Face Value - Accutane Side Effects

Accutane Side Effects and Dangers

If Accutane were a dietary supplement, you wouldn’t even know its name. It would have been banned decades ago.

But after 25 years, not only is this acne medication still on the market, it’s still doing harm. And you won’t believe the absurd hoops the FDA is jumping through to keep this junk on the shelf.

What’s the hold up?

I won’t burden you will all the details about a new Accutane study, published last month in the American Journal of Gastroenterology. But here are the highlights from the University of Chicago investigation of 85 cases of inflammatory bowel disease (IBD) that were believed to be related to Accutane use (all cases were reported to the FDA between 1997 and 2002):

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

That’s pretty bad. Now here’s the part that’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.”

What!? Accutane has been on the market since the first Reagan administration! The Accutane web site has acknowledged for some time that the drug “has been associated with inflammatory bowel disease in patients without a prior history of intestinal disorders.” And we’re only NOW getting the first review of this link?

I expect that’s unnerving news to the hundreds of Accutane users who may have developed IBD, which the Mayo clinic describes as “chronic inflammation of the intestinal tractpainful and debilitating and sometimes may lead to life-threatening complications.”

Pledging fidelity

In an e-Alert I sent you more than two years ago (“Private Parts” 3/10/04), 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 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!

In 2001, Roche (the manufacturer of Accutane) began a program that encouraged all females who took Accutane to use contraceptives and take regular pregnancy tests. When the rate of birth defects linked to Accutane stayed about the same, an FDA panel recommended that the guidelines become mandatory.

In March 2006, the FDA implemented iPLEDGE, a program that requires all Accutane users who are females of childbearing age to be registered with the agency. Once registered, female patients must receive counseling about risks involved with the drug, take regular pregnancy tests, and promise to use two forms of birth control. Pharmacists who prescribe Accutane are also required to register in iPLEDGE.

You have to wonder; why in the world is the FDA going to these lengths to keep such a dangerous drug on the market? Especially considering an announcement from the agency in July 2005, warning that all Accutane users “should be observed closely for symptoms of depression or suicidal thoughts.”

First line of defense

If I had a severe case of acne, I’d have to wonder: IBD? Birth defects? Depression? Suicidal thoughts? Vision impairment? There has to be a better way.

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, cereal or potatoes are consumed, digestion increases glucose levels, insulin production rises and triggers hormones that secrete sebum in pores of the skin, and the sebum attracts acne-promoting bacteria.

According to many dermatologists, a wide body of anecdotal evidence supports the theory that a low-carbohydrate diet may be the best first defense against acne for patients of all ages. Side effects of such a diet include a lower risk of developing type 2 diabetes.

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