The FDA is requiring all benzodiazepines to carry an updated boxed warning that addresses the risks of misuse, abuse and addiction associated with their use.
FDA Action on Loperamide Misuse; Plus Phase 1 Trials for BAT2506 Biosimilar Begin
The FDA has limited the package size of some over-the-counter loperamide products to prevent its potential misuse and abuse…
Ethics Forum: Patient Safety at Home—What Are Our Legal & Ethical Responsibilities?
A 60-year-old woman with a six-month history of retroperitoneal fibrosis transfers her care to you. She initially presented with severe bilateral flank pain radiating to the abdomen and chest. A computerized tomography (CT) angiogram of the abdomen demonstrated an infrarenal abdominal aortic aneurysm surrounded by a thick inflammatory rind entangling the left renal vein and…
FDA Receives Reports of Loperamide Abuse
The FDA is seeking to limit the number of loperamide doses per package due to reports of heart-related problems and death from the misuse and abuse of the treatment…
Rheumatology Drug Updates: Opana ER Painkiller Pulled from U.S. Market; Upadacitinib to Treat RA, and More
Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…
U.S. Panel Backs Approval of Abuse-Resistant Opioid Painkiller
WASHINGTON (Reuters)—A U.S. advisory panel on Thursday recommended approval of Egalet Corp’s long-acting opioid painkiller, Arymo ER (morphine sulfate), saying it dulls pain and could deter abuse by addicts seeking a quick high. The panel recommended that the U.S. Food and Drug Administration (FDA) approve the drug and said it deters, but does not eliminate,…
New FDA Warnings: Patients on SGLT2 Inhibitors at Risk of Acute Kidney Injury & Loperamide Abuse on the Rise
The FDA is strengthening its warning that canagliflozin and dapagliflozin may increase the risk for acute kidney injury in some patients. Also, the FDA has issued a warning that patients should not exceed recommended doses of loperamide due to increased risks of serious cardiac events…
Prescription-Drug Monitoring Saves Lives, Could Save More
(Reuters Health)—State programs that monitor narcotic prescriptions help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day, a new study finds. States with the most robust programs—ones that tracked a greater number of potentially addictive medications and updated their databases at least weekly—saw the biggest drops…
Five Most Important Fraud, Abuse Laws Applicable to Physicians
Know what’s included in the federal False Claims Act, Anti-Kickback Statute and other regulations and guidelines to prevent Medicare abuse