July 6, 2015
By Alex Keown, BioSpace.com Breaking News Staff
VANCOUVER – Pfizer Inc. , its controversial smoking-cessation drug Champix and the company’s relationship with the British Columbian Liberal government have been loosely linked to the termination of two health care workers researching a government anti-smoking program, the CBC reported this morning.
The CBC reported there have been more than 2,300 reports of adverse drug reactions related to Champix since it was approved by Health Canada in 2007, including 44 suicides. However, the drug continues to be prescribed in British Columbia, the media outlet reported. The CBC noted that Champix has been prescribed to 68,000 residents of British Columbia, generating approximately $20 million in sales for the region.
The CBC also noted that Pfizer has made more than $40,000 in donations to the British Columbia Liberal government. Alan Cassels, a pharmaceutical policy researcher at the University of Victoria, told the CBC that there are speculations the drug company’s close ties to the ruling government have created ideal situations for the continued prescribing of the anti-smoking drug.
A health minister told the CBC research shows Champix is safe for use.
The CBC noted that another anti-smoking drug Zyban, which has also been approved in the Canadian province, has had far fewer adverse reactions. Zyban is manufactured by GlaxoSmithKline .
British Columbia is not the only place Champix has been linked to psychological problems. Champix, sold as Chantix in the United States, has a history of being linked to psychological issues in the U.S, as well. In March the U.S. Food and Drug Administration (FDA) announced there are new risks to be considered for individuals using 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.
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.
In 2014 Pfizer settled approximately 2,900 U.S. lawsuits charging Chantix triggered suicidal thoughts and other psychological problems in patients for about $300 million.
Chantix generated $647 million in revenue in 2014. When the drug launched in 2006 it generated $883 million in sales, but revenues lessened over the years following reports of side effects and the warning label.
Last year the FDA said Chantix should retain the severe warning label on its packaging. The “black box warning” was first affixed to Chantix in 2009, three years after its approval. The warning lists possible side effects of the drug, such as suicidal thoughts, erratic behavior and drowsiness.
Some consumer groups have sought FDA support to issue a warning that people working in certain occupations shouldn’t take the drug. According to a Wall Street Journal report, the Federal Aviation Administration banned the use of Chantix by pilots and air traffic controllers.
After Bristol-Myers Squibb Wonder Drug Meets Endpoints, Will FDA Process Be Up to Snuff?
Our most popular story last week was about a new wonder drug that wowed the FDA. An experimental anticoagulant drug under joint development between Portola Pharmaceuticals, Inc., Bristol-Myers Squibb Company and Pfizer Inc. met all primary and secondary endpoints in a Phase III study determining safety and efficacy—and our readers responded. The hope now is it will be sped to patients as fast as possible.
That’s lead BioSpace to ask, what do you think about the drug approval process in this country? Let us know your ideas.
