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Controversial Acne Drug Could Get Popped (With More Regulation)

By Ori Twersky
WebMD Health News

Dec. 4, 2000 (Washington) -- Recent reports suggesting the popular acne drug Accutane (isotretinoin) may trigger depression and suicide have spurred a congressional hearing Tuesday to investigate whether tighter controls need to be placed over the drug. But experts are cautioning that, despite the drug's side effects, further restrictions on its use and distribution could, in effect, lead to the drug's withdrawal.

Accutane was approved in 1982 as a treatment for severe acne. It is the only drug proven to effectively control severe cystic acne, the most serious form of this skin disease.

The congressional hearing follows a claim by Rep. Bart Stupak (D-Mich.) that Accutane was responsible for his son's recent suicide. At a press conference, Stupak called upon the drug's maker, Roche, to conduct independent studies of Accutane's mood-altering effects. He also called for enhanced surveillance over the drug.

According to the FDA, Accutane has been associated with about 44 suicides since 1983. But the agency says there is not enough data to establish a definite link, although the drug does appear to have mood-altering effects.

Calling the suicides "spontaneous," Roche says they simply reflect "the multiple risk factors in the adolescents and young adults afflicted with the disfiguring disease." The company also notes that the drug's label already warns that Accutane has been associated with depression and suicide, although a clear link has yet to be established.

Still, some experts fear that Tuesday's hearing might lead to further restrictions because of Accutane's other well-known side effect: The drug is known to cause birth defects.

Birth defects occur in an estimated one of every four babies born to women who take Accutane while pregnant. But the number may be higher, some experts believe, since about 40% of the pregnancies that occur among women on Accutane end in a miscarriage.

As a result, the FDA has required the company to make a number of labeling changes since the drug's approval, to the point where few drugs are as explicitly labeled. But despite all the labeling changes, new patient information inserts, and "Dear Doctor" letters alerting doctors to these changes that the agency has required over the years, the absolute number of pregnancies among women on Accutane has remained largely unchanged.

At an FDA meeting in September, a panel of medical experts indicated that while the reported psychiatric events do not appear to be of major concern, the ongoing pregnancies are of particular concern considering that the use of Accutane has tripled since its approval. The panel commended Roche for its ongoing efforts to educate physicians and patients, but then recommended that a mandatory registration program be created to ensure that patients use the drug as directed. Roche wants a voluntary registration program.

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