FDA approves generic versions of antibiotic linked to serious illnesses
The Food and Drug Administration has just approved the first generic versions of the antibiotic Levaquin despite new reports that the drug has caused serious illnesses.
Levaquin, known generically as levofloxacin, is in a class of drugs called fluoroquinolones, or quinolones. They are the most popular antibacterial drugs on the market and are used to treat bacterial infections that cause bronchitis or pneumonia. They also are approved for infections of the skin, sinuses, kidney, bladder and prostate. While useful, some doctors say the drug may be over-prescribed and may cause more problems than the condition it is treating.
Jenne Wilcox began taking the drug following routine sinus surgery. Soon after, she developed severe pain in her joints and muscles that continued even after she stopped taking the medication. The symptoms grew worse and worse until Wilcox could no longer walk. “I couldn’t even hold my head up. And I was bedridden for over a year. And when I say that, I mean, I couldn’t get myself out of bed to get into my wheelchair to go use the restroom. I had to be picked up out of bed,” she told PBS.
John Fratti had no major medical problems before he took Levaquin to treat a minor bacterial infection. The drug caused him nerve damage, tendon damage and central nervous system damage – also known as brain damage. “I lost my job. I have lost over a quarter of a million dollars in lost wages. I have spent about $30,000 out of my own pocket in medical and insurance costs, haven’t received a dime back for this,” he told PBS.
After taking just one quinolone, Philadelphia writer Stephen Fried’s wife became psychotic and developed seizures. The ordeal led him to write the bestseller “Bitter Pills,” which looked into the mysterious world of adverse drug reactions.
A Food and Drug Administration (FDA) database for adverse reactions to medications has linked quinolones to 2,500 deaths and 45,000 negative side effects between 1997 and 2010. However, the FDA says its voluntary reporting system only picks up about 10 percent of all adverse drug reactions. The agency says it is working to improve its reporting system.
Meanwhile, the FDA has approved generic versions of Levaquin from 12 different manufacturers, which will make the drug even more readily available to the public despite the risks.
Sources:
Business Week
PBS
Related posts:
