New calls for stronger warning about popular antibiotic

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ATLANTA - There are new side effects and new calls for stronger warnings on a popular antibiotic Channel 2 Action News exposed during a consumer investigation.

Channel 2 consumer investigator Jim Strickland first warned about local deaths and permanent disabilities attributed to Levaquin or the generic levofloxacin back in November.

Since then, Channel 2 Action News viewers have flooded Strickland with calls and emails about more side effects associated with the drug.

A Marietta nurse told Strickland Levaquin made her crazy.

"I locked the bedroom door. I wouldn't let anybody in. At some point I was beside the bed hiding on the floor," said Judy Shuman.

She took just three doses of the drug for a fever following knee surgery.

"I felt so paranoid and just saying things that I would have never said before," Shuman added. "I accused people of trying to hurt me. It was really strange."

The FDA is now considering a petition to include serious psychiatric events to the pill's black box warning.

WATCH: ORIGINAL INVESTIGATION

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"I don't write a citizen petition light-heartedly," Bennett said. "There's too much work and you can't afford to be wrong."

Strickland learned Bennett's plea for more warnings has backing, even among the drug's defenders.

Former insider speaks out

"A black box warning is a flag to the physician to be very careful using this drug," said Dr. Paul Schnipelsky.

Schnipelsky is a retired vice president for research at Johnson & Johnson, Levaquin's manufacturer. He was not directly involved in the drug's development, but said he watched closely when the FDA approved it.

Strickland traveled to his home in upstate New York to interview him.

"Unless there's some data that can offset the obvious effects that people have already noticed, then it ought to have the warning," Schnipelsky added.

He said only now are new patterns of complaints emerging, 20 years after Levaquin, and later its generic, hit the market.

He said the complaints warrant changes to the label, and doctors to use restraint when prescribing it.

"If you have the right organism and this is the only antibiotic you have to use, you use it with a black box warning because you don't want the patient to die," Schniepelsky said.

Patients say it changed their lives

Wendy Seghi was given the drug.

"They gave me Levaquin intravenously. I think it saved my life," she said.

Still, she told Strickland she wished she knew more about the potential for trouble. 

Two years ago, she began shaking. She has had trouble walking, and her immune system is destroyed. Seghi wears a mask and gloves and rarely leaves home.

"It's affected my life," she said. "Totally affected my life."

Cancer survivor Diane Powell got the drug in the hospital as part of her treatment for a brain tumor.

The cancer is gone, but Powell endured some painful occupational therapy.

Her rotator cuff disintegrated while she lay in bed. That risk was on the label, but she said no one told her.

"When I found out what I found out, that's when I contacted Channel 2, because we have got to get the word out," Powell told Strickland.

The FDA reports petitions for new warnings raise complex issues that deserve a lot of time to investigate.

Whatever the outcome, Schnipelsky said after hundreds of millions of successful doses, there's a place for the pill.

"Taking it off the market would put people at risk," he warned.

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