FDA: Use Caution – NSAIDS Can Cause Heart Attacks or Strokes

The risk of heart attack and stroke with NSAID use was first reported in 2005.  Since then, numerous studies have been conducted to determine the degree of risk and what factors affect those risks.  The studies were discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee in 2014.

After that meeting, the FDA issued a Drug Safety Communication in July 2015 which strengthened their warning for this family of medications.  The Safety Announcement, the Additional Information for Patients and Consumers, and link to the full document on the FDA website are included below.

If you are considering taking NSAIDS for pain relief, you have options.  Chiropractic care is safe and highly effective for many patients with various types of pain including arthritis, spinal pain, menstrual pain, headache just to name a few.

Contact your local chiropractor to schedule an evaluation and see how chiropractic can help you get on the road to pain relief without the risks associated with many medications.

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.

Additional Information for Patients and Consumers

• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke, either of which can lead to death. There are a large number of studies that support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied. These serious side effects can occur as early as the first weeks of using an NSAID and the risk may increase the longer you are taking an NSAID.
• The risk appears greater at higher doses; use the lowest effective amount for the shortest possible time.
• Seek medical attention immediately if you experience symptoms such as:
  • Chest pain
  • Shortness of breath or trouble breathing
  • Sudden weakness or numbness in one part or side of the body
  • Sudden slurred speech
• Many medicines contain NSAIDs, including those used for colds, flu, and sleep, so it is important to read the labels and avoid taking multiple medicines that contain NSAIDs.
• Patients who take low-dose aspirin for protection against heart attack and stroke should know that some NSAIDs, including those in over-the-counter (OTC) products such as ibuprofen and naproxen, can interfere with that protective effect.
• Read the patient Medication Guide you receive with your NSAID prescription. It explains the risks associated with the use of the medicine. You may access Medication Guides by clicking on this link.
• Read the Drug Facts label before taking an OTC NSAID. Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them.
• Report side effects from NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

 

SOURCE:  The U.S. Food & Drug Administration. https://www.fda.gov/Drugs/DrugSafety/ucm451800.htm