FDA Warns Of Severe Bleeding Risks Associated With Over-The-Counter Antacid Containing Aspirin


FDA Issues Warning Stating OTC Antacids Containing Aspirin Pose Risk of Severe Internal Bleeding. Antacids That Include Aspirin And Could Be Associated May Include Alka-Seltzer, Bromo Seltzer, And Other NSAIDS.

Antacid-Bleeding Risk-Side-EffectThe U.S. Food and Drug Administration (FDA) is warning that over-the-counter aspirin-containing antacids may cause internal bleeding. The agency advises consumers to read safety labels of over-the-counter medications that treat upset stomach, sour stomach, acid indigestion or heart burn to see if they contain aspirin before taking them. Some OTC antacids containing aspirin, and that may pose a risk of severe internal bleeding may include Alka-Seltzer, Bromo Seltzer, And Other NSAIDS. The FDA first warned about bleeding risks with aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) in 2009. Since that time, the agency reviewed its Adverse Event Reporting System database and found eight new cases of serious bleeding caused by aspirin-containing antacid products. In some cases, blood transfusions were needed.

In its warning, the FDA cautioned that since it only reviewed cases from its own database, more OTC aspirin-related bleeding cases have probably occurred but have gone unreported. OTC Aspirin-containing antacid products are sold under different trade names such as Alka-Seltzer Original, Bromo Seltzer, Picot Plus Effervescent, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. In its safety warning issued in June, the FDA recommended consumers take over-the-counter products that relieve heartburn and stomach symptoms and do not contain aspirin.

“Consumers may not realize that the familiar antacid products they routinely use to treat stomach upsets or heart burn can cause side effects, and even more serious health conditions. People should be aware of the FDA’s findings” says Southern Med Law attorneys.

Southern Med Law is currently investigating antacid bleeding risk lawsuits after speaking with people who have had side-effects from over-the-counter antacids. The firm has also launched a webpage to keep consumers aware of any information or news on this and other dangerous drug lawsuits. If you or a loved one believe you have experienced internal bleeding as a result of regularly taking over-the-counter antacids that contain aspirin to remedy acid indigestion, heart burn or an upset stomach, contact Southern Med Law for a free antacid bleeding risk lawsuit consultation and get the help you deserve. You can speak with one of the firms attorney’s by calling 205-547-5525 or you can visit www.southernmedlaw.com and fill out the contact form on our website.

Aspirin is considered a nonsteroidal anti-inflammatory drug (NSAID) that consumers commonly use to treat headache, body aches and pains, and reduce fever. In addition to aspirin, other popular NSAIDs include ibuprofen (Advil, Motrin) and naproxen (Aleve). The eight antacid cases the FDA highlighted were among 41 total reports the agency received from 1969 to 2014. All of the patients were hospitalized in these reports. Most of the patients recovered. However, one death was reported but the case provided few details of the patient’s underlying medical conditions or the cause of death. [fda.gov/ForConsumers/ConsumerUpdates/ucm505110.htm, FDA, June 6, 2016]

The FDA says individuals at risk for internal bleeding:

• Are over 60
• Have a history of stomach ulcers or bleeding problems
• Take blood thinners
• Take a steroid medicine to reduce inflammation
• Take other medicines containing NSAIDs
• Drink three or more alcoholic drinks every day.

These were underlying conditions reported in the eight cases of severe bleeding reported to the FDA since 2009.

In 2009, the FDA issued a safety alert that NSAIDs could cause bleeding in the stomach and gastrointestinal tract. Besides internal bleeding, the federal regulator also warned that NSAIDs have the potential to cause heart attacks and strokes. Due to the life-threatening injuries associated with NSAIDs, the FDA required NSAID manufacturers to carry a warning on their products’ safety labels about the bleeding and cardiovascular risks.
[fda.gov/ForConsumers/ConsumerUpdates/ucm453610.htm, FDA, July 9, 2015]

About Southern Med Law And Filing An Antacid Bleeding Risk Lawsuit

Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Southern Med Law
Southern Institute for Medical and Legal Affairs
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526

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