Chantix Recall Should Be Considered by FDA
A recent report by the Institute for Safe Medication Practices (ISMP) indicates that side effects of Chantix continue to account for a large number of the serious psychiatric problems reported to the FDA, despite a “black box” warning added to the label and a medication guide that is given to every patient. That should be a sign that the medication needs even more restrictions or other regulatory action, such as a Chantix recall.
>>MORE INFORMATION: Chantix Suicide Side Effects
On this blog, we have been calling for a recall of Chantix for a long time due to the increased risk of suicide, suicide attempt, hostility, aggression, depression and psychosis. In addition, prior studies have suggested that the drug may be no better than other treatment options to help people stop smoking.
Last month, the Institute for Safe Medication Practices (ISMP) released a report (PDF) on adverse drug side effects reported to the FDA in the second-quarter of 2010.
Chantix has now caused more than 8,500 reports involving serious injuries, with a steady stream that exceeds most other prescription medications. According to the report, in the second quarter of 2010 alone there were 130 possible cases of Chantix clinical depression, 112 possible cases of hostility-aggression from Chantix and 70 cases of Chantix psychosis and reports by people who say the drug made them lose touch with reality.
ISMP indicated that these case reports continue to exceed the number reported with the most powerful antipsychotic and antidepressant medications, which are used in much more vulnerable groups of patients with mental disorders.
After observing that these Chantix problems continue to be reported, despite the FDA having deployed most of its regulatory tools short of a Chantix recall, ISMP concluded:
The evidence shows that the numerous regulatory actions from the FDA and other restrictions have not succeeded in achieving substantially safer use of (Chantix) varenicline beyond a possible effect in reducing dispensed prescriptions. A major reassessment of this drug’s place, if any, in a program of treatment to assist in smoking cessation is needed.
CHANTIX RECALL LAWSUITS
The Chantix lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a Chantix suicide lawsuit or other injury claim from the medication. Despite information that should have led the drug maker to recall Chantix long ago, the medication has been marketed as a safe method of helping people quit smoking.
If you, a friend or family member have suffered a serious injury or death from Chantix, compensation may be available through an individual Chantix lawsuit. To review a potential claim, request a free consultation and case evaluation.