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P&G: Bone Treatment Drug Approved

April 2, 1998

CINCINNATI (AP) _ The Food and Drug Administration approved Procter & Gamble Co.’s Actonel, a drug used to treat patients who have Paget’s bone disease, the company said Thursday.

P&G and Hoechst Marion Roussel Inc., a German pharmaceutical company, are jointly marketing Actonel in tablet form.

Paget’s disease is caused by breakdown of the bone, followed by abnormal regrowth that leaves bones weak and prone to fracture. It can be debilitating.

P&G said that in an 18-month study of 123 patients with Paget’s disease, treatment with Actonel for two months caused remission of the disease in the majority of patients tested.

Actonel has generally been well tolerated in most of the nearly 400 patients studied, P&G said. The drug should not be used on patients who have low calcium, known as hypocalcemia, or in those sensitive to bisphosphonate drugs like Actonel, P&G said. Bisphosphonates may cause gastrointestinal problems including ulcers, inflammation of the esophagus and make swallowing difficult, P&G said.

The companies have also asked Canada to approve sale of the drug in that country.

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