  |
The MedWatch August 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/ucm460662.htm
The following drugs had modifications to the WARNINGS AND PRECAUTIONS sections:
Actimmune (Interferon gamma-1b)
Adcetris (brentuximab vedotin)
Botox (onabotulinumtoxin A)
Copegus (ribavirin) Tablets
Daytrana (methylphenidate transdermal system)
Geodon (ziprasidone hydrochloride) Oral Suspension
Geodon (ziprasidone mesylate) Injection
Geodon (ziprasidone) Capsules
Gilenya (fingolimod) Capsules
Glyxambi (linagliptin and empagliflozin)
Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride)
Implanon (etonogestrel implant)
Janumet (sitagliptin and metformin)
Janumet XR (sitagliptin and metformin extended release)
Januvia (sitagliptin)
Jentadueto (linagliptin and metformin)
Kazano (alogliptin and metformin)
Kombiglyze XR (saxagliptin and metformin extended release)
Lotensin HCT (benazepril hydrochloride/hydrochlorothiazide) Tablets
Mircera (methoxy polyethylene glycol-epoetin beta)
Myrbetriq (mirabegron) Extended-release Tablets
Nesina (alogliptin)
Nexplanon (etonogestrel implants)
Onglyza (saxagliptin)
Oseni (alogliptin and pioglitazone)
Prestalia (perindopril arginine/amlodipine besylate) Tablets
Prinivil (lisinopril) Tablets
Sovaldi (sofosbuvir) Tablets
Sprycel (dasatinib) Tablets
Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension, and Tegretol-XR (carbamazepine extended-release) Tablets
Thalomid (thalidomide) Capsules
Tivicay (dolutegravir) Tablets
Tradjenta (linagliptin)
Triumeq (abacavir/dolutegravir/lamivudine)
Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets
Vasotec (enalapril maleate) Tablets
Xenical (orlistat) Capsules
Xtandi (enzalutamide) Capsules
Zelboraf (vemurafenib) Tablets
Zestoretic (lisinopril/hydrochlorothiazide) Tablets
Zestril (lisinopril) Tablets
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 |  |
