9/27/2000 – Further study on Accutane’s mental effects

Once again we ask how many children are being prescribed antidepressants due
to the effects of their acne medication?

Further study urged on Accutane, mental effects
Updated 9:07 PM ET September 19, 2000By Lisa Richwine

GAITHERSBURG, Md. (Reuters) – A federal advisory panel Tuesday recommended
further study to shed light on whether some psychiatric problems may be
linked to Roche Holding Ltd.’s prescription acne drug Accutane.

Patients and physicians also could benefit from new efforts to boost
awareness that Accutane may be linked to cases of depression, mood disorders
or suicide, panel members said. Some suggested a plain-English pamphlet
attached to Accutane packaging that would explain signs of depression or
other problems.

Since 1998, Accutane has come with a warning that users have reported
depression, suicidal thoughts or mood disorders. But the label notes that the
link is uncertain.

Neither the Food and Drug Administration nor Roche could provide evidence
settling the question of whether there is a certain connection. A large
number of patients taking Accutane are teenagers, a group already commonly
affected by depression.

The data “suggest an association with Accutane but do not allow a definitive
determination;” said Diane Wysowski of the FDA.

Accutane, made by Roche unit Hoffmann-La Roche Inc., has been sold in the
United States for nearly two decades and is widely known to cause birth
defects. On Monday, the advisory panel urged health officials to limit
prescriptions for Accutane in order to minimize pregnancies among women
treated with the drug.

The panel, a group of outside experts that advises the FDA, said evidence of
psychiatric side effects were much less certain and did not require such
extensive measures.

Further study might provide clues, particularly by providing signs of whether
certain Accutane patients are more at risk for psychiatric effects, panel
members said.

Also, a federally approved medication guide that gives consumer-friendly
information about depression could help patients recognize symptoms, panel
members said. The committee also suggested new efforts to advise doctors of
depression risks and urge them to tell patients about potential problems.

The FDA usually follows its panels’ advice.

Roche Vice President Russell Ellison said the company would meet with FDA
officials to discuss the panel suggestions. Regarding new research, Ellison
said Roche "will be discussing with FDA what we think is useful, and
what has the best chance of reducing uncertainty the most."

Roche also presented data on a new once-a-day formulation of Accutane that
can be taken with or without food. Directions for the current version of
Accutane, Roche’s second-best-selling product, are for twice-a-day with food.

Roche said the new formulation may be more convenient for patients. The FDA
is considering whether to approve the newer version, but the agency did not
ask the panel’s input on whether it should go to market. REUTERS

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