Home -> Law Blog Directory -> Personal Injury Law Blogs -> New York City Personal Injury Lawyer

Personal Injury Law

: New York City Personal Injury Lawyer

FDA Warns of Label Confusion and Medication Errors with Maalox Liquid Products

By Paul Napoli

February 17, 2010

The U.S. Food and Drug Administration (FDA) is warning consumers and doctors that similar packaging of liquid Maalox and Maalox Total Relief may cause consumers to choose the wrong product for their condition, which can have harmful consequences. The FDA has received five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products.

Maalox and Maalox Total Relief are available without a prescription. Both over-the-counter products have similar packaging and labeling, but they contain different ingredients for the relief of different symptoms. The FDA is advising that consumers and healthcare professionals carefully check the labels of all Maalox products to ensure they are choosing the appropriate product for the patient's symptoms.

'Maalox Total Relief and Maalox are not interchangeable and shouldn't be used in place of each other,' says Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis.

Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate, which is chemically related to aspirin and may cause serious adverse effects such as bleeding. Maalox Total Relief should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder. Children and teens also should not take it if they are recovering from a viral infection, nor should individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.

Novartis Consumer Health, the maker of Maalox branded products, has agreed to change the name of Maalox Total Relief to one that will not include the name 'Maalox' and revise the graphics and information displayed on the front of the product to help distinguish the active ingredients and uses of this product from the Maalox antacids. The company expects to begin selling the renamed product in September 2010.

The company will also carry out an educational program that includes outreach to health care professionals and consumers to inform them about the different products sold under the Maalox brand, including how to select the appropriate Maalox brand product and will monitor the safety of Maalox brand products and report side effects related to their use.

'The FDA is concerned about the public health impact of medication mix-ups for products that have the same names or portions of the same name, but contain different active ingredients,' said Ms. Holquist. 'We want companies to consider the potential for name confusion when choosing names for their drugs.'

If you or a loved one has suffered a dangerous drug interaction or harmful side effects of over-the-counter or prescription medication, contact Napoli Bern Ripka, LLP at 888-529-4669 to discuss your options for filing a claim and recovering compensation for your medical expenses, lost wages and pain and suffering.

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on February 21, 2010 (boomark / email).