Pharmaceutical companies remove growth hormone from the market – 11/25/2023 – Balance and Health

Two multinational pharmaceutical companies recently announced a cut in the supply of somatropin, known as growth hormone, to the Brazilian market. The medicine produced by Novo Nordisk has been unavailable since July, with no restocking date yet. Merck will stop distribution in January 2024, also for an indefinite period.

The medicine is indicated for the treatment of growth disorders in children and adolescents. Patients should seek medical advice to replace the medication with another with the same active ingredient. The therapeutic alternatives available in the country are in regular supply, according to the manufacturers.

When questioned, pharmaceutical companies attributed the shortage to logistical and production difficulties, and said that other countries were also being affected. According to Danish company Novo Nordisk, “interruptions in the implementation and operation of a new filling line” resulted in production being lower than expected. Germany’s Merck, in turn, said it is “working around the world to speed up our processes and increase our production capacity to resolve this situation.”

The cut in supply by multinationals should not affect the distribution of the hormone by the SUS (Unified Health System). The public medication is produced by the Brazilian laboratory Cristália in partnership with the BioManguinhos institute, from Fiocruz (Fundação Oswaldo Cruz).

Free treatment is guaranteed to children and adolescents with proven growth hormone deficiency (also known by the acronym GH – growth hormone in English) and girls with Turner syndrome (a genetic condition that causes short stature in women). Around 30 thousand patients are currently served by the SUS.

There are also other indications approved by Anvisa (National Health Surveillance Agency), but only available in the private network, with a medical prescription. In general, somatropin is indicated to stimulate the growth of children with a condition that inhibits growth – the list includes malformations, chronic renal failure and some rare syndromes. The medicine is also indicated for adults with hormone deficiency.

The broadest use, however, is for the treatment of so-called idiopathic short stature. “The word means ‘of unknown cause’, when we do all the tests and are unable to determine it. It is a large group of patients, which may include 1% to 2% of children”, explains the director of the pediatric endocrinology department at Sbem ( Brazilian Society of Endocrinology and Metabology), Sonir Antonini.

“Of every 100 patients who have growth problems, 5% have hormone deficiency. Of the remaining 95%, the largest contingent is idiopathic short stature”, he added. According to the doctor, GH is indicated when other treatable diseases have already been ruled out as the cause of short stature.

Doctors consulted by the report warn about the inappropriate use of somatropin for aesthetic and behavioral reasons, including in children without hormonal deficiency so that they can grow more.

“Anvisa is very careful in defining short stature, the standard has very clear and rigid parameters. But there is a laxity when it comes to prescribing and there are doctors who end up prescribing for a lot of people who officially have no indication”, says Margaret Boguszewski , professor at UFPR (Federal University of Paraná) and vice-president of the department of pediatric endocrinology at Sbem.

According to experts, the medicine has a high level of safety and has few contraindications – its use is prohibited in children with diabetes and those undergoing cancer treatment.

The increase in use without medical indication, however, worries experts. Despite not being indicated on the leaflet, GH is widely used to gain muscle mass and improve sports performance. The medicine is advertised for this purpose on social networks, such as Facebook and Telegram.

“Use is safe in adequate and controlled doses, but when an adult who already produces [o hormônio] Take too much, the risks increase. It then causes several joint problems, blood sugar rises, there is an increased risk of diabetes, blood pressure rises and can even favor the formation of cancer”, explains Antonini, who is a professor at the Faculty of Medicine of Ribeirão Preto, USP (University of São Paulo).

In April, the CFM (Federal Council of Medicine) published a resolution prohibiting the prescription of anabolic androgenic steroids for aesthetic purposes. The list includes 31 substances, including somatropin.

According to Annelise Meneguesso, the entity’s advisor, the measure met the demands of eight medical societies, such as cardiology, dermatology and endocrinology – specialties that would be dealing with the “after-effects” of the inappropriate use of these hormones.

“We had to do something about this bad practice. If I offer a treatment to a patient that could leave him less healthy than when he came in, I am not being ethical. Outside of formal indications the prescription is not justified, because the risks are greater than the benefits”, said the endocrinologist.

The measure provides for punishments ranging from a warning to the revocation of professional registration. According to Meneguesso, the CFM frequently judges complaints of non-compliance with the rule.