Is Accutane (Isotretinoin) Worth Its Risks?

12/5/2010
Shapiro, Lewis & Appleton
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Is Accutane (Isotretinoin) Worth Its Risks?

If you or a family member takes Accutane, Amnesteem, Clavaris or Sotret to treat severe acne , you and they need to decide whether it's safe to keep using products containing isotretinoin. Since the U.S. Food and Drug Administration gave Roche the OK to start marketing Accutane in 1982, patients and their parents have reported these problems:

Birth defects that can lead to miscarriages and lifelong disability
Depression and other mental and behavioral changes
Digestive problems ranging from diarrhea to bloating and weight gain
Suicide

Evidence shows that severe acne itself can raise a person's risk for depression and suicide. If, as many dermatologists, mental health professionals and other health experts accept, Accutane and the other FDA-approved isotretinoin products constitute a separate and additional risk for severe problems for patients, then should the medication be prescribed?

Decisions about medication use need to be made between patients, doctors, pharmacists and the parents of younger children. But it seems almost unnecessary to state that dangerous drugs -- medications whose risks for most patients outweigh their benefits -- should not be on the market.

A final consensus on whether Accutane its isotretinoin equivalents are dangerous drug products has not been reached. Still, the known side effects of the acne drug concerned enough federal regulators, companies and health care professionals to convince them to create the iPLEDGE program so patients could receive isotretinoin only from specially trained prescribers and pharmacists. Patients also had to agree to submit to extensive safety counseling and to follow strict pregnancy prevention guidelines.

Earlier in 2010, a former Accutane user received a $25.1 million judgment against Roche after he developed inflammatory bowel disease, or IBD. That drugmaker is currently facing hundreds of Accutane lawsuits from families shattered by suicide, failed pregnancies and mental health disease. Roche stopped selling Accutane in the summer of 2009, but the other forms of isotretinoin remain available.

So Accutane and other forms of isotretinoin do seem to pose significant dangers. You need to educate yourself and decide whether those risks are too much to bear.

EJL

Category: Dangerous Drugs/Medical Product Recalls

Labels: Accutane acne birth defects Cooper depression drugs failure to warn IBD inflammatory bowel disease injury isotretinoin lawyer medications Roche safety side effects suicide

About the Editors: Shapiro, Lewis & Appleton is a law firm whose attorneys focus on injury and accident law and have experience handling dangerous drugs cases and prescription drug errors. Check out our dangerous drug information page to learn more about side effects and recalls. We serve every area of North Carolina, including the Outer Banks, Nags Head and the western mountains, as well as all the cities and counties in between. In South Carolina, we cover the state from Myrtle Beach and Charleston to Orangeburg, Columbia, Florence, Rock Hill, Darlington, Aiken, Anderson, Greenville and Spartanburg.

Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008 and the firm has been named a North Carolina "Best Law Firm" for personal injury law since 2010 by U.S. News & World Report. In addition, Rick and Jim have been listed in the National Million Dollar Advocates Forum since 2009 and our firm has the highest rating of AV from national lawyer ranking organization Martindale-Hubbell. That means we have a reputation for demonstrating preeminent legal skill.

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