FDA: Reflux drugs don't carry heart risks

The FDA didn't expect to find much, and it didn't. After a six-month review of 16 studies submitted by AstraZeneca, the agency concluded that heartburn remedies Nexium and Prilosec do not increase the risk of heart problems.

You'll recall that the agency started a safety review in May, when AstraZeneca submitted two small, long-term studies that suggested Prilosec could boost the risk of heart fairue, heart attack, and sudden death. The FDA then asked AstraZeneca for more data. Conclusion: Nexium and Prilosec are "not likely to be associated with an increased risk of heart problems."

- see the statement from AstraZeneca
- check out this release from the FDA
- read the story in the New York Times

Suggested Articles

The efficacy between Keytruda and FerGene's nadofaragene firadenovec look comparable in their studies, though Merck has at least one upper hand.

Thursday, the FDA approved the first three generic versions of Gilenya, but they may not hit the market anytime soon due to ongoing litigation.

Gilead is hoping to score a patent extension on TAF meds, but patient advocates say that would reward conduct that harmed patients.