FDA Issues New Labeling for Fluoroquinolone Drugs
This is Amy German, Managing Associate attorney for the Michael Brady Lynch Firm.
A few months ago, I told you how popular fluoroquinolone antibiotics like Cipro and Avelox were associated with an increased risk of dissection and aneurysm within 60 days of using the medication. Now, the FDA is changing the labeling but not to warn of aneurysms. There is a new concern with fluoroquinolone drugs – severe, disabling and potentially permanent nerve damage.
About Fluoroquinolone Drugs
Fluoroquinolone drugs are the most commonly prescribed class of antibiotics in the United States; more than 26 million Americans take them in some form every year. Pharmaceutical companies are raking in the profits. In 2010, Bayer’s top two fluoroquinolones (Cipro and Avelox) brought in $1 billion in sales. Johnson & Johnson’s Levaquin sold $1.3 billion. These drugs work by using fluoride to penetrate into very sensitive tissues, including your brain. This deep tissue penetration makes a potent neurotoxin and breaks down collagen in the body, as well. Collagen is in tendons, muscles, and joints. When the collagen breaks down, patients experience chronically debilitating pain.
The FDA database lists almost 100,000 reports of adverse reactions from these popular antibiotics and linked the drug to more than 1,500 deaths. The new labeling and updated Medication Guide will include a warning about the disabling side effects, caution about not using fluoroquinolone antibiotics for common infections (e.g. sinusitis, bronchitis and urinary tract infections) and will warn doctors to stop treatment immediately if a patient reports any side effects.
Unfortunately, this warning comes too late for the thousands of people afflicted by the crippling and potentially fatal side effects from these antibiotics.
If you or a loved one experienced an adverse event from taking a fluoroquinolone, call us at 877-513-9517 for a free consultation.