? FDA Wants Black Box On Antibiotics, Epilepsy Drugs
? Stronger Warnings Requested for Fluoroquinolones

?  FDA Wants Black Box On Antibiotics, Epilepsy Drugs 
The U.S. Food and Drug Administration requested black box warnings on fluoroquinolone antibiotics, citing the yet poorly understood risk of tendon rupture. Also, the FDA announced it pushes for black box warnings on epilepsy drugs, claiming they carry a risk of suicidal thoughts and behavior.

Ciprofloxacin is the primary antimicrobial drug targeted by the black box warning, sold by Bayer A.G. under the brand names Cipro, Ciproxin and Ciprobay. It is a broad-spectrum antibiotic which causes double-stranded breaks in the bacterial chromosome and is effective gainst both Gram-positive and Gram-negative bacteria.

Cipro already carries, since 2005 and per FDA request, the warning for tendon ruptures and the development of irreversible neurological conditions. However, the regulator now wants it enclosed in a black box. However, the incidence and severity of side effects is comparatively lower than those triggered by other drugs in its class.

Levofloxacin is also targeted, sold by Ortho-McNeil under the trade name Levaquin and is usually prescribed in respiratory infections. Also, the drug is currently the only respiratory fluoroquinolone approved by the U.S. FDA for the treatment of nosocomial pneumonia. The drug is also targeted by the black box request, as well as Factive (gemifloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin and generic ofloxacin.

Regarding the push for a black box warning on epilepsy drugs, the U.S. Food and Drug Administration underlined the risk of suicide, associated with all drugs used to treat seizures. The FDA found, after analyzing 200 cases, that those taking the drugs face twice the risk of people who are not on anti-epileptic drugs.

However, FDA Director of Neurology Products Russell Katz said that there is no explanation as to why this happens, but reminded there is strong empirical evidence in this direction. Pfizer's Lyrica and GlaxoSmithKline's Lamictal are the drugs most commonly used.

Reuters reports that Pfizer maintains its drug is safe, while Glaxo said the information gathered by the FDA should make it into the drugs' labels. Russell Katz said that at least one company challenges the FDA findings with its own research data, which will be presented to the regulator Thursday.

? Stronger Warnings Requested for Fluoroquinolones
The Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. A boxed warning on a drug's label calls attention to serious or life-threatening risks.

The agency has also determined that manufacturers should provide patients with a Medication Guide about possible side effects. Medication Guides are paper handouts that come with certain prescription medications.

What are fluoroquinolones?
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.

Which drugs are involved in this action?
These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

What should patients know?
• The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in people taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients.
• Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should stop taking their fluoroquinolone medication and contact their health care professional promptly about changing their antimicrobial therapy.
• Patients should also avoid exercising and using the affected area at the first sign of tendon pain, swelling, or inflammation.

For More Information
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01858.html

Fluoroquinolone Antimicrobial Drugs
http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm

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