Levaquin, Cipro and Avelox Heart Rhythm Problems Need Black Box Warning: Public Citizen

The prominent consumer watchdog group Public Citizen is calling for federal health regulators to add a new black box warning to fluoroquinolone antibiotics, strengthening warnings provided to the public about the risk of heart rhythm problems from side effects of Levaquin, Avelox, Cipro and other similar drugs. 

Dr. Sidney Wolfe, founder and senior advisor of Public Citizen’s Health Research Group, appeared at a recent FDA advisory committee meeting convened to discuss fluoroquinolone safety, and urged the agency to place the strongest label warning possible on the medications.

Wolfe told the advisory committee that their is strong enough evidence linking the antibiotics and heart rhythm problems to warrant a “black box” warning, which would be prominently placed on the label in a bold box. He also pointed out that FDA reviewer Dr. Andrew Mosholder called for such a warning.

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Levaquin, Avelox and Cipro are among the most widely used members of a controversial class of antibiotics, known as fluoroquinolones, which are used in a variety of infection treatments, including urinary tract infections, acute bacterial sinusitis, bronchitis linked to chronic obstructive pulmonary disease and other conditions.

The hearing was held over to review concerns about the risk of nerve damage, heart problems, tendon ruptures and other health concerns linked to drugs in recent studies and adverse event reports, as well as concerns that the drugs are ofter mis-used to treat conditions that do not benefit from antibiotic medications.

In advance of the advisory committee hearing, FDA reviewers said these appear to be a cluster of apparently related side effects of Levaquin and other related antibiotics, which they labeled Fluoroquinolone-Associated Disability (FQAD).

Inappropriate Antibiotic Use Highlighted

In testimony (PDF) presented at the hearing, Dr. Wolfe noted that fluoroquinolones now account for about 25% of all antibiotics prescribed, and that about 81% of those prescriptions are inappropriate.

More than half of the inappropriate fluoroquinolone prescriptions were because there was another front-line preferred antibiotic available. However, in a third of those inappropriate prescriptions, there was no evidence the patient even had an infection that would benefit from antibiotic treatment.

Those inappropriate uses have raised concerns that some patients are being exposed to the side effects of fluoroquinolone antibiotics for no reason, and could suffer long-term and disabling side effects or death as a result.

The advisory committee voted overwhelmingly to call for stronger warnings on the drugs. However, the FDA is not bound to follow the committee’s recommendations, even though those recommendations tend to have a strong impact on the agency’s final determinations.

According to documents submitted by FDA officials before the panel meetings, the fluoroquinolone problems occur when previously healthy individuals take one of the drugs and suffer two or more adverse events, such as peripheral neuropathy, musculoskeletal problems, heart problems, skin problems or conditions that negatively impact their senses. These problems result in disability or significant disturbance of normal life function.

Antibiotic Nerve Damage Risks

Levaquin, Avelox and Cipro are among the most widely prescribed antibiotics in the United States, generating billions in annual sales.

In 2013, the FDA issued a drug safety communication to announce that it was requiring the manufacturers of Levaquin and other fluoroquinolones to change their warning labels about the risk of peripheral neuropathy problems, providing warnings for the first time that symptoms of nerve damage may continue for months or even years after an individual stops taking the drug.

Prior warnings suggested that peripheral neuropathy from Levaquin, Avelox and Cipro was only a rare risk, indicating that the problems often resolve once the medications are no longer used. However, many users have been left with a long term and permanent nerve damage from the antibiotics, leading the FDA to require warnings about the permanent nature of the nerve damage in many cases.

In 2014, a study published in the medical journal Neurology added further support for these warnings, indicating that side effects of fluoroquinolones may double the risk of peripheral neuropathy.

Hundreds of consumers who have been left with long-term peripheral neuropathy injuries after using the antibiotics are now pursuing a Levaquin lawsuit, Avelox lawsuit or Cipro lawsuit against the drug manufacturers, alleging that they provided false and misleading warnings that failed to adequately inform users and the medical community about the risks associated with the medication.

In August, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all of the fluoroquinolone litigation pending throughout the federal court system before U.S. District Judge John R. Tunheim in the U.S. District Court for the District of Minnesota.

Given the similar questions of fact and law, the cases have been consolidated for pretrial proceedings to reduce the risk of duplicative discovery into common issues, avoid conflicting pretrial orders from different courts and to serve the convenience of the parties, witnesses and the courts.

The parties are scheduled to meet for an initial status conference in the antibiotic peripheral neuropathy cases on December 8.


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