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Drug Safety Update

From:: Medicines and Healthcare products Regulatory Agency

Alerts, recalls and safety information: medicines and medical devices

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61 updates

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61 updates

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61 updates

About Immunosuppression and transplantation

Basiliximab: indicated for renal transplantation only; efficacy and safety not shown in heart transplantation

Basiliximab (Simulect) is indicated for preventing acute organ rejection only for allogeneic renal transplantation in patients receiving organ transplantation for the first time.
- Therapeutic area: Immunosuppression and transplantation
- Published: 11 December 2014
Fingolimod (Gilenya鈻�): bradycardia and heart block

Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
- Therapeutic area: Immunosuppression and transplantation and 1 others
- Published: 11 December 2014
Reporting suspected adverse drug reactions to vaccines and biological medicines

The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.
- Therapeutic area: Cancer and 6 others
- Published: 11 December 2014
Oral tacrolimus products: prescribe and dispense by brand name only, to minimise the risk of inadvertent switching between products, which has been associated with reports of toxicity and graft rejection

The growing number of oral tacrolimus products available on the market increases the potential for inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. Therefore, to鈥�
- Therapeutic area: Immunosuppression and transplantation
- Published: 11 December 2014
Fingolimod (Gilenya鈻�): not recommended for patients at known risk of cardiovascular adverse events

New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
- Therapeutic area: Immunosuppression and transplantation
- Published: 11 December 2014
Sirolimus: different immunoassays for therapeutic drug monitoring鈥攔isk of incorrect dose adjustment

Needs a summary
- Therapeutic area: Immunosuppression and transplantation
- Published: 11 December 2014
Drug alert: recall of Gaviscon Advance Peppermint Flavour, Boots Heartburn Relief Peppermint Flavour, Peptac Peppermint Liquid, and Peptac Liquid Aniseed Flavour

Batches of this medicine are being recalled from the market because of low levels of microbial contamination.
- Therapeutic area: Cancer and 2 others
- Published: 11 December 2014
Mycophenolate mofetil: pure red cell aplasia

Healthcare professionals should consider a dose reduction or discontinuation of mycophenolate mofetil if patients develop pure red cell aplasia.
- Therapeutic area: Immunosuppression and transplantation
- Published: 11 December 2014
Info on progressive multifocal leukoencephalopathy (PML) from Yellow Card reports

Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
- Therapeutic area: Cancer and 3 others
- Published: 11 December 2014
Ecoflac infusion solutions: risk of air embolism

To avoid the risk of air embolism, these products should not be infused under pressure.
- Therapeutic area: Anaesthesia and intensive care and 22 others
- Published: 11 December 2014
Corticosteroids: early psychiatric side-effects

Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.
- Therapeutic area: Anaesthesia and intensive care and 9 others
- Published: 11 December 2014

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