WASHINGTON — Drugs used by millions of patients to control epileptic seizures must carry warnings about heightened risks of suicide, federal regulators said Tuesday.
The Food and Drug Administration announcement comes almost a year after the agency first said patients taking the drugs have a slightly higher risk for suicide than those taking dummy pills.
According to the new language, only about one in 500 patients faces an increased risk of suicidal thoughts and behavior while taking the drugs. The new warning emphasizes that the risks are about the same among all anti-seizure drugs.
The FDA advised patients to consult their doctor before making any changes to their treatment.
The new warnings apply to 21 medications, including blockbuster products like GlaxoSmithKline’s Lamictal, Johnson & Johnson’s Topamax and Pfizer’s Lyrica.
