FDA gives new safety warning on Pfizer’s Champix
pharmafile | March 10, 2015 | News story | Manufacturing and Production, Sales and Marketing | Champix, Cochrane, FDA, MHRA, Pfizer, varenicline
The FDA has warned that Pfizer’s stop smoking drug Champix is linked with seizures, aggressive behaviour and blackouts.
In its latest decision the FDA says it has approved an update to the drug’s label in September, but issued the public notice now to ensure patients are aware of the changes and “can consider this new information when making prescribing decisions”.
The US regulator approved Champix (varenicline, which has the brand name Chantix in the US) in 2006. But the drug has been dogged by safety doubts ever since. The FDA has already warned that the drug “may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease”.
In 2009 the FDA added a boxed warning – reserved for the most serious of drug safety risks – after reports emerged that people taking Champix were experiencing anxiety, self-harming thoughts or suicidal thoughts. In the UK the MHRA has also issued a similar warning.
However, in May 2013 a systematic review of the efficacy of Champix and other stop smoking products – conducted by researchers at the Cochrane Library – concluded that “the evidence for the safety of Champix is still under investigation”, but researchers said “we found no evidence from the trials that it is linked to an increase in neuropsychiatric problems, or with increased heart and circulatory problems”.
Pfizer has backed the safety profile of its drug, and has frequency contested the validity of research that linked Champix with a higher than expected frequency of adverse events.
The US firm, which registered $142 million from Champix sales in 2014 – up 6% on the year before, is conducting a safety study of the drug which is expected to be published later in the year. The FDA says it will keep the black box in place at least until the results of the trial are announced.
Lilian Anekwe
Related Content
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
FDA grants ODD to Candel Therapeutics’ pancreatic cancer treatment
Candel Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan …
