30/08/2010

Epilepsy Drugs May Not Increase Risk Of Suicidal Actions Among Patients With The Disorder

Bloomberg News (8/5, Kay) reports, "Using epilepsy drugs doesn't increase the risk of suicidal actions among patients with the disorder, a study found, contradicting a safety warning issued by the US Food and Drug Administration." The observational study "looked at 10 UK-approved treatments, including Pfizer Inc.'s Lyrica [pregabalin]," and "compared the effects of the medicines in patients with epilepsy and those with mental-health conditions including depression, according to the report published today in the New England Journal of Medicine." The FDA in May 2009 "approved new warnings that suicidal behavior or thoughts were higher among patients who received antiepileptic drugs compared with those who had taken a placebo," but this study's lead author said, "Our results do not confirm the findings previously reported by the FDA."

WebMD (8/4, Boyles) added that "neurologist and epilepsy researcher Josemir W. Sander, MD, of the University College London, says the assessment of risk in different subtypes of patients is a major strength of the study." However, an "increase in suicide risk associated with treatment was found in patients with depression alone and in patients with an unknown diagnosis without epilepsy, depression, or bipolar disorder." In addition, researchers "were not able to assess risk associated with specific seizure medications." Reuters (8/5), Medscape (8/4) and HealthDay (8/4, Behen) also covered the story.

25/08/2010

Director of the FDA's neurology-products division, said patients who experience symptoms of aseptic meningitis "should consult their healthcare professional immediately." FDA Warns Of Aseptic Meningitis Associated With Anti-Seizure Drug Lamictal.

The AP (8/13) reports that FDA is "warning doctors and patients" that GlaxoSmithKline PLC's anti-seizure drug Lamictal (lamotrigine) "can cause rare inflammation of the brain and spinal cord." The agency "is working with the British drugmaker Glaxo to add new warnings and labeling information to the" drug. The FDA also said "it has received reports of 40 cases of aseptic meningitis between 1994, when Lamictal was approved, and last November," and 35 "patients needed to be hospitalized, the agency said in a statement. The symptoms usually emerged within the first month and a half of treatment".

The Wall Street Journal (8/13, Dooren) adds that the drug is used to treat seizures in children and bipolar disorder in adults. Russell Katz Reuters (8/13, Heavey) notes that FDA said the symptoms of aseptic meningitis are similar to bacterial meningitis and include stiff neck, chills, drowsiness, confusion, headaches and sensitivity to light.

MedPage Today (8/12, Gever) also reported, "Symptoms resolved in most cases after the drug was stopped. In 15 patients, restarting the drug led to a return of symptoms within one day, the FDA said." Lamictal "is sold in several forms: a conventional oral pill, an orally disintegrating tablet, and a chewable tablet. It also comes in an extended release pill." Medscape (8/12, Jeffrey), WebMD (8/12, Hendrick) and the UK's Press Association (8/13) also cover the story.