An Arizona woman has come forward to warn the public about the side effects potentially associated with Cipro.
“Gretzinger was prescribed multiple courses of Cipro years ago to treat urinary tract infections. She now suffers from tendinitis, fatigue, and resistance to antibiotics, which she attributes to Cipro.
“I found out there was a black box warning in 2008, and I told my urologist that there was a black box and he was not aware of it,” Gretzinger recently told ABC 15. “I am a victim of this drug.”
She is now warning others to read warning labels before taking any antibiotic.
“I want people to know that there are drugs out there that they shouldn’t be taking and they need to be their own medical advocate,” she said.
Cipro is a fluoroquinolone antibiotic, a class of medications that also includes Levaquin and Avelox, among others, and which are used to treat urinary tract infections and other bacterial infections.
Over the years, the U.S. Food & Drug Administration (FDA) has issued numerous warnings regarding the side effects potentially associated with Cipro and other antibiotics in the fluoroquinolone class. In 2008, for example, the drug’s labels were updated with a black box warning – the strongest possible safety notice – regarding a risk of tendon injuries, including rupture of the Achilles tendon.
In August 2013, the manufacturers of oral and injectable fluoroquinolones were ordered to updated their labels with information about a serious and often permanent form of nerve damage called peripheral neuropathy. While mention of the condition had been included fluoroquinolone labels since 2004, the FDA determined that the prescribing information did not reflect the possible rapid onset of the condition, or the potential for permanent nerve damage.
The black box warning for systemic fluoroquinolones was updated in May 2016, after the FDA cautioned that that the drugs’ risks generally outweigh their benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections when other treatment options are available. The FDA’s warning followed a review that confirmed fluoroquinolone antibiotics could cause serious and potentially permanent side effects involving the tendons, muscles, joints, nerves and central nervous system.
Hundreds of peripheral neuropathy lawsuits involving Cipro, Avelox and Levaquin have been centralized in a multidistrict litigation currently underway in the U.S. District Court, District of Minnesota. Plaintiffs allege that the drugs’ manufacturers failed to adequately warn patients and doctors about the potential for fluoroquinolones to cause permanent nerve damage. They further assert that the labels’ peripheral neuropathy warnings remain inadequate and confusing, despite the modifications made in August 2013.
The Court overseeing the federal fluoroquinolone litigation has indicated it will convene a series of bellwether trials involving Avelox and Cipro lawsuits beginning next year. Four Avelox trials are scheduled to start on August 6, 2018, October 8, 2018, February 4, 2019, and June 10, 2019, while two involving Cipro will be convened on December 3, 2018, and April 8, 2019.