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Healthcare Issues / 10 Jul 2018

Ministry of Health and Prevention recalls some anti-hypertensive medications containing Valsartan

Ministry of Health and Prevention recalls some anti-hypertensive medications containing Valsartan

The Ministry of Health and Prevention (MOHAP) issued a circular ordering the recall of some antihypertensive medicines containing the active ingredient Valsartan, manufactured by Chinese company Zhejiang Huahai Pharmaceutical after the detection of impurities in the active ingredient.  This recall is a precautionary measure taken by the Ministry following the report issued by the European Medicines Agency indicating the detection of a contamination of the active ingredient with N-nitrosodimethylamine (NDMA), a chemical that might lead to cancer. Valsartan is a medicine used for the treatment of hypertension to prevent related cardiovascular complications.

According to the Ministry, the circular was released and addressed to all directors of the medical districts, directors of public and private hospitals, doctors, pharmacists and assistant pharmacists, directors of government and private pharmacies. The recall was issued after the Ministry's senior officials reviewed Ministerial Resolution No. (366) of 2010 governing the withdrawal, suspension, or prevention of distribution of pharmaceutical and medical products to protect public health.

Products affected by the MOHAP recall orders 

The circular includes a list of affected products, that have been registered with the Drug department of MOHAP. The recall order was sent to authorized agents and distributors of the recalled products with an order to quarantine all quantities of the products present within their warehouses. The circular has also directed that all healthcare practitioners and doctors should not prescribe or dispense the affected products and also advises patients to not discontinue use of the medicine unless they consult with the doctor to prescribe other alternatives registered with the Ministry.

The list of recalled products includes;  

Product Name Manufacturer Name

CINFAVAL LABORATORIOS CINFA S.A- Spain

CO-CINFAVAL LABORATORIOS CINFA S.A - Spain

BIOSTAR PLUS PHARMA INTERNATIONAL CO. - Jordan

VALDIO™ GLOBALPHARMA The Sanofi CO. LLC- UAE

VALDIO HCT GLOBALPHARMA The Sanofi CO. LLC- UAE

Novartis says hypertension medication Diovan is safe to use 

Meanwhile, MOHAP also explained that other medicines containing Valsartan, which are manufactured using the same active ingredient from other sources, are intact and unaffected--meaning that these are still safe to use. In connection with this, Swiss multinational pharmaceutical company Novartis informed the Ministry that their products containing Valsartan--Diovan, Co-Diovan Entresto and Exforge--are not impacted because these products do not contain the active ingredient from an external supplier, where the active ingredient was manufactured in a Novartis site in Ireland and Switzerland. Diovan is widely used to treat hypertension and all its related pharmaceutical products in the UAE and the rest of the world are safe to use.

Discontinuing the use of drugs as a result of misleading advertisements can cause serious complications for patients

The Ministry pointed out that the spreading of rumors without obtaining the proper information from official sources have serious consequences that can affect the community--causing doubt among patients that can drive them into stopping or modifying medication without obtaining proper advice from a healthcare professional. MOHAP is routinely doing quality checks by testing random samples to ensure a quality of medicines in the country through the quality control of the laboratory at the Dubai Science Park. This explanation was given in response to the recent spread of an inaccurate news report on social media covering the supposed withdrawal of Diovan, which caused panic among patients who stopped the use of medication, which badly affects their health.

MOHAP in constant contact with global pharmaceutical agencies to circulate any warning

The Ministry has affirmed that it is always in close coordination and communication with the FDA and the European and Australian Medicines agencies to get any updates and take any necessary actions as soon as possible to protect the health of patients and people in the country. 

Contacting MOHAP in case of rumors about medicines

The Ministry urged members of the community to contact them for any questions about medical products—including official information on medical matters, pharmaceutical products, medical warnings and details about approved medical devices. The Ministry can be contacted via 04-2301448; fax: 04-2301947; or e-mail: pv@moh.gov.ae  or through the link:

http://www.moh.gov.ae/ar/Services/Pages/TaminiService.aspx

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