FDA orders Pfizer and GlaxoSmithKline to Put Warning Labels on Stop Smoking Drugs

July 2, 2009

On Wednesday, the FDA ordered prescription makers Pfizer and GlaxoSmithKline to put warning boxes on their products Chantix (Pfizer) and Zyban (GlaxoSmithKline). The warning label is to detail specific side effects of the stop-smoking drugs. The FDA labeled these mental health side effects as changes in behavior, depressed mood, hostility, and suicidal thoughts.

Some assert that these side effects may come from the nicotine withdrawals because neither of the drugs contains nicotine.

Aside from the warning label on the boxes the FDA also wants more warnings in the information for both products, and urges anyone experiencing behavioral changes to contact their physician immediately.

According to the FDA, both manufacturers are pushing their drugs into clinical trials to test their products effects on patients that have psychiatric disorders.