MedWatch September 2013 Safety Labeling Changes


The MedWatch September 2013 Safety Labeling Changes posting includes 49 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of product names and safety labeling sections revised:

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

Arzerra (ofatumumab)
CombiPatch (estradiol/norethindrone acetate transdermal system)
Potiga (ezogabine)
Rituxan (rituximab)
Tasigna (nilotinib)
Tygacil (tigecycline)

Accupril (quinapril hydrochloride)
Accuretic (quinapril hydrochloride/HCTZ)
Altace (ramipril)
Arixtra (fondaparinux sodium)
Janumet (sitagliptin and metformin HCl)
Plasma-Lyte 148 and Plasma-Lyte A pH 7.4 (Multiple Electrolytes, Type 1, USP)
Septra and Septra DS (Trimethoprim and Sulfamethoxazole)
Suprane (desflurane, USP)

Apidra (insulin glulisine [rDNA origin])
CellCept (mycophenolate mofetil)
Biaxin (clarithromycin tablets, USP)
Biaxin Granules (clarithromycin for oral suspension, USP)
Biaxin XL Filmtabs (clarithromycin extended release tablets)
Gemcitabine Injection
Golytely (PEG 3350 and electrolytes)
Jentadueto (linagliptin and metformin hydrochloride) 
Myfortic (mycophenolic acid)
Nulytely (PEG 3350 and electrolytes)
Plavix (clopidogrel bisulfate)
Prograf (tacrolimus)
Prograf (tacrolimus)
Remodulin (treprostinil)
Terazol (terconazole)
Unisom SleepTabs (doxylamine succinate)
Vimpat (lacosamide)
Zometa (zoledronic acid)
Zosyn (piperacillin and tazobactam for injection, USP)


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