PHARMACY

Lawyers argue for class-action Fosamax suit, dental care for plaintiffs

BY Allison Cerra

NEW YORK Users of a Merck & Co. osteoporosis drug should be provided with a dental monitoring program, lawyers urged a federal judge on Friday.

Lawyers asked U.S. District Judge John Keenan to order the pharmaceutical company to provide a dental monitoring program for Fosamax users, whose jaws were reportedly damaged after using the osteoporosis drug.

The lawyers made the suggestion as they argued for the case to be certified as a class-action, in order to pursue claims by users who believe the drug caused osteonecrosis of the jaw, a condition in which portions of the jaw bone die, sometimes leaving the bone exposed.

Timothy O’Brien, a lawyer for plaintiffs, said many patients would benefit from the program that would include regular dental screenings, X-rays and lab tests, all aimed at preventing the need for dental surgery.

Paul Strain, a Merck attorney, called Fosamax a “life altering and life saving drug” that evades bone fractures that can expedite the deaths of people as they age, and also said there was no proven link between degeneration of the jawbone in some patients and Fosamax. Strain indicated that the drug was a pioneer 11 years ago.

Damage to the jawbone can result in many ways, including from the use of steroids, from diseases or weaknesses in the body and from poor dental hygiene, according to the Associated Press.

A study cited on April 4, 2006, by United Press International, found more than 2,400 patients who were taking the injected form of bisphosphonate had suffered bone damage to their jaws since 2001, and an additional 120 patients taking the oral form of the drug had been stricken. The American Association of Endodontists said that “while bisphosphonates [what Fosamax is made of] support the buildup of bone in areas weakened by disease, as a side effect of treatment, patients may experience the opposite in their lower and upper jawbones.”

O’Brien said as many as one in every 296 patients who uses Fosamax develops the severe damage to the jaw, though Merck disputed the figure. O’Brien said jaws were more susceptible to damage because they are used so frequently and are under greater stress than most bones.

Keenan did not immediately rule after hearing arguments.

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RPCS to expand $3 generics program to Food Pyramid

BY Allison Cerra

SPRINGFIELD, Mo. A regional, employee-owned company is set to celebrate the successful one-year anniversary of its $3 generic drug program by expanding its services.

RPCS, based in Springfield, Mo., launched its $3 generics program last year at its 20 pharmacies located inside the corporation’s four regional chains: Ramey, Price Cutter, Price Cutter Plus and Smitty’s grocery stores.

For Black Friday this year, the company debuted a similar program at nine pharmacies in Food Pyramid stores in the Tulsa area.

The $3 price applies to specific generic drugs with up to a 30-day supply of commonly prescribed dosages. Quantities over 30 days or above recommended common dosages will be at usual and customary pricing.

Since its launch, RPCS’ pharmacists have filled more than 100,000 prescriptions.

“Senior citizens, as you would imagine, make up a large portion of customers taking advantage of the program,” Larry Storey, pharmacy administrator for RPCS, said. “However, we’ve found that everyone appreciates saving money. We’ve filled $3 generics for people from all walks of life and all age groups. We’ve actually saved the customer anywhere from $5 to $20 for each prescription on the list.”

The top five generics that customers are purchasing on the program are metformin, used to treat diabetes; hydrochlorothiazide, diuretic for cardiac patients; levothyroxine, for thyroid patients; lisinopril, to treat high blood pressure; and amoxicillin, an antibiotic.

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UCB files application with FDA for new pain reliever

BY Allison Cerra

BRUSSELS, Belgium Belgian pharmaceutical group UCB said on Thursday that it has filed a drug application with the Food and Drug Administration for its pain-relieving drug, according to Reuters.

Lacosamide, designed to treat epilepsy and pain associated with diabetic neuropaths, was filed to become an additional therapy in the treatment of partial onset seizures in adults with epilepsy and includes three formulations—tablets, syrup and intravenous injection, UCB said in a statement.

The drug’s proposed trade name is Vimpat.

UCB made a similar filing with the European Medicines Agency earlier this year, Reuters reported. The Belgian company already has blockbuster drug Keppra to treat epilepsy, although patent protection is set to expire in the United States by January 2009 and in Europe in May 2010.

Reuters also reported that the company’s other drug, with the proposed trade name Rikelta, is in Phase III trials to treat epilepsy and genetic epilepsy disorder Unverricht Lundborg Disease, while lacosamide is in Phase II trials for fibromyalgia, migraine prophylaxis and osteoarthritic pain.

UCB had also sought approval from the U.S. authorities for lacosamide to treat adults with diabetic neuropathic pain in tablet formation. The condition is often described as causing patients to feel a stabbing and burning sensation in the legs, feet or hands. Close to 7.7 million Americans suffer from the condition.

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