Other safety alerts
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| The United States: Over-the-Counter Antacid products containing Aspirin: FDA Drug Safety Communication - serious bleeding risk |
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The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.
These widely used products already contain warnings about this bleeding risk on their labels; however, FDA continues to receive reports of this serious safety issue. As a result, FDA will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed.
OTC aspirin-antacid products are sold under various trade names in the U.S., including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generic products.
In 2009, a warning about the risk of serious bleeding was added to the labels of all OTC products that contain NSAIDs, including aspirin-containing antacid products. However, a search of the FDA Adverse Event Reporting System (FAERS) database identified eight cases of serious bleeding events associated with these products after the warning was added. All of these patients were hospitalized. Patients had underlying conditions such as the risk factors above that put them at greater risk for developing serious bleeding events. Data summary can be found at the FDA website. The FAERS database includes only reports submitted to FDA so there are likely additional cases about which FDA is unaware.
Aspirin is a commonly used pain reducer and fever reducer. It is a nonsteroidal anti-inflammatory drug (NSAID) that can increase the risk of bleeding, including in the stomach and gastrointestinal (GI) tract. Patients at a higher chance of serious bleeding when taking aspirin-containing antacid products include:
• Are 60 years or older
• Have a history of stomach ulcers or bleeding problems
• Take a blood-thinning or steroid medicine
• Take other medicines containing NSAIDs such as ibuprofen or naproxen
• Drink three or more alcoholic drinks every day
Patients taking more of these medicines than the amount recommended or for a longer period than recommended will increase the risk of serious bleeding.
Consumers are advised to read the Drug Facts label carefully when purchasing or taking an OTC product to treat heartburn, acid indigestion, or sour or upset stomach. If the product contains aspirin, consider whether they should choose a product without aspirin to relieve their symptoms.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm505190.htm
In Hong Kong, there are two registered pharmaceutical products which are antacid products containing aspirin, namely Alka Seltzer Tab 324mg (HK-45813) and Alka-Seltzer Effer Tab 324mg Lemon Flav (HK-44990). The warning that aspirin irritates the stomach and can cause bleeding is a labelling requirement for all registered pharmaceutical products containing aspirin. The sales pack label and package insert of both Alka Seltzer products have already included the information on risk of gastrointestinal bleeding. So far, the Department of Health (DH) has not received any adverse drug reaction case related to antacid containing aspirin. As the FDA is evaluating this safety concern to determine whether additional actions are needed, DH will remain vigilant on the conclusion of the evaluation and any safety updates by other overseas drug regulatory authorities.
Ends/ Tuesday, June 07, 2016
Issued at HKT 15:00
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