Health alert in Spain: Batch of popular prostate cancer treatment withdrawn due to dangerous defect

A popular injectable medicine used to treat prostate cancer in Spain has been withdrawn from pharmacies by the Spanish Medicines Agency (AEMPS).

The Spanish Medicines Agency (AEMPS), warned this Friday, March 17, of the withdrawal from the market of a batch of an injectable medicine used to treat prostate cancer in Spain.

With an incidence in Spain of more than 27,000 new cases each year, it is the most common tumour among men and the third most deadly. It is estimated that one in four men will suffer from prostate cancer at some point in their lives.

In its statement, the AEMPS reported that the affected medicine is the injectable treatment, Gonapeptyl Depotel. The defective batch has the identification code U12671F, with an expiration date of December 31, 2024. This drug is manufactured in Switzerland by Ferring International Centre SA.

The reason that led to the order for its withdrawal from pharmacy shelves was given as the possible ‘lack of sterility of the injection needle’. All distributed units of the affected lot of Gonapeptyl Depot 3.75 milligrams powder and solvent for suspension for injection have been withdrawn from the market explained the Ministry of Health. They will be returned to the laboratory through the usual channels it added.

Drug quality defects are classified into three categories (1, 2 and 3) by the Aemps. The first of them corresponds to a higher risk, with class three having a lower risk. In this case, AEMPS pointed out that it is a class one defect, the highest category of severity.

Gonapeptyl Depot contains triptorelin – as triptorelin acetate – a medicine that belongs to the group of so-called GnRH analogues. One of its actions is to decrease the production of sex hormones in the body, which makes it possible to treat hormone-dependent locally advanced or metastatic prostate cancer, as reported by elespanol.com.

In Spain, this drug can also be prescribed to women to suppress ovarian hormone levels. This is intended to reduce the size of uterine fibroids. Commonly known as fibroids, these are non-cancerous tumours arising from the myometrium, the smooth muscle layer of the uterus. It is also used to treat endometriosis, the presence of uterine tissue outside the uterus.

Finally, it can also be used for the treatment of central precocious puberty when it occurs prematurely, causing the physical and hormonal changes of normal puberty. As a result, it is possible to delay sexual development in girls under 9 years of age and in boys under 10 years of age until they reach the biological age for it to occur naturally.

It is supplied with two injections, one of powder for suspension for injection and the other pre-filled with solvent, which will be injected by health professionals on an outpatient basis. Long-term treatment consists of one injection every four weeks on average.

Since it interferes with the production of sex hormones, side effects are frequent and severe. In men, low testosterone levels can cause impotence, decreased libido, hot flushes, bone pain, and difficult and painful urination.

In women, side effects include decreased libido, mood swings, sleep disturbances, hot flushes, abdominal pain, bone pain, excessive sweating, vaginal bleeding/spotting, vulvovaginal dryness, pain during intercourse, painful menstruation, enlargement ovaries, pelvic pain, weakness, and headaches.

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