X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development

EMA Urges The Withdrawal of Pholcodine Drugs From EU Market

Content Team by Content Team
7th December 2022
in Drug Development, News
Arena Financial results

PRAC, EMA’s safety committee, has completed its review of pholcodine-containing medications used to treat nonproductive (dry) cough in adults and children as well as cold and flu symptoms when combined with other active ingredients. PRAC has recommended that the EU marketing authorizations for these medications be revoked.

The PRAC reviewed all available information, including the ALPHO study’s final findings, post-marketing safety data, and information provided by third parties, including medical experts. Using pholcodine within a year of receiving neuromuscular blocking drugs (NMBA) during general anaesthesia increased the likelihood of experiencing an anaphylactic reaction, which is a quick, severe, and sometimes fatal allergic reaction.

Pholcodine-containing medications are being removed from the EU market and will no longer be offered by prescription or over-the-counter because it was impossible to determine effective ways to reduce this risk or a patient population for whom pholcodine’s advantages exceed its dangers. Medical providers should urge patients to discontinue taking medications that include pholcodine and think about appropriate therapeutic alternatives. As well as asking patients who will be receiving general anaesthesia with NMBAs if they have used pholcodine lately within the past 12 months, healthcare personnel should be alert to the possibility of allergic responses in these patients.

The Coordination Group for Mutual Recognition and Decentralized Procedures—Human (CMDh)2 will now receive the PRAC suggestions for consideration at its upcoming meeting in December 2022.

Anaphylactic reactions, or sudden, severe, and potentially fatal allergic reactions, are caused by certain medications called neuromuscular blocking agents (NMBA), which are used in general anesthesia. A recent study found a link between the use of pholcodine-containing medicines, which are used to cure dry cough in adults and children, and a risk of anaphylactic reactions.

Pholcodine medications are being pulled off the EU market since there are no proven ways to reduce this risk.

If one is taking pholcodine, speaking with the doctor or pharmacist is the ideal choice, as they can recommend an alternative course of action.

Ask the healthcare provider any questions one may have if they need general anaesthesia with NMBAs and have taken pholcodine within the previous 12 months. According to the results of the recent ALPHO study, using pholcodine in the 12 months before receiving anaesthesia increases the likelihood of a reaction to neuromuscular blocking agents (NMBAs) during anaesthesia.

The EU is revoking the marketing authorizations for medicines containing pholcodine because no practical steps have been found to reduce this risk.

Pholcodine-containing medications should no longer be prescribed or distributed, and healthcare practitioners should think about appropriate therapy alternatives. Patients need to be told to discontinue using these medications.

Healthcare practitioners should ask patients who will get general anaesthesia with NMBAs whether they have taken pholcodine-containing medications within the previous year and to stay informed about the possibility of an anaphylactic reaction to NMBAs. The healthcare professionals who are prescribing, dispensing, or administering these medications will soon receive a direct healthcare professional communication (DHPC) that includes the aforementioned advice. Additionally, the DHPC will be made available on a specific page of the EMA website.

Notably, Pholcodine is an opioid medication used to treat nonproductive (dry) cough in both adults and children. It is also used, in conjunction with other active ingredients, to treat cold and flu symptoms. By lowering the nerve signals sent to the coughing muscles, it directly affects the brain, suppressing the cough reflex.

Since the 1950s, pholcodine has been employed as a cough suppressant. Pholcodine-containing medications are currently permitted in the EU in Belgium, Croatia, France, Ireland, Lithuania, Luxembourg, and Slovenia, either on the basis of a prescription from a physician or as over-the-counter medications. They are sold as either oral solutions, syrups, or capsules under numerous trade names and as generics, and frequently combine pholcodine with other ingredients. Pholcodine is sold under a number of brand names, including Broncalene, Biocalyptol, and Dimetane.

At France’s request, and in accordance with Article 107i of Directive 2001/83/EC, the review of pholcodine was started on September 1, 2022.

The Pharmacovigilance Risk Assessment Committee (PRAC), which is in charge of assessing safety concerns for human medications, conducted the review and provided a list of recommendations. The Coordination Group for Mutual Recognition and Decentralized Procedures—Human (CMDh), which will take a stance, will now receive the PRAC recommendations. The CMDh is a group that speaks for Norway, Iceland, and the EU’s member states. It is in charge of establishing uniform safety standards for medications approved through national processes all across the EU.

Previous Post

Launch of The First Pipeline Assessment By Vaccines Europe

Next Post

Q3 Market Capitalization Declines For Top Biopharma Firms

Related Posts

Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
Pharma Drugs Gain From Tardigrade Proteins, Says Research
Drug Development

Pharma Drugs Gain From Tardigrade Proteins, Says Research

22nd March 2023
Next Post
The Falling Graph of Dose Contract Manufacturing

Q3 Market Capitalization Declines For Top Biopharma Firms

Latest News

Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In