NEJM: Drug labels lack key info

Are drug labels too optimistic? A New England Journal of Medicine commentary claims they are, at least in the U.S. Labeling often makes medicines seem safer and more effective than they are, the article contends, by leaving out info on severe side effects and omitting data that would undercut efficacy claims.

The NEJM article offers Sepracor's sleep remedy Lunesta as an example. The label claims the drug is superior to placebo, but the largest and longest clinical trial found that Lunesta patients still had insomnia and experienced "no clinically meaningful improvements" in alertness or functioning. FDA had that data, but healthcare providers would have to ask to get it.

Meanwhile, the initial labeling for Novartis' bone drug Zometa left out the fact that 33 percent of study patients given the 8-milligram dose died, compared with 19 percent given the 4-milligram dose and 19 percent on placebo. It mentioned a higher risk--but didn't specify that it was 14 percentage points higher. Even when the label was changed to advise against the higher dose, the numbers weren't given.

Of course, U.S. drug labeling is overseen by FDA. But even though FDA has all the data, important info can end up MIA, Dr. Steven Woloshin, one of the commentary authors, told Reuters. "How can I decide if the potential harms of this drug are worth the risk if I don't know how well the drug works, and vice versa?" Woloshin and his colleagues have come up with a new labeling format under consideration by FDA.

- read the commentary in NEJM
- see the Reuters story