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

Chantix, manufactured by Pfizer, was approved in 2006 and since that time has been prescribed to more than 4 million patients. However, not long after its release, the drug was linked to psychiatric problems including depression, suicidal thoughts and actions, and aggressive behavior. The drug also has been linked to serious physical side effects including heart problems, diabetes and serious allergic reactions such as Stevens Johnson Syndrome.

According to the Stars & Stripes, the drug was removed from the military pharmacy at Yokota Air Base in Japan. The decision came after a May 21 report by the Institute for Safe Medication Practices, which says Chantix has had more serious adverse incident reports in the fourth quarter of 2008 than any other drug in this time period.

In response to the ISMP report, the Federal Aviation Administration banned pilots and air traffic controllers from using the drug. The Stars & Stripes reports that the Defense Department’s Office of the Chief Medical Officer also recommended that “varenicline should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.”

The paper says the DOD safety notice also had recommendations for “vehicle operators, operational personnel, and other DOD personnel” under consideration.

Stars & Stripes says the Yokota base has not reported any adverse reactions to Chantix, but seems to be banning the drug as a precautionary measure, and has suspended refills of Chantix until patients review the drug use with their physician. Other base hospitals overseas have not banned the drug, but air crewmembers cannot take the drug, and other Chantix patients are required to discuss their use of the product with their physician. Pharmacies can special-order the drug based on those prescriptions.

According to the report, when Chantix was first licensed in 2006, it was prescribed 262 times in military treatment facilities. By fiscal year 2007, there were 67,580 prescriptions written for Chantix in military facilities.

SOURCE: Chantix Recall › Military pharmacy pulls Chantix

As a result of its study, the ISMP is recommending the FDA strengthen warnings on the drug, which has been prescribed to more than 3 million people since it was approved in May 2006. Also as a result of the report, the Federal Aviation Administration banned use of Chantix by pilots and air traffic controllers.

The Bloomberg story cites FDA spokesperson Susan Cruzan as saying the ISMP study will prompt the FDA to conduct immediate further research to confirm numbers. Because the FDA’s adverse event reporting system is voluntary, she is cited as saying, there are no controls in place to determine if the reported side effects are the result of Chantix use, or if they are coming from another drug that reporters may be using.

SOURCE: Chantix Recall › More than 3,000 side effect reports