FDA releases guidance on safe use of Tussionex
ROCKVILLE, Md. The Food and Drug Administration issued an alert Tuesday on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events—including death—associated with the misuse and inappropriate use of the prescription cough medication.
“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” stated Curtis Rosebraugh, acting director of the FDA’s Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”
Tussionex contains hydrocodone and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours.
Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.
Schering Plough files NDA for Zegerid OTC heartburn treatment
KENILWORTH, N.J. Schering-Plough has submitted a new drug application to the Food and Drug Administration for an over-the-counter branded version of its prescription heartburn treatment drug Zegerid.
The application was submitted due to a license agreement between Schering and Santarus, which was signed in October 2006. The agreement grants the right to market the OTC Zegerid product using Santarus’ patented technology.
Under the agreement with Santarus, Schering-Plough is responsible for the development, manufacturing and commercialization of Zegerid OTC products for heartburn-related indications in the United States and Canada. Santarus continues to manufacture, promote and sell its Zegerid prescription products in both 20 mg and 40 mg strengths for the proton pump inhibitor market.
“Schering-Plough is looking forward to working with the FDA to bring this prescription product to consumers as an OTC treatment for frequent heartburn,” said John O’Mullane, group vice president of research and development at Schering-Plough Consumer Health Care. “When approved, Zegerid will be a valuable addition to our expanding portfolio of gastrointestinal OTC products, such as Miralax, which was launched last year for the treatment of occasional constipation.”
Santarus is entitled to receive up to $22.5 million in regulatory milestones and up to $37.5 million in sales milestones. Schering-Plough previously had paid Santarus a $15 million upfront license fee, and a $5 million milestone payment.
Kmart rewarding pharmacy customers with $1 promotion on OTC medicines
HOFFMAN ESTATES , Ill. Kmart is launching a new promotion that rewards its pharmacy customers with low-cost over-the-counter medications for every prescription they have filled at one of its pharmacies.
Under the new American Fare Dollar Program, pharmacy customers can choose from 10 OTC medications from Kmart’s proprietary American Fare brand for a cost of $1 with every prescription purchase. OTC medications in the program include aspirin, ibuprofen, children’s pain reliever, baby aspirin, nasal decongestant, cough suppressant, anti-diarrhea medication and cold and allergy tablets.
“We’re always looking for ways to provide more value … especially when healthcare costs are generally on the rise,” said Mark Doerr, vice president of Kmart Pharmacy. “The American Fare Dollar Program rewards our pharmacy customers with an amazing deal and introduces them to our great private-label OTC products at the same time.”
The discount chain, a division of Sears Holdings Corp., unveiled the program in its Florida pharmacies Friday. The promotion will roll to all Kmart pharmacies in April, the company reported. All of the $1 American Fare products, which are specially labeled, will be available behind the pharmacy counter. Regular-priced versions of the 10 American Fare products in the program will continue to be available on store shelves.