San Francisco, CAIt’s bad enough when a manufacturer is alleged to have known about a potentially serious side effect and didn’t tell anyone about it. When you finally face the music and include Levaquin side effects on product labeling, it helps to be thorough and upfront with just how bad things can get.
In August 2013, the US Food and Drug Administration (FDA) decided that a Levaquin label warning - and similar warning labels for all drugs in the fluoroquinolone antibiotic class - didn’t go far enough against the potential for Levaquin Peripheral Sensorimotor Neuropathy.
There is little doubt that fluoroquinolone drugs such as Levaquin are extremely effective in knocking a serious or persistent bacterial infection out of a patient’s system. No fewer than 23.1 million prescriptions for fluoroquinolone tablets (ingested orally) were written in 2011.
Many a Levaquin Antibiotics Lawsuit have accused manufacturer Johnson & Johnson (J&J) of withholding important safety information, and doing so for some time. One plaintiff, Karyn Joy Grossman, alleges that J&J had known about the potential for Levaquin Peripheral Sensorimotor Neuropathy as early as 1992. For its part, the FDA finally got with the program and mandated a warning for all fluoroquinolone antibiotics with regard to the potential for Peripheral Sensorimotor Neuropathy. That was in 2004.
Nine years later, the FDA was back with a more thorough warning alluding to the possibility of severe nerve damage that could be permanent.
There is plenty of reason for concern. The rate of Levaquin Peripheral Sensorimotor Neuropathy could not be identified or calculated, according to the FDA. There are also no identifiable risk factors that patients, were they aware of their particular individual risk, could weigh when considering the use of a fluoroquinolone such as Levaquin. There is no age range that is a greater or lesser risk than any other.
Levaquin Peripheral Sensorimotor Neuropathy can emerge as quickly as a few days following treatment with a fluoroquinolone or delayed by more than a year. A patient could literally wake up one morning, without warning, with the grievous Levaquin side effects.
Grossman, in her Levaquin lawsuit, asserts that “the warning label for Levaquin during the period from September 2004 through August 2013 misled Plaintiff and her treating physician by incorrectly advising patients and physicians that peripheral neuropathy associated with Levaquin was ‘rare’ and in any case could be avoided by discontinuing the drug upon the onset of certain symptoms.
“The truth, however, is that the onset of irreversible peripheral neuropathy is often rapid and discontinuation of the drug will not ensure that the peripheral neuropathy is reversible.”
Karyn Joy Grossman’s lawsuit was filed August 6 in US District Court for the Northern District of California. Defendants include Ortho-McNeil-Janssen Pharmaceuticals, Inc.; Johnson & Johnson Pharmaceutical Research & Development, LLC; and Johnson & Johnson and McKesson Corporation.
The Levaquin lawsuit is Grossman v. Johnson & Johnson et al, Case No. 3:2014cv03557.
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