By Dilip Kuner • 28 December 2019 • 13:29
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CRIMINAL proceedings to be brought in a case where 23 children suffered from ‘werewolf’ syndrome after they were mistakenly given the wrong medicine.
Malaga’s Public prosecutor has told the city’s District Court that investigations show there is evidence of criminal responsibility in the case. The children suffered from hypertrichosis, a condition that causes hair to grow all over the body.
The Malaga Public Prosecutor’s Office opened an investigation on August 29 after several very young children were affected by the condition.
Health authorities confirmed last September that 23 children were affected – 10 in Cantabria, 10 in Andalusia and three in the Community of Valencia.
The prosecutor has now referred the proceedings to the court for the initiation of criminal proceedings and requests that two heads of the company Farma-Química Sur SL, based in Malaga, be heard as investigated people.
The pharmaceutical company marketed a mislabelled product that included minoxidil instead of omeprazole. Minoxidil is usually used to treat alopecia. The children – who were aged between two months and seven years – had been prescribed medicine to treat gastric reflux.
The public prosecutor has also requested that the Spanish Agency for Medicines and Healthcare Products provide detailed information on the children affected by the intake of minoxidil and to specify in each case the outcome suffered and whether or not they suffered and long term effects on their health.
Following this incident and the inspections carried out at its facilities, Farma-Química Sur S.L., has had its registration to carry out manufacturing, import and/or distribution activities of pharmaceutical active ingredients suspended since July.
Like the UK’s MHRA Yellow Card system, any individual in Spain can report suspected adverse reactions.
Dr Francisco Abad Santos from the Clinical Pharmacology Service at the University Hospital of the Princess of Madrid Said that “the Spanish System of Pharmacovigilance, which is similar to that of other European countries, has announced that any healthcare professional, or even any citizen or patient, may report suspected adverse reactions via the yellow cards – which is now done online on the Internet. The system, which is based on spontaneous notification, covers all marketed drugs and all exposed patients.”
He continued: “Although it is compulsory for healthcare professionals to report all suspected adverse drug reactions, the main problem is under-notification (it is estimated that only 10% of cases are reported). This is partly due to the difficulties that may exist in warning about some unknown or uncommon adverse reactions,” he added.
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