We in practice are confused about “sartans” (ARBs or
angiotensin receptor blockers). Every other day, a preparation is withdrawn
from the market.
Now Torrent Pharmaceuticals Limited is
expanding its recall for Losartan Potassium Tablets USP and Losartan
Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to
detection of trace amounts of an unexpected impurity found in an active
pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The
Recall is expanded to include an additional 36 lots of Losartan Potassium
Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.
The impurity detected in the API is
N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of
losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA)
above the acceptable daily intake levels released by the FDA.
The Drugs Controller General of India (DCGI) should act
to ensure availability of such information on its website. The safety profile
of all internationally debated drugs should be updated to keep up with the
latest developments.
Today, most patients come to know of such controversies
through Google and they begin to question their doctor.
As doctors we need to talk in “one voice” and that to
what the DCGI has conveyed to us.
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of
India
Past National President
IMA
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