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Losartan and Valsartan Containing Medicines in Brunei Are Safe

LOSARTAN AND VALSARTAN CONTAINING MEDICINES IN BRUNEI DARUSSALAM ARE NOT ASSOCIATED WITH PRODUCT RECALL STATED IN PRESS RELEASE FROM MALAYSIA, UNITED STATES OF AMERICA AND UNITED KINGDOM

 

1.       The Ministry of Health Brunei Darussalam would like to reassure members of the public with regards to the quality of Losartan and Valsartan containing medicines in Brunei Darussalam. This is with respect to the recent news of Losartan and Valsartan containing medicines being recalled by Ministry of Health, Malaysia dated 23rd November 2018 which was reported in various newspapers and social media (Annex B).

 

2.       The recall from Ministry of Health, Malaysia was based on product recall by the Food and Drug Administration (FDA), United States of America where an impurity known as N-Nitrosodimethylamine (NDMA) was discovered in the active substance of Losartan and Valsartan. Losartan and Valsartan are generally used to treat patients with high blood pressure (to reduce complications such as heart attack and stroke) and patients who have heart failure.

 

3.       Losartan: 

The FDA had recalled Losartan Potassium 100mg/Hydrochlorothiazide 25mg tablet with batch number JB8912 manufactured by Sandoz Inc. This product was manufactured by Lek Pharmaceuticals, Slovenia and the active substance was from Zhejiang Huahai Pharmaceuticals Co Ltd, China. This product is not registered and not imported by Brunei Darussalam.

Based on this FDA product recall, further investigation by Ministry of Health, Malaysia had identified 3 registered products where the active substance Losartan is from Zhejiang Huahai Pharmaceuticals Co Ltd, China as listed below:

List of products containing active substance Losartan from Zhejiang Huahai Pharmaceuticals Co Ltd, China which are registered in Malaysia and its current status in Brunei Darussalam:

 

No.Brand and strengthActive IngredientCurrent status in MalaysiaCurrent status in Brunei Darussalam
1Rasoltan 50 mg film- coated tabletLosartan Potassium Registered in Malaysia but not marketed in MalaysiaNot registered and not imported by Brunei Darussalam
2Lostad HCT 50/12.5mg film- coated tabletLosartan Potassium/ HydrochlorothiazideRegistered in Malaysia and marketed in Malaysia. This brand is being recalled in MalaysiaNot registered and not imported by Brunei Darussalam
3Lostad HCT 100/25mg film- coated tabletLosartan Potassium/ HydrochlorothiazideRegistered in Malaysia but not marketed in MalaysiaNot registered and not imported by Brunei Darussalam

All of these products including Lostad HCT 50/12.5mg are not registered and not imported by Brunei Darussalam.

 

4.      Valsartan: 

The FDA also recalled products with active substance Valsartan manufactured by Mylan Pharmaceuticals Inc and Mylan Laboratories Limited where the active substance Valsartan is manufactured by Mylan Laboratories Limited, India. This product is not registered and not imported by Brunei Darussalam.

Further investigation by Ministry of Health, Malaysia had identified 2 registered products made using the active substance Valsartan manufactured by Mylan Laboratories Limited, India as listed below: 

List of products containing active substance Valsartan from Mylan Laboratories Limited, India  which are registered in Malaysia and current status in Brunei Darussalam:

No.Brand and strengthActive IngredientCurrent status in MalaysiaCurrent status in Brunei Darussalam
1Hovid- Valsartan film-coated tablet 80mgValsartanRegistered in Malaysia but not marketed in MalaysiaNot registered and not imported by Brunei Darussalam
2Hovid- Valsartan film-coated tablet 160mgValsartanRegistered in Malaysia but not marketed in MalaysiaNot registered and not imported iby Brunei Darussalam

All of the products listed above are not registered and not imported by Brunei Darussalam.

 

5.       With regards to all the above, the Ministry of Health, Brunei Darussalam would like to remind the public of the following:

    1. All registered pharmaceutical products in Brunei Darussalam are not affected by the product recalls in Malaysia, USA and UK.
    2. Members of the public should be aware that not all Losartan and Valsartan-containing medicines are affected and being recalled.
    3. Patients who have been prescribed on Losartan and Valsartan containing medicines are advised not to stop their treatment unless they have been advised to do so by the doctor.
    4. In cases where patients do have the brands being recalled in Malaysia, USA & UK, please consult with your doctor.
    5. Patients can obtain further advice from their doctor or pharmacist.

 

6.       The Ministry of Health, Brunei Darussalam would also like to remind and encourage all healthcare professionals in the country to report adverse events or side effects related to the use of medicinal products to the National Adverse Drug Reaction Monitoring Centre c/o Pharmacovigilance Section, 1st Floor, Department of Pharmaceutical Services Building, Kg. Madaras, Mukim Gadong A at 2393298 extension 201/206/207 or send an e-mail to nadrmc.dps@moh.gov.bn.
 

7.       The safety of the public is of the highest concern for the Ministry of Health. Urgent and continuous safety and quality review of all these products has been undertaken to ensure that the registered medicines in the Brunei Darussalam market is of quality, safe and efficacious for use in Brunei Darussalam. For more information on registered or banned pharmaceutical products in the country, public can visit the Ministry of Health website at www.moh.gov.bn.

annex A (valsartan and losartan).jpg


Annex B

bharian.com.my




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Reference     : KK/PR/3

Date               : 28  November 2018 / 20 Rabiulawal 1440H




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