Trusted Pharmacy Blog|New Drugs, Drug News, Health, Medications, Diseases

An estradiol/levonorgestrel generic trans­dermal system (Climara Pro, Schering) is now available for the prevention of postmenopausal osteoporosis in the U.S.

This patch was approved in 2003 to treat moderate-to-severe vasomotor symptoms such as hot flashes and night sweats associated with menopause.

The transdermal patch allows for week-long continuous delivery of the hormone estradiol drug (0.045 mg/day), combined with levonorgestrel (0.015 mg/ day). The thin, translucent patch is easily affixed to the skin.

The FDA has issued a nonapprovable letter for Merck’s etoricoxib drug (Arcoxia), an osteoarthritis medication, because of concerns that it might carry cardiovascular risks similar to those associated with the company’s rofecoxib (Vioxx). Rofecoxib was withdrawn from the market in 2004.

The FDA stated that Merck needed to provide more data in support of the benefit-to-risk profile for the proposed doses of Arcoxia in order to gain approval. The FDA’s decision was anticipated after an FDA advisory panel voted 20-1 against the approval in April.

Arcoxia is a pain reliever in the same class of drugs known as COX-2 inhibitors. It has been sold for the past five years in 63 other countries.

Merck had been awaiting approval of Generic Arcoxia since December 2003 and had asked the FDA to approve 30-mg and 60-mg doses.

In a study from Israel, about one-fifth of women taking anti-osteoporosis  stopped taking them after two years, often without reporting any defined reason.

The study included 178 patients who had been receiving alendronate medication (Generic Fosamax, Merck) or raloxifene drug (Generic Evista, Lilly). The researchers assessed adherence at a clinic visit after six months and by telephone two years after the patients began treatment.

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