Schlagwort: medical product alerts

Medicine Regulatory Authorities first became aware of the presence of the nitrosamine impurity, Nnitrosodimethylamine (NDMA), in products containing valsartan in July 2018. Valsartan is an Angiotensin II Receptor Blocker (ARB) and belongs to a family of analogue compounds commonly referred to as the sartans.

Further nitrosamine impurities were subsequently detected in other medicines belonging to the sartan family, including: N-nitrosodiethylamine (NDEA), N -nitrosodiisopropylamine (NDIPA), N -nitrosoethylisopropylamine (NEIPA) and N -nitroso-N-methyl-4-aminobutyric acid (NMBA).

Falsified Amoxicillin + Clavulanic Acid products circulating in Haiti

This Medical Product Alert relates to four confirmed falsified products: quinine sulphate circulating in Central African Republic and Chad and quinine bisulphate circulating in Uganda. It should be noted that this is the second WHO Medical Product Alert issued on the same batch number of falsified quinine bisulphate circulating in the African region. Please refer to the previous WHO Medical Product Alert N°2/2017 issued 27 July 2017. Quinine bisulphate and quinine sulphate are listed on the WHO Model List of Essential Medicines for management of severe malaria. This alert compiles details of four different falsified products that have been discovered at different times and locations over the past year. This repeated occurrence highlights the need for additional vigilance in Central and East Africa for such products that display common characteristics and distribution patterns.

WHO was informed by a non-governmental organization (NGO) that this falsified quinine sulphate was found at patient level in the Central African Republic. At this stage, testing has not yet been conducted. Product details are listed in Table 1 below.

Falsified Augmentin found in Uganda and Kenya

This Medical Product Alert relates to 3 different falsified rabies vaccines (Verorab, Speeda, and Rabipur) and 1 falsified anti-rabies serum (Equirab) circulating in the Philippines. It is linked to the WHO Medical Product Alert N°1/2019 issued on 30 January 2019 regarding falsified Verorab rabies vaccines circulating in the Philippines. Rabies is a vaccine-preventable viral disease that is almost always fatal following the onset of clinical symptoms. Rabies is present worldwide, with over 95% of human deaths occurring in the Asia and Africa regions. Genuine Verorab, Speeda and Rabipur vaccines are used for pre-exposure vaccination or post-exposure prophylaxis. Genuine Equirab anti-rabies serum provides passive immunization against rabies.

WHO recently received confirmation that falsified batches of Verorab, Speeda, Rabipur and Equirab were available at patient level in the Philippines. Investigations are ongoing, and laboratory analyses are being facilitated for available samples to determine their contents and better assess the risk to public health. At this stage, no adverse reactions attributed to the below mentioned falsified products have been reported to WHO. A rabies vaccine shortage is ongoing in the Philippines.