You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
On January 17, 2014, FDA approved changes to the Victrelis (boceprevir) package insert to expand the list of contraindicated medications and update the Drug Interaction section.
Doxazosin, silodosin and tamsulosin, alpha 1-adrenoreceptor antagonists, were added to the section 4Contraindications due to the potential for alpha 1-adrenoreceptor antagonist-associated adverse events such as hypotension and priapism.
In section 7 Drug Interactions the calcium channel blockers, amlodipine, dilitiazem, nisoldipine and verapamil were added.
The complete, revised label will be posted soon to the Drugs@FDA, and DailyMed sites.
Victrelis is a product of Merck & Co.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDAPatient Network News, a twice monthly electronic newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.
This email was sent xxxx@yahoo.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
--------------------------
No comments:
Post a Comment