FDA Fails to Disclose Serious Side Effects Linked to LevaquinJul 31, 2015
The Food and Drug Administration (FDA) has failed to disclose serious side effects associated with one of the most widely used prescription drugs on the market, the family of antibiotics known as fluoroquinolones.
Fluoroquinolones are marketed under brand names including Levaquin and Cipro and the generic form levofloxacin. These antibiotics are used to combat serious infections such as pneumonia and kidney infections and are powerful enough to have been used to treat anthrax cases. But an investigation by Cleveland television station ABC5 obtained a 2013 FDA report that raises concerns about possible "mitochondrial toxicity."
Since 2008, fluoroquinolones have carried the FDA's most serious drug label warning-a black box-alerting doctors to side effects including ruptured tendons and nerve damage. ABC5 obtained an FDA database of adverse effects and found 3,000 deaths and 200,000 complaints of serious effects associated with Levaquin and similar drugs.
Among those experiencing side effects was Cindy Rapkin, who stopped taking Levaquin after complaining of vision problems and sore tendons. "I was having such horrible, horrible pain, my knee was killing me," said Rapkin. For Karen Paddock, her husband said, Levaquin use caused so much pain that she was forced to used knee pads and wooden board on rollers to move around. Bob Paddock said, "It was just an accumulation of the various pains from that and other health conditions that pushed her over the edge." Karen Paddock took her own life.
The FDA had not disclosed mitochondrial toxicity, an alarming side effect, according to ABC5. Symptoms of mitochondrial toxicity include muscle weakness, peripheral neuropathy (numbness of fingers and toes), and pancreatitis. The most severe symptom is lactic acidosis, in which a build-up of lactic acid in the tissues leads to loss of energy, organ failure, and eventually death. According to the Mayo Clinic, the most common organs that may experience damage are the brain, heart, liver, muscles, kidneys and the endocrine system.
Dr. Charles Bennett, a drug safety advocate and holder of an endowed chair in Medication Safety and Efficacy at the Centers of Economic Excellence at the University of South Carolina, has been following the side effects associated with Levaquin and similar drugs for years. Bennett does not recommend removing these drugs from the market, but he calls for increased warnings to ensure both doctors and patients are more fully aware of side effects. Bennett says, "Mitochondria are the gas tank, mitochondria toxicity means there's no gas in the tank and your body really cannot function."
In June 2014, Bennett filed a citizens petition with the FDA urging additional warnings based on the FDA's 2013 report on mitochondrial toxicity. But the FDA did not act. The agency notified Bennett that it had "been unable to reach a decision" and would continue to study the issue. But Bennett says the FDA's review could take years and delays could cost additional lives. Reports of drug side effects to the FDA are voluntary and Bennett argues that the only about one percent of adverse events are reported. If Bennett is correct, then based on the 3,000 deaths acknowledged in the 2013 FDA report, the actual number of death may be closer to 300,000.