Cough Medicines Containing Pholcodine - EMA Confirms Positive Benefit-Risk Balance

Editor's Choice
Main Category: Ear, Nose and Throat
Also Included In: Flu / Cold / SARS;  Respiratory / Asthma
Article Date: 21 Nov 2011 - 0:00 PST

email to a friend   printer friendly   opinions  

According to confirmation given by The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), pholcodine-containing cough medicines should remain available for treating non-productive (dry) cough in children and adults as its benefits outweigh the risks. Patients can continue to take pholcodine-containing medicines and should contact their doctor or pharmacist if they have any questions.

Pholcodine-containing medicines were reviewed due to concerns of a cross-sensitization between pholcodine and neuromuscular blocking agents (NMBAs). Scientists suspected that a cross-sensitization could result in anaphylactic reactions in some patients who had taken pholcodine-containing cough medicines earlier and received NMBAs during emergency surgery.

The concerns came to light after a study indicated that the reduction of pholcodine consumption following its withdrawal from the market in Sweden and Norway was linked to a decrease of reports of anaphylactic reactions to NMBAs in both countries.

The FDA Committee found no strong evidence substantiating the theories of cross-sensitization between pholcodine and NMBAs and a subsequent increased risk of anaphylactic reactions during surgery following a thorough review of all available safety- and efficacy data of pholcodine-containing cough medicines.

They pointed out that pholcodine-containing medicines have been available for decades to treat non-productive cough in the EU, and that existing data confirm a positive benefit-risk balance of these medicines. In light of this evidence, the Committee decided that marketing authorizations of pholcodine should be maintained in all EU Member States where it is currently authorized, and that no further regulatory action is required.

Pholcodine, also known as morpholinylethylmorphine, molecular formula C₂₃H₃₀N₂O₄, is an opioid antitussive (cough suppressant. It helps in the suppression of unproductive cough, and also has a mild sedative effective. Pholcodine has very little or no analgesic (painkilling) effect. It is readily absorbed by the GI (gastrointestinal) tract, from where it freely crosses the blood-brain barrier. It acts mainly on the central nervous system by depressing the cough reflex.

Written by Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

• Additional
• References
• Citations