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Raised risk: FDA strengthens heart safety warnings on painkillers

Jul. 9, 2015 at 6:22 PM

Maggie Fox

TODAY

The Food and Drug Administration is strengthening its warnings about painkillers like ibuprofen, saying  they do raise the risk of heart attack or stroke.

People should think carefully about taking these drugs, both over-the-counter versions and prescription pills, the FDA says. It's asking manufacturers to change the labels.

"They used to say they might cause risk of heart attack or stroke. Now we are saying they do cause increased risk of heart attack and stroke," FDA spokesman Eric Pahon told NBC News.

The warning covers drugs called nonsteroidal anti-inflammatory drugs or NSAIDS for short. They include ibuprofen, sold under brand names like Advil or Motrin; naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors, such as Celebrex. Tylenol, known generically as acetaminophen, is not an NSAID.

Cough and cold remedies can also contain NSAIDs as an ingredient.

"Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient," the FDA said

FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death," the agency said in a statement.

"Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn't apply to aspirin.)"

Last year, FDA said it was reviewing the safety of these drugs.

Some of the studies they looked at showed a clear pattern: people who took NSAIDS were more likely to have heart attacks or strokes.

"There is no period of use shown to be without risk," said Dr. Judy Racoosin, deputy director of FDA's Division of Anesthesia, Analgesia and Addiction Products.

"In the coming months, the FDA will request that manufacturers update the existing cardiovascular risk information in Drug Facts labels for over-the-counter (OTC) non-aspirin NSAIDs. Consumers and health care professionals should remain alert for the development of heart- and stroke-related symptoms throughout the time a consumer takes any NSAID," FDA said.

This doesn't mean people should just stop taking NSAIDS, FDA said.

"Take the lowest effective dose for the shortest amount of time possible," said FDA's Dr. Karen Mahoney.

The American Heart Association advises people to try acetaminophen (Tylenol) first.

"If you have heart disease or high blood pressure, consult a health care provider before using an NSAID," FDA added.

"Balance the benefits of NSAIDs with the possible risks and weigh your options. If you take low-dose aspirin for protection against heart attack and stroke, you should know that some NSAIDs, including ibuprofen and naproxen, can interfere with that protective effect."

And the agency gives advice on what symptoms to look for.

"Stop taking NSAIDs and seek medical help if you 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."

In 2013 Americans bought more than 275 million boxes of over-the-counter NSAIDs, racking up $1.7 billion in sales, according to retail tracker IRI.


FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

[ 7-9-2015 ]

Safety Announcement

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on our comprehensive review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. We will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs).

The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials,2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

Based on our review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:

  •        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.
  •         It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
  •         NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
  •         In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
  •         Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  •         There is an increased risk of heart failure with NSAID use.

We will request similar updates to the existing heart attack and stroke risk information in the Drug Facts labels of OTC non-aspirin NSAIDs.

In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to reflect the newest information available about the NSAID class.

Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. We urge you to report side effects involving NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page

·        NSAIDs are a class of medicines available by prescription and over-the-counter (OTC). They are some of the most commonly used pain medicines.

·        NSAIDs are used to treat pain and fever from medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu.

 Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib. See table below for a list of non-aspirin NSAIDs.

Generic name

Brand name(s)

celecoxib

Celebrex

diclofenac

Cambia, Cataflam, Dyloject, Flector, Pennsaid, Solaraze, Voltaren, Voltaren-XR, Zipsor, Zorvolex, Arthrotec (combination with misoprostol)

diflunisal

No brand name currently marketed

etodolac

No brand name currently marketed

fenoprofen

Nalfon

flurbiprofen

Ansaid

ibuprofen*

Advil, Caldolor, Children’s Advil, Children’s Elixsure IB, Children’s Motrin, Ibu-Tab, Ibuprohm, Motrin IB, Motrin Migraine Pain, Profen, Tab-Profen, Duexis (combination with famotidine), Reprexain (combination with hydrocodone), Vicoprofen (combination with hydrocodone)

indomethacin

Indocin, Tivorbex

ketoprofen

No brand name currently marketed

ketorolac

Sprix

mefenamic acid

Ponstel

meloxicam

Mobic

nabumetone

No brand name currently marketed

naproxen*

Aleve, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprosyn, Treximet (combination with sumatriptan), Vimovo (combination with esomeprazole)

oxaprozin

Daypro

piroxicam

Feldene

sulindac

Clinoril

tolmetin

No brand name currently marketed

*There are many over-the-counter (OTC) products that contain this medicine.

References

1.       Food and Drug Administration [Internet]. Silver Spring, MD. FDA Briefing Information for the February 10-11, 2014 Joint Meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM383180.pdf. Accessed December 23, 2014.

2.       Coxib and traditional NSAID Trialists' (CNT) Collaboration, Bhala N, Emberson J, Merhi A, Abramson S, Arber N, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet 2013;382:769-79.

Drug Safety Communication (PDF- 84KB)

Related Information

·        Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

·        2014 Meeting Materials, Arthritis Advisory Committee

·        Medication Guides

·        FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs

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