Weight-loss jabs investigated for suicide risk

1 year ago 25

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By Michelle Roberts

Digital wellness editor

Europe's drugs regulator has told BBC News it is conducting a reappraisal of immoderate weight-loss jabs aft being alerted to a imaginable nexus to thoughts of termination and self-harm among users.

Member authorities Iceland notified the European Medicines Agency aft seeing 3 cases.

The information appraisal volition look astatine Wegovy, Saxenda and akin drugs, specified arsenic Ozempic, that assistance curb appetite.

Product leaflets already database suicidal thoughts arsenic a imaginable broadside effect.

Suicidal behaviour is not presently listed for these medicine drugs.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which is conducting the review, volition see whether different treatments successful aforesaid broader class of medicines, glucagon-like peptide-1 (GLP-1) receptor agonists, besides request assessing.

But initially, it volition measure lone the risks of utilizing weight-loss medicine that contains either semaglutide oregon liraglutide.

An EMA authoritative said: "The reappraisal is being carried retired successful the discourse of a awesome process raised by the Icelandic Medicines Agency, pursuing 3 lawsuit reports.

"A awesome is accusation connected a caller oregon known adverse lawsuit that is perchance caused by a medicine and that warrants further investigation.

"The lawsuit reports included 2 cases of suicidal thoughts - 1 pursuing the usage of Saxenda and 1 aft Ozempic.

"One further lawsuit reported thoughts of self-injury with Saxenda.

"The EMA volition pass further erstwhile much accusation becomes available."

Global shortages

Social media posts astir people, often celebrities, shedding ample amounts of value has led to large request for these types of treatment.

Saxenda and Wegovy are approved and licensed for value loss. Wegovy is not yet disposable successful the UK - but the premier curate has said GPs successful England whitethorn soon commencement offering it to immoderate patients, arsenic good arsenic specializer weight-management clinics.

Ozempic is for radical with diabetes to assistance power humor sweetener arsenic good arsenic value but contains a little dose of the aforesaid medicine, semaglutide, arsenic Wegovy. And with immoderate radical without diabetes buying the pre-filled pens to suffer weight, determination person been continuing planetary shortages.

All medicines person imaginable broadside effects. For weight-loss drugs, which should beryllium utilized alongside a steadfast fare and exercise, much communal ones include:

  • nausea
  • vomiting
  • headaches
  • diarrhoea
  • constipation
  • stomach ache
  • tiredness

Depression oregon thoughts of termination is listed successful the product-information leaflet, which advises users: "You should wage attraction to immoderate intelligence changes, particularly abrupt changes successful your mood, behaviours, thoughts, oregon feelings. Call your healthcare supplier close distant if you person immoderate intelligence changes that are new, worse, oregon interest you."

Prescribers are besides advised to show for this.

Manufacturer Novo Nordisk is moving with the EMA and says diligent information is simply a apical priority. A typical said: "GLP-1 receptor agonists person been utilized to dainty type-2 diabetes for much than 15 years and for attraction of obesity for 8 years, including Novo Nordisk products specified arsenic semaglutide and liraglutide that person been successful the UK marketplace since 2018 and 2009 respectively.

"The information information collected from ample clinical-trial programmes and post-marketing surveillance person not demonstrated a causal relation betwixt semaglutide oregon liraglutide and suicidal and self-harming thoughts.

"Novo Nordisk is continuously performing surveillance of the information from ongoing objective trials and real-world usage of its products and collaborates intimately with the authorities to guarantee diligent information and capable accusation to healthcare professionals.

"EMA continuously monitors for information signals and truthful does Novo Nordisk.

"Novo Nordisk remains committed to ensuring diligent safety."

The UK's cause regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said it was monitoring the situation.

Dr Alison Cave, MHRA Chief Safety Officer, said: "As portion of our adjacent monitoring, immoderate emerging grounds is routinely considered alongside different sources of information, including suspected adverse cause reactions. We volition pass immoderate caller proposal to healthcare professionals and patients if appropriate.

"If you are experiencing suicidal thoughts oregon thoughts of self-harm, delight question contiguous aesculapian assistance.

"We inquire everyone to study immoderate suspected broadside effects utilizing our Yellow Card scheme website."

If you person been affected by immoderate of these issues, sojourn BBC Action Line, wherever you tin find support.

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