Processing Magazine

Reports of serious drug reactions hits record high, including deaths

October 22, 2008

A health industry watchdog group has announced that the number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, according to the Associated Press. The Food and Drug Administration 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, known as ISMP. Two drugs accounted for a large share of the latest reports. One was heparin, the tainted blood thinner from China that caused an international safety scandal. The other was Chantix, a new kind of anti-smoking drug from Pfizer. Chantix, which had the most reports of any medication, works directly in a smoker''s brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient is tempted to light up again. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer stands by Chantix, and claims that the volume of reports might be linked to publicity about the side effects. But FDA officials are not sure whether reports are up because problems are getting worse, or simply due to greater awareness about drug safety issues. The watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. Known as ISMP, the organization is now trying to reach consumers with regular reports on drug safety trends. 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 heparin was largely to blame. 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. The FDA should forcefully warn patients taking Chantix 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 patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA said it was taking a second look at the Chantix warnings. The agency received 1,001 reports of serious injuries linked to Chantix, more than for the ten best-selling brand name drugs combined.