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Drug Updates

Subcategories:AnalgesicsBiologics/DMARDs

Tofacitinib on Hold for Psoriasis, Plus Anti-TNFs Top FDA List for Adverse Events

Michele B. Kaufman, PharmD, BCGP  |  October 28, 2015

The FDA is asking for more safety analysis before approving tofacitinib to treat psoriasis. Also, adalimumab and etanercept received the greatest number of adverse and serious adverse events reported to the FDA in 2014…

FDA Reviewers Question Safety of AstraZeneca’s Gout Drug

Amrutha Penumudi  |  October 23, 2015

(Reuters)—The U.S. Food and Drug Administration staff reviewers have raised concerns about kidney- and heart-related side effects noted in trials on AstraZeneca Plc’s gout treatment, especially at higher doses. FDA reviewers, in a preliminary review published on Wednesday, expressed concerns over higher death rates related to the side effects in patients who took the drug,…

J&J’s Stelara Succeeds in Phase 3 Crohn’s Disease Trial

Bill Berkrot  |  October 22, 2015

(Reuters)—Johnson & Johnson’s Stelara (ustekinumab) was significantly better than placebo at inducing clinical response and remissions in patients with moderate to severe Crohn’s disease, according to data from a late stage trial, providing ammunition for a potential expanded approval of the medicine. Stelara, a biotech medicine that blocks inflammation, is approved to treat plaque psoriasis…

Rituximab May Benefit Patients with Refractory JIA-Associated Uveitis

Lorraine L. Janeczko  |  October 21, 2015

NEW YORK (Reuters Health)—Rituximab may calm juvenile idiopathic arthritis (JIA)-associated uveitis and especially benefit patients who haven’t responded to other biologic treatments, a study from Italy suggests. With its convenient dosing schedule, rituximab may be a new treatment option for patients with autoimmune diseases, especially for those who have not responded to tumor necrosis factor…

FDA Warns ‘Don’t Use Tramadol in Children’ & More

Michele B. Kaufman, PharmD, BCGP  |  October 21, 2015

New studies show ABT-494 is an effective alternative to anti-TNF alpha agents, as well as methotrexate, for RA. Also, the FDA issued a warning against using tramadol for young patients due to their increased risk of respiratory side effects…

Adalimumab, Tacrolimus Effective for Treating Refractory Ulcerative Colitis

Will Boggs, MD  |  October 15, 2015

NEW YORK (Reuters Health)—The human IgG1 anti-TNF antibody adalimumab is safe and effective for short- and long-term treatment, and the calcineurin inhibitor tacrolimus given short-term brings remission, in patients with refractory ulcerative colitis, according to two new studies in the Journal of Crohn’s and Colitis. In the first study, online Sept. 21, Dr. Tamas Molnar…

FDA Declines to Expand Approval of Pfizer Arthritis Drug Xeljanz

Reuters Staff  |  October 14, 2015

(Reuters)—U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) to treat moderate to severe cases of plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must be addressed in order…

FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning

Michele B. Kaufman, PharmD, CGP, RPh  |  October 14, 2015

The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and…

Phase 3 Trials: Secukinumab for Psoriatic Arthritis & DA-DKP for OA

Michele B. Kaufman, PharmD, BCGP  |  October 14, 2015

In a global Phase 3 trial, subcutaneous secukinumab proved safe and effective in patients with psoriatic arthritis. Also, a version of aspartyl-alanyl diketopiperazine, a biologic for knee OA, has entered Phase 3 trials…

Transatlantic Divide: How U.S. Pays Three Times More for Drugs

Reuters  |  October 13, 2015

LONDON (Reuters)—U.S. prices for the world’s 20 top-selling medicines are, on average, three times higher than in Britain, according to an analysis carried out for Reuters. The finding underscores a transatlantic gulf between the price of treatments for a range of diseases and follows demands for lower drug costs in America from industry critics such…

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