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Update on the Heparin Over-Sulphated Chondroitin Sulphate (OSCS) issue

Notice type: Advisory

Date: 07/04/2009

  

Product name or type:
Multiparin, Monoparin and Heparin Sodium Products marketed by CP Pharmaceuticals/Wockhardt Uk Ltd. – See batch listing below for specific product names.

Reference:
IMB Reference: QDR-H-09-130

Authorisation Number:
PA 409/7/1, PA 409/7/2, PA 409/8/2, PA409/8/3, PA1339/9/3, PA1339/9/4 and PA1339/9/6

Active Substance:
Heparin Sodium

Product Classification:
CP Pharmaceuticals Ltd., Wrexham, UK 
Wockhardt UK Ltd., Wrexham, UK 

Problem Or Issue:
Further to the communication on the 3rd March 2009, further batches of CP Pharmaceuticals/Wockhardt heparin sodium products have been identified as having been manufactured with the affected active substance batch containing 0.6% Over-Sulphated Chondroitin Sulphate (OSCS). 

The IMB is continuing to investigate this matter, but in the absence of replacement product to meet therapeutic needs, and within the context of the specific patient monitoring advice given below, the distribution of the batches listed in the attached appendix will continue so as to avoid an out-of-stock situation, as such an out-of-stock situation could have adverse clinical consequences. 

Any further developments regarding this issue e.g. the identification of further batches will be posted on the HPRA website. Please check this website regularly or sign up online to receive notification of website updates. 

Background Information Or Related Documents:
Update on the Heparin Over-Sulphated Chondroitin Sulphate (OSCS) issue Document

Actions To Be Taken:
Healthcare Professionals are therefore advised that: 

• Other presentations of the same product may be sourced to meet clinical requirements, but caution should be exercised if you are unfamiliar with these alternative presentation types (e.g. single use ampoules and /or different vial or ampoule volumes). 

• With regard to the potential risks for patients associated with the administration of the listed batches of Multiparin, Monoparin and Heparin Sodium, in the absence of any alternative batch of a suitable heparin sodium medicinal product, it is important to consider the potential risk of administering a batch containing a low level of OSCS in the context of the clinical benefit for the patient. 

• To date, the IMB is aware of three allergic type adverse reactions where Multiparin is considered co-suspect. Two additional reports of non-serious allergic type adverse reactions were reported with Multiparin as the suspect drug. However, the IMB wishes to emphasise that an absence of spontaneous reports of adverse reactions does not necessarily represent an absence of risk. 

• The IMB advises that, if any heparin-containing product is being administered, Healthcare Professionals should closely monitor patients during and after treatment, particularly for signs of allergic or hypotensive reactions. 

• In all cases, where any batch of the above mentioned heparin products are used, prescribers should be alerted to the possibility of severe allergic reactions and be prepared to administer standard therapies (e.g. vasopressor treatment and steroids). 

• Healthcare professionals are advised to exercise vigilance when administering any heparin containing products, and any suspected adverse reactions observed during or after administration should be reported to the IMB and CP Pharmaceuticals Ltd./Wockhardt UK in the usual way. 

Further Information:

Appendix: Batch Details Affected Product Presentations

Irish Authorised Medicinal Products

Product Name

Batch number

Expiry date

Monoparin 1000IU/ml,Solution for Injection or Concentrate for Solution for Infusion

10ml Ampoules

PA409/8/3

 

003088

 

 

Aug 2011

 

004088

 

Aug 2011

Monoparin 25000IU/ml, Solution for Injection or Concentrate for Solution for Infusion

0.2ml Ampoules

PA409/8/2

 

PH40345

 

Sep 2011

 

PH40576

 

Sep 2011

Multiparin 1000IU/ml,Solution for Injection or Concentrate for Solution for Infusion

5ml Vials

 

PA409/7/1

011098

Feb 2010

012098

Feb 2010

013098

Feb 2010

014098

Feb 2010

015098

Mar 2010

016108

Mar 2010

Multiparin 5000IU/ml,Solution for Injection or Concentrate for Solution for Infusion

5ml Vials

 

PA409/7/2

 

012088

 

Jan 2010

 

013088

 

Jan 2010

 

014108

 

Mar 2010

 

015108

 

Mar 2010

Heparin Sodium 1000IU/ml,Solution for Injection or Concentrate for Solution for Infusion

5mlAmpoules

 

PA1339/9/3(Wockhardt UK Livery)

 

009118

 

Oct 2011

010118

Oct 2011

011118

Oct 2011

012118

Oct 2011

Heparin Sodium 1000IU/ml,Solution for Injection or Concentrate for Solution for Infusion

10mlAmpoules

 

PA1339/9/4(Wockhardt UK Livery)

 

005118

 

Oct 2011

 

006118

 

Oct 2011

 

007118

 

Oct 2011

Heparin Sodium 1000IU/ml,Solution for Injection or Concentrate for Solution for Infusion

5ml Vials
PA1339/9/6(Wockhardt UK Livery)

 

017118

 

Apr 2010

 

018118

 

Apr 2010

 

Unauthorised Products Possibly Supplied as Exempt Medicinal Products in Ireland

Wockhardt UK Heparin Sodium (Preservative Free) 1000IU/ml

1ml Ampoules

Unauthorised Product

 

002118

 

Oct 2011

Wockhardt UK Heparin Sodium (Preservative Free) 5000IU/ml

1ml Ampoules

Unauthorised Product

 

004118

 

Oct 2011

CP Pharmaceuticals Monoparin 1000IU/ml

20ml Ampoules

 

Unauthorised Product

 

PH40273

 

Jun 2011

 

PH40274

 

Aug 2011

 

PH40359

 

Nov 2011

CP Pharmaceuticals Monoparin 5000IU/ml

1ml Ampoules

Unauthorised Product

 

003088

 

Jul 2011

CP Pharmaceuticals Monoparin 5000IU/ml

5ml Ampoules

Unauthorised Product

 

005108

 

Sep 2011

CP Pharmaceuticals Monoparin 25000IU/ml

1ml Ampoules

Unauthorised Product

 

PH40265

 

Aug 2011

 

The HPRA contact person for this issue is: 

Mr. Kevin O'Donnell, 
Market Compliance Manager & GMP Senior Inspector, 
Health Products Regulatory Authority, 
Earlsfort Terrace, 
Dublin 2, 
Ireland 
Tel:  +353 1 6764971  
Fax: +353 1 6767836 
Mobile:  +353 87 9562818 

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