Fosamax Scare On Safety Issue

31 March 1996

Merck & Co has urged doctors to make sure their osteoporosis patients take Fosamax (alendronate) in the appropriate way, following reports of gastroesophageal side effects in patients monitored during post-marketing surveillance. Some of these side effects were serious enough that patients required hospitalization.

Merck believes that improper use of the drug (ie not with enough water or at the wrong time of day) was the root of the problem. The company has also advised the US Food and Drug Administration.

Analysts have noted that the scare could limit take-up of Fosamax, which is one of Merck's most important new products and has been tipped as a billion-dollar drug. The effect is not expected to last long, however, and should not stand in the way of the drug gaining an additional indication for prevention of osteoporosis.

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