FDA to Investigate Safety of Antibiotics Cipro, Avelox and Levaquin

Friday, October 9, 2015
Cipro Antibiotics

Earlier this year, the FDA disclosed it had received more than 1,000 side effect complaints from the often-used antibiotics known as fluoroquinolones - Avelox, Levaquin and Cipro.

These side effects range from psychiatric problems to tendon and nerve damage.

After a recent FDA study suggested the makers of these drugs weren’t doing enough to warn patients of the dangers of a permanent nerve condition called peripheral neuropathy, the agency forced manufacturers to add label warnings.

Now, as a federal commission forms a unique court venue for victims of antibiotic nerve damage to seek compensation from the manufacturers, the FDA has announced it will hold a public hearing to examine their risks.


FDA Committee to Meet in November

On October 1st, the FDA announced the meeting of two public advisory committees, the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, on November 5th at the agency campus in Silver Spring, Maryland.

The meeting, which is open to the public, will review specifically the dangers of using antibiotics known as fluoroquinolones to treat common conditions like sinusitis, bronchitis and urinary tract infections.


Concern Over Antibiotic Overuse

These drugs, developed in the 1970s, have been updated several times to maintain effectiveness, and are crucial in the fight against serious infections encountered in hospitals and emergency treatment.

However, experts say the overuse of fluoroquinolones Avelox, Levaquin and Cipro for common ailments like sinus infection of UTI have put their effectiveness at risk. It has also exposed millions more patients to their side effects.


Avelox, Levaquin and Cipro linked to Nerve Damage

All three flouroquinolones contain warnings that users may experience the nerve condition peripheral neuropathy. However, this is buried in the fine print of each medication’s prescribing information.

A 2013 FDA study determined that the makers of these drugs, Bayer and Johnson & Johnson, weren’t doing enough to protect consumers of this risk.

Peripheral neuropathy is a permanent disorder brought on by damage to the peripheral nerves. The most common symptoms of peripheral neuropathy are tingling, numbness, pain or weakness in the upper and lower extremities.

This permanent nerve damage is often caused by diabetes, infection or injury; however, it has also been linked to the toxins in some medications.


Special Court Created for Avelox, Cipro & Levaquin Lawsuits

In August of 2015, the Judicial Panel on Multidistrict Litigation ordered the creation of a multidistrict litigation court for the handling of all federal cases filed by patients alleging nerve damage from fluoroquinolone antibiotics.

The move was the result of the rapid growth of lawsuits as more and more patients realize the possible cause of their nerve damage. At present, more than 200 cases have been filed alleging peripheral neuropathy from Avelox or Levaquin.

The special antibiotic court, known as MDL 2642, IN RE: Fluoroquinolone Products Liability Litigation, is being presided over by U.S. District Judge John R. Tunheim in the Minnesota federal district.

Currently, a few select law firms that specialize in drug injury litigation are helping those affected investigate their cases and file lawsuits. Contact DrugNews today to speak directly with a lawyer.



FDA Notice. Joint Meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. (October 1, 2015). Retrieved from www.federalregister.gov

WRIC ABC News. FDA to hold hearing on benefits of 3 common antibiotics. (October 2, 2015). Retrieved from www.wric.com


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