FDA Petition Seeks Stronger Mental Health Warnings for Fluoroquinolone Antibiotics

Published on July 5, 2019 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) is being pushed once again to strengthen side effect warnings for fluoroquinolone antibiotics, a class of drugs that includes Levaquin, Cipro, and Avelox.

Fluoroquinolone Antibiotics and Suicide

In a petition filed with the FDA on June 17th, the Southern Network for Adverse Reactions (SONAR) requested that potential psychiatric adverse events, including suicide and suicidal behavior, be highlighted in a Black Box Warning on all fluroquinolone labels.

“The goal of this petition is to make sure a patient is well informed of the potentially dangerous and they’re informed of alternative treatments that don’t involve fluoroquinolones,” Heather McCarthy said during a news conference announcing the group’s petition. “Shea can’t speak out now. He’s gone, but I can.”

In 2013, McCarthy’s son, Shea, jumped from a second story window and died after crashing his car into an embankment. He was taking Levaquin at the time to treat an infection following surgery for a deviated septum.

“He was suffering from anxiety and depression, and I believe it just overcame him,” she said. “This was a young man who wanted to live. This didn’t need to happen, and he didn’t need to go through this.”

FDA Petition Also Seeks FQAD Black Box Warning

McCarthy is not directly involved in SONAR’s petition. But according to 6-RTVS in Indianapolis, she is willing to provide formal testimony to the FDA regarding her son’s Levaquin experience.

SONAR is also seeking a new Black Box Warning for Fluoroquinolone-Associated Disability (FQAD), a cluster of debilitating and permanent symptoms reported by many who have used the antibiotics.

McCarthy believes Shea was suffering from FQAD when he died.

“This is serious,” said SONAR’s Dr. Charles Bennett. “We want FQAD in the Black Box Warning. Everyone should know about it, and you certainly want to know about suicide in a Black Box Warning.”

Known Side Effects of Fluoroquinolone Antibiotics

Fluoroquinolone antibiotics have been linked to range of serious and disabling side effects, including tendon damage and peripheral neuropathy. In fact, a Black Box Warning added to their labels in May 2016 advises that fluoroquinolones only be prescribed to treat serious infections, such as pneumonia, and cautions against their use for more common ailments, including sinusitis, bronchitis, and uncomplicated UTIs.

Most recently, the FDA warned that patients taking Levaquin or similar drugs might be at risk for a life-threatening aortic aneurysm or dissection.

Last July, the FDA did add information about certain mental health side effects to all fluroquinolone labels. But those adverse events did not include suicide or suicidal behavior, and none were highlighted in the prominent Black Box Warning.

Late last year, Janssen Pharmaceuticals announced it would stop manufacturing injectable and oral versions of Levaquin. However, the drugs will remain on the market until 2020.

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