The U.S. Food and Drug Administration (FDA) is calling on drug
makers of some popular painkillers to strengthen their warning labels after a
review of new safety information. The warning labels on non-aspirin non steroidal anti-inflammatory drugs, known as NSAIDs, must be updated to
identify an increased risk of a heart attack or stroke.
NSAIDs are typically given to relieve pain or
fever that results from, but not limited to, arthritis flu, headaches and
menstrual cramps. Higher doses require a prescription, while lower doses are
available over-the-counter. The warning applies to both. Brand names include
Celebrex, Advil, Naprosyn, Aleve and Daypro, to name a few.
Bayer (manufacturer of Aleve) released a statement to CNN
saying: "When taken as directed on the label, Aleve (naproxen sodium 220
mg) is a safe and effective pain reliever, used by millions of consumers since
its introduction as an OTC product 20 years ago. Importantly, data collected
for nearly 20 years indicates no signal (i.e., trend) for OTC naproxen sodium
with regard to the occurrence of (cardiovascular) thrombotic and overall
The statement added: "We will work with the FDA to incorporate
additional label information as appropriate."
Pfizer (manufacturer of Celebrex and Advil) released a statement
saying: "For over 30 years, extensive consumer use and several clinical
studies have shown that Ibuprofen, when used as directed, is a safe and
effective over-the-counter pain reliever delivered in a lower strength than
"We are committed to patient safety, and we will work with
the FDA to make sure that new safety information is appropriately added to our
packaging/drug facts label so that consumers can continue to safely use our
The FDA issued, what it calls a drug safety communication,
saying the labels must include, "the risk of heart attack or stroke can
occur as early as the first weeks of using an NSAID. The risk may increase with
longer use of the NSAID. The risk appears greater at higher doses."
Additionally, labels should say that the risk is not limited to patients with
heart disease, and that patients with heart disease have a higher risk. The FDA
says there is not sufficient evidence to determine whether the risk is the same
for all NSAIDs. There is also an increased risk for heart failure associated
with these medications.
The risks for prescription NSAIDs are greater because they are
higher dosages and prescribed for daily use. In contrast, over-the-counter
NSAIDs are taken intermittently and at lower dosages and thus carry a lower
The move comes after an advisory committee reviewed these
medications and the associated risks for cardiovascular events in February
2014, and recommended a strengthened warning.
Dr. Steven Nissen, chief of cardiovascular medicine at the
Cleveland Clinic, agrees with the evidence that these drugs do increase a
person's risk for heart attack and stroke. He says the warning, though is vague
but has to be because there is no good data to give consumers or doctors a
definitive answer. "What patients need to know is, if you take the drugs,
'What is my risk of heart attack?' and that's not known yet," Nissen says.
He blames this on the drugs being approved before current vigorous outcome data
was required by the FDA.
Nissen told CNN, "The writing has been on the wall for a
long time." After all, he is no stranger to these concerns. His 2001 study
was the first to raise a red flag over the drug Vioxx, a COX-2 inhibitor, made
by Merck, that was pulled from the market. On the heels of that, another COX-2
inhibitor, Bextra, was withdrawn.
Fifteen years later there is still not a definitive answer.
"We don't have any good data," Nissen says. In search
of that robust scientific data on the risk of these drugs and whether or not
the risk varies between these drugs, he and a group of his colleagues have been
following 24,000 patients since 2007 in a randomized clinical trial. The study
participants are divided into three groups treated with ibuprofen, Celebrex, or
naproxen. The patients nor the doctors know who is getting which drug. The
Precision trial, as its called, is funded by Pfizer and results are expected
Atlanta internist Dr. Anna Steinberg agrees that the FDA's
warning is too vague. She says doctors already avoid NSAIDs for patients with
congestive heart failure or high blood pressure. For patients with no risk,
"I am not going to tell them to stop taking these," she says, adding
that alternatives for pain relief other than acetaminophen are limited. She
believes the FDA should have waited until it could offer more definitive
guidance, saying this creates, "Way to much room for mass hysteria."
In the meantime, Nissen says the best advice for patients is
"take these at the lowest dosages for the least amount of time that
relieves symptoms." He says people should not be afraid to take ibuprofen
but if you have heart disease you should be more cautious.
FDA advises patients who experience shortness of breath, chest pain, sudden
numbness or weakness, or sudden slurred speech to seek immediate medical
attention. Other side effects should be reported to the agency.