MHRA reviewing impact of warning labels on sales and prescribing of codeine linctus

Exclusive: A review of the benefits and risks of codeine linctus will consider sales, prescribing and misuse before and after labelling changes.
Woman taking cough medicine.

The Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing the sales, prescribing and misuse of codeine linctus to assess the impact of warning labels introduced in 2019, The Pharmaceutical Journal has learned.

Responding to a freedom of information request submitted in April 2022, the MHRA said that it regularly monitors the safety of medicines and intends to review the impact of safety warnings in relation to the risk of addiction and dependence to opioids.

“As there are currently over 20 different opioids we will select a small and representative number of opioids to review in a phased approach,” the response said.

“We are currently reviewing the benefits and risks of codeine linctus, which will include a review of sales, prescribing, and misuse over a number of years prior to labelling changes up to the current day. In line with usual practice, we will seek independent expert advice on this issue.”

In 2019, Matt Hancock, then health and social care secretary, announced that all opioid medicines would need to carry prominent warnings about the risk of addiction.

The decision followed initial recommendations from the UK’s Commission on Human Medicines (CHM) opioid expert working group who advised that the label warning should appear prominently on the front of the medicine pack and should state “can cause addiction” and “contains opioid”. 

Claire Anderson, president of the Royal Pharmaceutical Society (RPS), said that she welcomed the work of the opioid expert working group in reviewing the current benefits and risks of codeine linctus.

“Many community pharmacies decide not to stock this product due to the potential for misuse,” she said.

“There are many other non-codeine based proprietary products on the market for the treatment of dry cough, which pharmacists and their teams are well placed to advise on.

“With studies showing up to 60% of people are genetically predisposed to opioid dependence, the role of codeine linctus in treating what is ultimately a self-limiting condition is questionable.”

Anderson said the RPS was looking forward to the outcome of the review and sharing the findings with its members.

“We also look forward to the further work of the group in reviewing other codeine-based medicines available over the counter,” she said.

Codeine linctus is indicated in adults to relieve dry or irritating coughs. It is currently classified as a pharmacy medicine but, in April 2021, calls were made to reclassify it to a prescription-only medicine. This followed a coroner’s report, which made recommendations after a woman died from “excess consumption of codeine” that had been obtained from online pharmacies.

Last updated
The Pharmaceutical Journal, PJ, June 2022, Vol 308, No 7962;308(7962)::DOI:10.1211/PJ.2022.1.146408

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