FDA Under Pressure to Add Serious Side Effects to Label of Widely Prescribed Antibiotics

The Food and Drug Administration (FDA) has been criticized for the omission of serious and sometimes fatal side effects of the fluoroquinolone class of antibiotics.

Florida television station WFTS reports that a 2013 Food and Drug Administration (FDA) database contains 3,000 reported deaths and 200,000 complaints related to Levaquin (levofloxacin), Cipro (ciprofloxacin) and other drugs in their class.

According to the National Library of Medicine (of the National Institutes of Health), side effects of the fluoroquinolones include tendinitis, tendon ruptures, liver damage, severe diarrhea, heart rhythm changes, blood sugar level changes, and nerve damage in the arms and legs. Tendinitis and tendon rupture may occur after treatment ends. Fluoroquinolones have carried a black box warning—the FDA’s most serious drug label warning—since 2008. In 2013 the FDA expanded the black box warning; it now includes both the ruptured tendons and nerve damage suffered by many who take these drugs.

But fluoroquinolone labels do not carry a warning about mitochondrial toxicity, another serious side effect. Dr. Charles Bennett, a drug researcher at the University of South Carolina, who holds the endowed chair at the Medication Safety and Efficacy Center of Economic Excellence (CoEE), explains that mitochondria are the body’s “gas tank.” Without mitochondria, “there is no gas in the tank and your body cannot function,” WFTS reports. Last year Bennett filed a petition with the FDA urging that drug companies be required to expand the warning to include mitochondrial toxicity. The FDA said it is “considering the matters raised by the petition and giving it our careful attention.”

Mitochondrial toxicity causes symptoms that 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. The Mayo Clinic says the brain, heart, liver, muscles, kidneys and the endocrine system most frequently experience damage from mitochondrial toxicity.

Janssen Pharmaceuticals, a unit of Johnson & Johnson, and the maker of Levaquin, said the company “collects and monitors information . . .on the safety and effectiveness of all our medicines, and, in cooperation with the US FDA and other health authorities, we incorporate new data into our product labels so doctors and patients can make informed decisions.” But according to Bob Paddock, his wife, Karen, was not aware of the original warning related to tendon damage when she took Levaquin. Paddock said the side effects of the drug left her unable to walk as it attacked the tendons in her ankles. After years of struggling with pain in all of her limbs, Karen Paddock took her own life, ABC Action News reports. It could take another year or longer before the FDA announces its decision on the petition for expanded warnings, according to the television station.

 

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