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The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release.
In the US, the drug label contains warnings for increased heart rate, suicidal behavior and ideation, glaucoma, mood and sleep disorders, creatinine elevation, and metabolic acidosis. Some of these warnings are based on historical observations in epilepsy patients taking topiramate.
The new drug will carry a list price of $15.50 per pill, making it many times more expensive than comparable opioids, which are often available as generics for $1 or less.
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize its ...
People who use drugs were generally given sedatives and non-opioid analgesics to cope with withdrawal symptoms. [107] Brazilian footballer assistant Robson Oliveira was arrested in 2019 upon arriving in Russia with methadone tablets sold legally in other countries for what was considered drug trafficking under Russian law.
The Food and Drug Administration issued a new warning late Tuesday about supplements that contain the ingredient tianeptine, commonly known as "gas station heroin." The products — sold under the ...
Each drug has a benefit-risk profile and balancing the risk of no treatment with the competing potential risks of various therapies should be considered. [49] For people over the age of 65 years old, the balance between the benefits of pain-relief medications such as NSAIDS and the potential for adverse effects has not been well determined. [50]