The medication was administered to the father of a woman, who is a doctor by profession, without the knowledge or consent of the patient or his family. After taking Actilyse, the man suffered a hemorrhage and unexpectedly passed away. The allegations made by the deceased's family have been confirmed by the Commissioner for Patient Rights, according to the Polish news outlet Onet.pl.
Vascular surgeons in Poznań had been administering Actilyse to patients with blood clots in their legs, despite the fact that this drug is not registered for such use. According to European Medicine Agency (EMA), it should only be used in prescribed doses for specific conditions such as heart attacks, strokes, or pulmonary embolism.
"Although some patients have died, the prosecution has already dropped the case twice and is on track for a third dismissal," the report states.
Doctors in Poznań allegedly failed to inform patients about the risks associated with the use of Actilyse outside its official indications.
The patients were unaware of how they were being treated. The prosecution repeatedly dismissed the investigation, citing opinions from vascular surgeons who defended the use of the drug despite its lack of registration for treating blood clots in the lower limbs.
Experts question legality of Actilyse use after sudden deaths in Poland
After the Commissioner for Patient Rights appointed a medical expert at the request of the deceased patient's family, a professor from outside the field of vascular surgery questioned both the medical and formal aspects of administering Actilyse, according to Onet.
"We hope that now the Poznań prosecution will finally conduct a thorough investigation and confirm what has been obvious from the very beginning. That patients were not informed about the medication they were receiving, that the dosage was unknown at the time, and that this therapy could result in death," said attorney Jarosław Głuchowski, the representative of the family of one of the deceased patients, in a comment to Onet.
Source: Onet/EMA
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