FDA updates heart warnings on popular pain relievers – Business – NorthJersey

Doctors now say those and other NSAID drugs can increase your risk of heart attack and stroke by as much as 50 percent.

The Food and Drug Administration (FDA) is issuing warning against the use of painkillers due to the possibility of these medicines to cause heart attacks or strokes, according to Today. Common OTC NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve).

While the revamped warnings still say that NSAIDS may increase the chance for heart attack or stroke, new language will say that these serious, life-threatening side effects can occur as early as the first few weeks of use. Acetaminophen, the active ingredient in Tylenol, has also come under scrutiny in the past year after reports that it presents higher risks for liver damage, especially at high doses or in combination medicines.

“Everyone may be at risk, even people without an underlying risk for cardiovascular disease”, Dr Judy Racoosin, the deputy director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products said explaining the adjustment.

“NSAIDs will increase risk of heart attack, but when you balance benefit and risk you need to know what your starting risk is”, he said. Painkillers have been reported as being the most commonly prescribed drugs in the United States, with studies showing that 70% of Americans are on one or more prescription drugs. Vioxx, an NSAID, had been linked to heart attack and stroke.

While both over-the-counter (OTC) and prescription NSAID labels already have information on stroke and heart attack, results of a comprehensive review performed by the FDA led to the update. Consequently, the amplified effects will result in higher risk of death.

Prescription NSAIDs are an important treatment for the symptoms of many debilitating conditions, including osteoarthritis, rheumatoid arthritis‎, gout and other rheumatological and painful conditions.

It was previously thought that all NSAIDs may have a similar risk. Perhaps you even take them on a regular basis for some minor chronic pain.

Why is the FDA requiring stronger warning labels? She added that everyone’s heart is at risk when taking NSAIDs, not just of people who have symptoms of cardiovascular disease.

The FDA said the new warning does not apply to aspirin which is also an NSAID.

A similar warning was also added to lower dose and over-the-counter NSAIDs with those drugs warning patients to take only the lowest dose possible for a short period of time. Take for example a huge Lancet analysis of more than 600 studies and 350,000 people, which showed that significant doses of these medications daily can increase your risk of a cardiovascular event by up to a third.