What is in a name? A good deal, according to the Food and Drug Administration (FDA), as 2 medications for unlike ailments have just about the same name. Confusing the 2 may indicate risk for consumers.
The federal agency is cautioning consumers around the potential for dangerous fallouts from erroneously utilizing Maalox Total Relief rather than other Maalox merchandise. The two products are meant for the alleviation of unlike symptoms and comprise differing active agents.
In the meantime, the Food and Drug Administration has squeezed Novartis Consumer Health to modify the name of one of the products.
Maalox Total Relief is an indigestion comforter and antidiarrheal drug medicine, whereas traditional Maalox fluid products, Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength, are antiacids. Both products can be bought as nonprescription fluid medicines.
Below FDA insistency, Novartis has concurred to alter the name of Maalox Total Relief to one that doesn’t contain the word “Maalox” and will modify the drug’s boxing to avert additional disarray, the federal agency said.
Maalox Total Relief’s active component, bismuth subsalicylate, is chemically associated to aspirin and could induce similar adverse fallouts including bleeding. Due to this, Maalox Total Relief isn’t suitable for persons with a history of gastrointestinal ulceration disease or a bleeding condition.
Maalox Total Relief likewise shouldn’t be consumed by minors and teens if they’re convalescing from a virus infection, nor by persons who are consuming specific medicines such as: oral antidiabetics (OADs), anticoagulation (thinning out the blood) drugs including warfarin (Coumadin) and clopidogrel (Plavix), nonsteroidal anti-inflammatories (NSAIDS), and additional anti-inflammatory drugs.
Boxing and marking of Maalox Total Relief and traditional Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are very alike and often jumbled up, the FDA says.
The renamed merchandise is anticipated to start distribution in Sept 2010. Till that time, the Food and Drug Administration is notifying consumers and health care professionals to cautiously verify the tags of all Maalox merchandise to guarantee the suitable product is being picked out for the patient’s symptoms.
