Maalox Total Relief isn’t the same Maalox patients may know

Error Alert

Many OTC products have trade names that are well known to patients. When the companies making these products develop new ones—even those with different active ingredients and for different conditions—they sometimes use the same trade name because of the product’s name recognition and popularity. As a result, patients may unknowingly use a product containing an ingredient that could put them at risk or that is meant for a different condition.

Similar name, different ingredients and uses

FDA alerted the public about the potential for serious adverse effects if patients mistakenly use Maalox Total Relief, which contains bismuth subsalicylate, instead of other Maalox products that contain magnesium and aluminum hydroxides.1 FDA had received five reports of harmful medication errors in patients unknowingly taking the bismuth subsalicylate product.

Bismuth subsalicylate may cause serious adverse effects such as bleeding. Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease, a bleeding disorder, or an allergy to aspirin. Because of the threat of Reye’s Syndrome, it should not be taken by children or teens recovering from a viral infection. It should be used with caution by individuals taking certain drugs, such as oral antidiabetics, anticoagulants, clopidogrel, NSAIDs, and other anti-inflammatory drugs.2

Maalox brand-name extensions may cause confusion

"Bismuth subsalicylate" may be overlooked if patients and practitioners associate the name Maalox with the magnesium and aluminum hydroxides component. For OTC monograph drugs, a new drug application (NDA) or abbreviated NDA does not have to be filed. These are OTC drugs that have not been approved by FDA through a direct application but are legally marketed under regulations referred to as “OTC monographs” established through FDA’s OTC Drug Review.

According to FDA, monograph drugs are “generally recognized as safe and effective” for their intended uses. Thus, companies are able to market certain OTC products, such as bismuth subsalicylate, without specific FDA approval of the product names. Without FDA’s review, companies have been able to capitalize on a well-known, trusted brand name and use it for any product, including OTC products with different ingredients. However, many safety experts, including the Institute for Safe Medication Practices (ISMP) and others at FDA, believe that brand-name extensions for OTC products present a safety concern and should not be used unless at least one ingredient from the original product is present in the new or modified product.

The pharmacist’s role

Pharmacists are readily available to advise patients on proper OTC selection as well as to counsel patients on managing common adverse effects. To help prevent errors, pharmacists should continue to teach patients what conditions these products can treat. Namely, Maalox Total Relief, with the active ingredient bismuth subsalicylate, is indicated for the relief of diarrhea as well as upset stomach associated with nausea, heartburn, and gas.

On the other hand, the more traditional Maalox liquid products containing aluminum hydroxide, magnesium hydroxide, and simethicone, such as Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength, are indicated for the relief of acid indigestion, heartburn, and pressure and bloating. In addition, Maalox Advanced Maximum Strength is also available in a chewable form that contains ingredients different from the liquid formulation. The chewable tablets contain calcium carbonate and simethicone.

Consider posting an alert near these products advising patients to consult a pharmacist before purchasing one of them. Teach patients to look for and read the Drug Facts labels, specifically the active ingredients and uses, which are required by FDA on all OTC products.

References

www.fda.gov/downloads/forconsumers/consumerupdates/ucm200773.pdf

www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm199476.htm