FDA Fails to Warn Consumers about Levaquin
Jan 12, 2009 at 05:26PM 
I have a sinus infection that has already survived two courses of antibiotics -- first Azithromycin, and then Augmentin. So my doctor prescribed 21 days of Levaquin and put me on Prednisone as well. It turns out that's a dangerous combination, but my doctor never said a thing about it. It turns out he's not required to, and except to a limited degree, neither is the pharmacist.
When tendon problems started to surface for people taking fluoroquinolone antibiotics -- including Levaquin -- Public Citizen compelled the FDA to require the drug maker to add a "black box" warning on the package. For all the hoopla this bold move generated in the press, you'd think the FDA had solved the problem. Think again.
I wrote to the FDA and asked how I was able to get my hands on a bottle of Levaquin that doesn't have a warning encircled by their highly touted “black box”. In fact, the pill bottle has no warning on it at all. The response, from a very nice fellow named BD, informed me that the FDA's ruling required the black-box warning be given to the pharmacist, but not to the consumer. My warning was buried withing the information sheet provided by the pharmacist -- a page of 6-point type without any highlight on the risk of tendon damage. Many lesser threats, such as dizziness and sunburn, are clearly highlighted. But the one about tendon rupture is buried under mountains of medical mumbo jumbo.
Why did the FDA, tasked with protecting consumers, mandate a highlighted warning about Levaquin's risks but fail to mandate that it be given to consumers? That failure gives merit to the pending class action lawsuit, which specifically alleges that if victims had been properly warned, they could have stopped taking the drug in time to avoid injury.
With dangerous drugs, the FDA needs to ensure that consumers are adequately warned, by their doctors as well as their pharmacists.
Reader Comments (2)
Wow, Mark, I hope you didn't take this drug. My dad did and is still suffering from the damage done by it. He's almost 79 now and wasn't in the greatest health in the first place - now he's almost crippled.
Ya I would never try these pills. Honestly I have suffered from very bad sinus infections along with allergies and I found out on "kiwi drug" that recommend Flonase over the counter. I have been faithfully using it for this home fall season its amazing! Plus, the fact that you can breath easily after wards increases your lung function