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Article: FDA ISSUES HISMANAL WARNING
- Article from:
- PR Newswire
- Article date:
- July 20, 1992
CopyrightCOPYRIGHT 1992 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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FDA ISSUES HISMANAL WARNING
WASHINGTON, July 20 /PRNewswire/ -- The Food and Drug
Administration and Janssen Pharmaceutica, manufacturer of the prescription antihistamine drug Hismanal, today announced that Janssen will inform doctors and other health professionals of cardiovascular risks to patients who exceed the recommended dose.
Rare cases of serious cardiovascular events, including death, cardiac arrest and arrhythmias, were reported in patients exceeding the recommended dose of 10 mg (one tablet) per day. While the majority of these cardiovascular events have occurred in patients who have greatly exceeded the recommended ...