A woman from Virginia is calling for change, after she says that side effects associated with the antibiotic Cipro killed her mother.
“This was a healthy woman who was vibrant and completely took care of herself and took this pill that she didn’t even need,” Valeri Barnett recently told WRIC-TV.
Her mother, 85-year-old Magdalene Fuchs, survived being shot in World War II and escaped from Hungary.
But she could not survive Cipro.
According to her daughter, Fuchs was prescribed Cipro to treat a bladder infection. Shortly after she began taking the powerful fluoroquinolone antibiotic, Fuchs began to look jaundiced.
A specialist from Johns Hopkins Hospital diagnosed Fuchs with liver failure, with Cipro suspected as the cause.
Just three months after being prescribed the drug, Fuchs was dead. “Drug-induced cholestatic hepatitis from Ciprofloxacin” is listed as the cause of her death.
Barnett told WRIC-TV that she hopes sharing her mother’s story will save lives.
“She doesn’t have the time I do,” adds Barnett.
Cipro and other fluoroquinolone antibiotics, including Levaquin and Avelox, are indicated to treat a wide range of serious bacterial infections, such as pneumonia, plague and anthrax. However, they are frequently prescribed off-label for more minor infections, despite their known link to a wide range of debilitating – and potentially permanent – side effects, including peripheral neuropathy and tendon damage.
In May 2016, the U.S. Food & Drug Administration (FDA) modified the black box warning included on all fluoroquinolone labels to state that their risks outweigh any potential benefits for patients with certain uncomplicated infections when other treatment options are available. The FDA acted after a safety review linked to the drugs to disabling and potentially permanent side effects involving the tendons, muscles, joints, nerves, and central nervous system.
Hundreds of people have filed lawsuits against the manufacturers of Cipro, Avelox and Levaquin after suffering serious side effects allegedly associated with their use of the drugs. The most recent cases have involved peripheral neuropathy, a debilitating and potentially permanent nerve disorder.
While the labels for fluoroquinolone antibiotics were updated with information about peripheral neuropathy in December 2004, a later FDA safety review found that the prescribing information did not adequately describe the “potential rapid onset and permanence” of the condition. This prompted the FDA to order further label modifications in August 2013, including the removal of wording that characterized peripheral neuropathy as a “rare” side effect.
Like Cipro lawsuit plaintiffs, Dr. Charles Bennett, a Professor of Medication Safety at the University of South Carolina, believes that the drug’s current label warnings, including the black box warning, are ineffective because most doctors don’t read the package inserts and can’t keep up with label changes.
“There’s been 35 warning changes for Cipro over the last ten years,” he noted.
Bennet told WRIC-TV that a registry program should be established for Cipro and other fluoroquinolone antibiotics that would require doctors to inform patients of their risks.
“The doctor signs the consent, the patient and the pharmacists,” he said.