Rheum for Everyone, Episode 24 (video)| Webinar: ACR/CHEST ILD Guidelines in Practice

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Drug Updates

Subcategories:AnalgesicsBiologics/DMARDs

EMA Flags Faulty Generic Drug Data, Backs Sales Halt

Reuters Staff  |  

(Reuters)—The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable. The EMA’s list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG’s Sandoz….

Underprescribing Adds to Mortality, Hospitalization for Oldest Patients

Will Boggs, MD  |  

NEW YORK (Reuters Health)—Inappropriate underprescribing of medications is associated with increased mortality and hospitalization rates among community-dwelling adults aged 80 years and older, researchers from Belgium report. “Patients with five or more medications (a standard cut-off used for polypharmacy) can have a well-tailored and balanced medication therapy with an acceptable risk for adverse events,” Dr….

U.S. FDA Panel Backs Valeant Psoriasis Drug with Risk Program

Toni Clarke  |  

(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…

Valeant Psoriasis Drug’s Suicide Risk Hard to Assess, Say FDA Staff

Reuters Staff  |  

(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday. The review comes two days ahead of a meeting of outside experts who will advise the FDA on…

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff  |  

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…

FDA Panel Backs Amgen Biosimilar of Humira

Toni Clarke  |  

(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…

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…

Prescription-Drug Monitoring Saves Lives, Could Save More

Ronnie Cohen  |  

(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…