FDA, Lancet raise ARB safety questions

Blood pressure meds are in the safety spotlight today. FDA is looking into whether Daiichi Sankyo's angiotensin-receptor blocker Benicar increases the risk of heart-related death, while new data in Lancet Oncology suggests that ARBs may increase patients' risk of developing cancer.

First, the Benicar news: FDA says it's looking at two clinical trials in which diabetes patients using the drug had a higher rate of heart-related death than patients using placebo did. The FDA did say that it believes the drug's benefits do still outweigh its risks, and Daiichi said that it's "very confident" in the drug's safety.

Chief Scientific Officer Dr. Glenn Gormley told Reuters that the company does want to study the data FDA is reviewing, however. "There was a numerical imbalance in some of the cardiovascular side effects," Gormley told the news service. "We've never seen that before in other studies and I don't think we've seen that with other ARBs."

Then there's the Lancet data. The ARB drug class includes Merck's Cozaar and Novartis' Diovan, but as the Wall Street Journal notes, most of the data in the new study concerns the Boehringer Ingelheim drug Micardis. The researchers looked at clinical trials of ARBs and found that patients using the drugs had a slightly higher risk of developing a new cancer: 7.6 percent versus 6 percent in the control group.

The data raises more questions than it answers; the researchers said the cancer risks should be studied further, and the various drugs in the class should be compared as well. In an accompanying commentary, Cleveland Clinic's Dr. Steve Nissen advised "greater caution" when using ARBs in general and Micardis in particular. For its part, however, Boehringer said that its internal data contradicts the new study. We'll have to wait and see how the data develops.

- check out the FDA announcement
- see the Reuters news
- get more from the WSJ
- read the Bloomberg piece

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