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PRAC Reviews Ambroxol, Bromhexine Meds

Destiny Baker2 years ago

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has begun its review of medications that contain ambroxol and bromhexine in response to serious safety concerns.

Medications Linked to Severe Allergic Reactions

According to Medscape, PRAC’s review is being carried out in response to a request made by the Belgium’s Federal Agency for Medicines and Health Products (FAMHP) which claims to have received reports of allergic and anaphylactic reactions in patients taking ambroxol.

The Belgian agency claimed that the most concerning reports involved children under the age of six and questions whether the benefits of the drug outweighed its risks.

PRAC decided to include bromhexine in the review as bromhexine is largely converted into ambroxol by the body. Allergic reactions have been linked to bromhexine as well.

Among the items to be addressed in the review are how the drugs are being used and whether manufacturers have included adequate warning labels.

PRAC Questions Marketing Authorization Holders

Marketing holders for bomhexine and ambroxol are expected to submit summaries detailing the following:

  1. Product characteristics and the packaging leaflet.
  2. Therapeutic benefits stratified by age group.
  3. Information regarding risks of immediate hypersensitivity and delayed hypersensitivity.
  4. Benefit/risk balance evaluation in each of the drugs’ licensed indications.
  5. Proposals and justifications with supportive evidence for any risk minimization measure that may improve the benefit/risk balance.
About Ambroxol and Bomhexine
  • Currently, bromhexine and ambroxol are used as oral treatments to help thin mucus so it can be cleared by patients with short- or long-term airway problems.
  • The drugs are also used to treat sore throat and some are used to treat breathing disorders in premature and newborn babies.
  • The drugs are authorized in 28 European jurisdictions.
  • The U.S. Food and Drug Administration has received report linking amboxol to several adverse events, including:
    • Skin disorders
    • Liver disorders
    • Suicide attemtp
    • Rash
    • Hypersensitivity
    • Stevens-Johnson Syndrome
    • Toxic epidermal necrolysis
    • Death

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