Class 4 Drug Alert (Caution in use): CP Pharmaceuticals/Wockhardt UK - CP Multiparin / Monoparin products (Wockhardt Heparin Sodium products) - EL (09)A/08 Rev 1

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Dear Healthcare Professional,

See attached appendix for presentations, batch numbers, expiry dates and pack sizes.
Please replace the Drug Alert issued yesterday (31 March 2009) with this revised document. There are two changes present in this update:

1. Wockhardt UK have informed us that some of the batches involved are presented in Wockhardt (unbranded) livery.
2. Wockhardt UK have informed us that two additional batches are involved which have been added to the attached appendix.

A very low level (0.6%) of over sulphated chondroitin sulphate (OSCS) has recently been identified in the active raw material used in the manufacture of 31 batches of CP Pharmaceuticals and Wockhardt UK heparin sodium injections distributed in the UK. This was identified using a more sensitive test method than was previously available. Wockhardt UK have provided details of affected presentations and batch numbers.  Batches are in both CP (branded) and Wockhardt (unbranded) livery.  See the attached appendix. No other batches of either product are affected.

Due to a potential out-of-stock situation which would have adverse clinical consequences, these products are not being recalled. There is no evidence that this very low level of OSCS is associated with the anaphylactoid reactions reported following use of heparin with OSCS levels of 17 to 21% after i.v. administration, which were observed outside of the UK during 2007/8. Nonetheless Healthcare Professionals are advised to exercise particular caution when using the affected batches. Current evidence suggests that the risk of adverse reactions (ADRs) may be reduced by s.c. administration. Patients should be carefully monitored for signs of anaphylactoid or hypotensive reactions both during and after treatment, and standard therapies (ie vasopressor treatment and steroids) should be available as a precaution. Any suspected ADRs observed should be reported to the MHRA and Wockhardt UK in the usual way. As an extra precaution, it is suggested that batch details are recorded routinely in the patient’s notes when using any heparin product.

MHRA will continue to liaise with Wockhardt UK to ensure that affected batches of products remain in the supply chain for as short a time as possible.

Recipients of this Drug Alert should bring this information to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this information to the attention of relevant clinics, General Practitioners and Community Pharmacists by copy of this letter.
Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

 

Appendix: Batch details for affected presentations

CP Pharmaceuticals Branded Monoparin and Multiparin

 

 

Wockhardt UK (Unbranded) Heparin Sodium products

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)