Adverse event reports hit record high

Prescription drugs posted a new record during the first quarter of this year, but it's a milestone drugmakers would probably rather forget. The number of deaths and serious injuries associated with prescription drug use rose to new highs, with 4,825 deaths and nearly 21,000 injuries, a watchdog group said. That's nearly a threefold rise from the previous quarter and 38 percent more than last year's quarterly average.

According to the Institute for Safe Medication Practices, the Pfizer stop-smoking drug Chantix tallied the most adverse reports, with 1,001 injuries and 50 deaths. As you know, Chantix has attracted widespread media attention for the psychiatric effects--even suicide attempts--seen in some of its users. (That attention probably boosted the number of reports, too.)

Second on the list was the blood thinner heparin--subject of a much-publicized recall and an international investigation--which was associated with 779 injuries and 102 deaths. These adverse reactions were traced back to contamination of raw heparin used to make the drug.

The Institute took its stats from the FDA's adverse events reporting system, which can be problematic for a couple of reasons. One, adverse events often go unreported, so the numbers can understate the problem. But--and this is the second reason--the individual reports don't prove that the drug caused the problem.

- read the story in the Los Angeles Times
- check out the WSJ Health Blog post

Suggested Articles

Compared with the FDA "boxed warning," the EMA version puts a smaller restriction on the higher dose but broadens the cautionary language.

Shionogi's newest antibiotic Fetroja has now earned the FDA's approval, but will a mortality-rate warning scuttle the drug's chances?

Novartis' Sandoz doubled down in Japan as Lupin retreated. Dr. Reddy's posted a loss tied to its Zantac recall. Aslan's varlitinib failed again.