Suicidal Actions Linked With Epilepsy Drugs

Suicidal Actions Linked With Epilepsy Drugs

Suicidal actions linked with epilepsy drugs

Last Updated: 2008-06-12 15:24:53 -0400 (Reuters Health)

By Lisa Richwine

WASHINGTON (Reuters) - Epilepsy drugs are associated with a higher
risk of suicidal thoughts and behavior, U.S. drug reviewers said in an
analysis that was released on Wednesday and mirrored earlier findings.

"The effect appears consistent among the group of 11 drugs" that were
reviewed, according to a summary from statistical reviewers at the
Food and Drug Administration. There were about two more cases per
every 1,000 patients given the drugs instead of a placebo, the FDA
staff said in a review dated May 23.

The findings are similar to data released by the FDA in January,
agency spokeswoman Sandy Walsh said.

Epilepsy drugs include Pfizer Inc's Lyrica, GlaxoSmithKline's
Lamictal, Johnson & Johnson's Topamax, and Abbott Laboratories Inc's
Depakote.

Agency officials have said they are working with drugmakers to add
information about the suicidal behavior risk to the prescribing
instructions for the drugs.

A panel of outside advisers to the FDA is scheduled to discuss the
issue on July 10.

Epilepsy is marked by seizures stemming from abnormal electrical
activity in the brain, causing involuntary movement or behavior. Drug
treatment is given to prevent seizures.

Some of the drugs are big sellers. Lamictal sales were $2.2 billion in
2007, while Lyrica sales were $1.8 billion, according to the
companies.

The FDA staff reviewed 199 trials involving about 44,000 patients who
were given an epilepsy drug or a placebo. Some of the medicines also
are approved for depression, migraines and other conditions.

Four patients given drug treatment committed suicide, compared with
zero who got a placebo, the FDA staff review said. Overall, about 0.4
percent of drug-treated patients reported suicidal thoughts or
actions, compared with 0.2 percent of placebo patients.

In January, the FDA said all patients taking epilepsy drugs should be
closely watched for behavior changes that could indicate suicidal
thoughts or behavior or depression.

Kara Russell, spokeswoman at Johnson & Johnson's Ortho-McNeil
Neurologics Inc unit that makes Topamax, said the company was
reviewing the agency's report but added that language about possible
suicide "has existed in our labeling since the beginning."

UCB SA spokeswoman Andrea Levin said prescribing instructions for its
epilepsy drug, Keppra, already included data on suicidal behavior
reported in clinical trials, and the company would comply if the FDA
asked for changes.

A Glaxo analysis of Lamictal found a trend for suicidal thoughts and
behavior that was similar to the FDA analysis, company spokeswoman
Holly Russell said. Glaxo is working with regulators to update the
drug label, she said.

Abbott spokeswoman Laureen Cassidy said the company would work with
the FDA to implement any changes requested for the class of drugs.

Representatives of other makers of the drugs could not immediately be
reached or had no immediate comment.

Copyright © 2008 Reuters Limited

URL: http :// www .reutershealth,com /archive/2008/06/12/eline/links/20080612elin017.html