Class 4 Drug Alert (Caution in use): Teva UK Limited - Ondansetron IV Injection 2mg/ml (2ml) and 2mg/ml (4ml) (All supplied in Pliva livery) - EL (09)A/35

---

Dear Healthcare Professional,

Teva UK Limited have informed us that they have not complied with regulatory undertakings to update the SPC or patient information leaflet contained in already distributed packs. All stock in the distribution chain is missing some safety information.

We understand that it will be about four months before acceptable stock enters the supply-chain. To avoid stock shortages existing stock is not being recalled.

The missing information is listed in the attached annex. Please forward this to relevant physicians.

For medical information enquiries and questions about the patient information leaflet or SPC, please contact Teva UK medical information on 0207 5407717

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter. Primary Care Trusts are asked to forward this to Hospices and relevant clinics.

Yours faithfully
Ian Holloway
DMRC Manager

 

Annex

Ondansetron IV Injection 2mg/ml (2ml) and 2mg/ml (4ml) supplied by Teva UK Ltd has the following information omitted:-

The SPC leaflet dated 05/2007 does not have these paragraphs in the relevant sections.

4.4 Special warnings and precautions for use
Very rarely and predominately with intravenous ondanestron transient
ECG changes including QT interval prolongation have been reported.
Therefore caution should be exercised in patients with cardiac rhythm
or conduction disturbances, in patients treated with anti-arrhythmic
agents or beta-adrenergic blocking agents and in patients with
significant electrolyte disturbance.”

4.5 Interaction with other medicinal products and other
forms of interaction
Ondanestron is metabolised by multiple hepactic cytochrome P450
enzymes:CYP3A4, CYP2D6, CYP1A2. Due to the multiplicity of
metabolic enzymes capable of metabolising ondansetron, enzyme
inhibition or reduced activity of one enzyme (e.g CYP2D6 genetic
deficiency) is normally compensated by other enzymes and should
result in little or no significant change in overall ondansetron clearance
or dose requirement.

The Patient Information Leaflet dated 05/2007 does not include the second sentence regarding symptoms of overdose.

“If you receive more Ondansetron than you should
Ondanestron injections will be given to you
by a doctor or nurse, so if you think that you may have
had too much, let them know. Symptoms of overdose
include visual disturbances, severe
constipation, light-headedness, dizziness, fainting.”

 

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)