Zanaflex FDA Alerts
The FDA Alert(s) below may be specifically about Zanaflex or relate to a group or class of drugs which include Zanaflex (tizanidine).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for tizanidine
Zanaflex (tizanidine hydrochloride) Tablets and Capsules
Apr 11, 2007
Audience: Healthcare professionals[Posted 04/11/2007] Acorda Therapeutics and FDA informed healthcare professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections of the product labeling for Zanaflex, a drug used to treat spasticity. In pharmacokinetic studies where tizanidine was coadministered with either fluvoxamine or ciprofloxacin (CYP1A2 inhibitors), the serum concentration of tizanidine was significantly increased and potentiated its hypotensive and sedative effects. Although there are no clinical studies evaluating the effects of other CYP1A2 inhibitors on tizanidine, coadministration of tizanidine with other CYP1A2 inhibitors (zileuton, other fluroquinolones, antiarrythmics, cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine) should be avoided.
[March 27, 2007 - Letter - Acorda Therapeutics]