New Advice On OTC Analgesics Containing Codeine

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Alcohol / Addiction / Illegal Drugs
Article Date: 04 Sep 2009 - 3:00 PDT

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The Medicines and Healthcare products Regulatory Agency (MHRA) announced new advice on over-the-counter (OTC) medicines containing codeine and dihydrocodeine (DHC) to minimise the risk of overuse and addiction.

This follows recent advice from the government's scientific advisory body, the Commission on Human Medicines (CHM).

The package of measures include clear and prominently positioned warnings on the label and patient information leaflet (PIL) about the risk of addiction, and the importance of not taking these medicines for longer than three days.

The revised guidance on the use of these products will focus on treating moderate pain not relieved by simple painkillers such as paracetamol and ibuprofen. There will also be updated controls on advertising to ensure the new warnings are clearly presented.

Large packs of effervescent codeine containing products will no longer be sold in the pharmacy but will be available on prescription, which further strengthens the voluntary action taken by manufacturers in 2005 on pack size reduction. All packs containing up to 32 tablets remain available for sale through a pharmacy.

MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said that taken in the correct manner and for the right purposes, codeine and DHC are very effective and acceptably safe medicines.

"However, these products can be addictive and we are taking action to tackle this risk," she said.

"The MHRA is ensuring that people have clear information on codeine containing medicines on what they are to be used for and how to minimise the risk of addiction.

"Anyone who has concerns should speak to their pharmacist or a doctor."

The MHRA's action is being taken in parallel with the Department of Health's review of policy on addiction to prescription and OTC medicines.

Notes

1. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

2. The package of measures are:

- Indications

All indications related to colds, flu, coughs and sore throats, and references to minor painful conditions will be removed. The remaining list of indications will be for the short term treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

- Patient Information Leaflets (PIL) and Labels

The PIL and Labels will state that the products are for short term use only (up to three days) for the treatment of moderate, acute pain, and that the products can cause addiction or overuse headache if used continuously for more than three days. In particular, the following warning will be positioned clearly and prominently on the front of the pack:
'Can cause addiction. For three days use only'
The PIL will also carry information about the warning signs of addiction, ie if the medicine is needed for longer periods and in higher doses than recommended, and if stopping the medicine makes you feel unwell but you feel better when you start taking it again.

- Pack size

All packs greater than 32 tablets of codeine or DHC containing OTC medicines, including effervescent formulations, will no longer be available as P products.

- Advertising

The advertising and promotion code of practice for manufacturers and retailers will be updated to reflect the new indications and warnings, and to remove references to painkilling power and strength. Also, all advertisements will include the statement 'Can cause addiction. For three days use only'.

Source
Medicines and Healthcare products Regulatory Agenc