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September 21, 2017

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More knockoff drugs uncovered

The Food and Drug Administration (FDA) ordered a recall Tuesday of Taiwan's most widely used lipid-lowering drug after more counterfeit versions of the drug were found.

The drug's maker, pharmaceutical giant AstraZeneca, issued a statement through its Taiwan affiliate on Tuesday announcing a recall of the Crestor (冠脂妥) drug in a joint effort with the FDA.

FDA Director Wu Shou-mei (吳秀梅) said investigators had found counterfeit Crestor drugs with the batch number MK479.

The discovery came after counterfeit Crestor drugs with the batch number MV503 were found on Sunday.

"Given that the FDA has been unable to confirm how many batches of fake Crestor drugs have entered the market, the administration and AstraZeneca Taiwan have decided to recall all Crestor drugs currently used or sold at hospitals and pharmacies nationwide," Wu said.

Taiwan Pharmacist Association Director Gu Bo-ren (古博仁) said counterfeit drugs were more likely to be found in community pharmacies than in public hospitals.

Top-selling Drug

Seeking to calm patients who may have already consumed the counterfeit drugs, Wu said that atorvastatin, the ingredient used in the counterfeit MK479 Crestor, was "still a lipid-lowering drug."

"It's just that even when both drugs are used to lower lipid levels, pretending to be medicine 'A' when you're in fact medicine 'B' still makes it a counterfeit,"Wu said.

Deputy section chief of the FDA's Planning and Research Development Division Chih Lan-hui (遲蘭慧) said that an average of 200,000 boxes of Crestor were used every month nationwide, with more than 570,000 patients relying on the drug. The drugs are manufactured and packaged in the U.K. before being exported into Taiwan.

"The company and the administration have reached a consensus on how the replacement of the current drugs on the market will be processed (after they are recalled) to ensure sufficient supply for patients and hospitals," Chih said Tuesday.

Addressing local media reports that suggested the presence of other counterfeit drugs on the market, including Januvia, Livalo and Vytorin, Wu said that the FDA would continue its investigations.

Chih promised to implement routine inspections on popular drugs once details regarding the counterfeit medications were established.

Two suspects who allegedly manufactured the fake MV503 batch of Crestor were detained on Monday, Wu said.

The suspects would be charged with violating the Pharmaceutical Affairs Act and could face a maximum of 10 years in prison and NT$100 million fine, Wu added.

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