Information on safe use of medicinal products containing sitagliptine as the active substance
05.10.2009
U.S. Food and Drug Administration (FDA) issued a press release informing the public about the reports of cases of acute pancreatitis in patients receiving the medicinal products containing sitagliptine as the active ingredient.
The Agency for Medicinal Products and Medical Devices (ALMP) received a statement from Merck Sharp & Dohme d.o.o., the marketing authorisation holder in the Republic of Croatia for the medicinal products Januvia, Janumet and Efficib, that after careful consideration it was impossible to establish unequivocally a causal link between the cases of acute pancreatitis and use of the aforementioned medicinal products.
The European Medicines Agency (EMEA), based on this information, approved a safety variation whereby acute pancreatitis was included as an adverse reaction in the documentation relating to the medicinal products containing sitagliptine as the active ingredient. The Agency for Medicinal Products and Medical Devices will approve the same variation as soon as possible, and continue to closely monitor the safety of the medicinal products Januvia, Janumet and Efficib, as well as other medicinal products from the same group.
In the Republic of Croatia, so far the Agency for Medicinal Products and Medical Devices has not received any reports of acute pancreatities as an adverse reaction in patients taking any of the aforementioned medicinal products.
