Adr bulletin 

by

Shinu.c ,Asst professor, Alshifa college of pharmacy.

Non-aspirin Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

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 e.t.c.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.

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, FDA have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications.Based on the review and the advisory committees’ recommendations, 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.

·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.

·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.

Additional Information for patients:

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 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.

· 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.

Additional Information for health care professional:

Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, either of which can be fatal. There are a large number of studies that support this finding, with varying estimates of how much the risk is increased. Estimates of increased risk range from 10 percent to 50 percent or more, depending on the drugs and the doses studied. This risk may occur as early as the first weeks of treatment and may increase with duration of use.

·Remain alert for the development of cardiovascular adverse events throughout the patient’s entire treatment course, even in the absence of previous cardiovascular symptoms.

·Inform patients to seek medical attention immediately if they experience symptoms of heart attack or stroke such as chest pain, shortness of breath or trouble breathing, sudden weakness or numbness in one part or side of the body, or sudden slurred speech.

·The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses.

·To minimize the risk for an adverse cardiovascular event in patients treated with an NSAID, prescribe the lowest effective dose for the shortest duration possible.

·Some NSAIDs, including those in OTC products such as ibuprofen and naproxen, can interfere with the antiplatelet action of low dose aspirin used for cardio protection by blocking aspirin’s irreversible COX-1 inhibition.

Report adverse events involving NSAIDs .