Chantix Side Effects Not Reported Properly, FDA Says

The U.S. Food and Drug Administration (FDA) just announced that it asked drug maker, Pfizer Inc., to submit—again—a large amount of its adverse event reports from 2010 for <"http://www.yourlawyer.com/topics/overview/chantix_side_effects">Chantix, its stop smoking medication, said the Wall Street Journal.

On its website, the FDA wrote that it became aware that Pfizer and some other drug makers that remain unnamed, have been processing adverse event reports through what the agency described as “improper” channels, wrote the Journal.

Companies report adverse events to the FDA in two ways: Through periodic safety summary reports or via a process that enables faster reporting through the FDA’s adverse event reporting system (AERS), said the Journal. Reports that discuss side effects covered on the medication’s labeling are able to be submitted through the periodic reports; however, reporting of what the Journal described as “unexpected or fatal” events must be filed as 15-day reports filed into the agency’s AERS system.

The FDA said that it asked Pfizer to resubmit “thousands” of its reports, which were submitted as periodic summary reports, to the AERS system, said the Journal, which pointed that while adverse events are not always about a problem, the agency doses use this reporting tool to track if reports are drug related. Pfizer said it “takes the safety of all patients it serves very seriously. Pfizer has complied fully with FDA requirements regarding adverse events reports it has received related to the use of Chantix,” quoted the Journal.

The Institute for Safe Medication Practices (ISMP), a nonprofit group that monitors drug safety, said 1,055 serious adverse events reports were linked to Chantix in 2010’s third quarter; 150 suicides are included, noted the Journal. The ISMP also said that the total included 589 serious adverse event reports that took place prior to 2010, but which were entered into AERs in July 2010, said the Journal.

The FDA approved Chantix (generic: varenicline) in the United States in 2006 as a treatment for smoking cessation. Chantix blocks nicotine by targeting the brain’s nicotine receptors. About a year after being on the market, reports began emerging about patients exhibiting strange and dangerous behavior while on Chantix; the FDA received a number of adverse event reports and issued information on the potential risks. In 2009, the FDA announced that a Boxed Warning regarding such side effects would be added to the Chantix label.

We recently wrote that a study from the ISMP suggested a link between some prescription drugs—including Chantix—and violent behavior. The study revealed that Chantix is a whopping 18 times likelier to be associated with “violence and aggression” versus other drugs.

The FDA’s black box warning states that Chantix increases the risk for neuropsychiatric events such as “suicidal thoughts or actions,” quoted the Journal. The agency also said it continues to monitor Chantix safety and initiated two new safety studies with the Department of Defense and the Veterans Administration.

Last year, the agency sent Pfizer a warning letter for not appropriately following its AER rules for products such as Lyrica and Lipitor; Chantix was not mentioned.

We recently wrote that the estates of a couple killed in a murder-suicide two years ago filed a Chantix lawsuit against Pfizer Inc. The lawsuit alleges that Chantix prompted the rage that led to the fatal events in which Sean Wain, 34, killed his wife Natalie, 33, before killing himself in May 2009. The Wain’s had four children. Mr. Wain was taking Chantix for one week prior to the murder-suicide.

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