Message for parents and carers re ranitidine

Message for parents and carers re ranitidine

Message for parents and carers re ranitidine

15th Nov 2019

You may be aware that there is currently a disruption to the supply of ranitidine medicines.

Ranitidine is a medicine that reduces the amount of acid your stomach makes. It's used to treat conditions like indigestion, heartburn, stomach ulcers and acid reflux. It is also prescribed to patients who have gastro-oesophageal reflux disease (GORD).

Following a review of ranitidine medicines by the European Medicines Agency, some products were found to contain small amounts of an impurity called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen but is a known environmental contaminant sometimes found in water supplies and foods including meat, dairy products and vegetables.

We would like to reassure patients and families that NDMA is not thought to cause harm when ingested at low levels. The Medicines and Healthcare Products Regulatory Agency has not indicated that there is currently any risk to patients. Ranitidine has not been withdrawn and can continue to be prescribed.

However manufacturers have been asked by the EMA to review their products and this has led to disruption in the supplies of ranitidine available on the market.

All manufacturers of ranitidine have now voluntarily withdrawn their brands from the market. Ranitidine will remain unavailable for an unknown period of time, whilst manufacturers respond to the EMA review.

We will liaise with patients directly to prescribe an appropriate alternative treatment.

If you are prescribed ranitidine by your Alder Hey clinician, please contact your clinician if you have any concerns.

If your child is prescribed ranitidine by their GP and you are experiencing problems with supply, please make an appointment to see your GP who can advise an alternative appropriate treatment.

The EMA are continuing to monitor the situation. They will be issuing further guidance following their review which is not expected to conclude before December 2019. We will share an update re ranitidine medication as soon as it becomes available.

Frequently Asked Questions (FAQs)

What is ranitidine?

Ranitidine reduces the amount of acid your stomach makes. It's used to treat conditions like indigestion, heartburn, stomach ulcers and acid reflux. It is also prescribed to patients who have gastro-oesophageal reflux disease (GORD). Sometimes, ranitidine is taken for a rare illness called Zollinger-Ellison syndrome.

Ranitidine comes as a liquid and is also available as tablets and as soluble (dispersible) tablets that dissolve in water.

Why is there a shortage?

The European Medicines Agency (EMA) commenced a review of ranitidine medicines in September 2019, after tests revealed that some products contained small amounts of the impurity N-nitrosodimethylamine (NDMA). The EMA is evaluating whether patients using ranitidine are at any risk. Manufacturers have been asked by the EMA to review their products with regards to preventing nitrosamine formation. All manufacturers of ranitidine have now voluntarily withdrawn their brands from the market. This means that Ranitidine will remain unavailable for an unknown period of time, whilst manufacturers respond to the EMA review.

What is NDMA and is it dangerous?

NDMA is classified as a probable human carcinogen, but is not thought to cause harm when ingested at very low levels. It is a known environmental contaminant and is found in water supplies and foods including meat, dairy products and vegetables.

Should I be worried that my child is taking ranitidine?

NDMA is not thought to cause harm when ingested at low levels.  It is a known environmental contaminant found in water supplies and foods including meat, dairy products and vegetables.

The Medicines and Healthcare Products Regulatory Agency (MHRA) - the UK Authority - are aware of the EMA review, but not of any specific information that would indicate that there is any risk to patients. They are continuing to monitor the situation and will take appropriate action if necessary. The MHRA have not withdrawn ranitidine from the market, but all manufacturers have now voluntarily withdrawn their ranitidine products from the market proactively. This means that Ranitidine will remain unavailable for an unknown period of time so we will need to offer appropriate alternative treatments to patients.

What happens next?

Due to ranitidine products being withdrawn we need to prescribe alternative appropriate treatments.

If you are prescribed ranitidine by your Alder Hey clinician, please contact your clinician if you have any concerns.

If your child is prescribed ranitidine by their GP and you are experiencing problems with supply, please make an appointment to see your GP who can advise an alternative appropriate treatment.

The EMA are continuing to monitor the situation. They will be issuing further guidance following their review which is not expected to conclude before December 2019. We will share an update re ranitidine medication as soon as it becomes available.

How do I find out more information?

Please speak to your hospital Doctor/GP or Pharmacist directly if you have any concerns about your child’s medication.

We will continue to update patients and families on the shortage of ranitidine and the EMA review once new information becomes available.

Further Information can also be found on the following websites:

https://www.ema.europa.eu/en/documents/press-release/ema-review-ranitidine-medicines-following-detection-ndma_en.pdf

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