Last Updated on December 26, 2023 by The Health Master
The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI), has flagged drug safety alert revealing that popular blood pressure drug, Losartan is associated with adverse event known as muscle spasm.
This came to light after the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database.
Losartan is an angiotensin II receptor blocker (ARB) used to treat hypertension. The drug reversibly and competitively prevents angiotensin II from binding to the AT1 receptor in tissues like vascular smooth muscle and the adrenal gland.
Losartan and its active metabolite bind the AT1 receptor with 1000 times more affinity than they bind to the AT2 receptor. The active metabolite of Losartan is 10-40 times more potent by weight than unmetabolized Losartan as an inhibitor of AT1 and is a non-competitive inhibitor.
Losartan’s prevention of angiotensin II binding causes vascular smooth muscle relaxation, lowering blood pressure.
The drug is available as losartan potassium oral tablets as well as a combination tablet of losartan potassium and hydrochlorothiazide.
Losartan, sold under the brand name Cozaar among others, is also used for diabetic kidney disease, heart failure, and left ventricular enlargement. It is taken by mouth. It may be used alone or in addition to other blood pressure medication.
Patients taking Losartan should have their renal function and potassium levels monitored. Losartan was granted FDA approval on April 14, 1995.
As per drug safety alert issued by IPC recently, Losartan is linked with muscle spasm which results in continuous, involuntary, painful, and localized contraction of an entire muscle group, individual single muscle, or select muscle fibers.
Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADR associated with the use of Losartan. If such a reaction is encountered, it needs to be reported to the NCC-PvPI for suitable action.
IPC had earlier also flagged drug safety alerts revealing that anti-inflammatory drug, ibuprofen was linked with an adverse event known as fixed drug eruption while Covid-19 drug remdesivir was associated with sinus bradycardia.
Besides this, it had earlier also flagged drug safety alerts revealing that diclofenac, a NSAID, was linked to skin hyperpigmentation while dimethyl fumarate, used for relapsing-remitting multiple sclerosis, was associated with adverse drug reaction alopecia.
Cefazolin, a cephalosporin antibiotic, was linked to acute generalized exanthematous pustulosis (AGEP), according to the preliminary analysis of ADRs from the PvPI database.
The CDSCO had started PvPI in July 2010 across the country. Since then, IPC has been mandated to establish clinical evidence between the drug and the ADR event through a robust system of causality assessment.
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