By Susan Heavey
WASHINGTON (Reuters) – U.S. health officials on Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong “black box” warnings on their anti-smoking drugs to highlight the risk of serious mental health problems, including suicidal thoughts.
The warnings, which must be added to Pfizer’s Chantix and Glaxo’s Zyban, follow more than five thousand reports of depression, hostility and other behavioral changes, the Food and Drug Administration said.
“We don’t want to scare people off from trying to use the medication to stop smoking. We just want them carefully monitored,” said Dr. Curt Rosebraugh, who oversees the FDA office that reviews smoking-cessation drugs.
Additionally, the FDA strengthened its caution about possible accidents and serious injuries with Chantix linked to loss of consciousness, mental confusion, dizziness and muscle spasms. But it stopped short of adding it to the boxed warning as some health advocates had urged.
The warnings will limit Pfizer’s ability to run some types of advertisements for Chantix, which the world’s largest drugmaker had been counting on to help revive profits.
Instead, Pfizer has seen the drug’s sales plunge over the last year amid safety concerns. Global first-quarter sales of Chantix fell 36 percent to $177 million.
Some analysts said investors have already factored in the continuing safety concerns.
But some consumer advocates said the FDA’s Chantix warning was not strong enough for a drug that has been banned for use by pilots.
the agency received 4,762 reports of serious psychiatric events since Chantix’s 2006 approval.
98 reports of suicide and 188 reports of attempted suicide with Chantix