The risk of heart attack and stroke from taking these medications is greater than the FDA previously said. There is "no period of use shown to be without risk," one doctor told Time. Heart attack or stroke may occur even early in treatment, the FDA said.
The agency said it will strengthen its existing label about the risk.
Still that risk is "far smaller" than the risk from smoking, uncontrolled blood pressure or obesity, reports the Times — though their use could compound the risk from other conditions and habits.
The people who should be most careful are those over 65 with a history of heart disease, Wilson said.
“The thought is these are good for short-term relief, probably for your younger person with no history of cardiovascular trouble,” he said.
The risk increased like this: The over-the-counter medications probably increased risk by about 10 percent, while low-dose prescription medications increased the risk by about 20 percent and higher-level prescription medications increased the risk by about 50 percent, Wilson told the Times.
But: "He emphasized that there was significant variability in each estimate. ... The risk for the over-the-counter drugs might be zero or might be 20 percent," according to the Times.
Cardiologist Sanjay Kaul told the Times that the evidence was not yet strong enough to differentiate between one drug in the group as being better than another.
“The FDA is basically hedging — they still have questions,” he said.
“The point of this warning is that we have to be very careful,” he continued. “There has to be a good reason to take [the drugs]. We shouldn’t just be using these drugs willy-nilly."