Formulary Watch |

Incretin-based therapies: A focus on safety concerns and emerging uses

Incretin-based therapies are now the most promising therapies for type 2 diabetes.

New online tool available for Janssen products

Janssen Pharmaceuticals, Inc. is making it easier for pharmacists and healthcare professionals to look up drug information by launching an online scientific resource tool.

FDA approves Humira to treat ulcerative colitis

FDA has approved adalimumab (Humira, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.

FDA approves regorafenib tablets for treatment of metastatic colorectal cancer

FDA approved regorafenib (Stivarga, Bayer HealthCare) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy).

Gingko biloba does not stop incidence of Alzheimer's disease, Lancet reports

The long-term use of gingko biloba extract does not lower the risk of Alzheimer’s disease, according to a report published September 6 online for The Lancet.

Tight glycemic control after pediatric heart surgery shows no benefit

Tight glycemic control can be achieved in children following cardiac surgery, but it does not reduce the infection rate, mortality, or length of hospital stay compared to standard care, according to a study published in the September 7 issue of The New England Journal of Medicine

New guidelines: Screen adults for hypertriglyceridemia every 5 years

An Endocrine Society task force has established new clinical-practice guidelines that recommend screening adults for high triglyceride levels once every 5 years because of the potential risk of cardiovascular disease and pancreatitis associated with hypertriglyceridemia.

FDA task force to work on antibacterial drug development

FDA is supporting antibacterial drug development by launching a new internal task force, according to a press release today.

FDA grants priority review to opioid-induced constipation indication for lubiprostone

FDA has given priority review to an additional indication for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

Hydrocodone bitartrate and acetaminophen lots recalled for potential for oversized, superpotent tablets

Watson Laboratories issued a voluntary nationwide recall for 2 lots of hydrocodone bitartrate and APAP Tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

FDA approves aflibercept injection for macular edema following central retinal vein occlusion

FDA has approved aflibercept (Eylea, Regeneron) injection for the treatment of macular edema following central retinal vein occlusion (CRVO). The recommended dose for Eylea is 2 mg every 4 weeks (monthly).

FDA approves new indication for denosumab for bone loss in men with osteoporosis at high risk for fracture

FDA approved a new indication for denosumab (Prolia, Amgen) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.

Biologics for RA treatment do not increase cancer risk

Biologic response modifiers developed for the treatment of rheumatoid arthritis do not appear to be associated with an increased risk of cancer, according to a study published September 5 in the Journal of the American Medical Association.

Glucocorticoid inhalers may impact adult height

Children with asthma who use glucocorticoid inhalers may grow shorter on average than those who do not use inhaled corticosteroids (ICS), according to a study published September 6 in the New England Journal of Medicine.

Kidney stones increase risk of ESRD

The risks of end stage renal disease, chronic kidney disease, and sustained doubling of serum creatinine concentration are significantly higher in people with at least 1 symptomatic kidney stone episode, according to the results of a study published August 30 in the British Medical Journal.

FDA warns of possible heart failure risk with Mirapex

FDA notified healthcare professional about a possible increased failure of heart risk with pramipexole (Mirapex).

FDA fast tracks drugs for Ebola and Marburg viruses

FDA has granted fast-track designation for the development of AVI-7288 and AVI-7537 (Sarepta Therapeutics), for the treatment of Marburg virus and Ebola virus, respectively.

FDA issues safety alert on Intestinomicina marketed as treatment for infectious diarrhea

FDA is warning consumers not to use Intestinomicina (Laboratorios Lopez), a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a healthcare provider.

FDA approves poly-ureaurethane 16% for brittle nails

FDA has approved poly-ureaurethane 16% (Nuvail, Innocutis) nail solution to help manage fragile, damaged or brittle nails with cracking or splitting, a condition medically referred to as "nail dystrophy."

Pain drug kills resistant tuberculosis

Researchers at Weill Cornell Medical College have discovered that an off-patent anti-inflammatory drug kills both replicating and non-replicating drug resistant tuberculosis in the laboratory.

Caffeine may improve Parkinson movement

Caffeine may offer promise to patients with Parkinson disease, according to a small study published in Neurology.

Prasugrel versus clopidogrel in patients with ACS

Prasugrel may not improve outcomes for patients under the age of 75 years with unstable angina or non-ST-segment elevation myocardial infarction who have not undergone revascularization, according to a study published in the New England Journal of Medicine.

ACIP: 2012-13 influenza vaccination recommendations

Recommendations for the 2012-2013 influenza season were recently published by the Advisory Committee on Immunization Practices. The recommendations include an updated vaccination schedule for children and information on virus strains, seizures, and egg allergy.

Aspirin may benefit prostate cancer patients

Anticoagulant therapy, particularly the use of aspirin, may reduce the risk of prostate cancer-specific mortality in men treated with radical prostatectomy or radiotherapy for prostate cancer, according to a study published online in the Journal of Clinical Oncology.

Acetaminophen dosing guidelines needed for overweight children, study shows

There is considerable discrepancy among caregivers and pharmacists regarding the appropriate dosage of acetaminophen for overweight and obese children, according to a recent study published online in the European Journal of Hospital Pharmacy Science and Practice.

FDA's CRDAC recommends against approving lixivaptan

FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approving lixivaptan (CRTX 080, Cornerstone Therapeutics), for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.

FDA approves teriflunomide for patients with relapsing forms of MS

FDA has approved teriflunomide (Aubagio, Genzyme, a Sanofi company), a once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis.

Qualitest issues voluntary, nationwide recall for lot of hydrocodone bitartrate and acetaminophen tablets

Qualitest, a subsidiary of Endo Health Solutions, has issued a voluntary, nationwide retail-level recall for 1 lot of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg.

FDA approves production of imaging agent to help detect prostate cancer

FDA has approved the production and use of Choline C-11 Injection (Mayo Clinic PET Radiochemistry Facility), a PET imaging agent used to help detect recurrent prostate cancer.

Gabapentin effective for chronic cough

Gabapentin may be an effective and well-tolerated treatment for patients with refractory chronic cough, according to a study published August 28 in The Lancet.