On October 23, 2008, The Institute for Safe Medication Practice, (a nonprofit group that educates the healthcare community about safe medication practices), issued a report on the number of serious injuries and death reported to the U.S. Food and Drug Administration in the first quarter of 2008. (See Inst. For Safe Med. Practices: 10/23/08, “Quarter Watch: 2008 Q 1.”)

According to this report, the number of reports of serious injuries and death linked to medications hit a record high. In the first three months of 2008, there were 20,745 new cases of serious injury and 4,824 reports of death. This total was 38% higher than the average for the previous four quarters, and the highest for any quarter. Death cases also accounted for a larger share with 23% for the first quarter of 2008 as compared to a historical average of 16%. This represented a 2.6 fold increase from the previous quarter and the highest number of deaths in a calendar quarter since 2004.

Two drugs accounted for a disproportionate share, including Chantix, a new anti-smoking drug from Pfizer, Inc. (with 1001 cases of serious injury and 50 deaths), and Heparin imported from China, (with 779 cases of serious injury and 102 deaths). (The FDA has actually reported receiving 238 reports of death from contaminated heparin over a longer period, but 102 represent the first quarter.)

Even scarier for the American public is the fact that because reporting is voluntary, these reports represent “only a small fraction of the adverse drug events that occur.” Id. at 1.

As concluded by the Institute, “While prescription drugs bring great benefits to millions of patients and most are used safely, these data show the need for additional progress to better manage the risks to patients….It also underlines the importance of the nation’s system for assuring drug product stability and purity. The scale of injury--hundreds of deaths or serious injuries in a short period—underlines the importance of strengthening oversight of drug manufacture abroad.” Id. at 4.

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