The U.S. Food and Drug Administration reviews a wide variety of health care products. When a drug is ineffective or harmful, the FDA recalls the drug and issues a notice to health care providers. New York health care providers and consumers have reason to be concerned, though, about the adequacy of the FDA’s warning system.
FDA Recalls Tallied
In a recent study, researchers counted 1,734 FDA drug recalls occurring over an eight-year period. Included were 91 Class I recalls, the most serious type, covering drugs likely to cause death or serious adverse health consequences.
A significant portion of Class I recalls, 40 percent, were due to contamination. For example, contaminated heparin was recalled after dialysis patients had serious reactions, including some deaths. One-fourth of Class I recalls involved dosage, and the rest were for packaging issues like mislabeling which can lead to serious adverse drug interactions.
Drug Alerts Missed
Physicians and hospitals subscribe to an electronic system to receive messages from the FDA. The FDA used the Recall Alert System and the MedWatch system during the years covered by the survey. Between the two systems, the FDA sent providers notices announcing 73 out of the 91 Class I Recalls. Startlingly, notices for 18 of these serious recalls were not sent out.
An FDA spokesperson tried to excuse its poor performance, saying the recall program depends on manufacturers to take responsibility for their products.
Besides one fifth of the Class I notices not being sent out at all, there is the additional concern that recalls of truly dangerous medicines could get lost amid a flood of other notices. During the survey period, Recall Alert alone sent a total of about 2,900 notices to its subscribers. Information overload could result in a recipient ignoring or overlooking an important notice.
System Needs Improvement
An effective notice system should include every Class I recall, but may not need to include all the less important warnings. Missing a recall notice, a physician might continue to administer a harmful drug. The results could result in wrongful death. Over a third of the Class I recalls covered more than 100,000 units of the drug, and almost two thirds of the recalled drugs were distributed all over the country.
Patients are helpless if a physician administers a dangerous drug. If medical negligence causes harm, or death, patients and their families should retain an experienced personal injury attorney as they may be entitled to compensation for their injuries.
Source: ABC News, “U.S. Has Drug Recall Problem, Study Says,” Carrie Gann, June 4, 2012
