The U.S. Food and Drug Administration (FDA) recently strengthened its warnings
regarding nonsteroidal anti-inflammatory drugs (NSAIDs). The agency will
require medication labels to indicate that NSAIDs can increase the chance
of a heart attack or stroke, either of which can lead to death.
The FDA added a boxed warning (the most serious mandated by the FDA) to
prescription NSAID drug labels in 2005. According to the agency, more
recent data has prompted it to update NSAID labeling to clarify that the
risk of heart attack and stroke may occur early in treatment. In addition,
the risk might increase the longer people take NSAIDs.
“There is no period of use shown to be without risk,” Judy
Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia,
Analgesia, and Addiction Products,
stated in the FDA’s Consumer Update.
The new warning labels must also emphasize that individuals who have cardiovascular
disease, particularly those who recently had a heart attack or cardiac
bypass surgery, are at the greatest risk for serious complications associated
with NSAID use. "In basic, sufferers with heart disease or danger
aspects for it have a higher likelihood of heart attack or stroke,"
the FDA stated.
The new FDA requirements will apply to over-the-counter and prescription
drugs, which are taken by millions of Americans. NSAIDs are commonly used
to treat a range of health issues, including pain, inflammation and fever.
Common brand names include Aleve, Advil, Motrin, and Celebrex.
According to the FDA, consumers can still take NSAIDs but should be aware
of this increased risk of heart attack or stroke, especially at higher
doses. The agency further cautions that consumers should stop taking NSAIDs
and seek medical help if they experience symptoms that might signal heart
problems or stroke, such as chest pain, trouble breathing, sudden weakness
in one part or side of the body, or sudden slurred speech.
If you or someone you love has been seriously injured by a dangerous or
defective drug, don’t hesitate to
contacta San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.