Friday, 15 January 2016 00:00

Drug Safety Labeling Changes

Rate this item
(2 votes)

The attention of the Agency has been drawn to the labeling changes of some drug products by the FDA. The changes are under the following sections: boxed warning, contraindications, warnings, precautions, adverse reactions or patient package insert/medication guide.

The table below provides a listing of drug product names and the safety labeling sections revised;

Drug Safety Labeling Changes Table

S/N

DRUG NAME

SECTIONS MODIFIED

BW

C

W

P

AR

PPI/MG

1

Atropine Sulfate Injection

 

X

       

2

BiaxinFilmtab (clarithromycin tablets, USP)

   

X

X

   

3

Biaxin Granules (clarithromycin for oral suspension, USP)

   

X

X

   

4

Biaxin XL Filmtab (clarithromycin extended-release tablets)

   

X

X

   

5

Eloxatin (oxaliplatin) Injection, for Intravenous Use

   

X

X

X

 

6

INOmax (nitric oxide) for Inhalation

   

X

X

   

7

Jadenu (deferasirox) Tablets

   

X

X

X

 

8

Letairis (ambrisentan) Tablets

   

X

X

X

 

9

Mirena (levonorgestrel-releasing intrauterine system)

   

X

X

X

 

10

Myfortic (mycophenolic acid) Delayed-release Tablets

   

X

X

X

 

11

Nicoderm CQ (nicotine transdermal system)

   

X

     

12

Opdivo (nivolumab) Injection

   

X

X

   

13

Ortho Evra (norelgestromin and ethinylestradiol transdermal patch)

   

X

X

   

14

Ortho-Novum Tablets (norethindrone/ethinylestradiol) Tablets and Modicon 28 Tablets (norethindrone/ethinylestradiol)

   

X

     

15

Picato (ingenolmebutate) Gel

 

X

X

X

X

 

16

Pradaxa (dabigatranetexilatemesylate) Capsules

   

X

X

   

17

Technivie (ombitasvir, paritaprevir, and ritonavir) Tablets

 

X

X

X

X

PCI

18

Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use

 

X

X

X

X

PCI

19

Yervoy (ipililumab) Injection

   

X

X

   

Key to Label Section Acronyms:

BW= Boxed Warning

C= Contraindications

W=Warnings

P=Precautions

AR= Adverse Reactions

PPI/MG= Patient Package Insert/Medication Guide

PCI = Patient Counselling Information

Healthcare Provider’s Action

NAFDAC… Safeguarding the health of the Nation!

Read 6731 times Last modified on Wednesday, 18 May 2016 14:25

ONLINE PORTALS

napams

Contact Us from Mon - Friday: 08:00-16:00 GMT+1

Write Us:

NAFDAC Corporate Headquarters,

Plot 2032, Olusegun, Obasanjo Way,

Zone 7, Wuse, Abuja, Nigeria

 

Lagos Operation Office:

Plot 1, Industrial Estate, Lagos- Oshodi Apapa Express Way, Isolo, Lagos, Nigeria

 

 

 

 

 

 

For Enquiries:

Call: +234(0)-1-4609750

Email:nafdac@nafdac.gov.ng

 

 

 

 

 

 

 

 

 

 

 

For Complaints:

Call: +234(0)909-763-0506

         +234(0)909-763-0507

Email:reforms@nafdac.gov.ng

Or Send Us a Complaint

 

 

 

 

 

 

 

 

 

Contact Other NAFDAC Offices Nationwide