The Food and Drug Administration (FDA) has asked hospitals and pharmacies to recall batches of rosuvastatin — a drug to control cholesterol marketed as Crestor — which the agency said had been mixed with counterfeit drugs.
FDA official Chih Lan-hui (遲蘭慧) said that global biopharmaceutical company AstraZeneca received a report from a pharmacist in New Taipei City last month that its Crestor 10mg film-coated tablets might contain counterfeit drugs in similar packaging.
The company confirmed the product was fake after sending a sample abroad to be examined.
The FDA received the report from AstraZeneca on Thursday and the New Taipei District Prosecutors’ Office launched an investigation, Chih said.
Preliminary investigations showed that counterfeit drugs were mixed with batch number MV503 of Crestor, which was distributed in October last year.
National Health Insurance Administration (NHIA) data showed that more than 570,000 people are taking Crestor with about NT$2.3 billion (US$74.1 million) spent on the drug each year.
Chih said the counterfeit drug contained atorvastatin — another lipid-lowering medication — as its main ingredient, rather than rosuvastatin.
Taipei Department of Health official Wang Ming-li (王明理), director of the Food and Drug Division, yesterday said the department’s preliminary investigation at pharmacies in the city showed that another of the company’s film-coated cholesterol-lowering products might contain counterfeit drugs as well.
“We found 66 boxes of Crestor 10mg film-coated tablets with three different batch numbers and 44 boxes of 5mg film-coated tablets with one batch number” at a pharmacy that purchased the drugs from the same source as that which provided the confirmed fakes in New Taipei City, Wang said. “We collected them for testing.”
Taiwan Pharmacist Association spokesperson Shen Tsai-ying (沈采穎) said the patent on atorvastatin expired in November 2011, so the ingredients are 30 to 50 percent cheaper than rosuvastatin, so unscrupulous manufacturers of atorvastatin can captialize on the difference in cost.
Shen said many pharmacists reported that most of the MV503 batch has already been sold.
If people have medication from that batch, they should not take it, but should exchange it for the same drug from a different batch, Shen said.
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