IPCA asks USFDA to clarify on Hydroxychloroquine risk

By Sumit Blogs -

ipca-asks-usfda-to-clarify-on-hydroxychloroquine-risk

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 https://ift.tt/2Sj1uHA

The post IPCA asks USFDA to clarify on Hydroxychloroquine risk appeared first on Stay in Gurgaon.

Comments

Post a Comment

Popular posts from this blog

Flat sale of flu drugs hints at no unusual rise in infections

By Sumit Blogs -
Image
By Economic Times – Flat sale of flu drugs hints at no unusual rise in infections Industry executives and chemists said the April sales data showed a month-on-month decline of 30-40%. But even though the lockdown is seen to be impacting sales of most drugs, the pattern for medicines for infections and flus is no different.Last Updated: Apr 30, 2020, 11.23 AM ISTAgenciesExperts said the decline in sales was primarily because of the lockdown and other restrictions which forced people to stay indoors. (This story originally appeared in on Apr 30, 2020)NEW DELHI: Sales of anti-infectives (antibiotics and antivirals), respiratory drugs, painkillers and analgesics — some key medicines used for influenza-like illnesses — have remained mostly unchanged in last three months (January to March), partly explained by the lockdown but also indicating no unusual rise in flu-type infections that might point to a wider and undetected spread of Covid-19. Sales of most medicines, including this set of
Read more

10YearsForSimha: Reasons behind film’s success

By Sumit Blogs -
Image
By Times of India – 10YearsForSimha: Reasons behind film’s success TIMESOFINDIA.COM | Last updated on – Apr 30, 2020, 06:00 ISTclose01/6Take a look at the reasons behind the film’s successDirected by Boyapati Srinu, the 2010 film Simha was a game-changer among Tollywood films that was lauded, not only for Nandamuri Balakrishna’s intense performance in the dual role but also the gripping narration of the filmmaker. Balayya and Nayanthara were seen on the big screen for the first time ever in the film. The action drama made a special place in the hearts of the audience because of its simple storytelling, superhit songs and unbeatable chemistry between the lead pair. The movie has completed a decade, but the essence is as fresh as it was back then. As the film clocks 10 years of its release, find out the reasons behind the massive success of the Balakrishna starrer.readmore02/6​Boyapati Srinu’s gripping narrationBefore Simha, Boyapati Srinu had delivered Bhadra (2005) and Tulasi (2007),
Read more

Hrithik-Saif’s Vikram Vedha hits a roadblock

By Sumit Blogs -
Image
The stage was about to be set for Hrithik Roshan and Saif Ali Khan’s ‘Vikram Vedha’ in Mumbai’s Film City. The material had reached. The artisans had been hired. But the lights have now been dimmed. Madhavan and Vijay Sethupathi’s hit movie Vikram Vedha’s Hindi remake will not go on floors by mid-July as per the original plan. The new delta virus of COVID has sent shudders down many spines and many films which were being laid out on an expansive scale have been either held back or shifted their shoots abroad. The first schedule of this Hrithik-Saif movie will now be shot abroad. A source says, “The Mumbai schedule will be done but later.” Adds the source, “It’s a call that was taken yesterday. It wasn’t an easy call to take, no doubt, but the fact that it’s going to be a costly set made the makers take the safer route rather than be sorry later.” When contacted, General Secretary of FWICE (Federation of Western India Cine Employees), Ashok Dubey, confirmed that the makers of ‘V
Read more