Link Feared Between Acne Drug Accutane, Depression

One of the country’s most popular prescription acne drugs may be related to a small number of episodes of depression and suicide among teenagers who have used it, a pharmaceutical company warned Wednesday.

Hoffmann-La Roche, the Accutane manufacturer based in Nutley, N.J., urged physicians to be aware that some young patients who have used the drug--which is recommended only for the most severe cases of acne--may suffer from depression or even attempt to kill themselves.

The company said that it would add new and stronger warnings to the product’s label, which already advises of the possibility of depression as a side effect.

But the company stressed that “there is no definitive causal relationship at this time” between these reports and the drug and it emphasized that teenagers “are at particular risk for depression.”

The company also pointed out that the same hormones that contribute to depression also contribute to the formation of acne.

“There is no causality that we know of between this small number of reports and something in the drug,” said Kellie McLaughlin, a company spokeswoman.

But she said Hoffman-La Roche issued the warning “because we want doctors to be aware of the possibility and to watch their patients--and if they see signs or symptoms of depression, to refer them to specialists and take the appropriate steps. We are asking for closer supervision by physicians.”

Eight million people have used the drug worldwide since it was introduced in 1982, including more than 2 million in the United States. The majority of patients are teenagers and young adults, who are especially vulnerable to acne.

The possible relationship was discovered through the Food and Drug Administration’s “MedWatch” system, which requires health professionals to report adverse effects that may be connected to the use of licensed drugs in the marketplace.

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“We have received about 12 case reports since 1989 that patients who had been suffering from depression said it stopped when they stopped taking the drug and that it came back when they resumed taking it,” said Ivy Kupec, an FDA spokeswoman.

Kupec said there also were believed to have been about 12 suicides among those taking Accutane, although she emphasized that the information is preliminary and, at this time, “there is no direct link that anything in the drug caused them to do this.”

“Such problems could already be more common among the patient populations likely to be on the drug,” she added.

The drug is already closely monitored because it has been shown to cause birth defects. It is not recommended for pregnant women.

The American Academy of Dermatology estimates that virtually all teenagers will experience some form of acne, ranging from mild to serious, during adolescence.

Academy officials said there are no estimates on how many teens suffer from recalcitrant nodular acne, the most severe form and the type Accutane is recommended to treat.

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This form of the disease often fails to respond to other treatments and is characterized by numerous pimples and nodules or cysts that can appear on the face, chest and back.

Accutane has proved effective in treating this type of acne; several studies have shown that use of the drug cleared or almost cleared the acne in more than 75% of patients after a single course of therapy, which usually lasts about four months.

The dermatology academy issued a statement Wednesday calling depression a “common problem in adolescents with or without acne.” The statement added: “However, to our knowledge, there is no evidence in the [medical] literature that the rate of depression is higher among patients taking Accutane. There is also no evidence in the literature with regard to a higher rate of suicide among teens taking Accutane.”