CAS: Drug Alerts: Class 2 Medicines Recall & Supply Disruption

Source: Medicines & Healthcare Products Regulatory Agency (MHRA)

This post is compromised of three messages from the Central Alerting System related to Medication. Use the buttons below to take you to the relevant articles below.

CAS Alert: Drug Alert Class 2 Medicines Recall

Teva UK Limited trading as ratiopharm GmbH is recalling all unexpired stock of Ranitidine Effervescent Tablets from pharmacies.

Teva UK Ltd is recalling all unexpired stock of the above products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Ranitidine Effervescent Tablets 150mg PL 15773/066

Ranitidine Effervescent Tablets 300mg PL 15773/067

Advice for healthcare professionals

• Please stop supplying the above products immediately. Kindly quarantine all remaining stock without delay and return it to your supplier using your supplier’s approved process.

• If you receive queries about this issue from patients, advise them not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.

This is an on-going issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

» Click here to read the full alert

CAS Alert: Drug Alert Class 2 Medicines Recall

GlaxoSmithKline, trading as Glaxo Welcome UK Ltd., is recalling all expired stock of the below products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA), which has genotoxic and carcinogenic potential.

Advice for healthcare professionals

• Stop supplying the above products immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

• If you receive queries about this issue from patients, advise them not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.

This is an on-going issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses

Company contacts for further information

For stock control enquiries please refer to https://gskpro.com/en-gb/ or contact 0800-221-441.

For medical information enquiries please contact ukmedinfo@gsk.com, via the Live Chat facility on https://hcp.gsk.co.uk/contact-us/live-chat.html or on 0800 221 441 (option 2).

NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

» Click here to read the full CAS alert

CAS Alert: Supply Disruption Alert To All Ranitidine Oral Formulations

Summary

• All oral formulations of ranitidine are anticipated to be out of stock, with no date for resupply until further notice.
• An investigation by the Swiss and German regulatory agencies and the US Food and Drug Administration (FDA), has identified a contaminant, N-nitrosodimethylamine (NDMA), in samples of ranitidine active substance.
• All stock manufactured for the UK using the affected ranitidine active substance has been quarantined, whilst Medicines and Healthcare products Regulatory Agency (MHRA) investigations are ongoing.
• Although all oral formulations are expected to be out of stock, very limited supplies of unaffected oral ranitidine products may remain available and should be reserved for those patients in whom alternatives are not clinically appropriate.
• All other patients should be reviewed as repeat prescriptions are requested, and if ongoing treatment is required, be switched to clinical alternatives.
• Although some IV products are affected, there is sufficient unaffected IV stock available to meet current UK demand. This situation is currently under review and may change.

Action by

All healthcare professionals in primary, secondary or specialist healthcare services who prescribe or dispense ranitidine, should for:

Licensed use for gastrointestinal conditions

• Identify current patients prescribed ranitidine tablets, effervescent tablets and oral solutions, and:
  • Review to establish if ongoing treatment is still required.

• • If ongoing treatment is still required, then consider switching to an alternative treatment (see table below).

Please note:

• It is recommended that omeprazole is the first-choice proton pump inhibitor (PPI) where clinically appropriate, as there are currently sufficient supplies to manage an increase in demand.
• It is recommended that patients are not switched to alternative H2-receptor antagonists in the first instance as this may exacerbate a shortage of these products. Sufficient supplies will continue to be available to meet current demand.

Specialist indications

• Consult specialist clinicians who use ranitidine to identify circumstances when ranitidine cannot be substituted with clinical alternatives.
• Reserve any remaining supplies of oral ranitidine for circumstances where specialists consider there are no clinically appropriate alternatives.

Prescribers should work in close collaboration with their pharmacists to understand which clinical alternatives are available.

Deadlines for actions

Actions initiated: Immediately

Actions completed: 15 January 2020

» Click here to read the full alert

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