MAYNE PHARMA WARNED OVER MISLEADING VITAMIN PROMOTION

A promotional mailer for a vitamin infusion made by Mayne Pharma is false and misleading because it omits important risk information, according to an FDA warning letter that asks the company to immediately stop disseminating the materials.

The promotional materials for M.V.I.-12 (multivitamin infusion without vitamin K) misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act, says the warning letter, released recently by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC).

"This is particularly concerning from a public health perspective because the lack of risk information suggests that M.V.I.-12 is safer than has been demonstrated by substantial evidence or substantial clinical experience," the letter said.

The product is indicated for the prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition, and who also receive warfarin-type anticoagulant therapy. The labeling includes a warning the product contains aluminum that may be toxic, and an adverse reactions section that states there have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine.

Mayne's promotional mailer presents various effectiveness claims, including that it contains "minimAL aluminum" (emphasis original) and "optimAL nutrition for individuAL needs" (emphasis original), DDMAC said.

But the promotion fails to provide any risk information, the letter added. "The promotional mailer includes a reference to the full prescribing information; this statement, however, is not sufficient to provide appropriate qualification or pertinent information for claims made in the mailer," DDMAC said.

A copy of the letter is available at http://www.fda.gov/foi/warning_letters/g5705d.pdf (http://www.fda.gov/foi/warning_letters/g5705d.pdf).