Sunday, October 12, 2008

Yearly Osteoporosis Drug Approved for Men

Europe—The once-yearly Aclasta® an osteoporosis drug for men who are at risk of fractures was recently approved. Men have previously been under the radar for osteoporosis concerns but one in five men over 50 years old have suffered some kind of osteo fracture.

Data from more than 2,100 patients, showed that once-yearly Aclasta reduced the risk of new clinical fractures by 35% in men and postmenopausal women who have recently had a low-trauma hip fracture from a fall from standing height or less. Hip fractures can be a potentially life-threatening consequence of osteoporosis.

A 2-year head-to-head trial compared Aclasta with weekly oral alendronate provided additional data on the treatment of male osteoporosis.

Aclasta, which is administered by once-yearly infusion, was approved in the Europe Commission in October 2007 for the treatment of osteoporosis in postmenopausal women.

Aclasta/Reclast is the only treatment for postmenopausal osteoporosis approved in the EU and US to reduce the risk of fractures including the hip, spine and non-spine. Aclasta is also approved in more than 80 countries for the treatment of Paget's disease of the bone, the second most common metabolic bone disorder.

The most common adverse events associated with Aclasta were transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occurred within the first three days following Aclasta administration and resolved within three days.

Blogger's Note: The drug is in its infant stages. It's too early to know longterm side effects. Patient beware.

If you have had serious life-threatening side effects from taking any osteoporosis related drugs, please contact an unsafe drug law firm with experience pursuing these kinds of cases.

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