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FDA Issues "Black Box" Warning for Cipro, Similar Drugs

By Paul Dalton

July 9, 2008

The Food and Drug Administration (FDA) has added a "black box" warning for fluoroquinolones, a type of antibiotic that includes Cipro (ciprofloxacin) and Levaquin (levafloxacin). The warning refers to an increased risk of tendon problems, including tendinitis and ruptures that have been reported in people taking these drugs.

Cipro, the most widely prescribed fluoroquinolone, is used to treat many bacterial infections. In HIV, it is often used with other drugs to treat MAC (Mycobacterium avium complex) and drug-resistant TB (tuberculosis).

People taking any fluoroquinolone who experiences tendon pain or swelling are recommended to stop taking the drug and seek medical care.

Black Box warnings are the FDA's most important notices on potential dangers of a drug. They are set apart from other safety information to draw the attention of prescribers and patients.

Read more information about MAC.

Read more information about TB.

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