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Buprenorphine, sold under the brand name Subutex among others, is an opioid used to treat opioid use disorder, acute pain, and chronic pain. [18] It can be used under the tongue (sublingual), in the cheek (buccal), by injection (intravenous and subcutaneous), as a skin patch (transdermal), or as an implant.
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs. [1] The REMS program was formalized in 2007.
Singer and Bloom acknowledge that the FDA added clozapine to the REMS program in 2015 "because of a rare side effect (less than 3 percent frequency) called agranulocytosis, a reversible but life ...
These medications were designated as specialty drugs and required specialty pharmacies. When the FDA approves a new drug they may require a REMS program which "may contain any combination of 5 criteria: Medication Guide, Communication Plan, Elements to Assure Safe Use, Implementation System, and Timetable for Submission of Assessments". [46 ...
President Donald Trump rolled back a Biden administration executive order aimed at lowering prescription drug prices, including an effort to make more generic drugs available to Medicare patients ...
The company's main products are Sublocade, Subutex and its Naloxone-combined preparation Suboxone, both substitution products for opioid addiction. [2] Other products include remedies for cocaine and opioid analgesic overdose and treatment for alcohol dependence: the company claims this to be the largest pipeline of addiction drugs in the world.
The memo also indicated that Head Start, a preschool program serving nearly 800,000 low-income children that receives federal health funds, is not impacted by the funding pause.
The US label for sodium oxybate has a black box warning because it is a central nervous system depressant (CNS depressant) and for its potential for abuse.Other potential adverse side effects include respiratory depression, seizures, coma, and death, especially when it is taken in combination with other CNS depressants such as alcohol.