Baron & Budd: Quinolone Vigilance Foundation Director Meets with Senators, Urges Better FDA Oversight

Baron and Budd blog about QVF's meeting with Senators:

March 10, 2016

Rachel Brummert, executive director of the Quinolone Vigilance Foundation (QVF), recently met with U.S. Senators Thom Tillis and Richard Burr of North Carolina to urge increased scrutiny of the U.S. Food and Drug Administration (FDA). An article reporting the meeting appeared on the website of Charlotte TV station WSOC on Feb. 15.


According to the report, Brummert urged the senators to force the FDA to not only perform more aggressive follow-ups on drugs after they are approved, but also to form an oversight committee to watch the agency more closely. Brummert also wants the FDA to overhaul its Medwatch reporting program.

A Special Motivation
 
Brummert became involved in the QVF to increase awareness of the risks of a powerful class of antibiotics known as fluoroquinolones. She has first-hand experience of those risks, as she has had numerous tendon ruptures and even heart problems after taking a fluoroquinolone more than a decade ago.

These antibiotics, including Levaquin, Avelox and others, have been over-prescribed for several years. In many instances they are prescribed for relatively minor ailments such as sinus and ear infections even though they are designed to deal with much more severe infections.
One of the most serious complications linked to fluoroquinolones is a condition known as peripheral neuropathy, which can lead to permanent nerve damage. It can occur at any time after taking a fluoroquinolone. In fact, symptoms can begin within just a few days of taking the drug.

The disease causes damage to the nerves that help the brain and spinal cord communicate with the rest of the body. When this communication is interrupted, the results can be debilitating. They include a loss of reflexes, shooting pain, and a reduced sensation to pain, touch and temperatures. In extreme cases, paralysis can occur.