The article that appeared in the medical journal Neurology reporting three cases of optic and peripheral neuropathy associated with the use of Zyvox® has heightened concern about the use of Zyvox® beyond 28 days – the period of time during which Zyvox® was studied for safety and efficacy prior to its approval.
In its May 2006 issue of Current Problems in Pharmacovigilance, the Medicines and Healthcare products Regulatory Agency (MHRA) – which is England’s equivalent of the FDA – included an alert about Zyvox® and optic neuropathy. According to the MHRA:
"The safety and efficacy of linezolid [Zyvox®] therapy has not been established beyond 28 days in controlled clinical trials. Based on post-marketing experience, severe optic neuropathy that has progressed to blindness has been reported rarely in patients treated with linezolid [Zyvox®].These cases have occurred primarily in patients who have received linezolid [Zyvox®] for longer than the maximum recommended duration of 28 days. In some cases, vision has been reported to recover after early withdrawal of the drug, but this process may take some months." Volume 31, May 2006 (footnotes omitted).
An early report of suspected Zyvox®-induced optic and peripheral neuropathy appeared in Australia. In September of 2002, a Letter to the Editor appeared in the Medical Journal of Australia describing a case report of a man treated for 6-months with Zyvox® who began experiencing symptoms of both optic and peripheral neuropathy. This Letter to the Editor, written by the Deputy Director and a physician of a hospital in Australia, also described three additional case reports of optic/peripheral neuropathy reported to Australian health authorities.
If you or a loved one suffered from blindness, ongoing visual disturbances, pain or numbness/loss of sensation in the arms or legs while taking Zyvox®, or if you or a loved suffered from optic or peripheral neuropathy while taking Zyvox® and you have questions about your legal rights, please click HERE to find out about your potential legal rights.