Protecting public health

Monday, Oct. 27, 2008 | 2:06 a.m.

The Food and Drug Administration received a record number of reports of death and serious injury associated with prescription medications in the first three months of this year.

There were 4,825 deaths and nearly 21,000 serious injuries for the first quarter, according to an analysis of FDA records by the nonprofit Institute for Safe Medication Practices. That is a 38 percent increase over the quarterly average for the previous year.

There appears to be a combination of factors that led to the increase. For example:

• Part of the spike was blamed on the tainted blood-thinner heparin imported from China, which generated 779 reports of serious injury.

• Varenicline, marketed as Chantix, a drug to help patients stop smoking, was blamed for 1,001 cases of serious injury, including 50 deaths.

• Prescription painkillers such as oxycodone and the anti-anxiety medication Xanax were associated with 1,246 deaths. These medications have been widely prescribed and have become well-known as recreational drugs.

The institute says its report may contain only a small percentage of actual cases because the FDA’s records contain voluntary reports of injury associated with prescription medications. What is clear in the report is that there is a serious problem with prescription drug use, and the FDA hasn’t been doing its job, either in issuing warnings or working with other agencies to police doctors who wrongly prescribe medicines.

Although the report lauds the FDA for “promptly and effectively” responding to the heparin crisis, it notes that in other areas the agency has failed to respond.

For example, the drug Chantix has been linked to blackouts, and the Transportation Department has banned its use among pilots and air traffic controllers. After the report was issued last week, the FDA said it would consider a new safety warning for the drug.

The agency should be ashamed that a nonprofit group is doing its work for it by raising concerns about these drugs.

The bottom line is that the FDA should be moving more aggressively to protect the public health.