Diana Ernst, RPh

Fast-Act Rheuma Capsule, New Fast-Act Rheumatism Capsule, and UA-Block contain active hidden drug ingredients not listed on the product label.

Results showed that treatment with abaloparatide for 12 months resulted in significant increases in bone mineral density compared with placebo.

The FDA has approved changes to the prescribing information for tofacitinib to include new warnings, including a Boxed Warning, regarding an increased risk of blood clots and death.

The FDA has approved Otezla (apremilast; Celgene) for the treatment of adult patients with oral ulcers associated with Behçet’s disease.

The FDA has accepted for Priority Review the supplemental BLA for Rituxan for use in combination with glucocorticoids for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children ≥2 years old.

The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.

The Food and Drug Administration (FDA) has approved the intravenous (IV) formulation of Benlysta (belimumab; GlaxoSmithKline) for the treatment of pediatric patients ≥5 years old with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

Pfizer announced topline results from a long-term phase 3 study of tanezumab in patients with moderate to severe osteoarthritis (OA) of the hip or knee.

In an effort to better alert the public of unlawful ingredients in dietary supplements, the FDA has created the Dietary Supplement Ingredient Advisory List, a new reference tool for consumers and manufacturers.

The Food and Drug Administration (FDA) has approved Evenity (romosozumab-aqqg; Amgen) injection for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapies.

Overall, treatments that were associated with the greatest relative risk reduction in fragility fractures included teriparatide, abaloparatide, denosumab, romosozumab and most bisphosphonate.

The Food and Drug Administration has approved Gloperba (colchicine; ROMEG Therapeutics) Oral Solution for the prophylaxis of gout flares in adults.

Tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis.

The prescribing information for Uloric (febuxostat; Takeda) is being updated to include a Boxed Warning regarding an increased risk of cardiovascular (CV) death and all-cause mortality in patients treated with the gout drug.

Tanezumab, an investigational subcutaneously-administered, non-opioid treatment, may benefit patients with moderate to severe chronic low back pain.

The FDA has accepted for Priority Review the New Drug Application for upadacitinib, an investigational oral JAK1-selective inhibitor, for the treatment of moderate to severe rheumatoid arthritis.

Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline.

Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF).

In the Biologics License Application (BLA) resubmission, Amgen and UCB proposed to narrow the indication to treatment of osteoporosis in postmenopausal women at high risk of fracture.

Vascular EDS is the most severe subtype of Ehlers-Danlos syndrome where patients suffer from life-threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures.

The FDA has approved updated labeling for Rituxan to include information on follow up treatment for patients with GPA and MPA who have achieved disease control with induction therapy.

The approval was based on data from a randomized, double-masked, placebo-controlled study of 90 pediatric patients aged 2 to < 18 years with active JIA-associated non-infectious uveitis.

The FDA has approved Actemra SC for the treatment of active systemic JIA alone or in combination with methotrexate in patients ≥2 years old.

Pfizer and Lilly announced positive results from a study evaluating tanezumab, an investigational humanized monoclonal antibody, for the treatment of OA pain.

The case involved a 68-year-old female patient with rheumatoid arthritis on methotrexate 10 mg weekly who presented to the emergency department with complaints of lethargy and weakness after being prescribed a 2-week course of trimethoprim-sulfamethoxazole for a bacterial skin infection.

The FDA has approved updated labeling for Cosentyx that includes data demonstrating that the drug slows the progression of joint structural damage in patients with active psoriatic arthritis.

The FDA has approved use of Prolia for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.

Early treatment of undifferentiated arthritis may delay progression to rheumatoid arthritis.

Bisphosphonates did not show to be beneficial for patients with knee osteoarthritis.

The FDA has approved Durolane for treatinf pain from knee OA.