FDA orders warning for antibiotic class
The many makers of fluoroquinolone antibiotics--which include well-known and frequently prescribed meds Cipro (Bayer) and Levaquin (J&J)--will have to up the ante on a side-effect warning that apparently doesn't have enough oomph.
The labels of these medications already list warnings about side effects, including the possibility of tendon rupture. Tendons, such as the Achilles tendon, connect muscles to bones--and tendon rupture requires major surgery and is debilitating. The number of people experiencing this particular side effect was continuing to rise, prompting FDA to require that each company put an obvious "black-box" warning on the medication labels.
The ruling applies to all fluoroquinolone drugs, including ciprofloxacin (Cipro and generic ciprofloxacin), ciprofloxacin extended release (Cipro XR and Proquin XR), gatifloxacin (Tequin), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin) and ofloxacin (Floxin and generic ofloxacin).
A consumer group called Public Citizen first petitioned FDA to increase warnings on the drugs almost two years ago and resorted to a lawsuit about six months ago. While the warning was already on the medications, it was along with a laundry list of other possible side effects, and the number of individuals suffering tendon rupture was continuing to rise. FDA said the number was in the hundreds, but refused to be specific; however, a Public Citizen spokesperson said there were 407 tendon ruptures 341 reports of tendonitis in 2007 alone.
The benefit to increased information is that informed patients can take action if they experience pain or swelling in a tendon after starting the medication. Calling one's physician for an alternative antibiotic and stopping the drug at that point could help prevent a serious rupture. Most at risk are transplant patients, individuals older than 60 and people who are also taking steroids. The black-box warning will not apply to eye drop versions of the antibiotics.
Read the Washington Post story
See more at the Boston Herald
Find out what the LA Times blog says
Related Articles:
Levaquin approval expanded
Lawsuit seeks black box on antibiotics
Comments (2) | Post a comment
Comments
By Anonymous | Posted 12:10pm | July 9, 2008
Drugs have side effects. Macrolides can't be used with statins. Give a warning to all antibiotics.
By david fuller | Posted 9:19pm | August 11, 2008
Tendon rupture is the least of the patient's concerns. This class is associated with irreversible peripheral neuropathy, fatal liver and kidney damage, fatal hypo and hyperglycemia, SJS and TEN, toxic psychosis, spontaneous ruptures not only of the tendons but also muscles, ligaments and cartilage, the list of serious adrs is boundless. More than half of the drugs found in this class have been removed from clinical practice due to severe and even fatal adverse reactions.
Bayer issued a European "Dear Doctor Letter" in February of 2008 in regards to fatal liver injury as a result of being on Avelox. Yet we see no such letter being issued here in the States, nor do we see the FDA requesting one either. This class has been crippling and killing patients since the mid sixties. For more than forty years now the FDA has hidden the true safety profile from both the patient as well as the treating physician.
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