3 replies to this topic

[Grunt76]

FDA To Seek Black-Box Warning On Bayer's Cipro, Other Drugs

WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration will seek to add strong warnings about the risks of tendon rupture associated with a class of antibiotics used to treat bacterial infections.

The FDA wants to add black-box warnings, the strongest warning the agency issues, to a handful of drugs, including Bayer AG's (BAYRY) Cipro and Johnson & Johnson's (JNJ) Levaquin. The move comes six months after the consumer group Public Citizen sued the FDA to require the agency to add black-box warnings to the drugs.

Cipro and Levaquin belong to a class of antibiotics known as fluoroquinolones. The drugs are sold by several drug makers under various brand and generic names. The drug labels currently warn of the risk of tendon ruptures but don't include black-box warnings.

A black-box warning is in bold type and is surrounded by a black box to make it stand out. It typically appears at the top of drug labels and any advertising of products that carry black boxes must also include warning information as part of the advertisement.

Serious reports of tendonitis and tendon rupture continue to increase with use of the drugs, prompting the FDA to ask companies to add the stronger warnings, the FDA said in a posting on its Web site Tuesday. Such ruptures most frequently involves the Achilles tendon, but also include ruptures of the shoulder, hand, biceps, and thumbs.

The risk of tendonitis and tendon rupture associated with the drugs is " especially increased" in patients older than 60, and those with kidney, heart or lung transplants.

The FDA said it will also ask the companies to create a medication guide - which will be given to patients - to alert them about possible side effects.

[MissKBuff]

I HATE antibiotics I do understand that sometimes they are neccessary, but they can be so bad...

[PERSIANBOLIC]

Absolutely and most of the time over prescribed. Many third world countries give penicillin shots for the most basic infections.

[MissKBuff]

Absolutely and most of the time over prescribed. Many third world countries give penicillin shots for the most basic infections.

No kidding! Doctors seem to use them for a "solution" to any problem without even considering any kind of natural cure, etc...