May 27, 2020 by John Fernandez
Roundup: FDA Warns of Bleeding Risk From Antacid Products Containing Aspirin; Obesity Rates on the Rise for Women
The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, or over-the-counter (OTC), antacid products that contain aspirin. These products are used widely to treat heartburn, sour stomach, acid indigestion or upset stomach.
These products can cause stomach or intestinal bleeding in some people, warns the FDA. Many other products for these conditions that do not contain aspirin are available without prescriptions.
The FDA recommends that consumers always 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 you should choose a product without aspirin to relieve your symptoms.
“These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue,” the FDA said in a statement. “As a result, we 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.”
The FDA says that aspirin-antacid products are sold under various trade names, 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.
Aspirin is already known to cause stomach bleeding. Other drugs such as ibuprofen to treat pain or reduce fever also contain aspirin. They’re known as non-steroidal anti-inflammatory drugs or NSAIDs.
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. But the FDA said it found reports of eight people who had taken such products containing aspirin who had bleeding issues so serious they had to be hospitalized. The FDA said there are likely other cases that have gone unreported.
In its statement, the FDA said, “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. The FAERS database includes only reports submitted to FDA so there are likely additional cases about which we are unaware.”
If you have one or more of the following risk factors, you may have a higher chance of serious bleeding when taking aspirin-containing antacid products:
- 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
Obesity on the Rise for Women, CDC says.
Obesity rates among women continue to spike, according to a recent report from the U.S. Centers for Disease Control and Prevention (CDC). For women, the obesity rate was about 40 percent during 2013 – 2014 time period, the CDC reported in an article that appeared in the June 7 issue of Jama, the Journal of the American Medical Association. For men, the obesity rate was 35 percent for that same time period.
Morbid obesity trends were also troubling. Class 3 obesity is defined as a body mass index of over of over 40. About 5.5 percent of men and 10 percent of women were defined as class 3 obese, according to study results. The findings were based on information from 2,800 women (mean age of 48 years), and 2,600 men (mean age of 47), who had participated in the National Health and Nutrition Examination Survey.
“For women, the prevalence of overall obesity and of class 3 obesity showed significant linear trends for increase between 2005 and 2014; there were no significant trends for men,” the study says. “Other studies are needed to determine the reasons for these trends.”