Medication deaths hit record

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 (FDA) 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 (ISMP), 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.

The FDA had no immediate response to the report.

ISMP has served hospitals and pharmacists for years as a clearinghouse for information on drug safety and medication errors. It is now reaching out to consumers with regular reports on drug safety trends, drawn from FDA records.

“We believe that one of the most important tools to promote is to monitor trends on a regular basis,” said Thomas J. Moore, a senior scientist with the group. “Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety.”

The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency’s monitoring system relies on voluntary reports from doctors and is only thought to capture a fraction of overall problems.

The total of 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

Fatalities accounted for 23 percent of the cases. The total number of deaths, 4,824, was an increase of nearly 3 percent from the last calendar quarter of 2007.