WHO was notified in July 2021 that a suspected falsified Cytotec (misoprostol) product was circulating in the Democratic Republic of Congo. After investigating the incident with the manufacturer, it was found that the same batch number was circulating in two other countries and that another batch number was also circulating in two other WHO AFRO countries. This incident showcases the importance of reporting findings like these, so that they can be investigated and the information can be shared.
A WHO Medical Product Alert was published on 10 August 2021: https://www.who.int/news/item/10-08-2021-medical-product-alert-n-3-2021. Its purpose is to make the information public and alert as many people as possible. We especially want to reach health care providers that are likely to provide this Cytotec product, including for safe abortion. It says:
“This WHO Medical Product Alert refers to two batches of falsified CYTOTEC (misoprostol) 200 microgram tablets identified in the WHO Region of Africa and reported to WHO in July 2021. The genuine manufacturer of CYTOTEC has confirmed that the products listed in this Alert are falsified because these products failed laboratory analysis and/or display falsified variable data. These falsified products have been reported at wholesale and patient level in Cameroon, the Democratic Republic of Congo, Ghana and Nigeria.
Misoprostol is listed on the WHO Model List of Essential Medicines. Genuine Cytotec (misoprostol) is indicated for the treatment of duodenal and gastric ulcers. Other uses of misoprostol as recommended by current WHO guidelines include induction of labour, postpartum haemorrhage prophylaxis, treatment of missed and incomplete miscarriages, induction of abortion, and cervical preparation before uterine instrumentation.
The risk to patient health from falsified Cytotec (misoprostol) is ineffective or delayed treatment for all of the above uses and could also be life threatening in some circumstances. It is important to detect and remove any falsified Cytotec (misoprostol) from circulation so as to prevent harm to patients.
The products identified in this Alert are confirmed as falsified on the basis that they deliberately/fraudulently misrepresent their identity, composition or source:
- Batch B16519 – batch number does not correspond to genuine manufactured CYTOTEC. Laboratory analysis of samples has also confirmed the product does not contain any active ingredient and does not comply with specifications;
- Batch 14660 – the expiry date (12/2021) on this product is falsified.
… If you are in possession of the above products, please do not use them.
National regulatory/health authorities are advised to immediately notify WHO if these falsified products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact rapidalert@who.int
The official alert has been translated into three languages that have been circulated to national regulatory authorities. WHO Medicines regional advisors have also been alerted but we want to inform other relevant people working on SRHR.
N3_2021 Falsified CYTOTEC_EN.pdf (0,1MB)
N3_2021 Falsified CYTOTEC_SP.pdf (0,1MB)
N3_2021_FalsifiedCytotec_FR.pdf (0,1MB)
Please help us spread this information widely, so that you and other partners on the ground can be vigilant if using Cytotec.
For further details, contact:
Laurence Läser, Technical Officer
Prevention of Unsafe Abortion / Sexual and Reproductive Health and Research
— including HRP, the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. World Health Organization, Geneva
Office: +41 22 791 3418
Mobile: +41 79 613 65 76
E-mail: laserl@who.int
[See WHO: Substandard and falsified medical products for a wider global picture.]