Spectre of adulterated heparin emerges again, in Mexico

The authorities in Mexico have launched an investigation after seven deaths at a hospital among patients treated with the blood thinning drug sodium heparin.

The incident is developing at the Pemex Regional Hospital in Villahermosa, Tabasco, with dozens of other patients reported to have suffered side effects after receiving heparin, produced by domestic drugmaker Laboratorios PiSA SA de CV.

The Federal Commission for Protection Against Sanitary Risk (Cofepris) is investigating suggestions that the heparin used at the hospital was falsified or had been intentionally adulterated.

The pharma company has said that after examining the Inhepar 5000 IU / mL vials used at the hospital it concluded they had either been re-used – which is sometimes observed with falsified medicines – or tampered with.

In a statement, PiSA said it had filed a complaint with the Attorney General of the Republic (FGR), Tabasco delegation, for the “possible adulteration and/or falsification” of its Inhepar product with a batch number of C18E881 and an expiry date of January 2021.

Any Inhepar product with this batch and expiry found in the supply chain should be quarantined, according to the drugmaker.

In the complaint it notes that a man who delivered the drug to the hospital – one José Roche Pérez residing in the state of Tabasco – is “not an authorised distributor for the commercialisation of the product.”

More then 10 years ago, heparin contaminated with over-sulfated chondroitin sulfate (OSCS) – an adulterant used to fool quality control testing – injured thousands of patients around the world and killed dozens of people in the US and elsewhere.

Local media reports in Mexico suggest that some of the deaths attributed to the suspect heparin product appear to be linked to contamination with the bacteria Klebsiella pneumoniae. Most of the patients were given heparin to prevent blood clots whilst undergoing dialysis.

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