The Food and Drug Agency issued a strong warning today about the possibility of fatal consequences after taking commonly used painkillers.
CBS news reports on the new warning. The warning was specifically about the heightened danger of a heart attack and stroke associated with some of the most common pain relievers such as NSAIDs, or nonsteroidal anti-inflammatory drugs.
The most common drugs, which are available by prescription or over the counter, are generally utilized to relieve pain or reduce fever. NSAIDs are also an ingredient in many common cold, flu and sleep medicines.
“After analyzing a combination of clinical trials and scientific studies in two panels that convened in August of 2014, the FDA found evidence of increased risk for heart attack or stroke,” according to CBS news. The information showed the threat could happen as early as the first weeks of taking NSAIDs, even in people who have no history of these health issues.
Experts like Dr. Narula, a cardiologist from Lenox Hill Hospital, said that before doctors used to think of it as affecting people who really might be at higher cardiovascular risk, this study shows that actually everybody is at risk.
CBS explains, “Now, prescription drug manufacturers will be required to put much stronger language that highlights the cardiovascular risks on the warning label of any NSAID product, including naproxen products, which manufacturers used to claim had less risk.”
What are NSAIDs?
One example is ibuprofen. Common brands of NSAIDs include Advil, Motrin, Aleve and Celebrex. The pills are used for everything from headaches, cold, flu and menstrual cramps to chronic or long-lasting conditions like arthritis, back pain and muscle aches.
Researchers found that many people use them in larger doses than recommended and often like they are long-term medicines. Patients with chronic, serious pain or inflammation often take many NSAIDs every day, despite label warnings that the drugs should not be used longer than 10 days for pain or three days in the case of a fever.
A trade group that is representing the manufacturers and marketers of over-the-counter medicines, known as the Consumer Healthcare Products Association, told CBS This Morning that over the counter NSAIDS are safe and effective when used as they are supposed to be used.
Dr. Narula also told CBS, “The FDA is really saying there's no safe period, there's no safe duration of use. And the problem is that people don't really use it as the label states. I have many patients who chronically take Advil or Aleve. People don't think of these as being dangerous.”
What are manufacturers of these painkillers saying?
Bayer Healthcare for example, which manufactures Aleve, Midol and other NSAID products, said, they plan to work with ‘the FDA to incorporate additional label information" as appropriate.
The stricter warning for NSAIDs adds to the larger warning requirements that were included on labels in 2005, after the drug rofecoxib, commonly known as Vioxx was taken from the market when studies confirmed heightened heart attack and stroke threat.
What kinds of points will the FDA want to be one these warning labels?
The FDA's stricter language about the threat for heart attack and stroke for NSAID warning label includes things like: the threat of heart attack or stroke can occur as early as the first weeks of using an NSAID and may increase with longer use, and the risk appears greater at higher doses NSAIDs can increase the risk of heart attack or stroke in patients with, or without heart disease or risk factors.