Drug Safety Labeling Changes - October 2015
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October 2015
This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.
| Key to Label Sections |
| BW - Boxed Warning |
C - Contraindications |
W - Warnings |
P - Precautions |
| AR - Adverse Reactions |
PPI - Patient Package Insert |
MG - Medication Guide |
PCI - Patient Counseling Information |
|
Sections Modified |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Atropine Sulfate Injection | - |  | - | - | - | - | - | - |
| Picato (ingenol mebutate) Gel | - | | | | | - | - | - |
| Technnivie (ombitasvir, paritaprevir, and ritonavir) Tablets | - | | | | | - | - | - |
| Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use | - | | | | | - | - | - |
| Biaxin Filmtab (clarithromycin tablets, USP)Biaxin XL Filmtab (clarithromycin extended-release tablets)Biaxin Granules (clarithromycin for oral suspension, USP) | - | - | | | - | - | - | - |
| Eloxatin (oxaliplatin) Injection, for Intravenous Use | - | - | | | | - | - | - |
| INOmax (nitric oxide) for Inhalation | - | - | | | - | - | - | - |
| Jadenu (deferasirox) Tablets | - | - | | | | - | - | - |
| Letairis (ambrisentan) Tablets | - | - | | | | - | - | - |
| Mirena (levonorgestrel-releasing intrauterine system) | - | - | | | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Myfortic (mycophenolic acid) Delayed-release Tablets | - | - | | | | - | - | - |
| Nicoderm CQ (nicotine transdermal system) | - | - | | - | - | - | - | - |
| Ortho Evra (norelgestromin and ethinyl estradiol transdermal patch) | - | - | | | - | - | - | - |
| Ortho-Novum Tablets (norethindrone/ethinyl estradiol) Tablets and Modicon 28 Tablets (norethindrone/ethinyl estradiol) | - | - | | - | - | - | - | - |
| Pradaxa (dabigatran etexilate mesylate) Capsules | - | - | | | - | - | - | - |
| Yervoy (ipililumab) Injection | - | - | | | - | - | - | - |
| Adderall (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate) Tablets | - | - | - | | | - | - | - |
| Bloxiverz (neostigmine methylsulfate injection) | - | - | - | | - | - | - | - |
| Cefazolin For Injection USP and Dextrose Injection USP in Duplex Container, for Intravenous Use | - | - | - | | - | - | - | - |
| Coumadin (warfarin sodium) Tablets, for Oral UseCoumadin (warfarin sodium) for Injection, for Intravenous Use | - | - | - | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Olysio (simeprevir) Capsules, for Oral Use | - | - | - | | | - | - | - |
| Cimzia (certolizumab pegol) for Injection, for Subcutaneous UseCimzia (certolizumab pegol) Injection, for Subcutaneous Use | - | - | - | - | | - | - | - |
| Sodium Iodide I-131 Therapeutic Solution and capsules | - | - | - | - | | - | - | - |
| Tobi Podhaler (tobramycin inhalation powder), for Oral Inhalation Use | - | - | - | - | | - | - | - |
| Tobi (tobramycin) Solution for Inhalation | - | - | - | - | | - | - | - |
