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The popular antibiotic Levaquin, which has been prescribed to treat severe bacterial infection since 1996, has been subject to increasing concerns about its side effects.
Levaquin (Levofloxacin) is a quinolone antibiotic commonly used to treat conditions including pneumonia, skin infections, and sexually transmitted diseases. Its uses are so broad that over 6 million people are prescribed Levaquin every year, with over 1 million patients receiving the drug intravenously at hospitals.
It is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, with generic variations available since 2011. However, a side effect getting more attention lately is a form of nerve damage called peripheral neuropathy, when the peripheral nervous system is attacked and compromises the nerves between the brain and spine.
While all quinolones have been alleged to cause peripheral neuropathy, Levaquin has been one of the most commonly named in injury reports.
Overview of Peripheral Neuropathy
There are over 100 different types of peripheral neuropathy, which vary depending on which nerves are affected. Some forms only come with minor side effects like general numbness, muscle weakness, and coordination problems. More severe forms can cause severe, chronic pain, which can lead to permanent nerve damage.
The symptoms of peripheral neuropathy include:
- Numbness
- Burning pain
- Sharp, jabbing or electric-like pain
- Extreme sensitivity
- Loss of coordination
- Muscle weakness
- Paralysis
- Dizziness
- Fatigue
While peripheral neuropathy is not a fatal condition, it can cause permanent nerve damage in patients if not diagnosed and treated in a timely manner. Even though lawsuits over this side effect are a recent development, Janssen allegedly knew about this adverse effect decades earlier and didn’t warn consumers.
Levaquin’s warning label stated that nerve damage was a rare occurrence, and was only temporary. The numerous injury reports from patients indicate otherwise, with many of them reporting either permanent or long-lasting nerve damage.
The concern of Levaquin peripheral neuropathy was first raised in September 2004, when the drug’s warning label was first updated to include the risk of peripheral nerve damage. However, many complained that the information had been difficult to identify in the prescription information and failed to adequately describe the risks of the drug.
Additionally, Janssen also allegedly failed to send notification letters to the healthcare community about the label update.
In an update from the FDA in August 2013, the agency required a stronger warning of peripheral neuropathy to be applied to Levaquin and other quinolones. The warning stated that nerve damage could occur during the patient’s quinolone prescription, which may persist for months or years.
Many legal experts state that if stronger warnings had been initially used on Levaquin and other quinolone drug labels, many cases of peripheral neuropathy could have been avoided.
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