Report: FDA warns of long-term PPI use
SILVER SPRING, Md. — The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.
The reports quoted the FDA as saying that in a quarter of cases of proton-pump inhibitors depleting magnesium from the body, use of magnesium supplements did not bring levels back to normal, and use of the drugs had to be stopped.
The warning included popular drugs, such as AstraZeneca’s Nexium (esomeprazole magnesium), Prilosec’s (omeprazole) and others, as well as over-the-counter PPIs.
Drug makers file suit against Mylan over generic Vivelle-Dot
PITTSBURGH — A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.
The generic drug maker said that Novartis, Noven Pharmaceuticals and Vivelle Ventures had sued it in the U.S. District Court for the Southern District of New York and the U.S. District Court for the District of Vermont for its filing of a regulatory approval application for estradiol transdermal system, a generic version of Vivelle-Dot. Mylan’s application contained a paragraph IV certification, a legal assertion that the patent covering Vivelle-Dot is invalid, unenforceable or won’t be infringed, thus prompting the lawsuit.
The drug is used to treat menopause and hypoestrogenism and prevent postmenopausal osteoporosis. Sales of Vivelle-Dot were $215 million in 2010, according to IMS Health. Mylan was the first company to file for approval of a generic version and thus is entitled to 180 days of market exclusivity in which to compete directly with the branded version should it win final FDA approval.
Cardinal Health Foundation extends GenerationRx Initiative with grant program
DUBLIN, Ohio — The Cardinal Health Foundation is calling on nonprofits in select areas to apply for grant funding to support local efforts to prevent the abuse and misuse of prescription medications.
The program, which is an extension of the foundation’s GenerationRx Initiative it developed with the Ohio State University College of Pharmacy, invites nonprofits from the following areas to apply for grants ranging from $5,000 to $15,000:
El Paso, Texas;
Little Rock, Ark.;
Northern Chicago, Ill. (Lake, McHenry and Kenosha counties); and
Interested applicants can visit Cardinalhealth.com/community for complete grant program criteria. The deadline for applications is March 25.