MHRA investigates links in spate of counterfeits
pharmafile | June 6, 2007 | News story | Manufacturing and Production |
Counterfeit versions of a prostate cancer drug have prompted the MHRA to issue its third alert about fake drugs in less than a week.
The drug regulator confirmed it was investigating the possibility that the fake versions of AstraZeneca's Casodex were linked to discoveries of counterfeit versions of Lilly's Zyprexa and Sanofi-Aventis/Bristol-Myers Squibb's Plavix.
A batch of counterfeit Casodex was discovered in the pharmacy supply chain after a wholesaler reported its suspicions and the matter is now in the hands of the police.
Counterfeits are notoriously difficult to detect – even to the trained eye – and experts sometimes have to order forensic tests before they can say whether a product has been counterfeited.
Laboratory tests have now confirmed the batch of Casodex only contained about 75% of the labelled active ingredient and the MHRA is investigating what else it might have contained.
"At present, there is no evidence of patients having any adverse reactions specifically related to the counterfeits," the MHRA said in a statement: Patients are advised to consult their GP if they are concerned.
The counterfeit Zyprexa and Plavix have set the regulator working with its European counterpart, the EMEA, because both sets of fakes were discovered in French packaging for parallel-distributed products.
Parallel-distributed products differ from parallel imports by being licensed by the EMEA rather the MHRA. It is understood nearly 40 UK parallel distributors were allowed to supply the pharmacy supply chain with the schizophrenia drug Zyprexa and more than 30 firms were licensed for Plavix.
At-risk stock may be found in French livery cartons with an overlabel applied by a parallel distributor or it may have been re-cartoned into an English carton by the parallel distribution repacking process.
