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,…
Rheumatology Drug Updates: Labeling for Fluoroquinolones; FDA to Review Benzhydrocodone/Acetaminophen Combination
FDA Restricts Fluoroquinolone Use The U.S. Food and Drug Administration (FDA) has twice previously communicated safety information about systemic fluoroquinolones—in August 2013 and July 2008. The safety issues of this medication class described in its latest Drug Safety Communication were also discussed at a November 2015 FDA Advisory Committee meeting.1 The FDA is now advising…
Comment Period Open for FDA Draft Guidance on Osteoporosis Treatments; Plus FDA Rejects Abuse-Deterrent Apadaz
The FDA is currently accepting comments on a draft guideline for osteoporosis treatments, which calls for more research into the long-term effects of drugs on bone quality. Also, the FDA has rejected an application for approval of Apadaz in its current form…
Monitoring Doctors Cuts Opioid Prescriptions
(Reuters Health)—Doctors in states that track painkiller prescriptions were nearly one-third less likely to offer patients dangerously addicting opioids, a new study found. The launch of drug-monitoring programs in 24 states led to an immediate 30 percent drop in prescriptions for Schedule II opioids, the most addictive, in patients with pain complaints, the study showed….
NSAIDs Effective for Early Axial Spondyloarthritis
NEW YORK (Reuters Health)—Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective, but underused, in patients with early axial spondyloarthritis, researchers from France report. NSAIDs are the cornerstone of treatment of axial spondyloarthritis, but there is often a trade-off between prescribing doses high enough to decrease pain and other symptoms vs. keeping the doses low enough to decrease…
Patients with OA Respond to Low-Dose SoluMatrix Meloxicam; Off-Label Use of Ketoconazole Results in Death
In a clinical trial, patients with osteoarthritis taking low-dose SoluMatrix meloxicam used less rescue medication to manage pain. Also, the FDA has issued a new warning against using oral ketoconazole off label to treat onychomycosis and fungal skin infections…
FDA Panel Backs Teva’s Abuse-Resistant Opioid Painkiller
(Reuters)—A U.S. Food and Drug Administration (FDA) advisory panel recommended approving Teva Pharmaceuticals Industries Ltd’s long-acting opioid painkiller, Vantrela ER, saying data showed it reduces pain and has some abuse-resistant properties. The drug is designed for use every 12 hours for the management of pain severe enough to require around-the-clock treatment in patients who have…
FDA Restricts Use of Systemic Fluoroquinolones Due to Side Effects & Will Review Application of Apadaz for Pain
The FDA has issued new safety guidelines for systemic fluoroquinolones, restricting their use to patients with no alternative treatment options…
Lilly Says New Type of Pain Drug Could Reduce Need for Opioids
(Reuters)—Eli Lilly and Co. on Tuesday said it and partner Pfizer Inc. aim to seek approval by 2018 for a new type of pain drug that could be an alternative to opioids for osteoarthritis, chronic back pain and cancer pain. The Indianapolis drugmaker said tanezumab, given by injection every eight weeks, could be a far…
U.S. FDA Approves First-Ever Implant to Treat Opioid Addiction
(Reuters)—The first-ever implant to fight addiction to opioids, a class of drugs that includes prescription painkillers and heroin, was approved by the U.S. Food and Drug Administration on Thursday. The matchstick-sized implant, developed by Titan Pharmaceuticals Inc. and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues…
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