Pharmacy Daily | Safety data review is on

THE UK is reviewing the class of drugs that include Novo Nordisk's weight loss drugs Ozempic and Saxenda after "some patients reported suicidal or self-harming thoughts", two weeks after similar action by the European Union, Reuters has reported.

The Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement this week it was reviewing safety data on a class of drugs known as GLP-1 receptor agonists.

Novo Nordisk told Reuters it had received a request from the MHRA about the agency's review of potential "suicidal and self-harming thoughts related to GLP-1 drugs".

"The review is ongoing and a response will be provided within the requested timelines," the company said in a statement.

The MHRA said AstraZeneca's GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review.

AstraZeneca did not immediately respond to a request by the news agency for comment by Wed.

The MHRA said two other GLP-1 drugs, Sanofi's lixisenatide, and Eli Lilly's dulaglutide, were also included.

Sanofi told Reuters it is aware that the MHRA is conducting the review.

"We are working with the MHRA," it said.

"Sanofi confirms our continuous patient safety and pharmacovigilance monitoring system has not identified any safety concerns."

"We are aware of the MHRA's review," Eli Lilly said in a statement.

"Patient safety is Lilly's top priority, and we will respond to the review regarding safety signals related to dulaglutide (Trulicity) as part of our routine regulatory review processes."

MHRA said the review would consider safety data including adverse drug reactions reported by patients and clinicians to the agency, and other medicines' regulators that it did not name.

Between 2020 and 06 Jul this year, the MHRA received five reports of suspected adverse drug reactions involving semaglutide associated with "suicidal and self-injurious behaviour", via its Yellow Card scheme for collecting and monitoring safety concerns such as side effects from medicines.

Between 2010 and 06 Jul this year, the MHRA received 12 suspected adverse drug reactions involving liraglutide also associated with "suicidal and self-injurious behaviour", Reuters also reported.