Year: 2021
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Adverse event reports of Special Situations
Adverse event is any untoward change to medical condition affecting a patient receiving a medicine, although it is not known whether a causal relationship to treatment with this medicine exists.Adverse event can therefore be: any adverse or unintended sign (for example, an abnormal laboratory finding) symptom disease temporarily associated with the use of a medicinal product, whether ornot a…
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EMA update on AstraZeneca Covid19 Vaccine – blood clots event
EMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare (<1/10,000) side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with…
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AstraZeneca COVID-19 vaccine – European and UK reviews on blood clots
The European Medicines Agency (EMA) and the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) have completed preliminary reviews of the risk of blood clots in people vaccinated with the AstraZeneca COVID-19 vaccine. These reviews have found the benefits of the vaccine continue to outweigh the risks, and the vaccine is not associated…
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CDSCO – online SAE reporting system
India’s Central Drugs Standard Control Organisation (CDSCO) has released a notice informing sponsors that they are required to file Serious Adverse Event (SAE) reports electronically via the Sugam online portal from 14 March 2021. Following the Indian government’s implementation of The New Drugs and Clinical Trials Rules, 2019, SAEs are required to be reported to…
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MvPI – Severity of Medical device Adverse events (MDAE) and Timeframe for reporting an event
As per Guidance document on MvPI, Severity of an adverse event was broadly classified into three categories. Death of a patient, user of the device or other person Serious injury to a patient, user or other person – Serious Injury (also known as serious deterioration in state of health) is either a life-threatening illness or…
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MvPI – Reportable adverse events
The MvPI reportable adverse events include but are not limited to: A malfunction or deterioration in the characteristics or performance of the medical device An incorrect or out-of-specification test result The discovery of a design flaw during design review An inaccuracy in labeling, instructions for use and/or promotional materials.Inaccuracies include omissions and deficiencies. Omissions do…
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Safety Consequences of Off-Label Drugs Used for COVID-19
During a global emergency, making clever use of existing resources is a fundamental human impulse. But, the cavalier repurposing of hydroxychloroquine, chloroquine, and azithromycin during the COVID-19 pandemic has consequences. Seven deaths from cardiac adverse events occurred with the off-label use of drugs whose power to prevent COVID-19 has been discredited. A review article was…
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The Danish Health Authority has suspended use of the Oxford-AstraZeneca Covid vaccine
Based on the concerns raised by the drug authorities, the Danish Health and Medicines Authority has, based on a precautionary principle, chosen to pause vaccination with the COVID-19 vaccine from AstraZeneca. The break lasts so far for 14 days, and the Danish Health and Medicines Authority, together with the Danish Medicines Agency, will make a new…
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Materiovigilance Programme of India (MvPI) – Introduction
Regulation of Medical devices in India The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services in Ministry of Health and Family Welfare (MoHFW), Government of India (GoI) is the National Regulatory Authority (NRA) responsible for approval of manufacturing, import, conduct of clinical trials, laying down standards, sale and distribution of medical…
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Beware of alarming reports about Oxford-Astrazeneca Covid 19 vaccine
The Federal Office for Safety in Health Care (BASG) has received two reports in temporal connection with a vaccination from the same batch (ABV 5300) of the AstraZeneca vaccine in the district of Zwettl (Austria): a woman (49 y) died as a result of severe coagulation disorders, another woman (35 y) who developed a pulmonary…