Sunday, July 20, 2008

Health Canada asking makers of some antibiotics to put tendon warning on label

From the Canadian Press:
Health Canada announced Thursday that it will ask makers of a class of antibiotics to include a prominent warning on the label that the drugs can lead to tendon ruptures.

The announcement follows on the heels of a similar policy decision from the U.S. Food and Drug Administration. That agency revealed Tuesday that it was asking manufacturers of fluoroquinolone drugs to put a "black box" warning - the FDA's most stringent safety labelling requirement - on their products.

In an emailed response to questions posed Tuesday, Health Canada said it will ask manufacturers of fluoroquinolones to include a "box warning" on the product monographs alerting people who take the drugs of the fact they may be at higher risk of tendon ruptures.

Drugs in the fluoroquinolone class include ciprofloxacin (Cipro), levofloxacin, norfloxacin, ofloxacin, gemifloxacin and moxifloxacin. ..more

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