Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance

2015 ◽  
Vol 14 (9) ◽  
pp. 1341-1351 ◽  
Author(s):  
Maurizio Sessa ◽  
Claudia Rossi ◽  
Annamaria Mascolo ◽  
Enrico Grassi ◽  
Sonia Fiorentino ◽  
...  
Keyword(s):  
Contrast Media ◽  
Adverse Reactions ◽  
Campania Region ◽  
Post Marketing Surveillance ◽  
Suspected Adverse Reactions ◽  
Post Marketing

scholarly journals Vaccines and Allergic reactions: the past, the current COVID-19 pandemic, and future perspectives

2021 ◽  
Author(s):  
Vanitha Sampath ◽  
Grace Rabinowitz ◽  
Mihir Shah ◽  
Surabhi Jain ◽  
Zuzana Diamant ◽  
...  
Keyword(s):  
Disease Burden ◽  
Adverse Reactions ◽  
Future Research ◽  
Allergic Reactions ◽  
The Past ◽  
Post Marketing Surveillance ◽  
Different Types ◽  
Post Marketing ◽  
Underlying Mechanisms ◽  
Favorable Safety

Vaccines are essential public health tools with a favorable safety profile and prophylactic effectiveness that have historically played significant roles in reducing infectious disease burden in populations, when the majority of individuals are vaccinated. The COVID-19 vaccines are expected to have similar positive impacts on health across the globe. While serious allergic reactions to vaccines are rare, their underlying mechanisms and implications for clinical management should be considered to provide individuals with the safest care possible. In this review, we provide an overview of different types of allergic adverse reactions that can potentially occur after vaccination and individual vaccine components capable of causing the allergic adverse reactions. We present the incidence of allergic adverse reactions during clinical studies and through post-authorization and post-marketing surveillance and provide plausible causes of these reactions based on potential allergenic components present in several common vaccines. Additionally, we review implications for individual diagnosis and management and vaccine manufacturing overall. Finally, we suggest areas for future research.

scholarly journals Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

2021 ◽  
pp. 276-288
Author(s):  
S. Narmada ◽  
M. P. Gowrav ◽  
Akhilesh Akki ◽  
Vishakharaju Motupalli ◽  
V. Balamuralidhara ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Healthcare Providers ◽  
The United States ◽  
Reporting Rate ◽  
Global Perspective ◽  
Drug Reactions ◽  
Paediatric Patients ◽  
Post Marketing Surveillance ◽  
Post Marketing

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

Adverse reactions: getting the best from the yellow card system

1980 ◽  
Vol 18 (19) ◽  
pp. 75-76
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Yellow Card ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Card System ◽  
The Many ◽  
Source Of Information

Yellow cards provide the Committees on Safety of Medicines (CSM) and Dental and Surgical Materials (CDSM) with their major source of information on the occurrence of adverse drug reactions. Of the many forms of post-marketing surveillance now in use, it is the most widely applied and probably the cheapest. Three-quarters of the 23,000 reports received by the Committees in 1978 and 1979 were through the yellow card system. However, probably only 10% of serious adverse reactions are reported to the Committees.1 Why is reporting reactions important, and how can doctors help to make the system work better?

The method to detect the adverse drug events through the chronological relationship between the medication period and the presence of adverse reactions from electronic medical record systems. (Preprint)

2021 ◽  
Author(s):  
Kei Teramoto ◽  
Toshihiro Takeda ◽  
Naoki Mihara ◽  
Yoshie Shimai ◽  
Shirou Manabe ◽  
...  
Keyword(s):  
Medical Records ◽  
Adverse Reactions ◽  
Adverse Drug Events ◽  
Assessment Method ◽  
Medication History ◽  
Real World Data ◽  
Drug Induced ◽  
Drug Induced Liver Injury ◽  
Post Marketing Surveillance ◽  
Post Marketing

BACKGROUND Taking medicine may cause a variety of adverse reactions. An enormous amount of money and effort are spent investigating adverse drug events (ADEs) in clinical trials and post-marketing surveillance. Real world data from multiple electronic medical records (EMRs) can make it easy to understand the ADEs that occur in actual patients. OBJECTIVE In this study, we generated a database of the patients’ medication history from the records of physician orders of EMR, which allowed the period of medication to be clearly identified. METHODS We developed the method to detect the ADE based on the chronological relationship between the presence of the adverse event and the medication period. To verify our method, we detected the ADE with alanine aminotransferase (ALT) elevation for aspirin, clopidogrel and ticlopidine. The accuracy of detecting ADE were examined by chart review and by the comparison with Roussel Uclaf Causality Assessment Method (RUCAM) which was known as standard method for detecting drug induced liver injury. RESULTS The calculated rates of ADE with ALT elevation for aspirin, clopidogrel and ticlopidine were 3.33%, 3.70% and 5.69%, respectively, which were in line with the rates of previous reports. We reviewed the medical records of the patients in whom ADE were detected. Our method accurately predicted ADE in 90%, 100% and 100%, of patients with ALT elevation from aspirin, clopidogrel, and ticlopidine, respectively. With the comparison of the RUCAM, only 3 patients were not detected as ADE by our method. CONCLUSIONS These findings demonstrate that the present method is effective for detecting ADE from EMR data.

scholarly journals Mécanismes d’action et toxicités potentielles des anticorps monoclonaux

2019 ◽  
Vol 35 (12) ◽  
pp. 1114-1120
Author(s):  
Theodora Bejan-Angoulvant ◽  
Joachim Alexandre
Keyword(s):  
Monoclonal Antibodies ◽  
Immune System ◽  
Mechanism Of Action ◽  
Adverse Reactions ◽  
Specific Binding ◽  
Target Antigen ◽  
Post Marketing Surveillance ◽  
Anticorps Monoclonaux ◽  
Post Marketing ◽  
Infusion Reactions

Monoclonal antibodies are therapeutic monoclonal Ig that act by highly specific binding to their target antigen and by interacting with the immune system. Their side effects are mainly related to their mechanism of action. The most frequent adverse effects are infusion reactions. Post-marketing surveillance is essential for identifying adverse reactions and improving knowledge of their mechanism of action.

Post-Marketing Surveillance of Euhypnos® (Temazepam): A New Hypnotic

1980 ◽  
Vol 8 (4) ◽  
pp. 295-299 ◽  
Author(s):  
L K Fowler
Keyword(s):  
Adverse Reaction ◽  
Adverse Reactions ◽  
Surveillance Study ◽  
Short Acting ◽  
Post Marketing Surveillance ◽  
Post Marketing

A post-marketing surveillance study of Euhypnos (temazepam), a new short-acting benzodiazepine hypnotic. A total of 12,350 patients requiring a sleep inducer were treated for up to 3 months with doses of 10–30 mg at night. After 2 weeks 80% of First Reports (FRs) rated Euhypnos effective and at 3 months this had risen to 92% of 3062 Second Reports (SRs). Hangover was reported in 7% of FRs and 2% of SRs but in general the drug was well tolerated with adverse reactions consisting mainly of morning nausea, headache, drowsiness and vivid dreaming. Eighty-seven per cent of FRs and 93% of SRs were ‘Clean’ reporting no hangover, adverse reaction or event of any kind.

Euhypnos® Forte, High Dose Temazepam for Resistant Insomnia: Post-Marketing Surveillance in 10,057 Patients Unresponsive to Conventional Hypnotic Dosage

1980 ◽  
Vol 8 (6) ◽  
pp. 446-452 ◽  
Author(s):  
L Keith Fowler ◽  
Maureen Schiller
Keyword(s):  
Adverse Reactions ◽  
Surveillance Study ◽  
Common Reason ◽  
High Dose ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Stopping Treatment

A post-marketing surveillance study of Euhypnos® Forte (temazepam 20 mg) capsules for the treatment of insomnia in 10,057 patients previously unresponsive to other hypnotics given in conventional doses. Patients were prescribed a nightly dose of 40 or 60 mg, but 95% actually took 40 mg. At 2 weeks, 89% of patients found the treatment effective, as did 95% at 3 months. Hangover, severe enough to stop treatment, occurred in less than 3% of patients, and other adverse reactions such as headache, dreams, gastro-intestinal disturbance and hangover symptoms were reported by only 6% of patients at 2 weeks and 4% at 3 months. The most common reason for stopping treatment was the patient having no further need of hypnotics. Euhypnos Forte was effective in 88% of 3,800 patients who had found nitrazepam unsatisfactory and 90% of 1,013 patients unresponsive to barbiturates.

Euhypnos® Forte (Temazepam) for Resistant Insomnia: Post-Marketing Surveillance, an Interim Report

1979 ◽  
Vol 7 (5) ◽  
pp. 379-382 ◽  
Author(s):  
L K Fowler
Keyword(s):  
Adverse Reactions ◽  
Surveillance Study ◽  
High Dose ◽  
Interim Report ◽  
Post Marketing Surveillance ◽  
Post Marketing

An interim report at six months of a post-marketing surveillance study of Euhypnos® Forte, a new high-dose temazepam preparation for the treatment of insomniac patients resistant to conventional hypnotic dosage. The analysis includes 2,043 First Reports (FRs) of two weeks treatment and 669 Second Reports (SRs) of three months treatment. More than 95% of the patients took a nightly dose of two capsules, temazepam 40 mg. Adverse reactions were generally acceptable, consisting mainly of headache, vivid dreams, gastro-intestinal disturbances and hangover effects. The preparation was effective in 88.6% of patients at two weeks and 95.8% at three months. All patients had previously found other hypnotics ineffective. Euhypnos Forte was rated effective by 85.5% of the 874 patients who had previously found nitrazepam unsatisfactory, and by 90.0% of the 201 who found barbiturates unsatisfactory.

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