  |
The MedWatch May 2015 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections:BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm450062.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS sections:
Androderm (testosterone) Transdermal System
AndroGel (testosterone) Gel
Avastin (bevacizumab) Solution for Intravenous Infusion
Aveed (testosterone undecanoate) Injection
Axiron (testosterone) Topical Solution
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablet
Delatestryl (testosterone enanthate) Injection
Edurant (rilpivirine) Tablet
Erivedge (vismodegib) Capsules
Fluvirin (influenza Vaccine)
Fortesta (testosterone) Gel
Gilenya (fingolimod) Capsules
Intron A (interferon alfa-2b), Recombinant for Injection
Lamictal (lamotrigine) Chewable Dispersible Tablets
Lamictal (lamotrigine) Tablets
Lamictal ODT (lamotrigine) Orally Disintegrating Tablets
Natesto (testosterone) Nasal Gel
Nicorette (nicotine polacrilex) Lozenges
PegIntron (peginterferon alfa-2b), Injection for Subcutaneous Use
Perjeta (pertuzumab) Injection, for Intravenous Use
Prezista (darunavir) Tablet and Oral Suspension
Provera (medroxyprogesterone acetate) Tablets
Rebetol (ribavirin) Capsules and Oral Solution
Sirturo (bedaquiline) Tablets
Striant (testosterone buccal system) Mucoadhesive
Sylatron (peginterferon alfa-2b) for Injection, for Subcutaneous Use
Testim (testosterone) Gel
Testosterone Gel, for Topical Use
Trokendi XR (topiramate) Extended-release Capsules
Tysabri (natalizumab) Injection, for Intravenous Use
Vogelxo (testosterone) Gel
VPRIV (velaglucerase alfa for injection)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
