Medication Guide Will Inform Accutane Users.
The guide will include information about reports of depression and suicide in users of the acne medication.
Dr. Jonca Bull told the House Committee on Government Reform that the agency has been working with Accutane manufacturer Roche to develop such a guide, which she described as a "plain language tool" used to convey the possible risks of a drug to patients.
Dr. Bull, a deputy director of one of the offices of drug evaluation at the FDA, also told the panel that a registry that would enroll every female patient prescribed Accutane could be in place by the spring.
These efforts are part of the FDA's plan to work with Roche to implement recommendations made last October by the FDA's dermatologic drugs advisory panel. At that meeting, the possible link between suicide, depression, and Accutane use was evaluated, as were the continued reports of accidental pregnancies among patients on the highly teratogenic drug, despite the current voluntary pregnancy prevention program.
Whether there is a causal association between Accutane and depression and suicide was not resolved at either the FDA meeting or the congressional hearing, but Roche is now planning a study with the FDA and the National Institutes of Health to investigate the association.
Between August 1982 and May 2000, 37 suicides in people taking Accutane were reported to the FDA. Of these cases, 24 committed suicide while on the drug and 13 committed suicide within a median of 2.5 months after stopping therapy. The median age of the patients was 17 years; most were male.
Warnings about mood changes were first added to the Accutane label in August 1986. A stronger warning about psychiatric events that included suicidal ideation, suicide attempts, and suicide was added to the labeling in April 1998 after reports of suicide.
Testifying at the congressional hearing last month were the fathers of two adolescents who committed suicide while on Accutane. Both said they had not been told by their child's dermatologist about the potential risk of depression or suicide related to Accutane use, even though they were prescribed Accutane after the 1998 warning had been added to the labeling.
Rep. Henry Waxman (D-Calif.), the ranking minority member of the committee, said he was troubled by the lack of information given to patients and families and about "how little we know about the link between Accutane and psychiatric disorders."
Dr. Douglas Jacobs, a psychiatrist at Harvard Medical School, Boston, who has reviewed and evaluated the suicide cases in the Accutane-treated patients for Roche, testified that there is no causal association between Accutane use and suicide, which he described as a "multifactorial event."
The suicide rate for people aged 15-19 years has increased over the past 25 years, and suicide is the third leading cause of death in this age group--"the population most likely to be treated with Accutane," he noted.
The suicides reported in Accutane users that he has reviewed "are no different" from other suicides, Dr. Jacobs told the panel.
Earlier this year, the 17-year-old son of Congressman Bart Stupak (D-Mich.) committed suicide while taking Accutane.
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|Comment:||Medication Guide Will Inform Accutane Users.|
|Publication:||Family Practice News|
|Article Type:||Brief Article|
|Date:||Jan 1, 2001|
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