Packages of the weight-loss drug Wegovy from the pharmaceutical firm Novo Nordisk lie on the gross sales counter in a Danish pharmacy.
Stefan Trumpf | Picture Alliance | Getty Images
U.Ok. well being authorities on Wednesday mentioned they’re reviewing weight problems and diabetes medication like Novo Nordisk‘s Wegovy and Ozempic after some sufferers who took the remedies reported ideas of suicide or self-harm.
The probe into probably life-threatening unintended effects comes because the medication skyrocket in reputation within the U.S. — and draw heightened investor curiosity — for serving to folks obtain dramatic weight reduction over time.
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The Medicines and Healthcare merchandise Regulatory Agency, in a press release to CNBC, didn’t point out when it expects to finish its overview of security information on the remedies. Authorities within the European Union launched an identical investigation of the medication earlier this month.
The MHRA mentioned the overview contains all weight problems and diabetes medication obtainable within the U.Ok. Aside from Ozempic and Wegovy, it contains Novo Nordisk’s different weight reduction drug Saxenda. Other diabetes medication like AstraZeneca‘s Bydureon, Eli Lilly‘s Trulicity and Sanofi‘s Lyxumia are additionally included within the probe.
Those medication are all a part of a category of medication often known as GLP-1 receptor agonists, which mimic a hormone produced within the intestine to suppress an individual’s urge for food. GLP-1s may assist handle Type 2 diabetes as a result of they encourage insulin launch from the pancreas, decreasing blood sugar ranges.
“Patient safety is our top priority,” the MHRA mentioned in a press release to CNBC. “We will carefully consider all available evidence and communicate any further advice to patients and healthcare professionals as appropriate.”
Novo Nordisk mentioned in a press release that it obtained a overview request from the MHRA on Monday. The firm mentioned a “response will be provided within the requested timelines” of the overview.
Sanofi mentioned in a press release that it was conscious of the overview and is working with the MHRA. The firm added that its pharmacovigilance monitoring system, which tracks opposed drug results, has not recognized any security issues related to GLP-1s.
AstraZeneca and Eli Lilly didn’t instantly reply to a request for touch upon the MHRA’s overview. Reuters first reported the overview.
Between 2020 and July 6 this 12 months, the MHRA obtained 5 studies of suspected opposed drug reactions related to “suicidal and self-injurious” conduct in sufferers who took Ozempic and Wegovy.
The company additionally obtained 12 comparable studies involving those that took Saxenda, or liraglutide, between 2010 and July 6.
But the MHRA emphasised that these studies aren’t proof that the medication induced these opposed reactions.
The U.S. prescribing info for Wegovy and Saxenda, each accredited by the Food and Drug Administration, already recommends that health-care suppliers monitor for “suicidal behavior and ideation.”
Saxenda’s info additionally famous that medical trials in adults discovered 9 of three,300 folks on the drug reported suicidal ideation. That’s in contrast with 2 of greater than 1,900 folks on a placebo. The prescribing info says “there was insufficient information to establish a causal relationship” between suicidal ideation and Saxenda.
There isn’t any comparable advice within the U.S. prescribing info for Ozempic and different GLP-1s for diabetes, that are usually used at decrease doses.
If you might be having suicidal ideas, contact the Suicide & Crisis Lifeline within the U.S. at 988 or the Samaritans within the U.Ok. at 116 123.
Source: www.cnbc.com”