Class 4 Drug Alert (Caution in use): Sanofi-aventis - Priadel Liquid (Lithium Citrate Liquid) - EL(09)A/14

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Dear Healthcare Professional,

It has been brought to our attention that the current labelling for Priadel Liquid is confusing and may lead to overdosing if misinterpreted. The statement of active content on the front panel and some other panels of the carton and in large print on the bottle label is given as follows:

Priadel

200mg/5ml

Lithium Citrate.

The 200mg/5ml refers to the equivalent lithium carbonate content. The actual lithium citrate content of the liquid is 520mg/5ml and doses should be calculated on that basis.

The active content is stated correctly in the small print on the back panel of the carton and in the small print on the bottle label.

To avoid stock disruption, distribution of affected stock will continue. Corrected packaging is being produced and will be supplied to the market by early September 2009. Once the corrected packaging is available, distribution of product in affected packaging will cease.

Further information
For further enquiries please telephone Sanofi-aventis Medical Information on 01483 505515.

Primary Care Trusts are asked to bring this information to the attention of Community Pharmacists, General Practitioners, Mental Health Trusts and Clinics and other relevant clinics by copy of this letter.

Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

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)