14 DAY TRIAL // The Food and Drug Administration announced on Tuesday that it planned to ask pharmaceutical companies to label epilepsy drugs with a clear warning, following studies that had shown that they increased the risk of patients experiencing suicidal thoughts, after being on the prescriptions for a period of time. A user-friendly booklet also had to be included in the package, to explain people all the risks they were subjecting themselves to by ingesting the drugs.
In an FDA-backed study, some 11 types of anti-epileptic drugs were analyzed in 199 clinical trials, where patients either received a dose of one of these drugs, or a placebo pill. The results showed clearly that people who took the real pills were twice as inclined to have suicidal thoughts and behavior than the others, as reported by the participants themselves. These finds prompted the FDA to take immediate action on the matter, so as to prevent the spreading of the phenomenon among the general public.
"The risk of suicidal thoughts or behavior was generally consistent among the eleven drugs analyzed and was observed in patients who were treated for epilepsy, psychiatric disorders, and other conditions," said an FDA communicate.
Already, most of the major producers, including Pfizer Inc., GlaxoSmithKline PLC and Johnson & Johnson, announced that they were already in compliance with the new measure, or that they would implement it shortly. A spokeswoman for Glaxo said that the company would also review the finds that prompted the FDA action, but that it would be in compliance with them nonetheless.
Worldwide, some 50 million people suffer from this disease, and some 30 percent of them do not have control over their seizures even on medication. This causes sufferers a tremendous amount of inconvenience and decreases the quality of their life substantially. Though sometimes the disease disappears after a certain age or period of time, the forms that affect a person permanently are very difficult to cope with.