Novartis to change name, repackage Maalox Total Relief
ROCKVILLE, Md. Choosing the wrong liquid Maalox product can have harmful consequences, the Food and Drug Administration warned consumers as part of a consumer update posted to its site Wednesday.
The FDA is concerned that consumers may be confused by the similar packaging and labeling of liquid Maalox and Maalox Total Relief. The two products are intended for the relief of different symptoms and contain different active ingredients, the agency noted.
Maalox Total Relief is an upset stomach reliever and antidiarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.
Novartis Consumer Health has agreed to change the name of Maalox Total Relief to one that does not include the word “Maalox,” and will change the drug’s packaging to avoid further confusion, the FDA stated in a separate press release.
“Maalox Total Relief and Maalox are not interchangeable and shouldn’t be used in place of each other,” state Carol Holquist, director of FDA’s division of Medication Error Prevention and Analysis. “Consumer confusion and incorrect product use due to name confusion are serious public health issues. We appreciate Novartis’ efforts to work collaboratively with FDA and their decision to remedy this situation to avoid any confusion over Maalox products in the future.”
Maalox Total Relief’s active ingredient (bismuth subsalicylate) is chemically related to aspirin and may cause similar harmful side effects such as bleeding. As such, Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder. Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by 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.
The renamed product is expected to begin selling in September 2010. Until that time, FDA is advising consumers and healthcare professionals to carefully check the labels of all Maalox products to ensure the appropriate product is being selected for the patient’s symptoms.
CRN opens international headquarters
WASHINGTON The Council for Responsible Nutrition on Tuesday announced the opening of its international headquarters in Manno, Switzerland. CRN will be opening a new wholly-owned entity to be known as the Council for Responsible Nutrition-International (CRN-I), the dietary supplement industry association announced.
“This was a natural progression for CRN to formalize the work it’s been doing for decades by standing up for science-based principles for dietary/food supplements worldwide,” stated Mark LeDoux, CRN. “CRN-I will provide a new forum by which we can strengthen our current efforts, with a particular emphasis on promoting sound nutrition and food safety policies, and encouraging government bodies, regulators and other decision makers to make policy recommendations that are well-grounded in science. In this global economy, having a European-based platform from which to disseminate science-based policy recommendations has been imperative to maximize our influence on behalf of our multi-national members doing business around the world.”
The new organization announced its immediate first priority is to conduct a one-day scientific symposium –“Scientific Issues Related to Codex Goals” — taking place July 3 in Geneva, Switzerland, in tandem with the Codex Alimentarius Commission meeting. The CRN-I conference will include invited international regulators and policy makers, nutrition scientists and academics, to share perspectives on Codex-related issues relating to risk management and scientific standards for health claims.
“We have a responsibility to our members and to our consumers worldwide to ensure that regulators and policy makers have the opportunity to engage in intellectual, peer-reviewed, science-based discussions so that they can consider these viewpoints as part of their policy-making process,” LeDoux said.
The CRN-I Board will be announced at the first CRN-I annual meeting, scheduled for April 15 in Paris in conjunction with the meeting of the Codex Committee on General Principles.
For more information, visit www.crn-i.ch.
Shaking up protein times 6
ORLANDO, Fla. —BSN last month showcased its line of ready-to-drink protein supplements at the ECRM Vitamin, Diet & Sports Nutrition meeting here. The company’s RTD protein supplements already are best-sellers at specialty shop GNC and military retailer AAFES.
The new-to-mass RTD protein shake, called Syntha-6, features six proteins—including milk, whey and soy—that each are metabolized by the body at different rates, allowing for a more gradual supplementation of protein.
Sports enthusiasts and avid dieters may be credited with driving sales of protein supplements higher last year by some 22%; for the 52 weeks ended Dec. 26, 2009, sales of protein supplements reached $148.3 million across food, drug and mass (including Walmart), according to Nielsen Group data.
For 2010, BSN is planning $3.2 million in advertising.