March 10, 2015
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON -- The U.S. Food and Drug Administration (FDA) announced Tuesday there are new risks to be considered for individuals using Pfizer Inc. ’s anti-smoking drug Chantix, if the medication is coupled with alcohol use.
The FDA issued a safety warning to be placed on Chantix prescriptions warning the use of the anti-smoking drug can change the way people react to alcohol. Additionally the FDA said in rare cases Chantix can also cause seizures.
“Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately,” the FDA said in a press release.
The FDA said they reviewed cases in the FDA Adverse Event Reporting System (FAERS) database describing patients who drank alcohol during treatment with Chantix and experienced adverse reactions.
“Some patients experienced decreased tolerance to alcohol, including increased drunkenness, unusual or aggressive behavior, or they had no memory of things that happened,” the FDA said.
When it came to reports of the medication causing seizures, the FAERS database included 64 cases of seizures in patients using Chantix. In 37 cases, patients had no prior history of seizure, and in 10 cases there were no contributing factors to the seizures other than varenicline use, pulmonary news site Helio reported.
Chantix, known chemically as varenicline, was approved by the FDA in 2006 for use as an anti-smoking medication. In clinical trials, use of Chantix increased the likelihood of people quitting smoking and not smoking for as long as one year.
In 2009 and 2011 the FDA also issued warnings about possible serious neuropsychiatric side effects with Chantix, including suicidal thoughts, hostility and agitation. Those warnings are highlighted on the Chantix label and surrounded by a black box, which is reserved for the most serious of warnings by the FDA. The warning label includes information about several studies that investigated the risk of neuropsychiatric side effects on mood, behavior, or thinking occurring with Chantix, including observational studies, as well as analyses that Pfizer conducted of clinical trial data, the FDA said.
Those studies did not show an increased risk of neuropsychiatric side effects with Chantix; however, the FDA said they “did not examine all types of neuropsychiatric side effects, and they had limitations that prevented us from drawing reliable conclusions.”
The FDA and Pfizer are conducting their own safety studies of the medication. Results are expected sometime later this year.
Chantix generated $647 million in revenue in 2014.
BioSpace Temperature Poll
Vertex Pharmaceuticals made news last week when it terminated leases on three properties in Cambridge, Mass, that freed up 313,000 square feet of space in the Genetown area. The company has spent a significant part of 2014 consolidating its operations on the South Boston waterfront, leasing 291,000 square feet of office space at West Kendall Street in Cambridge’s Kendall Square. So we wanted to ask the BioSpace community: Is Boston going to be getting more biotech leases anytime soon, or fewer tenants?
