DRUG ALERT
DRUG SAFETY INFORMATION
For immediate dissemination during working hours
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28 September 2009
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EL (09)A/25
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Our ref:
MDR 55-09/09
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Dear Healthcare Professional,
Sanofi-aventis
Phenergan Elixir, PL 04425/0630, 100ml packs
Sanofi-aventis have informed the MHRA that the text on the current carton for Phenergan Elixir 5mg/5ml, 100ml may cause some confusion to diabetic patients. The statement ‘sugar-free’ is printed on the front panel and one side panel of the carton and the warning ‘not suitable for diabetics’ is printed on the other side panel of the carton.
The product does not contain sucrose, glucose or fructose, so technically it is sugar-free and there is no risk of dental caries. It does contain hydrogenated glucose, however, which is not suitable for diabetic patients.
Sanofi-aventis are in the process of reviewing and revising the labelling for this product. In the mean time, we would ask pharmacists to ensure that this information is brought to the attention of patients when supplying the product.
For further information please telephone Sanofi-aventis Medical Information on 01483 505515.
Primary care trusts are asked to bring this information to the attention of community pharmacists and other relevant healthcare professionals 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)
Medical Supplies Agency (MOD)
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)