BANNING COUGH MEDICINES CONTAINING PHOLCODINE

Anaesthetists are calling for 53 cough medicines and lozenges to be withdrawn from the Australian market because of concerns they are causing life-threatening allergic reactions during surgery.

A group of anaesthetists have asked Australia’s Therapeutic Goods Administration to ban or reduce access to cough medicines containing an opioid-based cough suppressant called pholcodine because of research linking it to anaphylaxis (a severe allergic reaction) in patients when they are given particular drugs.

[It] happens to people who are young and fit and well, so no one expects a problem. 

An anaesthetist who co-ordinates the Australian and New Zealand Anaesthetic Allergy Group, Dr Helen Crilly, said a growing number of specialists were concerned pholcodine in cough medicines has created sensitivity in people to muscle relaxant drugs, which are commonly given to people for surgical procedures such as appendix and gall bladder removals.

She said while about one in every 10,000 Australians suffer anaphylaxis during surgery, this rate almost doubled to one in 6000 when muscle relaxants were given.

”Even though it doesn’t sound particularly common, if you are the one in 6000 that it occurs to you, you would think it was worth preventing,” she said.

”One of the problems is that it happens to people who are young and fit and well, so no one expects a problem.”

Dr Crilly said in some cases, the allergic reaction was so rapid the patient’s heart stopped beating within minutes of having the drug.

AAA

While only about 1 per cent or 2 per cent of Australian patients who suffer anaphylaxis during surgery die from the allergy, it can cause brain damage and patients need special testing before having surgery again.

Australia’s register of therapeutic goods lists 53 products containing pholcodine. Most are liquid cough medicines, including Codral, Chemists’ Own and Priceline brands, and two are cough lozenges, Duro Tuss and Difflam products.

While scientists have not been able to prove that pholcodine sensitivity causes anaphylaxis when people are given muscle relaxants, Dr Crilly said there was a plausible biological pathway for the allergy to occur.

Furthermore, research has found very few cases of anaphylaxis related to muscle relaxants during surgery occur in countries where pholcodine is not available, including the US and Denmark, when compared with countries where the products are sold commonly.

Wild Secrets

In 2007, Norwegian health authorities banned pholcodine products over concerns about allergies. Since then, anaphylaxis rates have decreased significantly. Before 2007, authorities estimated about 40 per cent of the population had been exposed to pholcodine.

Dr Crilly said given research suggesting cough medicines were not very effective, the TGA should ban the products that contain it or make them only available on prescription.

She said there were many other cough medicine products available that did not contain pholcodine.

”At the very least, saying it would have to be prescribed would be a good start rather than having an over-the-counter medicine that anyone can buy for a tickle in the their throat without realising the potential risk,” she said.

However, a spokeswoman for the TGA said a review of available evidence ”did not seem to support any association”, and the European Medicines Agency had also concluded this after a review published in 2012.

AAA

Pholcodine in cough medicines

1. Chemists’ Own Kiddicol Children’s Cough Mixture [Chemists’ Own]
Pholcodine – Phenylephrine hydrochloride – Chlorpheniramine maleate – Ammonium chloride
Use: Relief of cough, cold symptoms
Dose: May be taken with or without food. May be taken every 4 hours as required; max 4 doses/24 hours. Children 6-8 yrs: 10 mL, 2-5 yrs: 5 mL
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
2. Demazin Cough and Cold Syrup [Merck Sharp & Dohme]
Pseudoephedrine hydrochloride – Chlorpheniramine maleate – Pholcodine
Use: Antihistamine, decongestant, cough suppressant. Relief of upper respiratory mucosal congestion, hypersecretion and cough
Dose: Children. 2-5 yrs: 2-5 mL 3 times daily; 6-11 yrs: 5-7 mL 3 times daily. Adults, children greater than or equal to 12 yrs. 10 mL 3 times daily
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
3. Difflam Anti-inflammatory Sugarfree Cough Lozenges [iNova]
Benzydamine hydrochloride – Pholcodine – Cetylpyridinium chloride
Use: Temporary relief of painful oropharyngeal conditions; suppression of unproductive cough
Dose: Adults, children > 12 years: suck 2 loz individually every 3 hours as necessary, max 12 loz/day; children 6-12 years: suck 1 loz every 3 hours as necessary, max 8 loz/day; for max 7 days
MIMS Class: Expectorants, antitussives, mucolytics, decongestants Topical oropharyngeal medication
4. Duro-Tuss Cough Liquid Expectorant [iNova]
Bromhexine hydrochloride – Pholcodine
Use: Cough suppressant and mucolytic
Dose: May be taken with or without food. Adults: 10-15 mL up to 4 times daily. Children, 2-5 yrs: 2.5-5 mL up to 4 times daily; 6-12 yrs: 5-10 mL up to 4 times daily
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
5. Duro-Tuss Dry Cough Liquid Forte [iNova]
Pholcodine
Use: Relief of unproductive cough
Dose: May be taken with or without food. Adults: 5 mL up to 4 times daily. Children, 6-12 yrs: 2-3 mL up to 4 times daily; 2-5 yrs: 1 mL up to 4 times daily; < 2 yrs: not recommended
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
6. Duro-Tuss Dry Cough Liquid plus Nasal Decongestant [iNova]
Pholcodine – Pseudoephedrine hydrochloride
Use: Cough decongestant, suppressant
Dose: May be taken with or without food. Adults: 10-15 mL up to 4 times daily. Children, 6-12 yrs: 5-10 mL up to 4 times daily; 2-5 yrs: 2.5-5 mL up to 4 times daily
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
7. Duro-Tuss Dry Cough Liquid Regular [iNova]
Pholcodine
Use: Relief of unproductive cough
Dose: May be taken with or without food. Adults: 10-15 mL up to 4 times daily. Children, 6-12 yrs: 5-10 mL up to 4 times daily; 2-5 yrs: 2.5-5 mL up to 4 times daily; < 2 yrs: not recommended
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
8. Duro-Tuss PE Dry Cough Plus Nasal Decongestant Oral liquid [iNova]
Pholcodine – Phenylephrine hydrochloride
Use: Antitussive + decongestant. Temporary relief of dry cough, runny or blocked nose
Dose: May be taken with or without food. Admin every 6 hrs as nec; max 4 times/day. Adults, children > 12 yrs: 10-15 mL. Children. 6-12 yrs: 5-10 mL; 2-5 yrs: 2.5-5 mL
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
9. Duro-Tuss Sugar Free Cough Lozenges [iNova]
Cetylpyridinium chloride – Pholcodine
Use: Relief of cough, sore throat
Dose: Adults, children > 12 years: 2 lozenges initially (1 at a time), then 1-2 every 3 hours as needed, max. 12 lozenges/day. Children 5-12 years: 1 lozenge every 3 hours, max. 6 lozenges/day
MIMS Class: Expectorants, antitussives, mucolytics, decongestants Topical oropharyngeal medication
10. Gold Cross Pholcodine Linctus [Biotech]
Pholcodine
Use: Temporary relief of cough
Dose: May be taken with or without food. Adults: 5-10 mL every 4 hours or as directed
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
11. Gold Cross Pholcodine Linctus APF [Biotech]
Pholcodine
Use: Relief from aches caused by irritant nonproductive cough in colds, flu
Dose: May be taken with or without food. Adults: 5-15 mL every 4 hours or as directed
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
12. Pharmacy Action Dry Cough Relief Oral liquid [Generic Health]
Pholcodine
Use: Antitussive. Temporary relief of dry irritating cough
Dose: Admin 3-4 times daily as needed; max 4 doses/24 hrs. Adults: 5-15 mL. Children 2-5 yrs: 2.5 mL; 5-10 yrs: 2.5-5 mL; greater than or equal to 10 yrs: 5-10 mL
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
13.  Tixylix Nightime Linctus [Aspen]
Pholcodine – Promethazine
Use: Cough
Dose: May be taken with or without food. Children, < 2 years: do not use; 2-5 years: 5 mL; 5-10 years: 5-10 mL; 2-3 times daily
MIMS Class: Expectorants, antitussives, mucolytics, decongestants
Source: Therapeutic Goods Administration