jueves, 10 de septiembre de 2015

FDA MedWatch - August 2015 Safety Labeling Changes includes 43 products with revisions to Prescribing Information

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The MedWatch August 2015 Safety Labeling Changes posting includes 4products 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:
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

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