Data pulled from the FDA’s Adverse Event Reporting System (AERS) between October and December of 2008 suggested that Chantix may be linked to the side effects. The FDA will continue to monitor Chantix for an unspecified length of time until it determines what, if any, regulatory action is needed.

The FDA does not fully test prescription drugs for safety before allowing them to enter into the market. Why? It’s a matter of logistics more than anything. Typically, FDA studies are designed to measure a drug’s effectiveness using thousands of patients who willingly participate in pre-market clinical trials. These patients obviously represent a very small slice of U.S. population. The FDA also relies on studies conducted by the pharmaceutical companies themselves to determine how effective test drugs are. If new drugs that have passed tests for efficacy appear to be reasonably safe, then FDA researchers give them the green light.

The FDA, incidentally, reviewed Chantix in six months rather than the regular review time of 10 months.

The millions of people in the U.S. and around the world who started taking Chantix when it debuted on the world market in May 2006 became patients in the world’s first mass clinical trial. Most people assume that the FDA seal of approval means that the drug will be perfectly safe, but the truth is that most of a drug’s risks are not known until it is prescribed to millions of consumers.

The first reports of adverse events linked to Chantix emerged just months after the drug was released to the public. On February 1, 2008, the FDA issued a statement saying “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”

By May 2008, Chantix was linked to more than 3,000 reports of serious side effects. By November of the same year, data from the FDA’s Adverse Event Reporting System showed that more reported serious injuries resulted from Chantix than any other prescription drug.

SOURCE: Chantix Recall › FDA monitoring Chantix for serious risks, new safety concerns

The dramatic increase of pharmaceutical drug related injuries occurred in the first three months of 2008, during which time 20,745 serious side effects and more than 4,800 deaths were reported. The incidents represent a 38 percent rise over the previous four quarters and constitute the single highest spike yet recorded.

Prescription drug related death historically accounts for 16 percent of all serious cases reported. That number soared to 23 percent in the first quarter of 2008.

According to the FDA standards, a serious drug reaction is one that leads to medical intervention or hospitalization and jeopardizes the life of the user. AERS data comes from reports that are voluntarily submitted by medical professionals. The data is generally regarded as a small representation of a much larger picture.

According to ISMP, “Some of the increases in quarterly totals could represent normal variation in the flow of reports rather than signaling a long-term trend in patient safety. However, the data are compelling and should serve as one source of information regarding drug safety in the US.”

More reported serious injuries result from Chantix usage than any other prescription drug. Chantix accounted for 1,001 new cases of serious injury, including 50 deaths.

Pfizer refuted the FDA data and ISMP’s interpretation of it. “Based on [the] totality of data, we stand by the efficacy and safety profile of Chantix when used as directed,” said Pfizer spokeswoman Kristen Neese in a statement.

SOURCE: Chantix Recall › Chantix plays role in record number of drug reactions