DULUTH, Ga. — A local woman is pushing for change after she says a popular antibiotic killed her husband.
Consumer investigator Jim Strickland reports the FDA is deciding whether to issue strong new warnings about potentially damaging side effects.
The generic name is levofloxacin, sold under the brand name Levaquin, a drug marketed by the Janssen Pharmaceutical division of Johnson & Johnson.
Kathy Dannelly of Duluth says just two pills killed her husband Chris.
"At 41, although Chris was always an athlete and stayed in shape, Chris was at his prime," recalled Dannelly.
She told Strickland her husband Chris had aced a physical two months before coming down with flu symptoms. An urgent care doctor diagnosed him with pneumonia and prescribed once-a-day Levofloxacin 750mg.
"But he couldn't tolerate it after 2 pills," she said.
"Two pills," she repeated. "And by Sunday night, I had him in the bathtub in the water trying to do whatever I could to cool him off. He just was stiff and just suffering."
Dannelly says their young children's last vision of their father was a man crying in pain in a hospital emergency room less than 48 hours after the first dose.
"That's really hard to get out of my mind that I couldn't help him. Nobody could."
Three days later, Dannelly was dead. The autopsy found rhabdomyolysis, a disease that destroys muscle.
The drug's label listed the disease only as a side effect by patients after approval. There is no formal warning of the side effect.
A pathologist who performed the autopsy listed the likely cause as "an adverse outcome to this drug."
"Absolutely he was poisoned," said Dannelly.
In Columbia, South Carolina, the state government funds its own drug watchdog agency. Strickland showed the Dannelly forensic report to the man who runs it.
"I think the pill killed him," said Charles Bennett, MD, Ph.D.
"When you read the report of a patient that takes one or two doses of a drug, has side effects that occur almost instantaneously, goes to the hospital and then is dead within a day or two, there's no doubt that this is a terrible side effect and a terrible tragedy," he said.
Bennett had already petitioned the FDA for tougher warnings about the drug's side effects on human cells and the brain.
In August 2013, regulators did strengthen warnings about the potential for nerve damage called peripheral neuropathy.
Man says the antibiotic ruined his life
The warnings came too late for Jeff Stephens of Carroll County. He took seven Levofloxacin pills two years ago for a sinus infection.
"Pretty much I went from an athlete to a cripple," he said as he was pumped with intravenous medication at a clinic in Dunwoody. His prognosis is uncertain.
"I might be one of those that's crippled for the rest of my life. It's terrifying," he said.
Levofloxacin is part of a family of six antibiotics called fluoroquinolones.
An FDA report in 2013 found Levofloxacin is responsible for half the severe nerve damage cases blamed on those drugs, which include the more well-known drug CIPRO.
Kathy Dannelly is hoping Levofloxacin's days are numbered.
"If I can get involved in this drug somehow coming off the market one day, then that's the least I can do in (Chris's) name. In his honor," she said.
A spokesperson for Janssen emailed this statement to Strickland:
"We are aware of the Citizen Petitions and we are evaluating them. LEVAQUIN® (levofloxacin) Tablets is part of an important class of anti-infective prescription medications that have been used for more than 20 years to treat infections, including those that may be serious or life threatening. When used according to the product labeling, LEVAQUIN® has been proven to have a favorable benefit-risk profile.
Ever since it was first approved by the FDA in 1996, the LEVAQUIN® label has included information regarding warnings and precautions including a boxed warning."
Cox Media Group