The Dallas Morning News today has an alarming story about the dangers of the prescription drugs Chantix and Heparin. Here are excerpts:
Previous research from ISMP has shown that serious drug safety problems reported to the FDA increased markedly from 1998-2005. The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation. If the FDA were a police agency, the reports would indicate “probable cause,” but not necessarily “guilt beyond a reasonable doubt.” 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 number of serious problems and deaths linked to medications reported to the government set a record in the first three months of this year, a health industry watchdog group said Wednesday.
The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths, said an analysis of federal data by the nonprofit Institute for Safe Medication Practices, which scrutinized data going back to 2004, and yearly totals dating to the 1990s.
Two drugs accounted for a disproportionately 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 tries to light up again. But earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. The government banned it for pilots. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the drug’s side effects.