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.