The (FDA) anounced to the makers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

Many people agree that the FDA is simply not doing enough about drugs like this.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

“Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations,” said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research.

“The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”

Black Box Warning, Consumer Alerts, Defective Drugs, FDA
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