Home » Health » Not even the suspicion of suicidal thoughts stopped the investigation for Ozempic

Not even the suspicion of suicidal thoughts stopped the investigation for Ozempic

“Ozempic is very sold out”, said a pharmacist in Porto, time SHOES 24after a few phone calls to randomly selected national pharmacies.

“The medicine comes in a box of 3 doses, 0.25, 0.50 and 1 mg, and, in the four warehouses that he gives us, everything is red, that is, all our suppliers have sold out the three doses”, said the pharmacist the .

The same is confirmed by another technician in a pharmacy in Esposende, also contacted by phone, “the medicine is now sold out”, he said, confirming “the strong demand for it to lose weight”. Pharmacies contacted could not explain the reason for the break in stock.

As far as SAPO24 could find out, the laboratory that produces this drug “is adjusting the stock, due to the high global demand for this drug”. “It is not out of stock”, guaranteed Novo Nordisk, the laboratory that produces the drug, on the phone and immediately confirmed in writing the request for the drug in question.

“Demand for Ozempic (semaglutide) in Portugal remains high, causing specific restrictions on access to the medicine, a situation that we are monitoring together with the Health Authorities. In case of risk of potential rupture, we will notify and act in . in advance, in the time provided for in Portuguese law”, stated the Danish laboratory in a note sent.

nonetheless, a source close to Infarmed says that there is no reason for concern on the part of patients with type 2 diabetes, because there are many Ozempic alternatives on the market.

Asked if the laboratory should increase the quota of the supply of this drug, the same source from the drug authority clarified that it does not work like that, and refutes the word “quota”.

The provision is calculated based on the information sent by the health systems of the countries and the number of people with a certain disease. This is the main basis for drug distribution, found SAPO24.

“The pharmaceutical industry studies the countries where it supplies the drugs and it is based on this information that it establishes the amount for each country”, the source said.

“The market is controlled, where research is done to develop alternative and similar medicines. The national authorities contact their partners and manage the amount with the pharmaceutical industry to see if there are similar drugs. This is where generics also come in “, he explained.

The drug fever started in the United States

The investigation for Ozempic began at the end of last year, in the United States, after a group of “influencers”, and well-known Hollywood actors, (and Elon Musk) shared messages about social media described that they used these drugs to lose weight quickly and effortlessly.

In June, the “fever” for Ozempic reached the Chinese market after social networks were also flooded with publications from users who said that they “lost 10 kilos easily using Ozempic”, wrote the. CNN Brazila country that is also experiencing an increase in demand for the same medicine and is spreading to Europe and other parts of the world.

Suspected side effects are not listed

nonetheless, suspected side effects may be attributed to taking the substances semaglutide and liraglutide.

The EMA is investigating the relationship between the consumption of the substances semaglutide and liraglutide, which are present in the medicines Ozempic and Saxenda, respectively, may be related to cases of suicidal ideation in people. “Possible negative effects that do not appear in the packages for these drugs”, said the European regulator, cited by the. Public.

The European Medicines Agency has approved the COVID-19 vaccine for children

epa09233394 (FILE) – An exterior view of the headquarters of the European Medicines Agency (EMA) in Amsterdam, EPA/REMKO DE WAAL

credit: Lusa/Archive

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epa09233394 (FILE) – An exterior view of the headquarters of the European Medicines Agency (EMA) in Amsterdam, EPA/REMKO DE WAAL credit: Lusa/Archive

In the first half of July, the European Medicines Agency (EMA, for its acronym in English) confirmed that it is investigating antidiabetic drugs with the active substances semaglutide and liraglutide, which were used for another purpose, different from what they were originally. authorized for the pharmaceutical market, the European drug authority said in a statement.

In the effects not listed in the leaflet, reported so far, the EMA monitors about 150 cases of suicidal ideation linked to the consumption of two active substances.

Information on reported cases is limited – PRAC investigations are ongoing. nonetheless, some media write that the possible idea of ​​suicide may be related to “psychiatric events” from which trauma from obesity.

“Obesity can trigger depression,” said a source. nonetheless, he emphasizes, one should not draw hasty conclusions, nonetheless, it is up to the doctor “to evaluate if the patient has a history of depression and, in this case, not prescribe”.

The risk assessment of these drugs follows an alert issued by Iceland that says it has identified reports of seizures and self-harm in people taking drugs with the active substances semaglutide or liraglutide.

In Portugal, there is a case record

For SAPO24, Infarmed confirmed that the National Medicines Authority is part of this Pharmacovigilance Risk Assessment Committee (PRAC), because there is “a suspected case of suicidal ideation” in Portugal.

“As the communication published on the page of the European Medicines Agency (EMA), this risk is being evaluated at the European level through a safety signal procedure”, wrote the medicine authority in response to the email sent by SAPO24.

“A safety signal is triggered when information emerges, from one or more sources, that suggests a new potentially causal association, or a new aspect of a known association, that warrants further investigation. The presence of a safety signal does not necessarily mean that a drug caused the adverse event in question.

Infarmed also clarified that the Portuguese case “is being investigated within the scope of the Pharmacovigilance Risk Assessment Committee (PRAC), of the EMA, in a total way with all other similar cases, in order to verify the probability that the drugs in the classes related to the occurrence of this risk”.

For this reason, the aforementioned PRAC “recommends to patients and health professionals that, like all drugs, drugs from the class of GLP-1 receptor agonists should be used according to the approved indications”.

And he adds that all information about this assessment procedure can be consulted on there EMA portal and name does Unfarmed“which started this month, and is expected to end in November 2023”.

Joining Ozempic is Saxenda, both sold in Portuguese pharmacies. Saxenda is indicated for weight loss and Ozempic for type 2 diabetes and is used, along with diet and exercise, to treat adults with poorly controlled diabetes.

The state pays for “the treatment of diabetes” and not for other reasons

Regarding Ozempic and Saxenda, Infarmed underlines that in addition to being duly authorized for marketing, in Portugal these drugs are reimbursed by the State, “in the treatment of diabetes” and not for other reasons.

“The drug Ozempic is authorized and subsidized for the treatment of adults with poorly controlled type 2 diabetes with a BMI equal to or greater than 35 kg/m2, as an adjunct to diet and exercise, in addition to other medications for the treatment of diabetes. must be used in the 2nd and 3rd line of therapy, so off-label use (ie, outside the AIM specification) for the treatment of obesity is not reimbursed”, writes Infarmed.

“This medicine was only submitted to the therapeutic indications described above and nothing else”, underlined the national medicine authority in the missive sent by email.

It seems that Ozempic was well requested by doctors in “off label”.

According to SAPO24, “off label” drugs are those prescribed for purposes other than those studied and produced by the pharmaceutical industry. Prescribing drugs “off label” means that the doctor will have to justify the clinical reasons for prescribing them.

“Sometimes, the doctor prescribes medicine “off the label” because there is no drug for a given purpose, nonetheless the prescription of these medicines needs justification in clinical reasons”, said a source in the Directorate General of Health (DGS), SAPO24, who which, referring, it is not in his competence to pronounce on the specific subject, referring to Infarmed and the Medical Association.

Infarmed also does not pronounce itself, making it clear that it is “responsible for evaluating medicine”, often, and in the vast majority, “with the collaboration of doctors”.

“Fortunately, it is possible for doctors to recommend “off-label” drugs. Otherwise,” as it should be, for example, in pediatric situations “, said a source contacted by SAPO24.

“Off label” prescription is a common practice, especially in the hospital environment, because “there is no medicine for all diseases, therefore resorting to medicines with active substances that are similar to or closer to what is needed for the most appropriate treatment” , he explained.

Infarmed recommends “prescribing in conscience”

To avoid supply disruption, Infarmed has even asked doctors to prescribe “in consciousness” this medicine, before even the PRAC recommendation.

SAPO24 knows that Infarmed has activated a message, in the form of a “pop-up” that appears in the doctor’s prescription system, when the medicine is selected.

“The existence of a specific alert in the prescription software (in the form of a pop-up) is confirmed to frame the prescription of semaglutide and other antidiabetic drugs of the same class, which was introduced by the decision of the Ministry of Health.

This justification remains active”, confirmed the authority, especially at this stage when Pharmacovigilance is investigating the medicine.

SAPO24 tried to get a comment on this topic from the Medical Association, but was unsuccessful in any of the attempts, until the publication of the article.

(article edited at 19:04)

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