The Food and Drug Administration (FDA) received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.

Two drugs accounted for a large share of the latest reports: One was the blood thinner heparin - tainted heparin imported from China - and the other was Chantix (also called Champix), Pfizer´s anti-smoking drug.

Chantix/Champix, which had the most reports of any medication, works directly in a smoker's brain to ease withdrawal symptoms.

The Food and Drug Administration has warned that Chantix/Champix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer, however, states it stands by Chantix/Champix, and that the volume of reports might be linked to publicity about the side effects.
The watchdog group, known as ISMP, is now trying to reach consumers with regular reports on drug safety trends.

The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said the heparin cases caused the increase in reports and deaths.

The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths. The FDA, using data that covers a longer time period, has reported 238 deaths possibly linked to heparin.

Heparin "illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood," the report said.

The same has not happened with Chantix/Champix, says the report.

The FDA should forcefully warn patients taking Chantix/Champix that they may have blackouts that could lead to accidents, the report said. Current warnings say patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications. The government has banned the drug for pilots.

The report found 15 cases of Chantix/Champix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The agency received 1,001 reports of serious injuries linked to this drug, and said it is taking a second look at the Chantix/Champix warnings.

Chantix/Champix "continued to provide a striking signal of safety issues that require investigation and action," the report said. The authors acknowledged Pfizer's concern that publicity may be driving up the number of reports, but concluded there's enough evidence to warrant stronger FDA action.

In spite of Pfizer´s defense of its drug, Chantix/Champix, previously one of Pfizer´s biggest earners, have been decreasing since the first quarter of 2008: $ 277 million dollars in 1Q, down to $ 182 million in 3Q, for a total of $ 666 million in the first nine months of the year.