Safety questions on Fosamax, Actos, et al.

It must be tough for pharma execs to open a newspaper these days. If reporters aren't going on about falling revenues [1] and patent expirations, they're propagating news about potential safety problems. Take today: Three different studies are linking four big-name drugs to safety risks.

• Women who take Fosamax [2] for osteoporosis may be at increased risk of developing an irregular heartbeat, or atrial fibrillation. While the condition isn't necessarily serious, it can lead to stroke. Nevertheless, the Archives of Internal Medicine study concluded that for most women the benefits of Fosamax outweighed the risks.
• The epilepsy remedy Dilantin may put young women at higher risk of developing osteoporosis, according to research published in Neurology. Women who took the drug for a year or more showed eight times the bone loss of premenopausal women who didn't take epilepsy meds. And calcium supplementation may not be enough to counteract the bone loss. Full disclosure: This was a small study--only 93 women--and it was partly supported by GlaxoSmithKline, which makes a rival epilepsy med, Lamictal.
• Diabetes treatments Avandia and Actos [3] double or triple the odds of non-spinal fractures, especially among patients who took the drugs for a year or more, another Archives of Internal Medicine study found. Previous studies established higher risk of fractures among patients using these drugs, but the new research shows the possible scale of the problem. The study authors said the link needs to be confirmed by additional research.

Now, none of these studies appears likely to send doctors rushing to their prescription pads to switch patients to new meds. But each represents one more obstacle to pharma marketers in an already-difficult environment.

- see the Fosamax coverage [4] from the BBC
- check out the epilepsy story [5] in the Washington Post
- read the diabetes-med news [6] in USA Today
- find US News' take [6] on two of these studies