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Analgesics

Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar

Michele B. Kaufman, PharmD, BCGP  |  September 21, 2016

After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…

U.S. Justice Department to Push Prosecutors on Opioids

Reuters Staff  |  September 18, 2016

WASHINGTON (Reuters)—The U.S. Justice Department will enlist federal prosecutors to help fight the nation’s opioid crisis by sharing information on overprescribing doctors and coordinating with public health officials to address addiction, USA Today reported on Friday. “You can’t just have an enforcement strategy alone,” Attorney General Loretta Lynch told the newspaper in an interview. She…

A Morphine Alternative with Less Overdose Risk?

Lisa Rapaport  |  August 18, 2016

(Reuters Health)—Scientists are testing an experimental drug that’s designed to have the painkilling power of morphine without some of the side effects that can lead to overdose deaths. Initial results in mice with the compound known for now as PZM21 suggest it might be less addictive than morphine and other opiate painkillers and avoid respiratory…

FDA Update: Committees Recommend Approvals for Abuse-Deterrent Opioid & Brodalumab

Michele B. Kaufman, PharmD, BCGP  |  August 17, 2016

FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…

Senior Drivers Taking Opioid Painkillers Have Higher Crash Risk

Linda Thrasybule  |  August 14, 2016

(Reuters Health)—Seniors who get behind the wheel soon after starting to use narcotic pain relievers have twice the risk of getting into a serious car crash as their peers who use non-opioid painkillers, Swedish researchers say. Senior drivers who’d been using opioid painkillers regularly for several months also had higher odds of getting into accidents,…

Most Seniors Won’t Abuse Opioids After Surgery

Andrew M. Seaman  |  August 13, 2016

(Reuters Health)—Seniors who receive prescriptions for opioid drugs to control pain after major surgery don’t usually end up addicted to them, research from Canada shows. One year after having major surgery, less than 1% of patients over age 66 were still taking opioids, according to a report in JAMA Surgery. Recent research has suggested the…

U.S. Panel Backs Approval of Abuse-Resistant Opioid Painkiller

Reuters Staff  |  August 7, 2016

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

Michele B. Kaufman, PharmD, BCGP  |  July 12, 2016

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

Michele B. Kaufman, PharmD, BCGP  |  June 22, 2016

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

Ronnie Cohen  |  June 11, 2016

(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….

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