Thalidomide returns to Spain, the drug after the scandal of malformations in babies

Those affected by the multiple myeloma -a type of cancer that forms in cells in the bone marrow known as plasma cells— you will see magnified from the February 2 your portfolio of treatments. As of that date, the Spanish Agency for Medicines and Health Products (Aemps) will allow the marketing of thalidomide for these patients. The problem is that this drug has a dark past, since it was the cause of thousands of serious malformations in newborns around the world.

“Thalidomide It is a drug that was on the market a long time ago, between the 50s and 60s, but which withdrew from the market because of the serious adverse effects it produced,” explains Cristina Aguilera, from the Clinical Pharmacology Service of the Vall d’Hebron University Hospital and spokesperson for the Spanish Society of the SEFC, to EL ESPAÑOL.

Within the pharmacological world, thalidomide is known as a teratogenic, that is, an agent that acts by irreversibly altering the growth, structure, or function of the developing embryo or fetus. The drama with this medication was, as Aguilera recalls, that her target audience was precisely pregnant women: “It went on the market for pregnant womenbecause it served as a sedative, to sleep, for nausea and vomiting”.

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The problems caused in newborns by the thalidomide focus on malformations in the lower or upper extremities, such as amelia (absence of the member), missing fingers and, above all, as the expert emphasizes, the phocomelia, a rare disorder that causes severe shortening of the arms or legs. It has also been shown to cause 40% mortality during the first year of life, cardiac, renal, digestive, ophthalmic and auditory alterations.

Up to 3,000 Spanish affected

To this day, it is still difficult to know the number of people affected by thalidomide. According to a figure published by the Spanish Association of Pediatrics, it is estimated that there are more than 10,000 recently born with malformations during its marketing period. In Spain, there are between 1,500 and 3,000, a figure that could have been much lower, since our country was one of the last to carry out its withdrawal, in January 1963.

Even so, as the expert points out, research has continued with thalidomide and, in fact, its dispensing has also continued: “Later it was seen that this medicine has anti-inflammatory effectsTherefore, it has been used for the treatment of some types of leprosy very aggressive, especially in South American countries like Brazil”.

First sedative and then anti-inflammatory, later researchers noticed thalidomide’s ability as a immunomodulatory, that is, as a type of agent used in immunotherapy cancer treatments to enhance the body’s response. “It has been seen that you can have this added effect together with other drugs for multiple myeloma, which is why it will be marketed again in Spain”, details Aguilera.

[El drama del cáncer durante el embarazo: un 40% son de mama y varias terapias están vetadas]

The question is: have the risks of thalidomide disappeared? “No, they’re still there,” the doctor says emphatically. What has been done is to apply a exhaustive protocol to prevent the drug from affecting the embryo or fetus.

The first thing, as Aemps specifies, is that its only authorization will be for patients with untreated multiple myeloma, unfit to receive high-dose chemotherapy and older than 65 years. Age is a way to guarantee that it will not affect women of childbearing age, but as Aguilera points out, in medicine “not everything is black or white“.

exhaustive protocols

For example, one of the problems is that the age limit would not apply to men, since thalidomide can be excreted through semen. Thus, during treatment, the male patient should always use a condom in order to have sexual intercourse.

For more care, the application for thalidomide must be made in compliance with the requirements of the Controlled Access System and adhering to the Pregnancy Prevention Program. Thus, women with gestational capacity will only be able to access it by fulfilling a series of requirements, such as the use of contraceptive measures, the performing pregnancy tests before treatment, every four weeks during treatment, and four weeks after the end of treatment.

“In principle it is a drug that has come out for very specific situations and it does not seem that there are going to be risks, but you have to be informed and give the alert so that everyone is aware and don’t make mistakes“, says Aguilera, who recalls a sad case in Brazil in which a pregnant woman he mixed up his medication with that of her husband, who was being treated with thalidomide for leprosy. “The child was born with a malformation,” laments the expert, who confesses that she still feels some chills when she hears the name of the medicine. “None of these things can be allowed to happen again,” she says.

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J. A. Allen

Author, blogger, freelance writer. Hater of spiders. Drinker of wine. Mother of hellions.

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