February 02, 2008	Saturday	Muharram 23, 1429

WASHINGTON: People taking epilepsy drugs may face higher risks of suicidal thoughts and actions and their behaviour should be closely watched, US health officials have warned.

The medicines include Pfizer Inc’s Neurontin and Lyrica, GlaxoSmithKline Plc’s Lamictal, Abbott LaboratoriesInc’s Depakote and Johnson & Johnson’s Topamax.

The US Food and Drug Administration said it analysed 199 studies involving 44,000 patients who took one of the prescription drugs. Some of the medicines also are approved for depression, migraines and other conditions.

The agency found patients treated with one of the drugs were about twice as likely to report suicidal thoughts or behaviour compared to those who received a placebo.

Overall, about 0.4 per cent of patients given the drugs reported suicidal thoughts or actions, compared with 0.2 per cent of placebo patients, the FDA said. The risks were higher for patients being treated for epilepsy rather than another ailment.

The FDA estimated there were two more cases per every 1,000 patients given the drugs instead of a placebo.

“All patients who are currently taking or starting on any antiepileptic drug should be closely monitored for notable changes in behaviour that could indicate the emergence or worsening of suicidal thoughts or behaviour or depression,” an FDA alert said.

Four people who were taking one of the epilepsy drugs committed suicide, while none of the placebo patients did.

The increased risk was seen as early as one week after starting the medicines and continued through 24 weeks, the FDA said. Risks after 24 weeks could not be assessed because most trials did not extend beyond that.

The agency said it expected the risk was shared by all anti-epileptic drugs and that changes to prescribing instructions would be made broadly throughout the class. The FDA also said it planned to discuss the data with a panel of outside advisers.

About 2.7 million Americans have epilepsy, according the US Centres for Disease Control and Prevention. Worldwide, about 50 million people have epilepsy at any given time, according to the World Health Organisation.

The condition is marked by seizures stemming from abnormal electrical activity in the brain, causing involuntary movement or behaviour.

Sales of anti-epilepsy drugs topped $13 billion in 2006, according to data from health information company IMS Health.

Some of the drugs are sold in generic forms.

DEPRESSION LINK

Abbott spokeswoman Laureen Cassidy said the FDA alert was “important information for caregivers to monitor patients, but this shouldn’t change how epilepsy is treated”.

A Glaxo spokeswoman said the company would work with the FDA to update the label. A Pfizer spokesman said the company is committed to “a thoughtful, objective review of the scientific evidence”.

A Johnson &Johnson spokeswoman said the company will work with the FDA and noted that Topamax already has a warning about the issue.

New York University neurologist Jacqueline French, speaking on behalf of the American Academy of Neurology, said it is known that some epilepsy drugs are linked with unusual behaviour and that epilepsy itself is associated with depression. But she said patients should not stop taking them.

“The worst possible thing that could happen is that people read this and decide against taking seizure medications. Seizures are absolutely life threatening if you don’t treat them,” said French.

—Reuters