A record number of deaths and injuries associated with drugs were reported to the Food and Drug Administration during the first quarter of 2008.
In all there were a total of 20,745 serious injuries and 4,824 deaths reported. That represents a 2.6 fold increase from the previous quarter.
Topping the list of dangerous drugs was the smoking cessation drug, Chantix, made by Pfizer. Chantix, (varenicline) was linked to more than 1,000 injuries and 50 deaths from January to March, 2008.
The blood thinner, heparin, was associated with 779 injuries and 102 deaths. Heparin is the same drug given to the twins of Dennis Quaid last year, in such mass quantities, they almost bled to death.
Heparin was also the drug that was contaminated somewhere in the manufacturing process in China. The contaminated lots were recalled.
The report was compiled by the Pennsylvania group, The Institute for Safe Medication Practices (ISMP). The nonprofit organization prepared reports and conducts educational campaigns to prevent mediation errors and encourage drug safety.
The report, compiled from the Food and Drug Administration (FDA) adverse events data, likely represents a small number of actual adverse events, as the reporting of deaths and injuries from drugs is voluntary.
Chantix is the same drug that the Federal Aviation Administration (FAA) banned for pilots and air traffic controllers in May. Truck drivers have been warned off using it by the Department of Transportation. Some reports link Chantix to serious psychiatric problems including blackouts, seizures, a sudden disturbance of heart rhythm and feelings of suicide.
After the bad report, Chantix maker, Pfizer pushed back with a public-relations campaign running ads in five major newspapers.
Chantix brought Pfizer $96 million in the third quarter, down almost 50 percent from the same period last year.
Ironically, it's the credibility of the FDA and its approval process that is the basis of the federal pre-emption argument. Corporations say if a drug or medical device is approved by the FDA, consumers should not be able to sue them for injury in state court.
That argument is coming before the nation's eyes November 3 in the Wyeth versus Levine case to be heard before the U.S. Supreme Court. #