Clinical News

FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance in children, teenagers, and young adults, the agency said on November 3 in an ongoing safety review of this class of biologic products.

Some essential chemotherapy drugs are in short supply for the first time in the United States, according to the October 3 New England Journal of Medicine.

The American Heart Association and American College of Cardiology Foundation have issued new guidelines for secondary prevention and risk reduction in patients with atherosclerotic vascular disease.

FDA approved zolpidem tartrate sublingual tablets (Intermezzo, Transcept Pharmaceuticals) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

Pfizer, Medco, and pharmacy groups are all battling to get their voices heard after a November The New York Times article raised questions about prescribing Lipitor versus Atorvastatin (the new generic form of Lipitor).

Patients using the relatively new blood thinner dabigatran (Pradaxa, Boehringer Ingelheim) failed to remain on the treatment 17% of the time after the first 4 months, increasing their risk of stroke, according to a new study.

FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

FDA approved ruxolitinib (Jakafi, Incyte) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.

FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.

FDA has approved bupivacaine hydrochloride injection, USP (Sagent and Strides Arcolab), a local or regional anesthetic, for use in surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.

In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition.

Children who are overweight or obese have 3 times as much risk of high blood pressure as children of normal weight have, reported a study published recently in Hypertension: Journal of the American Heart Association.

Vivus has resubmitted its New Drug Application (NDA) for Qnexa (phentermine/topiramate) to FDA.

FDA has approved deferiprone (Ferriprox, ApoPharma) to treat patients with iron overload resulting from blood transfusions in patients with thalassemia who had an inadequate response to previous chelation therapy.

A recent analysis of data from the Nurses' Health Study showed a link between physical inactivity and incident idiopathic pulmonary embolism.

FDA has approved fidaxomicin and telaprevir.

An FDA Drug Safety Communication sent to healthcare professionals states that Dasatinib (Sprycel, Bristol-Myers Squibb) may increase the risk of pulmonary arterial hypertension.

Seattle-based Bartell Drugs this month launched a fundraising program to benefit local community groups with the introduction of its ?B? Caring Card program.

Researchers found saw palmetto extract did not reduce urinary tract symptoms in 369 men with benign prostatic hyperplasia, a study reported recently in JAMA.

FDA has approved ipratropium bromide and albuterol (Combivent Respimat Inhalation Spray, Boehringer Ingelheim) for patients using a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

FDA has approved sitagliptin and simvastatin (Juvisync, MSD International GmbH Clonmel), a fixed-dose combination prescription medication that contains 2 previously approved medications in 1 tablet for use by adults who need both sitagliptin and simvastatin.

FDA has approved tadalafil (Cialis, Eli Lilly) for 3 indications: ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions.

FDA is now requiring prescribing information for Reclast (zoledronic acid, Novartis) to include a warning against use of the drug by patients with renal dysfunction.

An interaction between warfarin and acetaminophen may result in significant elevations of international normalized ratio (INR), putting patients at increased risk for hemorrhagic complications.

Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution during pregnancy, as exposure may increase the risk of spontaneous abortion, reported a study published online September 6 in the Canadian Medical Association Journal.

People who carry more weight for a longer period of time are at a greater risk of developing type 2 diabetes, a new study has reported.

An FDA advisory panel voted 9-2 (with 1 abstention) to recommend approval for rivaroxaban (Xarelto, Johnson & Johnson and Bayer AG), an oral, once-daily anticoagulant as a treatment to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Annual flu vaccines are the best way to protect children from life-threatening pneumonia, according to new guidelines from the Pediatric Infectious Diseases Society and the Infectious Disease Society of America.

FDA has issued a Safety Announcement warning that serious allergic reactions have been reported with the use of the antipsychotic medication asenapine maleate (Saphris).

FDA has approved orphenadrine citrate injection, USP (Sagent Pharmaceuticals), a skeletal muscle relaxant as an adjunct to rest, physical therapy, and other measures to support relief from acute, painful musculoskeletal conditions.