Andrea Ross has been trying to quit smoking since New Year's day.
She turned to Chantix, the smoking-cessation tablets. Ross says they really help but she’s had such vivid dreams that she now takes a quarter of a sleeping pill so she has undisturbed sleep. “Unbelievably vivid dreams otherwise,” she tells IB News.
The Food and Drug Administration believes it and has issued a public health advisory about Pfizer’s Chantix. The drug likely is tied to serious psychiatric symptoms including thoughts of suicide, depression and behavior changes.
The FDA has received nearly 500 reports of suicidal behavior and 39 reports of suicides, mostly in the U.S. among users of Chantix. Several suicide cases were in patients with no history of psychiatric problems.
Now, the FDA said, "it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms."
"We've become increasingly concerned as we've seen there are a number of compelling cases that truly look as if they are the result of exposure to the drug," Bob Rappaport, a director in FDA's unit that oversees Chantix, told reporters on a conference call Friday.
Pfizer, the world’ largest drug maker maintains there is no evidence of a casual link and some symptoms may be the result of nicotine withdrawl.
Still, Pfizer upgraded the warning label last month to more promenintly display the post-marketing reports of adverse effects. A stronger label was first added last November after an FDA assessment of the side effects consumers have been reporting.
The FDA said it was working with Pfizer to develop a guide that highlights the warning for patients and doctors. Patients are urged to tell their doctor about any history of psychiatric illness before starting Chantix as it could cause a recurrence. Patients are encouraged to report any mood changes to their doctor. They can also appear after you stop taking the drug.
Besides vivid dreams you are also warned that you may experience an inability to drive or operate heavy machinery while on Chantix.
The drug is said to be effective. Sales during the fourth quarter were $280 million up from $68 million during the same time period a year prior.
The tabled Chantix is taken up to twice a day for 12 weeks to help adults stop smoking. Unlike a patch that replaces nicotine, Chantix works on the brain centers affected by nicotine and recreates some of the pleasing effects of nicotine.
About four million people in the U.S. have used the drug since its approval in May 2006. The FDA continues monitoring the drug calling it an “evolving issue. #