ADR that result in revision of patient information
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| The United States: Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA strengthens warning of increased chance of heart attack or stroke |
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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 FDAs comprehensive review of new safety information, FDA is 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. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. 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.
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 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.
Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm454141.htm
In Hong Kong, NSAID-containing products are registered pharmaceutical products with ingredients such as diclofenac, ibuprofen, naproxen, indomethacin, mefenamic acid and piroxicam. Most of the products are prescription-only medicines, except ibuprofen which is a pharmacy-only medicine and aspirin which is an over-the-counter medicine.
Safety alerts regarding the cardiovascular risks associated with NSAIDs has been released by various overseas regulatory authorities, and was posted on the Drug Office website since 2011, with the last update posted on 27 June 2015. Letters to healthcare professionals to draw their attention to the alerts were issued on 30 September 2011 and 7 October 2014.
The matter related to cardiovascular risk of NSAID was discussed in the meeting of the Registration Committee of the Pharmacy Poisons Board (the Committee) in February 2013. The Committee concluded that NSAID-containing products, other than external preparations and aspirin, should include new safety warnings regarding the cardiovascular risk. So far, the DH has received 13 cases of adverse drug reaction related to NSAIDs, and none of them were related to cardiovascular event. In view of the latest news on strengthening of warning on cardiovascular effects caused by NSAIDs, the matter will be further discussed in the meeting of the Committee.
Ends/ Friday, July 10, 2015
Issued at HKT 15:00
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