Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • MCI News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Aborad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • MCI News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • IPC flags adverse...

IPC flags adverse reaction linked to Hepatitis C drug Sofosbuvir

Medical Dialogues TeamWritten by Medical Dialogues Team Published On 2021-09-01T14:13:33+05:30  |  Updated On 1 Sep 2021 8:46 AM GMT
IPC flags adverse reaction linked to Hepatitis C drug Sofosbuvir
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • koo
  • Email

New Delhi: The Indian Pharmacopoeia Commission (IPC) has recently issued a drug safety alert for the month of August, revealing that the antiviral medication Sofosbuvir, which is used to treat a specific strain of hepatitis C virus is associated with the Stevens-Johnson Syndrome.This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of...

New Delhi: The Indian Pharmacopoeia Commission (IPC) has recently issued a drug safety alert for the month of August, revealing that the antiviral medication Sofosbuvir, which is used to treat a specific strain of hepatitis C virus is associated with the Stevens-Johnson Syndrome.

This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Sofosbuvir is a direct-acting antiviral drug used in combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by Hepatitis C Virus infection (HCV).

HCV is a single-stranded RNA virus with nine genotypes, the most prevalent of which is genotype 1, which affects 72 percent of all chronic HCV patients in the United States. Since 2011, with the introduction of Direct Acting Antivirals (DAAs) like sofosbuvir, treatment options for chronic Hepatitis C have improved significantly.

Sofosbuvir is a nucleotide analogue inhibitor that functions by inhibiting the RNA-dependent RNA polymerase of the Hepatitis C Virus (HCV), NS5B (non-structural protein 5B).

Also Read: Natco Pharma launches Hepatitis C drug in Nepal

NS5B, an RNA-dependent RNA polymerase, is essential for the transcription of Hepatitis C viral RNA and for its high replicative rate and genetic diversity.

Sofosbuvir incorporates into HCV RNA by the NS5B polymerase and serves as a chain terminator. Sofosbuvir inhibits HCV viral replication by binding to the two Mg2+ ions found in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material.

Natco Pharma's Hepcinat 400mg, Abbott's Viroclear 400mg, and Mylan Pharmaceutical's Myhep 400mg are some of the brands of Sofosbuvir 400mg Tablets available in India.

However, following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, the Indian Pharmacopoeia Commission has reported that Sofosbuvir, which is indicated in combination with other medicinal products for the treatment of chronic hepatitis C in adults, is associated with Stevens-Johnson Syndrome.

Stevens-Johnson syndrome (SJS) is a rare, life-threatening skin and mucous membrane condition which is generally a drug reaction that starts with flu-like symptoms and progresses to a painful rash with blisters. Fever, sore throat, and fatigue are classic symptoms of SJS, which are frequently misdiagnosed and treated with antibiotics.

Stevens-Johnson Syndrome (SJS) is a type IV hypersensitivity reaction in which a medication or its metabolite triggers cytotoxic T cells (CD8+ T cells) and T helper cells (CD4+ T cells) to launch autoimmune responses against self-tissues.

As per the issued drug safety alert, the following suspected drug is associated with the ADR as given below:

Sl.

No.

Suspected Drug

Indication

Adverse Drug Reaction

1.

Sofosbuvir

In combination with other medicinal products for the treatment of chronic hepatitis C in adults.

Stevens-Johnson Syndrome

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADR associated with the use of above suspected drug.

Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPI Helpline No. 1800-180-3024 (Toll Free)."

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/drugsafetyalertaugust2021-159779.pdf

Also Read: Drug Safety Alert: Indian Pharmacopoeia Commission flags adverse reactions linked to Etoricoxib, others

sofosbuvirHepatitis C drugdrug safety alertsteven johnson syndromeadverse drug reactionPvPIIndian Pharmacopoeia CommissionPharmacovigilance Programme of Indiapvpi
Medical Dialogues Team
Medical Dialogues Team

    Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

    Show Full Article
    Next Story
    Similar Posts
    NO DATA FOUND

    Editorial

    Journal Club Today

    Health News Today

    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X