THOUSANDS of patients with high blood pressure and congestive heart failure will be forced to switch to a significantly costlier medicine after a generic drug was recalled from the market.
Valsartan, which is manufactured in China, was taken off Bahrain’s shelves yesterday after the European Medicines Agency (EMA) confirmed it contained harmful ingredients that could lead to cancer.
In a statement issued yesterday, the National Health Regulatory Authority (NHRA) said it has instructed all agents to withdraw the product from the market, adding that a notice of the recall has been circulated to all hospitals and pharmacies in the country.
Valsartan is a copy of Diovan, manufactured by Switzerland-based Novartis, which is available in the local market and public health facilities and costs around 80 per cent more than the generics.
“(The recall) is due to a problem with a preliminary manufacturing product in these drugs, which is impure and might cause cancer if used for a long time – hence the early alert,” NHRA chief executive Dr Maryam Al Jalahma told the GDN.
“The NHRA has asked to withdraw all the medicines from the market in order to identify the manufacturers.
“Those from China will be withdrawn and destroyed in Bahrain, while others, from Switzerland, will be returned to the market.”
Bahrain is one of 22 countries that received about 2,300 batches of the drug with manufacturing defects, supplied from Zhejiang Huahai Pharmaceuticals in Linhai, China.
However, Dr Al Jalahma maintained that the public has no reason to panic.
“People don’t have to panic as any effect will happen after a long time of the usage of the medicine,” she said.
“The company withdrew it as soon as they realised the issue and the recall was to curb the future effect of the drug, but using it for a while might not cause any side-effects.”
Novartis, the company that developed the original drug under the name Diovan, said Sandoz Valsartan and Valsartan/HCT film-coated tablets were being recalled because they did not meet “our high quality standards”.
A representative from Yousuf Mahmood Husain, the distributors for Novartis in Bahrain, said the safety of their products was attested by international regulators.
“We are the manufacturers of the original Valsartan, under the trade name Diovan in the market, which is supplied to all government healthcare facilities including Salmaniya Medical Complex, BDF Hospital and the King Hamad University Hospital,” he said.
“These drugs are safe, whereas the recalled drugs are a generic of this product.”
An official from a private hospital in Bahrain confirmed to the GDN yesterday that up to 20 per cent of their cardiac patients took Valsartan, which costs BD6 while Diovan costs BD11.
“Out of the more than 1,000 cardiac patients monthly, around 15 to 20pc used Valsartan, which has been taken off the shelf after the recall,” he said.
“This means they will have to resort to the original or other generics available, as guided by their doctors.”
The other countries where Valsartan has been recalled are Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, and Malta.
raji@gdn.com.bh
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发表于 2018-7-7 13:39:51
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