By Economic Times – IPCA asks USFDA to clarify on Hydroxychloroquine risk Hydroxychloroquine, besides being administered as an anti-malarial drug, is also used as a chronic therapy by patients suffering from auto immune diseases such as RA and Lupus. In the recent months the drug has been used in several countries including India and US in the treatment of critically ill Covid-19 patients.Last Updated: Apr 30, 2020, 08.27 AM ISTMUMBAI: Mumbai-based IPCA, the largest active ingredient manufacturer of the hydroxychloroquine (HCQ) in the world, has requested the US Food and Drug Administration (USFDA) and the European Medicine Agency (EMA) to issue a clarification on their recent advisory on the use of this drug and its possible side effects. In the letter the company has asked the regulators to clarify the low risk of the drug in approved indication and dosage for patients of rheumatoid arthritis (RA) and lupus.
HCQ, besides being administered as an anti-malarial drug, is also used as a chronic therapy by patients suffering from auto immune diseases such as RA and Lupus. In the recent months the drug has been used in several countries including India and US in the treatment of critically ill Covid-19 patients.
A week ago, USFDA and EMA issued an advisory cautioning the use of HCQ or chloroquine for Covid-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. IPCA has requested the regulators to issue a clarification mentioning the risk with usual dosage in approved indications, citing studies that show risks only when the dosage is given higher or taken in combination with Azithromycin.
“HCQ was approved by USFDA in 1955 and marketed internationally for six decades. In India, the drug has been approved for RA in 2001, so we have enough safety data about this drug,” said Anil Parekh, medical director, IPCA.
As the debate about the safety issue of the drug has dragged on, it is patients of RA who seem to be spooked about its alleged adverse effects. Rheumatologists ET spoke to said that in the past few months they have been getting panic calls from their patients checking about the safety of the drug.
“I have been getting frequent calls from my patients who want to get their heart condition checked after reading safety reports of this drug”, Dr Chadrashekhar, who only uses one name, a Bengaluru-based rheumatologist told ET. “I have been prescribing this drug for the last two decades for RA patients and haven’t seen any adverse impact,” Chandrashekhar added.
Also ReadNatco Pharma gets USFDA approval for Visakhapatnam facilityAlembic gets USFDA nod for generic ophthalmic solutionStrides receives USFDA approval for Flucytosine CapsulesGlenmark Pharma gets tentative USFDA nod for generic anti-diabetes tabletsCommenting feature is disabled in your country/region.Copyright © 2020 Bennett, Coleman & Co. Ltd. All rights reserved. For reprint rights: Times Syndication Service
For more details, please visit http://gestyy.com/e0wTwj