The National Pharmaceutical Pricing Authority on Wednesday allowed the immediate withdrawal of pharmaceutical company Abbott’s bioresorbable cardiac stent, citing safety concerns.
The NPPA in its order took note of “global safety concerns” over the enhanced adverse cardiac activity (for example cardiac death, heart attack) including increased level of thrombosis (developing blood clots).
Bioresorbable stent dissolve in the arteries, and are absorbed by the body after a period of time. These are the most expensive forms of stents.
The NPPA also decided to relax the mandatory six-month prior intimation under the Drug Price Control Order “in public interest”. The NPPA also directed Abbott to continue to follow up with the patients who have got the stents implanted, and and attend to all the issues arising in the cases. Abbott’s product is under price control since February 14 when the NPPA decided to cap the price of all these stents to Rs 29,600.
The safety concerns were raised by the US Food and Drug Administration in March. European Union and the Australian government had also raised concerns. In April, the Central Drugs Standard Control Organisation had ordered reporting of adverse events in the cases where the implant has been used to post-marketing registries.
Abbott had requested for withdrawal of the stent from the market as it planned to stop manufacturing the product. The company said it was withdrawing the product globally on account of “low commercial uptake”.
The NPPA, however, said that the prime reason for low uptake is the safety concern.