Recalls & Alerts Published by NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has been notified by the U.S Food and Drug Administration (FDA) of the safety concerns on hepatitis C treatments Viekira Pak and Technivie. Viekira Pak and Technivie, are oral antiviral agents used in the treatment of chronic hepatitis C, a viral infection that can last a lifetime and lead to serious liver and other health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing it from multiplying and may slow down the disease.

It is warned by the FDA that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. According to FDA, several cases of liver injury in patients using either drug have been reported within 1 to 4 weeks of starting treatment.

 As a result, FDA is requiring the manufacturer AbbVie Inc. to add new information about this safety risk to the drug labels.

Possible associated Risks

  • Hepatic decompensation and liver failure could result from such an exposure to these drugs especially in patients with underlying liver cirrhosis.
  • Liver injury could require liver transplant for patient to stand a chance of survival.
  • Death results when prompt accurate medical intervention has not been made.

Action required from Prescriber/Patients

NAFDAC….Safeguarding the health of the Nation

Friday, 15 January 2016 00:00

Drug Safety Labeling Changes

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!

The National Agency for Food and Drug Administration and Control hereby inform the general public that FDA and the New York Department of Health found potentially unsafe levels of mercury and lead in several Baidyanath brand ayurvedic dietary supplements manufactured by Shree Baidyanath Ayurved Bhawan in India which, if consumed, may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders. Short-term exposure to mercury consumption may lead to renal or gastrointestinal issues, while long-term exposure may cause psychiatric and personality disturbances, ataxia (or loss of coordination), visual or hearing loss, and other neurological conditions particularly fetal neurological issues with pregnant patients. Lead exposure in children younger than 6 years may lead to nervous system damage potentially causing learning difficulties or delayed development and in pregnancy can cause nervous system damage to the fetus or cause miscarriage. Symptoms associated with lead poisoning include memory loss, unexplained hypertension, severe constipation, or extremity numbness.

The products can be obtained from retail outlets and via the internet. Butala Emporium Inc. one of the major retailer of the products has recalled the following Baidyanath brand ayurvedic supplements: Agnitundi Bati, Arogyavardhini Bati, Brahmi Bati, Chitrakadi Bati, Gaisantak Bati, Marichyadi Bati, Rajahpravartini Bati, Saptamrit Lauh, Sarivadi Bati, Shankh Bati.

NAFDAC implores the members of the public, importers and consumers to be pro-active by ensuring that these products are not purchased.

NAFDAC…..Safeguarding the health of the Nation

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