Antibiotic Type Poses Severe Nerve Damage Risk, FDA Says

Share us on: By Jeff Overley

Law360, New York (August 15, 2013, 6:03 PM ET) -- The U.S. Food and Drug Administration on Thursday warned that severe nerve damage can result from drugs in a popular class of antibiotics, including those produced by Bayer AG and Johnson & Johnson, expanding a previous alert that regulators said was too vague about potential harm.

In its announcement, the FDA said it would require label updates for all fluoroquinolone antibacterial drugs, including Bayer’s Cipro and J&J’s Levaquin, after finding that earlier cautions about the risk of peripheral neuropathy failed to fully inform doctors and patients of the risks.

The possible nerve damage has been included on fluoroquinolone labels since 2004, but a recent analysis found a “continued association” between the drugs and neural harm, leading regulators to conclude that the “potential rapid onset and risk of permanence were not adequately described” in the original warning.

Because of the “spontaneous” nature of adverse event reporting, the FDA said it could not calculate the rate of side effects. There also were no identifiable risk factors, with patients of all ages developing peripheral neuropathy at far different stages of treatment, from a few days to more than a year, the agency said.

According to the Mayo Clinic, peripheral neuropathy is characterized by painful burning or tingling, typically in the hands and feet, and is often accompanied by diminished sensitivity akin to wearing a thin glove or stocking.

The warning only applies to oral and injectable fluoroquinolones — topical versions are not thought to pose such risks. In 2011, more than 23 million patients used an oral fluoroquinolone, and nearly 4 million more received an injection. Cipro and Levaquin, known generically as ciprofloxacin and levofloxacin, accounted for the overwhelming majority of prescriptions in both formulations.

Fluoroquinolones have been the subject of unrelated warnings from the FDA, which in 2008 slapped a "black box" warning on the drugs because of their potential to cause tendon tears. J&J subsequently found itself ensnared in multidistrict litigation over the issue, although it has had some success convincing judges that its warnings were sufficient.

The FDA has previously advised doctors to avoid turning to fluoroquinolones unless an infection is strongly believed to be bacterial. If symptoms of peripheral neuropathy arise in patients, the drug should be discontinued in favor of a different type of antibacterial, unless the risks of change outweigh the benefits, the agency said Thursday.

--Editing by Philip Shea.

Janssen Ignored Nerve Damage Risk Of Levaquin, Suit Claims

Janssen Ignored Nerve Damage Risk Of Levaquin, Suit Claims


By Steven Trader
Law360, New York (June 29, 2015, 10:02 PM ET) -- Drugmaker Janssen Pharmaceuticals and parent company Johnson & Johnson were hit with a lawsuit Monday in Pennsylvania federal court alleging the drugmaker mislabeled and continued to market an antibiotic drug despite a growing body of research indicating that it led to permanent nerve damage.

Gordon Olsommer, who was prescribed Janssen’s blockbuster fluoroquinolone antibiotic Levaquin in 2010 for a case of bronchitis and a sinus infection, contends that the drugmaker incorrectly advised consumers between 2004 and 2013 that the peripheral neuropathy side effects associated with the drug were rare and that symptoms would disappear once the drug was discontinued.

Further, Olsommer says that even after the FDA determined the warning label was inadequate in 2013, consumers of Levaquin, whose chemical name is levofloxacin, were still advised that stopping the drug immediately upon the onset of symptoms would prevent permanent nerve damage, which contradicted the later warning that the symptoms may be irreversible in any case, according to the lawsuit.

Olsommer says that shortly after he was prescribed Levaquin in June and July 2010, he began suffering the symptoms familiar to peripheral neuropathy, including weakness, numbness and pain in his hands and feet, and he was diagnosed with peripheral nerve damage shortly afterward.

“As a direct and proximate result of defendants’ carelessness and negligence, plaintiff suffered severe and permanent physical and emotional injuries including, but not limited to, irreversible peripheral neuropathy,” the complaint says. “Plaintiff has endured pain and suffering, has suffered economic loss, including incurring significant expenses for medical care and treatment, and will continue to incur such expenses in the future.”

The FDA approved Levaquin in 1996 for the treatment of bacterial infections of the skin, sinuses, kidneys, bladder or prostate, as well as infections such as bronchitis or pneumonia.

The complaint alleges that as early as 1990 there was scientific evidence of an association between fluoroquinolones and peripheral neuropathy, and a 2001 paper published after Levaquin hit the market reported neurological side effects in 45 patients, half of them lasting more than a year.

However, in 2004 the drugmakers altered the label of Levaquin only to state that peripheral neuropathy symptoms were rare, even after they were advised that patients were still suffering symptoms of neurological damage despite having discontinued the drug, according to the complaint.

It wasn’t until 2013 that Levaquin’s label was updated with a phrase stating peripheral neuropathy may be irreversible, and the plaintiff points to a 2014 study of more than 6,000 cases of peripheral neuropathy published in the journal Neurology which found that “those on fluoroquinolones were at a statistically significant higher risk of developing peripheral neuropathy.”

The plaintiff is seeking an unspecified amount of money for actual and punitive damages on claims that Johnson & Johnson and Janssen were negligent of the research and fraudulently concealed the danger of their product and are therefore liable for the resulting neurological effects.

Representatives for the parties did not respond Monday to requests for comment.

Janssen Hit With Another Levaquin Nerve Damage Suit

Janssen Hit With Another Levaquin Nerve Damage Suit


By Steven Trader
Law360, New York (July 29, 2015, 1:49 PM ET) -- Drugmaker Janssen Pharmaceuticals and distributor McKesson Corp. were slapped with a suit Tuesday in Pennsylvania federal court by a Texas woman who says the companies failed to warn her of the known dangers of an antibiotic drug that ultimately gave her permanent nerve damage.

Catherine Farmer, who was administered the Johnson & Johnson unit's blockbuster fluoroquinolone antibiotic Levaquin both during and after heart surgery in 2006, contends in her complaint that rather than warning patients and physicians directly that the drug may result in permanent nerve damage, the drugmakers relied on a confusing label that between 2004 and 2013 advised consumers the side effect was rare and symptoms would disappear by discontinuing use.

Farmer's is the second suit in about a month claiming Janssen ignored the risk of nerve damage related to Levaquin, which in 2007 was ranked as one of the top prescribed and highest-selling drugs in the world, generating $1.6 billion in revenue for Johnson & Johnson.

Farmer says within weeks of receiving a Levaquin IV and pill prescription following her surgery she began to experience pain and numbness in her arms and legs, according to the complaint. By 2008 she was on disability and unable to work. To this day Farmer experiences burning in her arms and legs and tingling in her scalp, “as if it is on fire,” despite taking medication to help her live with her peripheral neuropathy symptoms, according to the complaint.

Farmer's attorney Ahmed Diab of Gomez Trial Attorneys said one of the cruxes of the complaint, as in some others, is that not only were the patients not adequately warned but the physicians weren't either. Diab said patients like Farmer would call their doctors complaining of pain, only to be told to finish the course of medication then see if the pain goes away.

"Even the doctor's weren't adequately warned, so they couldn't even advise patients in a proper manner," Diab told Law360. "Ms. Farmer just never had a shot at knowing this was a potential risk."

The U.S. Food and Drug Administration approved Levaquin — whose chemical name is levofloxacin — in 1996 for the treatment of bacterial infections of the skin, sinuses, kidneys, bladder or prostate, as well as infections such as bronchitis or pneumonia.

The complaint alleges that as early as 1990 there was scientific evidence of an association between fluoroquinolones and peripheral neuropathy, and a 2001 paper published after Levaquin hit the market reported neurological side effects in 45 patients, half of them lasting more than a year.

However, in 2004 the drugmakers altered the label of Levaquin only to state that peripheral neuropathy symptoms were rare, even after they were advised that patients were still suffering symptoms of neurological damage despite having discontinued the drug, according to the complaint.

In 2013, the FDA warned that severe nerve damage can result from the drugs included in J&J’s Levaquin and required label updates, finding that earlier cautions about the risk of peripheral neuropathy failed to fully inform doctors and patients of the risks.

"There are a lot of cases like this being filed," said Diab. "I think we've hit a critical mass."

In her suit Farmer alleges Janssen, Johnson & Johnson and McKesson negligently developed the drug, failed to warn users of its dangerous effects and knowingly placed it into the stream of commerce despite its defect, then fraudulently concealed information about it from its users. She seeks an unspecified amount of compensatory and punitive damages.

Representatives Janssen and McKesson on Wednesday didn’t immediately return a request for comment. Counsel information for the defendants wasn’t immediately available.

Farmer is represented by Joseph G. Sauder and Matthew D. Schelkopf of Chimicles & Tikellis LLP, and John H. Gomez, John P. Fiske and Ahmed S. Diab of Gomez Trial Attorneys.

The case is Catherine and Timothy Farmer v. Johnson & Johnson, Janssen Pharmaceuticals Inc., and McKesson Corp., case number 3:02-at-06000, in the U.S. District Court for the Middle District of Pennsylvania.

--Editing by Jeremy Barker.