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Drug Administration]](https://webarchive.library.unt.edu/eot2008/20081006134547im_/http://www.fda.gov/icon/header.gif){kind=icon}
July 23, 1998
Dear Health Care Professional:
Sigma-tau Pharmaceuticals has recently revised the adverse reaction section of the Carnitor (Levocarnitine) tablets, oral solution and injection labeling. This revision provides for the following statement regarding the occurrence of seizures in some patients receiving Carnitor:
Seizures have been reported to occur in patients with or without pre-existing seizure activity receiving either oral or intravenous levocarnitine. In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported.
A copy of the revised labeling with the section highlighted is provided for your information. Please consider this information when using Carnitor in your practice and if appropriate provide to others involved with patient care in your professional environment.
Please feel free to contact the Medical Department of Sigma-Tau Pharmaceuticals, Inc. at 800-447-0169 for additional information if necessary.
Sincerely,
Antonio Amato, M.D.
Medical Director
Sigma-Tau Pharmaceuticals, Inc.
800 South Frederick Avenue
Gaithersburg, MD 20877
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