Notice Information: - Recall - 21/01/2010

Title:

Recall of all Sibutramine-containing Medicinal Products

Product:

Reductil 10mg Capsules and Reductil 15mg Capsules

Reference:

QDR-H-10-028 to QDR-H-10-035

Authorisation Number:

See Table Below

Product Classification:

Prescription Only Medicines

Active Substance:

Sibutramine

Serial / Batch Number(s) & Expiry Date:

All batches

Authorisation Holder:

Target Audience:

Patients, Doctors, Pharmacists and Wholesalers

Issue:

Recall of all Sibutramine-containing Medicinal Products

The Irish Medicines Board wishes to advise you that all batches of Reductil 10mg Capsules and Reductil 15mg Capsules are being recalled with immediate effect.

This recall is going to pharmacy level and is due to the suspension of the marketing authorisations of all sibutramine-containing medicinal products in Ireland, following the recommendation issued by the European Medicines Agency (EMA). The EMA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of sibutramine no longer outweigh its risks and that the marketing authorisations should be suspended across the European Union.

Following assessment of the available information on the benefits and risks of sibutramine, the CHMP concluded that there is an increased risk of serious cardiovascular adverse events, such as stroke or myocardial infarction, with sibutramine in patients with cardiovascular disease. The increased risk is also considered to be applicable to patients without known cardiovascular disease, given that obesity itself is a risk factor.

Prescription Required:

Yes

Recall Classification:

Wholesale and Pharmacy Level Recall

Action to be taken:

Patients are immediately requested to do the following:

1. Please discontinue treatment with the above-mentioned Reductil Capsule products.
2. Consult with your doctor or pharmacist to discuss treatment options.

Healthcare Professionals are immediately requested to cease writing prescriptions for sibutramine.

Pharmacists are immediately requested to do the following:

1. Please immediately cease the dispensing and supply of the above-mentioned Reductil Capsule products.
2. Identify and quarantine all units of Reductil Capsule products which are located within your hospital or retail pharmacy. Please note that this includes both unopened and partially used packs.
3. Identify and quarantine any promotional material relating to Reductil Capsule products which is located in your pharmacy. 
4. For Hospital Pharmacists Only: In addition to stock of Reductil Capsules and Reductil promotional materials which are located within your pharmacy, please also identify and quarantine all units of Reductil Capsules which are on wards and any promotional material pertaining to these products which is located within your hospital.
5. Reductil 10mg Capsules and Reductil 15mg Capsules are marketed in Ireland by four different companies. 
   They are: Abbott Laboratories Ireland Ltd, PCO Manufacturing Ltd, Imbat Ltd (distributed by Eurodrug) and B&S Healthcare. Please contact the company from which you received the packs in your possession to arrange the return of any units of their product(s) and any promotional materials which you have.

• Abbott Laboratories Ireland Ltd - Freephone 1800 938061
• PCO Manufacturing Ltd - Nicola Blendel, Tel. 01 835 6712
• Imbat Ltd (distributed by Eurodrug) - Mark Guildea, Tel. 01 854 4800 / 086 852 5891
• B&S Healthcare - Kamlesh Patel, Tel. 00 44 208 515 3700

Please note that patients are being advised via media statements that they should discontinue treatment with Reductil Capsules and should consult their doctor or pharmacist at a convenient time to discuss treatment options. If patients decide to return unopened or partially used packs to you, please receive this stock back and place in quarantine for return. Please report any suspected adverse reactions to the Marketing Authorisation Holder or the IMB in the usual way.

Wholesalers are immediately requested to do the following:

1. Please immediately quarantine any units of the above-mentioned products which you have in your possession.
2. Contact the relevant company to organise the return of this quarantined stock.

Further Information:

Further information on the background to this issue is available in other areas on the IMB website and a Q&A document is available from the EMA website, www.ema.europa.eu.