On November 3, 2016, the FDA warned consumers about the risk of serious bleeding when using nonprescription, 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. Heartburn is among the most common gastrointestinal symptoms presenting to both generalist physicians and gastroenterologists. Many products to treat this are available, but risks are present also.
Heartburn occurs when stomach contents flow back up into the esophagus, the muscular tube that carries food and liquids from the mouth to the stomach. Also called acid indigestion, heartburn is an uncomfortable, burning feeling in the mid-chest, behind the breastbone, or in the upper part of the abdomen. This feeling occurs because the stomach’s digestive juices contain acid. Sometimes people with this problem can taste food or acidic fluid in the back of the mouth. Pregnancy, certain foods, alcohol, and some medications can bring on heartburn. Treating heartburn is important because over time reflux can damage the esophagus.
There are three classes of over-the-counter (OTC) medications for the treatment of heartburn: antacids, proton pump inhibitors, and H2 blockers.
Antacids, such as Mylanta, Rolaids, and Tums, help to treat mild heartburn (indigestion). They work by changing the stomach acid that causes heartburn. Antacids are a good treatment for heartburn that occurs once in a while. Liquid ones work faster. Antacids may be taken about one hour after eating or when experiencing heartburn. When taking them for symptoms at night, they should not be taken with food.
OTC Proton pump inhibitors (PPIs), such as Prevacid 24h (lansoprazole), Nexium 24h (esomeprazole), Prilosec (omeprazole magnesium), and Zegerid (omeprazole and sodium bicarbonate), are used to treat frequent heartburn and work by reducing the amount of acid in the stomach. In contrast, prescription PPIs are used to treat conditions like gastoesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.
PPIs are taken by mouth. They are available as tablets or capsules. Commonly, these medicines are taken 30 minutes before the first meal of the day. OTC PPIs are only intended for a 14-day course of treatment and can be used up to three times per year.
H2 blockers, such as Tagamet HB (cimetidine), Pepcid Complete or Pepcid AC (famotidine), Axid AR (nizatidine), and Zantac (ranitidine), work by reducing the amount of acid in the stomach. These medicines are most often taken with the first meal of the day. In some cases, you may also take them before your evening meal. It takes 30 to 90 minutes for the medicines to work. The benefits will last several hours. People often take the drugs at bedtime, as well. Symptoms may improve for up to 24 hours after taking the drug. Side effects from H2 blockers are rare.
These medications should not be misused, abused, or taken for longer than stipulated on the label. If heartburn symptoms persist even after taking these drugs, a health care professional should be consulted.
These widely used products already contain warnings about bleeding risks on their labels. However, the FDA continues to receive reports of this serious safety issue. As a result, the agency will continue to evaluate this safety concern and plans 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, 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.
People having one or more of the following risk factors may have a higher chance of serious bleeding when taking aspirin-containing antacid products. The risk factors are: (1) being over 60 years of age, (2) having a history of stomach ulcers or bleeding problems, (3) taking a blood thinner or steroid medicine, (4) taking NSAIDs such as ibuprofen or naproxen, and (5) drinking three or more alcoholic drinks per day.
Consumers should 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 choosing a product without aspirin to relieve symptoms is preferable.
Use of Proton Pump inhibitors may also have risks including a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications. The safety information, released in 2010 and 2011, is based on the FDA's review of several studies that found those at greatest risk for fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older, and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the "Drug Facts" label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. The FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.
The FDA informed the public in 2012 that the use of PPIs may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve.
See the FDA Information for Consumers
See also Medical Law Perspectives, December 2016 Report: Gastrointestinal Disorder and Disease Liability Risks (to be published Dec 6, 2016)
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication