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Serious Drug Reaction Reports Reach A Record High Due to Heparin and Chantix

Oct 23, 2008 | Parker Waichman Alonso LLP

The Associated Press (AP) is saying that the number of adverse effects, including deaths, linked to medications reported to the government has set a record in the first three months of this year; this according to a health industry watchdog group.  It seems, according to the AP, that the U.S. Food and Drug Administration (FDA) “received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths.”  The FDA data was derived from an analysis of federal data by the nonprofit Institute for Safe Medication Practices (ISMP), which reviewed data as far back as the 1990s.

Two drugs accounted for what the AP termed a “disproportionately large share of the latest reports.”  One drug was heparin, the tainted blood thinner from China that caused an international safety scandal that, according to the ISMP study, accounted for 779 reports of serious problems, including 102 deaths.  The FDA, which relies on data spanning a longer time frame, reports 238 deaths possibly linked to heparin.

The other drug was Chantix, a new anti-smoking drug from Pfizer that has been blamed for a number of unusual and dangerous reactions and works in the brain to both ease withdrawal symptoms and block the pleasurable effects of nicotine when a smoker attempts to light up.  Chantix received the most reports of any medication.  The FDA should forcefully warn patients taking Chantix that they might suffer blackouts and other problems that could lead to accidents, the report said.  The report found 15 cases of traffic accidents, and 52 additional cases involving blackouts or loss of consciousness in Chantix patients; the FDA received 1,001 reports of serious injuries, possibly linked to Chantix, represnting more than for the ten best-selling brand name drugs combined.

Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. Meanwhile, we have long been reporting on the bizarre reactions Chantix users have been experiencing and, earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams.  Although the government has banned Chantix for pilots, Pfizer said yesterday  "We stand by the efficacy and safety profile of Chantix."

The FDA had no immediate response to the report, but defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy; its monitoring system relies on voluntary reports from doctors.  Many believe the system only captures a small percentage of actual cases.

The report also stated that the 20,745 cases reported from January-March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, said the AP.  Twenty-three percent—4,824—ended in death, a nearly three percent increase from the last calendar quarter of 2007.  Previous ISMP research revealed that serious drug safety problems reported to the FDA increased significantly from 1998-2005.

“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,” reported the AP.  For instance, if “the FDA were a police agency, the reports would indicate ‘probable cause,’ but not necessarily ‘guilt beyond a reasonable doubt,’” the AP pointed out.  As far as Chantix is concerned, many feel that reasonable doubt has been met.