Medical Product Alert N° 3/2016

Falsified Hepatitis C medicines circulating in South East Asia

This Medical Product Alert relates to the circulation of confirmed falsified versions of Sofosbuvir 400mg + Ledipasvir 90mg and Daclatasvir 60mg in South East Asia.

Both products are used to treat Hepatitis C. Daclatasvir 30mg and the fixed dose combination of Sofosbuvir 400mg + Ledipasvir 90mg are on the WHO list of Essential Medicines.

In February 2016, WHO was informed by a local NGO working in Myanmar that they had identified falsified versions of the two following products:

Product Name LEDSO capsules DAKAVIR

Batch Number 0022 0322

Expiry Date 4/2017 4/2017

Date of manufacture 5/2015 5/2015

Both products claim to be manufactured by PHARCO Corporation ; Alexandria, Egypt.

Photographs of both falsified products are available in annex (see PDF at bottom). Laboratory analysis is pending so as to better assess the threat posed to public health.

PHARCO Corporation has stated that:

• they do not manufacture the specific fixed dose combination of Sofosbuvir 400mg + Ledipasvir 90mg
• they do not manufacture any products under the names of LEDSO nor DAKAVIR
• they do not manufacture Daclatasvir 60mg at this moment in time.

It is necessary to ensure that all medical products are obtained from authentic and reliable sources. Their authenticity and origin should be carefully checked and verified with manufacturers before use.

No serious adverse reactions attributed to these falsified products have been reported at this stage. However, if you have taken this falsified product, or if you suffer an adverse event following its uptake, please seek immediate advice from a qualified healthcare professional and report the incident to your local Ministry of Public Health / National Medicines Regulatory Authorities/ National Pharmacovigilance Centre.

If you are in possession of these products, please do not use them, contact a healthcare professional as soon as possible for advice and report the incident as indicated above.

WHO requests increased vigilance for the supply chains of countries likely to be affected by these falsified products. Vigilance should include hospitals, clinics, pharmacies and any other suppliers of medical products.

Health authorities are asked to immediately notify WHO if these falsified products are discovered in their country. If you have any information on their supply and/or distribution please contact rapidalert@who.int

WHO Surveillance and Monitoring – Rapid Alert

Substandard, Spurious, Falsely labelled, Falsified and Counterfeit (SSFFC) Medical Products

All WHO Drug Alerts are available at the following link: http://www.who.int/medicines/publications/drugalerts/en/

MedicalProductAlertN.32016.pdf