EMA Takes Further Action in Ongoing Review of Tainted 'Sartans'

Megan Brooks

October 15, 2018

China's Zheijiang Huahai Pharmaceuticals (ZHP), the company at the center of the tainted valsartan crisis, will face increased scrutiny over other substances they produce, the European Medicines Agency (EMA) announced today.

The agency also announced that Indian drug maker Aurobindo Pharma will be prohibited from supplying irbesartan in the European Union (EU).

The latest action against ZHP stems from recent European and US inspections of the company's Chuannan facility in Linhai, China, which uncovered numerous manufacturing and quality control weaknesses.

"The inspection findings included deficiencies in the way the company investigated impurities in its valsartan products and led EU authorities to issue a statement of non-compliance with good manufacturing practice (GMP), prohibiting the use of its valsartan in EU medicines," the EMA said in a statement issued October 15

EU authorities will monitor corrective measures the company implements on a regular basis and increase the frequency of inspections of the Chuannan site. In addition, marketing authorization holders for EU medicines will be required to perform additional tests on all active substances supplied by ZHP, the EMA said.

Valsartan is an angiotensin II receptor antagonist used to treat hypertension and heart failure. This past July, some valsartan products manufactured by ZHP were found to be contaminated with N-nitrosodimethylamine (NDMA), a potential carcinogen, which led to an EU-wide review of all valsartan medicines. In late September, regulators in Europe and the US pulled all affected valsartan products from the market.

EU and US authorities have said a preliminary risk assessment for NDMA in valsartan has indicated that the lifetime risk of cancer is low.

The EU subsequently extended their review to four other 'sartan' drugs when very low levels of another potential carcinogen, N-nitrosodiethylamine (NDEA), were discovered in losartan made by Hetero Labs in India.

Low levels of NDEA have now also been found in a third sartan (irbesartan) made by another Indian company, Aurobindo Pharma. As a result, on October 8, the European Directorate for the Quality of Medicines & HealthCare (EDQM) suspended Aurobindo Pharma's certificate of suitability (CEP), effectively stopping the company from supplying irbesartan to the EU, the EMA said.

National authorities in the EU are currently deciding whether to recall medicines containing Aurobindo Pharma's irbesartan from pharmacies as a precaution.

"The review into the presence of impurities in sartans and their potential effects in patients is ongoing. EMA will continue working with national authorities, international partners and EDQM and will provide updates as more information becomes available," the EMA said.


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