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ACMT Toxicology Visual Pearls: Mushroom Mishap

ALiEM - Pharm Pearls

What well-known adverse reaction results from ingestion of the pictured mushroom? Acute hepatitis Disulfiram-like reaction with ethanol consumption Pneumonitis from inhalation of spores Seizures from glutamate agonist activity [Image from Canstockphoto] Reveal the Answer 2. What is the mechanism of the adverse reaction? [2-5]

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mRNA vaccine trial shows efficiency in older adults with RSV

European Pharmaceutical Review

To date, most solicited adverse reactions were mild or moderate. The most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. In August 2021, mRNA-1345 gained Fast Track designation in adults over 60 years old.

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FDA approves first gene therapy for Haemophilia B

European Pharmaceutical Review

Sponsorship of the clinical trials transitioned to Australian biopharma company CSL after it acquired global rights to commercialise the treatment in May 2021. The most common adverse reactions (AR) associated with Hemgenix included liver enzyme elevations (transaminitis), headache, mild infusion-related reactions and flu-like symptoms.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

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US FDA approves Amgen-AstraZeneca’s Tezspire for asthma treatment

Pharmaceutical Technology

It was initially FDA-approved in December 2021 and is claimed to be the only biologic approved to treat severe asthma with no phenotype or biomarker limitation. Pharyngitis, arthralgia, and back pain are the most common adverse reactions of the antibody.

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Adverse Drug Reactions

RX Note

Overdose (including prescribing or administration errors) Therapeutic failure Drug interactions Drug withdrawal NOTE: All adverse reactions are adverse drug event, but that not all adverse drug events will be adverse drug reactions. Does the reaction improve when a specific treatment is given?

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Koselugo approved in China for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas

LifeProNow

The most common adverse reactions in the SPRINT trial were vomiting, blood creatine phosphokinase increase, diarrhoea and nausea. Alexion Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc.