Label for Popular Antibiotic Family Omits Serious Side Effects

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Label for Popular Antibiotic Family Omits Side Effects
Label for Popular Antibiotic Family Omits Side Effects

Label for Popular Antibiotic Family Omits Side Effects
Label for Popular Antibiotic Family Omits Side Effects

A Tampa, Florida television station is among the news organizations investigating the serious and sometimes deadly side effects of the powerful family of antibiotics known as fluoroquinolones.

ABC Actions News (WFTS) reports that a 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 happen 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 to include both the ruptured tendons and nerve damage many people experience with fluoroquinolones.

But the label does not mention mitochondrial toxicity, another serious side effect. According to Dr. Charles Bennett, a drug researcher at the University of South Carolina, “Mitochondria. . .are the gas tank.” If you have no 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. The FDA said it is “considering the matters raised by the petition and giving it our careful attention.”

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. The Mayo Clinic says the most common organs to experience damage are the brain, heart, liver, muscles, kidneys and the endocrine system.

In a statement, Janssen, 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 Karen Paddock, who took Levaquin,  was not aware of the original warning related to tendon damage. Her husband, Bob, said side effects of Levaquin left his wife unable to walk because of damage to the tendons in her ankles. After years of struggling with pain in all of her limbs, Karen Paddock took her own life, according to ABC Action News, which reports that it could be another year or longer before the FDA makes a decision on the petition for expanded warnings.