Miacalcic 200 IU Nasal Spray Solution - withdrawn throughout the European Union

(Novartis Pharmaceuticals UK) Increased risk of malignancies with long -term use of calcitonin – class 2 action within 48 hours. (EL 13(A)11)

02 April 2013

Class 2 medicines recall

Action within 48 hours

Pharmacy, wholesaler and clinic-level recall

MDR 42-03/13

Product details

Novartis Pharmaceuticals UK Ltd

Miacalcic 200 IU Nasal Spray Solution

Calcitonin (salmon)

PL 00101/0586

Alert details

All unexpired stock of this product is being recalled to pharmacy, clinic and wholesaler level irrespective of batch number and expiry date.

The product is being withdrawn throughout the European Union after a study has shown an increased risk of malignancies with the long term use of calcitonin. Both the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee have concluded that the benefits no longer outweigh the risks.

No further Miacalcic 200 IU Nasal Spray Solution should be dispensed. Pharmacists should refer patients with new or repeat prescriptions to the treating physician to review their treatment plan on a non-urgent basis.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit.  For enquiries relating to stock returns please contact Novartis Pharmaceuticals Customer Care team on 08457-419442 or email novartis.customercare@novartis.com.

For medical information enquiries please contact Novartis Pharmaceuticals UK Ltd Medical Information on 01276 698370 or email medinfo.uk@novartis.com.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

MHRA distribution

Further recipients by cascade:

Regional contacts for NHS trusts and provider units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)

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