Accutane is gone, but the danger remains

Still Crazy After All These Years

Without ceremony, another best selling, but very dangerous drug was finally taken off the market last month.

Roche executives finally pulled Accutane, their notorious acne drug.

According to Bloomberg News, juries have awarded more than $33 million in damages against the drug, and thousands of additional lawsuits are in the works. Roche has already pulled Accutane from the market in France, Germany, Spain and more than half-a-dozen other countries.

But here’s the wrinkle that could only exist in Big Pharma World: Roche is pulling the drug because surging sales of generic versions of Accutane have made it unprofitable.

So if you want Accutane, no problem. Only now it’s called Accure, Oratane, Isohexal, Amnesteem, Claravis, Sotret, and other brand names, all of which contain the active ingredient isotretinoin.

Still very popular, still very dangerous.

What was the hold up?

It’s a pretty familiar story: If isotretinoin were a dietary supplement it would have been banned years ago.

In 2006, University of Chicago researchers investigated 85 cases of inflammatory bowel disease (IBD) that were believed to be related to isotretinoin use (all cases were reported to the FDA between 1997 and 2002).

RESULTS:

• Isotretinoin was found to be the “probable cause” in 58 IBD cases
• Isotretinoin was found to be the “possible cause” in 23 cases
• Number of cases in which researchers found the association between isotretinoin and IBD to be “doubtful”: zero

But here’s what’s flabbergasting…

According to a Reuters Health report on this study, “numerous cases have surfaced linking the drug to IBD. Until now, a systematic review of the association had not been conducted.”

Nice. Accutane was on the market since the first Reagan administration, but we had to wait until 2006 to finally get a thorough review of the IBD link.

Chain of events

In an e-Alert I sent you a few years ago, I told you about some of the other adverse side effects of Accutane listed on the drug’s web site: vision and hearing impairment, psychosis and acute pancreatitis. But by far the most controversial side effect is birth defects.

According to the defunct Accutane web site, “There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time.”

No gray areas there!

And in 2005, the FDA issued a warning that all Accutane users “should be observed closely for symptoms of depression or suicidal thoughts.” Of course, all these warnings still apply to generic brands of isotretinoin.

Cystic acne and nodule acne – which Accutane is designed to address – are painful and often disfiguring conditions. But while desperate conditions sometimes call for desperate measures, there is a dietary modification that provides a safe first step for anyone who’s coping with acne of any degree.

Alternative medicine practitioners and nutritionists like Jonathan V. Wright, M.D., and Adelle Davis have known for years that wheat intake can prompt acne outbreaks. And recent studies confirm that acne thrives when the diet is rich in high glycemic foods.

Here’s the suspected chain of events: Bread, refined cereals or potatoes are consumed, glucose levels spike, insulin production rises and triggers hormones that secrete sebum in pores of the skin, and the sebum attracts acne-promoting bacteria.

Side effects of a low glycemic diet include possible weight loss and a lower risk of developing type 2 diabetes.

No need to observe closely for suicidal thoughts.

Sources:
“Roche Pulls Accutane Off Market After Jury Verdicts” Jef Feeley and Sophia Pearson, Bloomberg, 6/26/09, bloomberg.com
“Possible Association Between Isotretinoin and Inflammatory Bowel Disease” American Journal of Gastroenterology, Vol. 101, No. 7, July 2006, amjgastro.com
“Acne Med May Trigger Bowel Disease” Reuters Health, 8/15/06, reutershealth.com