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Maker of Accutane Changes Labeling

Feb 28, 2002 | HealthScoutNews

The maker of Accutane, the acne medication linked to numerous reports of depression and suicide, has revised the controversial drug's labeling.

Since the number of people who decided to consult an Accutane lawyer in order to study their legal options concerning the Accutane side effects is increasing, as well as the number of reported drug’s adverse reactions, Hoffman-La Roche Inc. and the U.S. Food and Drug Administration (news - web sites) (FDA) have agreed on several changes to the drug's package insert, the most notable being a brochure for prescribers dealing with the potential psychiatric side effects of Accutane.

However, experts on drug safety and suicide say no medical studies have drawn a direct link between Accutane and depression or suicidal thoughts.

"There are case reports," says Alan L. Berman, executive director of the American Association of Suicidology. "What is being done is cautionary, but it is not based on any true research that demonstrates that Accutane indeed is causative of suicide."

In a supplemental new drug application dated Jan. 30, Hoffman-La Roche proposed changes in the "Warnings" section of the drug's product insert that took effect this month.

Under "Psychiatric Disorders," the section lists the possibility of depression, psychosis, suicidal thoughts, suicidal attempts or even suicide, but it notes the link is not clear and stopping use of the drug may not be enough to avoid the problem. The section will now refer those who prescribe the drug to a brochure called Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane (isotretinoin).

The brochure's stated goal is to help prescribers determine whether a patient taking Accutane may require a referral to a psychiatrist, noting that "in extreme cases, it can mean the difference between life and death."

The brochure lists behavioral warning signs for depression and suicide in children and adolescents, and cautions that a link between Accutane and depression should be considered even if other stresses exist in a patient's life.

Depression is a major risk factor for suicidal behavior, and the brochure warns that patients or the parents of a minor should be aware of the signs of depression. If they appear, it says, patients or parents should be told to stop Accutane treatment and seek immediate medical help.

The Boston Collaborative Drug Surveillance Program, co-directed by epidemiologist Susan S. Jick, published an October 2000 study that found no link between Accutane and an increased risk of depression, suicide or other psychiatric disorders.

Jick, an associate professor of epidemiology and biostatistics at Boston University, is familiar with the latest labeling changes.

"The FDA … has clearly been influenced by the anecdotal reporting of people who have taken Accutane who have had various suicidal and depressive events," she says.

Jick notes depression and suicidal behaviors are not uncommon among adolescents, and she points out teens who receive Accutane are taking the drug because they have severe acne. Their skin condition, she says, may put them at greater risk for depression and suicidal thoughts, but there is no clear evidence of this link.

She adds the current medical literature has not determined whether the depression or suicide rates among teens taking Accutane is higher than those not using the drug.

Government records seem to tell a different story.

FDA data show that 110 Accutane users have attempted suicide and 37 have killed themselves while on the medication. On the market since 1982, the drug's link to severe birth defects has already led to government restrictions on its prescription.

Depression has been listed as a possible side effect of taking Accutane since 1986. In addition, the drug's labeling was updated in 1998 to note that some people taking the medication had contemplated or even committed suicide. Patients under 18 must now have a parent or legal guardian's written consent to take the drug.

A congressional investigation has looked into Accutane's effects on mental health, and further congressional hearings are set for this spring.

On Feb. 20, just before the American Academy of Dermatologists' annual convention in New Orleans, Hoffman-La Roche scientists presented the results of several Accutane studies at a closed-door consensus conference attended by senior members of the academy. Following the presentations, the academy members discussed a forthcoming policy statement on Accutane, but they declined to say what the statement might cover, or when it might be released.

Hoffman-La Roche spokeswoman Gail R. Safian says, "We welcome the discussion, and we're confident that the findings will be consistent with previous observations that there's no cause-and-effect relationship between Accutane and psychiatric events."

Hoffman-La Roche is currently printing the redesigned labels and new brochures, which Safian says will be mailed in the next four to six weeks to all U.S. dermatologists and any physician who has prescribed Accutane in the past two years.

Used as a drug of last resort to treat severe, scarring acne, Accutane works by drying up the oil glands responsible for acne. However, it's also known to affect the metabolism and the body's gastrointestinal and neurological systems.

More than 30,000 Americans commit suicide every year, and the suicide rate among those aged 15 to 24 has increased 200 percent in the last 50 years.

What To Do

If someone you know shows signs of suicidal behavior, such as depression, talking about suicide or dying, social withdrawal, drastic behavior changes or previous suicide attempts, offer help. Remember: Talking with someone about suicide doesn't cause him or her to become suicidal.

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