European Pharmaceutical Review

JUNE 15, 2023

This microbial contamination can lead to a range of adverse events, such as infections, adverse reactions, or device failures, which can compromise patient safety and health outcomes. Sharma et al. concluded by emphasising the importance of microbiological testing of medical device development and manufacturing.

Adverse Reactions 103

Adverse Reactions 103

Pharmacy Times

MAY 7, 2024

Riello, PharmD, BCPS, discusses the adverse events associated with hepatic encephalopathy (HE) treatments and the importance of encouraging patients to continue first-line medications despite adverse reactions to prevent HE recurrence.

Adverse Reactions 26

Adverse Reactions 26

pharmaphorum

JANUARY 22, 2021

In both studies, the most common adverse reactions 2% or more of clinical trial participants receiving Cabenuva were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

Adverse Reactions 71

Adverse Reactions 71

RX Note

JULY 30, 2023

Adverse Drug Reactions The World Health Organization (WHO) defines an adverse drug reaction (ADR) as 'a drug-related event that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function'.

Adverse Reactions 52

Adverse Reactions Patient Counseling Medical Records Documentation 52

pharmaphorum

AUGUST 6, 2020

Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population and included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%) and dry eye (19%). Corneal adverse events were monitored with eye exams prior to each dose, allowing for dose reductions or interruptions as appropriate.

Adverse Reactions 87

Adverse Reactions Packaging 87

FDA Law Blog: Biosimilars

MARCH 7, 2024

As a final example, current regulations require a sponsor of an investigational medical device to report to FDA (and others) “unanticipated” adverse events, which are defined in part as “serious,” and sponsors of investigational drugs to report to FDA serious and unexpected suspected adverse reactions.

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

RX Note

MAY 1, 2025

The main questions that arise in such situations include: Is the adverse event related to a drug? Is the reaction due to an immune response to the drug (i.e. A person who takes a certain drug may experience rashes, while another person who takes the same drug may not have any adverse reactions.

Adverse Reactions 52

Adverse Reactions Immunization Immunity Drug Development 52

Pharmaceutical Technology

NOVEMBER 20, 2022

Additionally, data from these trials showed that local and systemic reactions following the booster dosing lasted for a median duration of nearly two days. The occurrence of Grade 3 or higher events were found to be comparatively low.

Vaccines 59

Vaccines Adverse Reactions Immunization Immunity 59

Pharmaceutical Technology

SEPTEMBER 14, 2022

Additionally, a reduced number of serious and severe adverse events were reported, which were balanced between the vaccine and placebo arms. Headache, nausea, arthralgia, myalgia, tenderness/pain at the injection site, malaise and fatigue were observed to be the most prevalent adverse reactions during the trials.

Vaccines 59

Vaccines Adverse Reactions 59

Express Pharma

JUNE 2, 2023

This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. Pharmacovigilance and adverse event reporting: Traceability systems enable effective pharmacovigilance, which involves monitoring and reporting adverse drug reactions (ADRs) and safety concerns.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

pharmaphorum

MAY 12, 2022

The software can be used to conduct an initial analysis of adverse reactions to medications that have already been approved to identify potential side effects and undesirable events, and provides a decision-making tool for those working in pharmacovigilance, helping them process each case more quickly.

Adverse Reactions 52

Adverse Reactions Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

SEPTEMBER 19, 2022

Additionally, no new safety events linked to the combination treatment were reported versus nivolumab monotherapy. Fatigue, musculoskeletal pain, rash, arthralgia diarrhoea and pruritus among others were found to be the most prevalent adverse reactions in the trial. In the Opdualag arm, median PFS was 6.7

Adverse Reactions 52

Adverse Reactions Drug Development 52

RX Note

NOVEMBER 18, 2023

Studies suggest that treatment with ESAs to high Hgb concentrations (greater than 13 g/dL) increases cardiovascular events. The Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) , for example, failed to show a benefit in outcomes, but treatment with ESAs was associated with increased stroke.

Adverse Reactions 40

Adverse Reactions 40

pharmaphorum

MARCH 10, 2021

The US biotech said the suspected serious adverse reaction reported in the phase 1/2 study of LentiGlobin gene therapy for sickle cell disease was unlikely to be related to the virus vector used in the therapy, used to deliver the genetic material to the body.

Adverse Reactions 59

Adverse Reactions 59

PharmaState Academy

MAY 29, 2024

a) Highlight positive findings b) Include only significant adverse events c) Comprehensive data including all adverse and positive outcomes d) Focus on long-term benefits Reports must include comprehensive data covering all adverse and positive outcomes to provide a complete and accurate picture of the drug's effects.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Adverse Reactions Communication 52

Digital Pharmacist

OCTOBER 24, 2022

Common adverse reactions include conjunctival/ocular hyperemia, photophobia, blurred vision, dry eye, pain, headache, irritation, and visual impairment. . Common adverse effects include serious or fatal respiratory failure, ischemic events, abdominal pain, nausea, and diarrhea, among others. .

Adverse Reactions 75

Adverse Reactions Labelling Pharmacy Management Immunization 75

Pharmaceutical Technology

JUNE 15, 2023

During these phases, data is obtained from participants and monitored for adverse reactions or changes to health indicators, such as blood pressure or heart rate. Ahead of clinical trials, AI can improve efforts to recruit high-potential candidates or predict which patients are at a higher risk of experiencing adverse reactions.

Drug Development 52

Drug Development Compounding Adverse Reactions Dosage 52

pharmaphorum

JANUARY 26, 2022

The regulatory move applies only to trials of magrolimab given alongside Bristol-Myers Squibb’s Vidaza (azacitidine), and stems from an “imbalance” in investigator-reported serious adverse events between study arms, said the drugmaker.

Adverse Reactions 40

Adverse Reactions Chemotherapy Immunization Immunity 40

Pharmacy Joe

MAY 24, 2020

The Naranjo Adverse Drug Reaction Probability Scale (commonly referred to as the Naranjo Scale) attempts to apply objective criteria to answer the subjective question of whether or not an adverse reaction is likely caused by a medication a patient was taking at the time the reaction occurred.

Adverse Reactions 40

Adverse Reactions Hospitals Inpatient 40

Birth Control Pharmacist

SEPTEMBER 20, 2021

Adverse Reactions. The most common adverse reactions (>2%) were bleeding irregularities, dysmenorrhea, headaches, mood disturbance, increase weight, acne, decrease libido and breast symptoms. As the BMI increased in the women participating in the study, the Pearl Index also increased. About the Authors.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52

epicur

AUGUST 24, 2023

Many animals experience anxiety or have adverse reactions when taken to a clinic. Read More » Event Recap: ACVO/Epicur National Service Animal Eye Exam 2023 July 19, 2023 No Comments It was another great year of the ACVO/Epicur National Service Animal Eye Exam Event!

Adverse Reactions 52

Adverse Reactions Packaging 52

pharmacy mentor

JULY 26, 2024

Patient Safety Risks Over-prescribing and dispensing can lead to medication misuse, addiction, and adverse reactions. Legal and Clinical Implications Incomplete records can have serious legal and clinical implications, including the inability to track patient progress or respond to adverse events effectively.

Online Pharmacies 52

Online Pharmacies Controlled Substances Adverse Reactions Medication Dispensing 52

pharmacy mentor

JULY 26, 2024

Patient Safety Risks Over-prescribing and dispensing can lead to medication misuse, addiction, and adverse reactions. Legal and Clinical Implications Incomplete records can have serious legal and clinical implications, including the inability to track patient progress or respond to adverse events effectively.

Online Pharmacies 52

Online Pharmacies Controlled Substances Adverse Reactions Medication Dispensing 52

PharmD Live

JANUARY 25, 2022

Adverse drug events are avoided. A pharmacist who can review the additional added medications and ensure no adverse reactions are expected, and no drug interactions considerably lowers the risk to this population. Patient health improves, as do satisfaction scores and CMS reimbursements.

Adverse Reactions 52

Adverse Reactions Doctor of Pharmacy Communication Diabetes 52

FADIC

OCTOBER 20, 2023

Aim The role of MTM provider to geriatric patient to reduce the rate of adverse drug event caused by medication errors, drug interactions. ■ Recognition of symptoms of adverse reactions and the appropriate procedures to follow. ■ Purpose of heart failure therapy and how it works.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medical Records Medication Therapy Management (MTM) 52

The Thyroid Pharmacist

JUNE 30, 2023

IW: What are some of the more common adverse reactions that people have to LDN? For recipes, a FREE Thyroid Diet Quick Start Guide, and notifications about upcoming events, be sure to sign up for my email list ! That allows us to figure out the correct dose for each person. References [1] Immonen JA, Zagon IS, McLaughlin PJ.

Compounding 98

Compounding Immunization Immunity Compounding Pharmacies 98

LifeProNow

APRIL 9, 2023

Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. The most frequent hemorrhagic events were gastrointestinal, including rectal hemorrhage (4.2%), hematochezia (3.1%), and hemorrhoidal hemorrhage (1%). Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Adverse Reactions 100

Adverse Reactions Labelling Documentation 100

pharmaphorum

OCTOBER 26, 2020

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot. There are many possible factors that could have caused the event.”.

Vaccines 95

Vaccines Adverse Reactions 95

European Pharmaceutical Review

JULY 20, 2022

1 But while data on adverse reactions is rightly used to help with these decisions, there is currently no additional modelling on the positive impact regulatory action could have on public health. Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Study focus.

Adverse Reactions 97

Adverse Reactions Diabetes Hospitals Vaccines 97

pharmaphorum

APRIL 1, 2021

The most frequent adverse reactions (occurring in 20% or more of patients) for Sarclisa versus the control arm included upper respiratory tract infection, infusion-related reactions and fatigue. In the trial, 8% of patients dropped out because of adverse events and 2.8% quit because of an infection.

Adverse Reactions 59

Adverse Reactions Labelling Chemotherapy 59

LifeProNow

MAY 8, 2023

The safety profile of Breyanzi is well-established, and in the TRANSFORM study, occurrences of cytokine release syndrome (CRS) and neurologic events were generally low-grade, and mostly resolved quickly with standard protocols and without the use of prophylactic steroids. Any-grade neurologic events were reported in 10.9%

Chemotherapy 130

Chemotherapy Adverse Reactions 130

European Pharmaceutical Review

DECEMBER 16, 2022

In a clinical setting, etranacogene dezaparvovec continued to be generally well-tolerated with no serious treatment-related adverse events (SAEs). No serious adverse reactions (SARs) were reported. The 24 months analysis showed a sustained and durable effect of etranacogene dezaparvovec.

Adverse Reactions 98

Adverse Reactions Labelling 98

pharmaphorum

NOVEMBER 4, 2020

Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. The most frequent serious adverse reactions for the combination, occurring in 2% or more of patients, were bleeding in the gastrointestinal tract and fever.

Adverse Reactions 64

Adverse Reactions Biosimilars Immunization Immunity 64

European Pharmaceutical Review

NOVEMBER 24, 2022

Immune-mediated adverse reactions (ARs) occurred in 21 percent of patients treated with Libtayo ® and led to permanent discontinuation in 4.6 Adverse events (AEs) were serious in 32.4 Safety was assessed in 1,281 patients with advanced solid malignancies who received Libtayo ® monotherapy in five clinical studies.

Chemotherapy 98

Chemotherapy Immunization Immunity Adverse Reactions 98

LifeProNow

APRIL 30, 2023

The most common adverse events in those treated with XTANDI plus leuprolide were fatigue, hot flush, and arthralgia and in those treated with XTANDI monotherapy were fatigue, gynecomastia, and arthralgia. Grade 3-4 ischemic events occurred in 1.4% events led to death in 0.4% of patients on XTANDI versus 0.7% on placebo.

Adverse Reactions 130

Adverse Reactions Chemotherapy Diabetes 130

FDA Law Blog: Biosimilars

JUNE 13, 2023

” (Sorry for the bowdlerization, but we’re trying to make it past everyone’s filter and HR warned us in any event.) It has boxed warnings for hepatoxicity and QT prolongation and is contraindicated in numerous patient populations and has 17 adverse reactions with an incidence of >20%. Would that it were so!

Adverse Reactions 40

Adverse Reactions 40

FDA Law Blog: Biosimilars

JUNE 4, 2025

However, as the Assessment notes, [t]here aremany possible adverse events for which there is inadequate evidence to accept or reject a causal relationship, which may otherwise lead manufacturers to opt not to include them in the labeling.

Labelling 59

Labelling Adverse Reactions Vaccines Documentation 59