Friday, 18 Oct 2019

Drug Safety

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28 Jul 2019 Social Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a negative opinion on Application for romosozumab (Evenity) for the treatment of severe osteoporosis (by Amgen & UCB); an appeal is planned
26 Jul 2019 Social The RheumNow Podcast is up! News, Announcements of generics/biosimilars, approvals and FDA hearings. Watch the video here>> or listen to the podcast on iTunes>>
26 Jul 2019 Social RT @RheumNow: The FDA Arthritis Advisory Committee has voted 10-7 in favor of approving the to consider the antifibrotic drug, nintedanib f…
26 Jul 2019 Social FDA puts a New Boxed Warning on #tofacitinib for Blood Clots and Death with Higher Doses (10 mg bid).
26 Jul 2019 News Tofacitinib Gets a New Boxed Warning for Blood Clots and Death with Higher Doses
25 Jul 2019 Social The FDA Arthritis Advisory Committee has voted 10-7 in favor of approving the to consider the antifibrotic drug, nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD)
25 Jul 2019 Social FDA warning about meds that may impair driving (car, bus, train, plane, or boat) - Especially opioids, benzodiazepines, antidepressants, muscle relaxants, sleep meds, motion sickness & diet pills, ADD or “stay awake” drugs
18 Jul 2019 Social anti-MDA5+ amyopathic dermatomyositis (ADM) with ILD is severe and refractory. NEJM letter reports on 18 ADM Rx w/ tofacitinibs who showed better 6 mo survival (100% vs 78%) (P=0.04) and improved ferritin, FVC, DLCO, & CT Chest over time.
18 Jul 2019 Social Can Febuxostat be given to Allopurinol Hypersensitivity? Such pts not included in registrations trials; yet many literature reports of no toxicity & rare cross-Rxn; PI says ULORIC indicated w/ intolerant to allopurinol, or when allopurinol Tx not advisable
10 Jul 2019 News EHR-Related Adverse Events Usually Involve Medications
10 Jul 2019 Social CBD isn't entirely safe. Forbes reviews evidence of hepatotoxicity, esp with the CBD-based epilepsy drug Epidiolex; in studies 5-20% had liver issues. FDA has also warned of suicidal ideation, agitation, suicide, depression, aggression & panic attacks
09 Jul 2019 Social Metanalysis of 277 RCTs &1 million evaluated 16 nutritional supplements & 8 dietary interventions showed largely no effect on mortality and CV outcomes in adults. There was evidence favoring reduced salt & omega-3, long-chain fatty acids.
09 Jul 2019 Social RTX product label list these postmarketing AEs (not seen in trials) - uveitis, optic neuritis, systemic vasculitis, pleuritis, lupus-like syndrome, serum sickness, polyarticular arthritis, and vasculitis with rash.
05 Jul 2019 Social RT @RheumNow: Dr. Kevin Winthrop - Expert Advice on TB Testing and Treatment from #EULAR2019
28 Jun 2019 Social RheumNow Podcast is UP! Discussions of MTX stomatitis, Loading doses, PPD Shortage, infection risk from steroids or THR/TKR and more. Watch it here>> or listen in on iTunes or SoundCloud >>
27 Jun 2019 Social Metanalysis of 3954 studies, 20 RCTs examined MTX toxicity and found the prevalence of alopecia to be 1- 4.9% and the prevalence of stomatitis to be between 5.7-8%
26 Jun 2019 Social ORAL Strategy, 216 or 18.8% received the Zostvax vaccine. Overall, 18 patients (1.6%) developed HZ (vaccinated=3; non-vaccinated=15). HZ IRs (95% CI) were 1.1 (0.3, 2.9), 2.3 (1.0, 4.6), and 1.7 (0.6, 3.7) for tofa monotherapy, tofa+MTX, & ADA+MTX, resp.
20 Jun 2019 Social Methotrexate assoc. lymphoproliferative disorders (LPDs), is a rare disorder that resolves w/ MTX withdrawal (in 3-10mos). Most common path was diffuse large B-cell lymphoma and 45-77% had Epstein-Barr virus encoded RNA positivity.
19 Jun 2019 ACR Video RNL Preview with Dr. Lisa Sammaritano: Anti-Rheumatic Drug Use with Pregnancy
17 Jun 2019 Social RT @tuna0sashimi: MTX withdrawal in tofacitinib MR 11mg ORAL shift 1y study @week 24, MTX blindly withdrawal for pt achieved LDA (CDAI <=10…