Safety concerns relating to pholcodine-containing dry cough products
Following a safety investigation by Malaysia’s National Pharmaceutical Regulatory Agency (NRPA), they have announced the decision to suspend the registration of pholcodine-containing medicines and initiate a Degree II Level A product recall. This decision was announced on March 20, 2023.
iNova’s understanding is that the NPRA’s decision is linked to a recently concluded French clinical study (the ALPHO Study) which reviewed a possible association between pholcodine and very rare but serious anaphylactic reactions to medicines called neuromuscular blocking agents (NMBAs) used in anaesthesia.
Data from the ALPHO study indicates that the use of pholcodine in the 12 months leading up to anaesthesia using NMBAs slightly increases the risk of developing an anaphylactic reaction, noting that this risk is very low.
The NPRA’s decision follows a similar precautionary withdrawal in Europe and recalls in the United Kingdom and Australia.
Further information about the safety alert can be found on the NPRA’s website: https://npra.gov.my/index.php/en/component/content/article/449-english/safety-alerts-main/safety-alerts-2023/1527471-pholcodine-risk-of-anaphylaxis-to-neuromuscular-blocking-agents-nmbas.html?Itemid=1391
Providing the community with safe and effective products is iNova Pharmaceutical’s top priority. We are working closely with the NPRA to recall our affected products immediately to ensure we meet all our regulatory requirements on this matter.
Which products are affected by this recall?
| Product name | Active ingredients | Registration number |
|---|---|---|
Duro-Tuss Regular Cough Liquid 1mg/ml |
Pholcodine 1mg/ml |
MAL13025049ACZ |
Duro-Tuss Forte Cough Liquid 3mg/ml |
Pholcodine 3mg/ml | MAL13025050ACZ |
Duro-Tuss Expectorant Cough Liquid |
Pholcodine 1mg/ml |
MAL13025051ACZ |
Difflam Anti-Inflammatory Anti-Bacterial Lozenges with Cough Suppressant (Blackcurrant) |
Each lozenge contains |
MAL14075076ACZ |
NO other Duro-Tuss or Difflam products are affected by this recall
FOR MORE INFORMATION ON MALAYSIAN PRODUCTS IMPACTED BY RECALL -
click the link below
Click to download
Consumers and Healthcare Professionals that want to report any adverse events relating to an iNova product, please contact drugsafety@inovapharma.com.
Frequently Asked Questions
Pholcodine is an effective cough-suppressant that has been recommended by healthcare professionals and used as a cough suppressant around the world since the 1950s for the treatment of dry coughs. Pholcodine is not used for the treatment of ‘wet’ or ‘chesty’ coughs. Dry cough products containing pholcodine are generally available behind the counter in Malaysian pharmacies.
On 20 March, the Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced a decision to suspend the registration of pholcodine-containing medicines and recall of products containing pholcodine in Malaysia. The recall will be a Degree II, Level A product recall and must be undertaken immediately.
The NPRA’s decision to recall pholcodine containing medicines is linked to a recently concluded French clinical study (the ALPHO Study) which reviewed a possible association between pholcodine and very rare but serious anaphylactic reactions to medicines called neuromuscular blocking agents (NMBAs) used during general anaesthesia.
Data from the ALPHO study indicates that the use of pholcodine in the 12 months leading up to anaesthesia using NMBAs slightly increases the risk of developing an anaphylactic reaction, noting that the risk of anaphylactic reactions to NMBAs during anaesthesia is already very low.
The relationship between pholcodine and anaphylactic reactions to NMBAs has been hypothesised over the last decade, however, until the ALPHO study no association had previously been established in any clinical study globally. There is still no evidence showing causal risk.
A list of affected products are listed in the table at the top of this page and click here for a file which identifies the relevant products by their packaging.
If you do have pholcodine containing dry cough medicines that are affected by this recall, please stop taking these and speak to your doctor or pharmacist so they can suggest an alternative treatment. Please return to your doctor or pharmacy any used or unused product immediately.
If you are due to have anaesthesia, where a neuromuscular blocking agent will be administered, it is important to advise your healthcare professional and anaesthetist of all medicines you have taken in the last 12 months before your surgery, including those that are purchased over the counter.
Consumers should seek advice from their doctor or pharmacist for an appropriate recommendation for their dry cough.
