Public Health Warning on Falsified Drug Product “CYTOTEC” Confirmed by the World Health Organization (WHO)

The Food and Drug Administration (FDA) notifies the public on the Medical Product Alert provided by the WHO, wherein drug product Misoprostol 200 microgram (mcg) tablets with brand name “CYTOTEC”, was detected in the African region on July 2021 and was recently confirmed as falsified by WHO by the manufacturer. It was reported that this product was at wholesale and patient level in Cameroon, the Democratic Republic of Congo, Ghana, and Nigeria.

Details of Falsified Batches

The following information identifies the specific drug products and batches confirmed as falsified:

• Drug Product: Misoprostol 200 mcg Tablet (CYTOTEC)
• Batch No. B16519: Expiry Date 05/2022, Language: English
• Batch No. B14660: Expiry Date 12/2021, Language: Spanish
• Stated Manufacturer: Pfizer, Inc.

A falsified drug product deliberately or fraudulently misrepresents identity, composition, or source. Upon confirmation with the genuine manufacturer, it was confirmed that the Batch No. B16519 does not correspond to genuine manufactured “CYTOTEC” and upon analysis, it does not contain any active pharmaceutical ingredient (API) and confirmed as non-compliant to its specifications. For Batch No. B14660, the expiry date on the said product is falsified.

Health Risks and Regulatory Warnings

The FDA strongly advises the public to be vigilant on the circulation of this falsified drug product since this poses a serious risk to global public health and could be also life threatening in some circumstances. Authentic Misoprostol 200 mcg tablet “CYTOTEC” is indicated for the treatment of duodenal and gastric ulcers. This is to emphasize that Misoprostol (CYTOTEC) 200 mg tablet is not registered with FDA. Therefore, all Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that these falsified drug products are not sold or not administered to patients in their localities or areas of jurisdiction.

Medication Abortion and Healthcare Standards

Beyond its use for ulcers, medication abortion is also known as abortion with pills or medical abortion. The Food and Drug Administration has approved medication abortion for up to 10 weeks of pregnancy and the World Health Organization authorizes its use for up to 12 weeks. It is endorsed by several organizations, including the American College of Obstetricians & Gynecologists and the American Medical Association. Medication abortions account for 53% of all facility-based terminations in the United States.

Legal Status of Mifepristone

Mifepristone is at the center of growing legal battles. On June 13, the Supreme Court justices in a unanimous decision preserved access to mifepristone, a medication that’s used for the safe termination of early pregnancy. This ruling followed a period where the legal future of mifepristone had hung in the balance for several months. In August 2023, the 5th U.S. Circuit Court of Appeals ruled that mifepristone should not be prescribed past the seventh week of pregnancy, prescribed via telemedicine, or shipped to patients through the mail. Despite these legal challenges, reproductive health experts emphasize that abortion remains legal in many areas, including Pennsylvania, New Jersey, and Delaware.