- bowel disease
- excessive bone growth
- night blindness and sight loss
Now, before my readers fire up their emails, I know this drug is not a cure for the minor zits accompanying adolescence. It's a last resort for people who experience acne as an intractable, socially debilitating skin condition. These pictures of "Kelli," who kept a photo blog of her Accutane experience, demonstrate that kind of medical misery that acne can bring in extreme cases. Her blog ends with her getting married -- aw! -- and looking lovely so only a real grinch would want this drug banned, right?
The problem is that an underclass of less-than-great generic companies is now churning out Accutane, much of it in the Third World where medical safety is less well regulated than it is in the U.S. Ranbaxy, (RANB.BO) the disastrous Indian generics maker that was named BNET's Worst Drug Company of 2009, had two lots of generic Accutane recalled last year. And that was just in the U.S.
There are alternatives to Accutane. And acne is not a fatal disease. The FDA should look again at whether this drug' benefits are worth the risks.