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Thalidomide, the drug that caused malformations in babies, is back on the market in February

It carries a dark past due to the dramatic side effects it had for years. Between 1957 and 1963, pregnant women who suffered from nausea during the first three months of pregnancy were prescribed thalidomide, a drug that was marketed throughout Europe and which hid enormously harmful consequences for the fetus. Many of the babies born during those years came into the world with a lack or excessive shortness of limbs, congenital malformations that have marked their lives and for which in recent decades they have claimed compensation that Health recognized as “insufficient.”

Now thalidomine will be marketed again, as announced by the Spanish Agency for Medicines and Health Products (Aemps), although only in hospital pharmacies. Those affected by multiple myeloma – a type of cancer that forms in bone marrow cells known as plasma cells – will thus see their portfolio of treatments expanded. «On February 2, thalidomide will be marketed for the first time in Spain, its only authorized indication, in combination with melphalan and prednisone, being the first-line treatment in patients with untreated multiple myeloma, aged 65 years or older or older. not suitable to receive high-dose chemotherapy, being a medicine dispensed in hospitals,” they detail from the Aemps.

From this organization they already warn that due to the “risk of producing serious congenital malformations”, in the European Union a series of requirements have been established for its prescription and dispensation with a “pregnancy prevention plan” and a “controlled access system” which aims to prevent any exposure to thalidomide in pregnant women. “These requirements will apply to any marketed medicine that contains this active ingredient and its use is contraindicated in pregnant women, as well as in women of childbearing capacity or men who do not meet the conditions established in the prevention plan.”

Thus, fertile women who must take thalidomide must use an effective method of contraception before, during and after treatment, and undergo regular pregnancy tests. In turn, men must use condoms if they have sexual relations with women who are pregnant or who may become pregnant, both during treatment and after.

Those affected by thalidomide, who today are between 60 and 66 years old, never stopped fighting to obtain compensation from the German pharmaceutical company Grünenthal GmbH in accordance with the immense damage caused. In 2015, the Association of Thalidomide Victims of Spain (Avite) took the case to both the Constitutional Court and Strasbourg after the Supreme Court dismissed its appeal, considering that the claims were “prescribed.”

Three years later and in its final stretch, Rajoy’s Government agreed with Ciudadanos for compensation of 56 euros per month, an amount that Avite called “a real shame and an insult to intelligence.” The Ministry of Health of that cabinet later recognized that this amount was “insufficient.”

This same week, the Supreme Court has rejected an appeal filed by the Avite Association against the Government for non-compliance with Law 6/2018 on General State Budgets, which gave one year for those affected by thalidomide to be medically recognized by the Carlos III Health Institute and compensated. «We are in 2023, and despite the failure to comply with the Law, the Supreme Court has not accepted our appeal and the order is final. According to it and the previous ruling of the National Court, the order that ‘resolves it’, the judiciary guarantees that the Government can completely fail to comply with the law,” the organization said.

For this reason, Avite has lamented that for the courts “not complying” with Law 6/2018, after four and a half years, “is still not enough.”