Cetrotide, a drug commonly used by women undergoing in vitro fertilization, will not be available in parts of Europe because of an unidentified production issue with its manufacturer, Merck KGaA.
The European Medicines Agency issued (PDF) the warning Wednesday, saying the problem forced the closure of the primary plant producing the drug from December 2021 to March 2022. The factory is owned by Merck’s subsidiary EMD Serono.
The quality of the drug is not affected by the production problem, the EMA said, but its supply could be reduced and/or delayed in 15 countries including Belgium, Greece, Ireland, the Netherlands, Poland and Portugal.
"We are experiencing reduced and delayed supply of Cetrotide because of the higher than expected demand and technical issues at our primary external supplier," Merck KGaA said in an email. "The technical problems causing the shortage initially are fully resolved and production resumed in early April 2022. We are working closely with our partners in manufacturing to ensure regular supply of Cetrotide as soon as possible."
Cetrotide is used for the prevention of premature ovulation during IVF. In a letter from Merck KGaA to healthcare professionals, the company says patients should not be started on Cetrotide in affected countries.
There are suitable alternatives to the drug, Merck KGaA added.
Cetrotide won approval in Europe in 1999. In 2013, Aeterna Zentaris licensed the rights to its manufacture to Merck Serono for $3.3 million.
Editor's note: This story was updated with comments from Merck KGaA.