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FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that Will Impact NDA/BLA Safety Analyses and Drug Labeling

The FDA Law Blog

For a number of years, FDA has been including groups of related preferred terms in tables in the Adverse Reactions Section of drug labeling (Section 6), generally describing such groupings with the use of footnotes. Such groupings have generally seemed to appear in labeling on an ad hoc basis, without standardization.

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Therapeutic-first for cold agglutinin disease haemolytic anaemia

European Pharmaceutical Review

The approval is based on data from two Phase III clinical trials: CADENZA, a trial for adults with CAD without having had a blood transfusion in the past six months and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. CADENZA Part A trial. Headache (22.7 percent vs 10.0

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Sanofi’s Sarclisa gains new US multiple myeloma indication

pharmaphorum

This label extension covers use of Sarclisa plus carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma, who have received one to three previous therapy lines. In the trial, 8% of patients dropped out because of adverse events and 2.8% quit because of an infection.

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4 foods to avoid on Contrave

The Checkup by Singlecare

There are a few reasons for this: Potential for adverse reactions: According to the FDA drug label, there have been a few cases of neuropsychiatric events (NPEs), a term that could refer to psychosis, seizures, mood changes, and more, when mixing alcohol with Contrave. Can you drink alcohol while taking Contrave?

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Lisinopril angioedema: Symptoms and treatment

The Checkup by Singlecare

Acute events are generally mild and resolve within twenty-four hours without treatment. According to the FDA label for Zestril , in clinical studies, 0.1% (one in one thousand) of patients reported angioedema as an adverse event. Angioedema can be classified as acute or recurrent.

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Penicillin allergy delabelling: A multidisciplinary approach for improved patient care

Hospital Pharmacy Europe

In developed countries, between five and 15% patients carry a penicillin allergy label , and patients receive a penicillin allergy label by their third birthday in approximately 75% of cases. However, a large body of evidence suggests upwards of 90% of patients with a penicillin allergy label are not truly allergic.

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Does Ozempic cause bruising?

The Checkup by Singlecare

Initially approved by the Food and Drug Administration (FDA) to help control blood glucose for people with Type 2 diabetes, Ozempic (semaglutide) has also been approved to reduce the risk of major adverse cardiovascular events in people with heart disease and Type 2 diabetes. And Ozempic’s label reports that only 0.2%