The popular painkiller naproxen, manufactured by German drug giant Bayer and sold under the brand name Aleve, has the same cardiovascular risks as rival medicines, US regulators said Tuesday.
Scientists from Oxford University had earlier concluded that painkiller naproxen posed a lesser heart risk than other painkillers.
AdvertisementBut a panel of experts assembled by the US Food and Drug Administration (FDA) decided by a vote of 16 to nine against softening the warning label on the medication, rejecting the scientists' analysis.
The Oxford researchers formed their conclusion after analyzing data from more than 700 studies and some 350,000 patients.
The FDA panel, on the second day of their two-day meeting, nonetheless said the study's evidence is insufficient to warrant exemption from the labels used by rival drugs.
Researchers have found a link between anti-inflammatory medications like ibuprofen and Celebrex and "cardiac events," including heart attack.
The lucrative painkiller market last year generated some $1.7 billion in sales, US industry experts said.