FDA MedWatch - May 2016 Safety Labeling Changes posting includes 86 products with changes to Prescribing Information

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - May 2016 Safety Labeling Changes posting includes 86 products with changes to Prescribing Information

 

The MedWatch May 2016 Safety Labeling Changes posting includes 86 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/ucm505586.htm

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, or PRECAUTIONS sections:

Adrenalin (epinephrine injection, USP)
alli (orlistat) Capsules
Anaprox (naproxen)
Ansaid (flurbiprofen)
Arthrotec (diclofenac sodium/misoprostol) 
Ativan (lorazepam)
AUVI-Q Autoinjector (epinephrine injection, USP)
Caldolor (ibuprofen)
Cambia (diclofenac potassium)
Cataflam (diclofenac)
Caverject Impulse (alprostadil for injection)
Caverject Sterile Powder (alprostadil for injection)
Cefepime Injection
Celebrex (celecoxib)
Cometriq (cabozantinib)
Cotellic (cobimetinib)
Crestor (rosuvastatin calcium)
Daypro (oxaprozin)
Daypro Alta (oxaprozin)
Dobutamine in 5% Dextrose Injection, USP in Flexible Plastic Containers
Doryx (doxycycline hyclate delayed-release tablets)
Duexis (ibuprofen and famotidine)
Dyloject (diclofenac)
Epinephrine Injection, USP (epinephrine, 1:1000)
EpiPen and EpiPen Jr. (epinephrine injection) Auto-Injector
Extavia (interferon beta-1b)
Fanapt (iloperidone)
Faslodex (fulvestrant)
Feldene (piroxicam)
Flector (diclofenac)
Folotyn (pralatrexate injection)
Habitrol (nicotine transdermal system) Patch
Indocin Capsules (indomethacin)
Indocin SR (indomethacin)
Indocin Suppositories (indomethacin)
Indocin Suspension (indomethacin)
indomethacin
Inspra (eplerenone)
Invokamet (canagliflozin and metformin HCl)
Invokana (canagliflozin)
Juxtapid (lomitapide)
Kynamro (mipomersen)
Lenvima (lenvatinib)
Lithobid (lithium carbonate USP) 
Mobic Suspension (meloxicam)
Mobic Tablets (meloxicam)
Nalfon (fenoprofen)
Naprelan (naproxen)
Naprosyn (naproxen)
Naprosyn Suspension (naproxen)
Naprosyn-EC (naproxen)
Nicoderm CQ (nicotine transdermal system)
Opdivo (nivolumab)
Orkambi (lumacaftor/ivacaftor)
Pennsaid 1.5% (diclofenac)
Pennsaid 2% (diclofenac)
Ponstel (mefenamic acid)
Potiga (ezogabine)
Solaraze (diclofenac sodium)
Sprix (ketorolac)
Sterile Water for Injection, USP
Teflaro (ceftaroline fosamil)
Tivorbex (indomethacin)
Treximet (naproxen and sumitriptan)
Twinject, Adrenaclick & Epinehrine Injection USP Auto-Injector
Tysabri (natalizumab)
Vimovo (naproxen/esomeprazole magnesium)
Vioxx (rofecoxib)
Voltaren (diclofenac)
Voltaren Gel (diclofenac)
Voltaren-XR (diclofenac)
Votrient (pazopanib)
Xarelto (rivaroxaban) 
Zarontin (ethosuximide)
Zelboraf (vemurafenib) 
Zipsor (diclofenac)
Zithromax (azithromycin)
Zithromax IV (azithromycin for injection)
Zorvolex (diclofenac)
Zytiga (abiraterone acetate) 

---

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

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 · 1-888-INFO-FDA (1-888-463-6332)