MADRID, 14 June (APM) - Shortly after a Madrid court filed a lawsuit against Sanofi over side effects associated with its epilepsy drug Depakine (valproic acid), the medicine is portrayed as "the new thalidomide" in a Thursday report carried by daily El Mundo.
Carmen Rosa Galán, one of the four claimants, told the newspaper that only when her son was 15 years old, a neurologist told her about the alleged association between taking Depakine during pregnancy and autism. Galán then contacted the specialist which prescribed the drug and he said: "We knew it could be bad, but not so much."
Galán is now president of valproic acid victims AVISAV. Four families whose offspring were affected by the drug's side effects, including Galán's, have sued Sanofi and healthcare insurance company Allianz.
It is going to be a long trial, with claimants asking for €5.1 million in damages caused to children. They argue that the manufacturer failed to properly inform mothers to be and physicians about the medicine's teratogenic effects, including congenital malformations and autism spectrum disorders (ASDs), El Mundo reported.
Sanofi claims that "information about teratogenic effects of the drug has been distributed from the 1980s" and that new safety data on the medicine have been shared with healthcare authorities.
The association's lawyer told El Mundo that there is a second Depakine class action in the making and that 60 more cases are being evaluated by neurologists and might also go to trial.
El País carries the story on Friday. The newspaper reports Sanofi is also facing lawsuits in France, where the firm has admitted the drug's side effects but denied withholding information about its safety.
Daily La Vanguardia and medical journal Diario Médico also carry the story on Friday.
Use of anxyolitics jumps in Spain
While a number of studies show that use of anxyolitics is escalating in Spain, other European countries are considering more strict regulation of these medicines, daily La Razón reported on Wednesday.
La Razón quoted the latest survey by the ministry of health on alcohol and drug abuse as saying the use of these drugs has increased by 57% over the past few years, to the point that it can be considered a public healthcare problem. According to the survey, in 2015, 22.8% of respondents between the ages of 35 and 65 years had used anxyolitics at some point.
It also quotes a report by pharmacists' association FEFE as saying that anxyolitics are the best-selling drugs in community pharmacies across Spain.
Healthcare authorities are concerned about a sustained increase in anxyolitics' consumption, because these are associated to addiction, the newspaper reported.
Psychiatrist Sergio Oliveros told the newspaper that among other side effects, these drugs can cause memory loss, attention deficit, tolerance [need to take higher doses to get the same effects], withdrawal syndrome and dependence.
Roche's Hemlibra approved for reimbursement
Spain's ministry of health has approved Roche's Hemlibra (emicizumab) for reimbursement, it was widely reported on Wednesday.
Daily El Mundo noted this is the first new drug for haemophilia in 20 years. It is indicated for routine prophylaxis of bleeding episodes in adults and children with severe haemophilia A, the most common form of haemophilia.
Out of the 3,000 patients with this condition in Spain, approximately 800 have developed antibiodies which makes treatment with factor VIII inhibitors difficult. Antibodies are linked to a 70% increase in mortality, the newspaper added.
Dailies ABC, El Español, Europa Press agency, medical journals Acta Sanitaria, Redacción Médica, Gaceta Médica, El Médico Interactivo and IM Médico Hospitalario also carried the story.
Rovi expects enoxaparin sales to boost
Rovi's chief executive Juan López-Belmonte Encina has told Cinco Días that the firm's Enoxaparine Becat (enoxaparin) is one of its key growth drivers, together with Hibor (bemiparin), the financial reported on Thursday.
Enoxaparine Becat is a biosimilar of Sanofi's thrombosis drug Lovenox. López-Belmonte said it will expand from the current 12 countries where it is sold to a total of 80 over the next two years.
Cinco Días quoted Bloomberg as predicting the drug will sell €342.1 million in 2019, compared to €304.8 million in 2018, with sales up to €380 million by 2020, the financial added.
On Thursday, financial El Economista reported that Rovi has appointed Marcos Peña, former head of government agency Social and Economic Council (CES) as independent external adviser. Peña takes over Miguel Corsini, sentenced to four months for misuse of Caja Madrid credit cards, the financial added.