Last Thursday two FDA Advisory Committees heard hours of
moving public testimony on Fluoroquinolon—Associated
Disability (FQAD). We also heard doubts about the effectiveness of this class
of antibiotics that is prescribed over 30 million times in the US each year.
FQs
were first approved by the FDA many decades ago, before better
effectiveness tests. New studies question the effectiveness of FQs in treating
infections compared to placebo. At the hearing, FQAD sufferers and family members
described serious, but somewhat rare, neuromuscular, psychiatric and cardiac effects
and deaths from taking just a few pills, generally in previously very healthy,
active people. Many were given the drug as a precaution, and never had an
underlying infection. We also learned that previous changes to strengthen warnings
on the drug label have been ineffective; prescribers and consumers were unaware
of the risks. Drugs companies that developed FQs minimized the risks and
questioned the integrity of disability reporting, because most reports come
directly from consumers rather than professionals. The committees recommended
even stronger label language, including the risks of disability, but also asked
the FDA to consider a public/prescriber education campaign about the risks,
measures to ensure FQs are used only as second line therapy, and to promote
informed consent by consumers using the medication.
