Plavix, or clopidogrel, is sold as a brand by Sanofi-Aventis and Bristol-Myers Squibb. It is the world's second biggest selling medicine, with worldwide sales of more than $9 billion a year.
The European Medicines Agency has recommended the recall of all batches of generic Plavix from Swiss drugmaker Acino made at a factory in India, due to quality concerns about the heart drug.
Plavix, or clopidogrel, is sold as a brand by Sanofi-Aventis and Bristol-Myers Squibb. It is the world's second biggest selling medicine, with worldwide sales of more than $9 billion a year.
However, the medicine is off patent in some European markets, where Acino is among the companies that have been supplying a cheaper generic version.
Europe's drugs watchdog said on Thursday it was taking the action because of good manufacturing practice (GMP) failure at a factory in Visakhapatnam, India, where the active substance for the affected Acino product is produced.
It added there were other clopidogrel-containing medicines, both branded and generic, available in the European Union to ensure adequate supply. Acino has now changed its supplier and future batches will be made at a site that is GMP compliant.
Acino said in a statement it could face writedowns on returned and existing goods if individual country authorities requested a recall of the clopidogrel products concerned.
"This would in all likelihood have a significant negative impact on the annual result 2010," Acino said.
While there have been no reports raising concerns from patients, pharmacists or prescribers, agency experts decided a recall was the appropriate precautionary measure.
Its recommendation that clopidogrel made at the Glochem Visakhapatnam factory be removed from the supply chain, starting at the level of pharmacists, has now been forwarded to the European Commission for the adoption of a legally binding decision.
The recall will cover eight clopidogrel-containing medicines for which Acino is the licence-holder, some of which are marketed by other generic drug companies.
The products are Clopidogrel A1 Pharma, Clopidogrel Acino, Clopidogrel Acino Pharma, Clopidogrel Acino Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel Ratiopharm GmbH and Clopidogrel Sandoz, the agency said.
Hexal and Sandoz are units of Novartis, while Ratiopharm is an unlisted German drugmaker that was sold last week to Israeli generic drugs group Teva.
Plavix is used widely in treating heart attack patients. It works in a similar way to aspirin by stopping platelets — tiny blood cells vital for the normal clotting process — from clumping together and forming life-threatening clots.
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
)
)
)
)
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}