NPC Archive Item: MHRA Drug Safety Update November 2011

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23 November 2011

The MHRA and CHM have published the November edition of Drug Safety Update. This edition includes a reminder of updated dosing recommendations for paracetamol in children and an update on the risk of second primary malignancy with lenalidomide (Revlimid▼). The value of the Yellow Card Scheme in identifying important public safety issues is highlighted using the reporting of rhabdomyolysis with rosuvastatin as an example.

Drug Safety Update is an essential read for everyone whose professional practice involves medicines. It is published every month in electronic format only.

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Updated dosing recommendations for paracetamol
In June 2011 the MHRA informed healthcare professionals that the UK dosing instructions for children’s liquid paracetamol products were being revised to clarify the most effective dose to be given to a child (see MeReC Rapid Review 3964). The revised dosing instructions are now being introduced and products labelled with the new recommendations are entering the market. A detailed report on this update is available here.

Risk of second primary malignancies with lenalidomide (Revlimid▼)
Clinical trials investigating the use of lenalidomide in patients with newly diagnosed multiple myeloma have shown a four-fold increased risk of second primary malignancy (including: haematological malignancies such as acute myeloid leukaemia, Hodgkin’s disease, and B-cell lymphocytic leukaemias; myelodysplastic syndrome; solid tumours; and melanomas). There seems to be a smaller increased risk of second primary malignancy in patients treated with lenalidomide for relapsed or refractory myeloma — the authorised indication.

Healthcare professionals are advised that the use of lenalidomide in unlicensed indications is not recommended unless it takes place as part of a clinical trial. Patients should be carefully evaluated before and during treatment with lenalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as indicated. All suspected adverse reactions, including second primary malignancy should be reported promptly to the MHRA via the Yellow Card Scheme.

The value of the Yellow Card Scheme
The Yellow Card Scheme principally acts as an early-warning system for identifying previously unrecognised adverse drug reactions (ADRs). It also provides valuable information on recognised ADRs, allowing the identification, refinement and understanding of risk factors that may affect the clinical management of patients.

In this edition of Drug Safety Update, the reporting of rhabdomyolysis is used as an example whereby a small number of Yellow Card reports with high-dose rosuvastatin, combined with data on the drug’s usage levels, provided enough evidence to trigger a full review that led to action to protect public health.

In this case:

  • The highest licensed dose of rosuvastatin (40 mg) was contraindicated in patients with predisposing risk factors for muscle toxicity
  • Specialist supervision was recommended when the 40 mg dose is initiated
  • Patients who were already taking 40 mg treatment were recommended to have a review of their treatment.

All suspected adverse reactions to medicines should be reported via the Yellow Card Scheme.

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