FDA warns against risk of heart attack and stroke with NSAIDs

The US drug regulatory agency, the FDA, has asked US-based drug manufacturers to strengthen the labeling of all non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen and diclofenac, because of the risk of myocardial infarction or stroke. The FDA reviewed several scientific studies to reach these conclusions. NSAIDs are sold without the need for a medical prescription and already contain the reference to the risk of heart attack and stroke in the leaflet, but it is not yet present in all leaflets. The novelty of this research says that an individual taking an NSAID, even if he has no history of cardiovascular problems, has an increased risk of suffering from a heart attack or stroke. In other words, everyone is at risk when taking a drug in this class.

NSAIDs, highly prescribed drugs

NSAIDs are pain and inflammation remedies and are among the most prescribed. These anti-inflammatories are indicated in many diseases and disorders such as arthritis , menstrual disorders, headaches , backaches , viral infections, etc. Unlike steroidal anti-inflammatory drugs such as cortisone, NSAIDs are believed to have fewer side effects and contraindications, which is why they are widely used without a prescription. Examples of NSAIDs are ibuprofen , diclofenac , celecoxib and naproxen (little used in Europe, but much more common in the Americas). It is important to mention that paracetamol does not belong to the class of NSAIDs.

New FDA decision

The FDA, probably the most influential drug agency in the world (by its budget and US weight in global medicine), has forced NSAID manufacturers since 2005, with the Vioxx scandal, to express a black warning on the drug packaging on the risk of myocardial infarction and stroke . Since 2005, the FDA has reviewed a number of studies on NSAIDs, including clinical data.

Risk even after a few weeks of treatment

Washington experts concluded that NSAIDs sold in the United States (except aspirin and generics), whether prescription or over-the-counter, should include the following information in the package insert:

– The risk of myocardial infarction or stroke can manifest itself already in the first months of treatment with an NSAID. Risk may increase with duration of treatment (note: according to scientists, more studies are needed to confirm or refute this hypothesis).

– The risk is greater with increasing dose.

– Scientists initially thought that the risk of heart attack and stroke was the same for all NSAIDs. However, and according to new FDA studies, researchers have doubts. It may be that some NSAIDs have a higher risk, but more studies are needed to see this effect more clearly. That’s why, for now, the FDA recommends putting the same information for all NSAIDs (except aspirin).

– NSAIDs may increase the risk of heart attack and stroke in people with or without a risk factor. In other words, each individual taking this class of drugs may be at greater risk.

Note that the list is not exhaustive, for simplicity we have taken the most essential points. You can find the full article in the FDA references at the end of this text.

Practical question, when to see a doctor?

If a person is taking an NSAID and has symptoms such as chest pain, difficulty breathing and shortness of breath, weakness on one side of the body, or slurred speech, see an emergency doctor immediately.

To remember

This study shows that it is important to consume a smaller amount of NSAIDs, with a smaller dose and duration. Do not hesitate to ask your doctor or pharmacist for advice and possibly find alternatives.

Jeanne Kenney
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I’m a stylist trainer, a content creator, and an entrepreneur passion. Virgo sign and Pisces ascendant, I move easily between my dreams, the crazy world I want, and my feet on the ground to carry out my projects.

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