Mexico warns of falsified clotting drug Xarelto

Mexico's health authority Cofepris has warned that it has identified three falsified batches of the anti-clotting medicine Xarelto circulating in the market.

Xarelto (rivaroxaban), which is marketed by Bayer and Johnson & Johnson, is a oral anticoagulant drug used to treat a range of cardiovascular disorders including strokes and heart attacks and is a widely-used medicine with worldwide sales of almost $7 billion in 2020.

Cofepris is advising healthcare workers to be vigilant and review batch numbers to "rule out any health risk" for patients. The suspect batch numbers are BXJG6V2, BXJG6V3 and 765289.

In the case of batches BXJG6V2 and BXJG6V3, the packs are considered counterfeit and adulterated if they contain 14 tablets, since this is half of the number of the legitimate medicine, according to the authority. The packages also had anomalies in the colours and fonts used.

Regarding batch 765289, the packaging indicates that it has 100 capsules, but the original medicine does not come in that quantity so the packaging and its contents are considered fake.

Cofepris "asks those who have these medicines to verify them, and in case of having counterfeit products, suspend their consumption immediately [as] they represent a risk to health."

It also says that distributors and other organisations handling medicines must verify whether any packs of Xarelto with the batch numbers are in their inventory, and if they have any the packs must be quarantined and any commercialisation and distribution ceased immediately.

Bayer warned in 2019 and  2020 that falsified Xarelto had been identified in the supply chain, and published information giving advice on how to identify genuine packs, including the safety features used on them to guard against counterfeiting.

Images of the falsified packs can be seen here.