Posted in Flagyl on September 10, 2015

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The MedWatch August 2015 Safety Labeling Changes posting includes 43 products through safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.

The “Summary Page” index provides a listing of product names and preservation 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 method) 
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 inculcate)
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 let loose)
Lotensin HCT (benazepril hydrochloride/hydrochlorothiazide) Tablets
Mircera (methoxy polyethylene glycol-epoetin beta)  
Myrbetriq (mirabegron) Extended-remit 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-loose) 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 narrate all serious adverse events and proceeds quality problems to FDA MedWatch at minutes of.htm

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