Latest Fda Approved Drugs Information Systems

Clinical Context The US Food and Drug Administration (FDA) has approved an extended-release formulation of exenatide injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. This is the first approved medication administered once weekly for type 2 diabetes. The FDA has required the manufacturer to perform a randomized, double-blind, placebo-controlled trial of effects of the drug on the incidence of major adverse cardiovascular events, pancreatic cancer, kidney disease, serious hypoglycemia, and on potential biomarkers of medullary thyroid carcinoma (MTC). An MTC case series registry and Risk Evaluation and Mitigation Strategy (REMS) are also mandated. Study Synopsis and Perspective The US FDA approved a once-weekly extended-release formulation of exenatide injection ( Bydureon , Amylin Pharmaceuticals) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is the first once-a-week medic...

February 16, 2012 — The black box warning about cancer risk that was added to the labeling for tumor necrosis factor (TNF) inhibitors in 2009 might have been premature, at least with regard to cancer risk in children with juvenile idiopathic arthritis (JIA), according to data reported in an article published online February 10 in Arthritis & Rheumatism . Timothy Beukelman, MD, MsCE, from the University of Alabama at Birmingham, and colleagues, on behalf of the Safety Assessment of Biological Therapeutics Collaboration, conducted one of the largest investigations into the rates of incident malignancy among pediatric patients with JIA, relative to their treatment. Using data from Medicaid records from 2000 through 2005, the researchers identified 7812 children with JIA and 2 comparator groups of children without JIA (1 group with asthma [n = 652,234] and 1 group with attention-deficit/hyperactivity disorder [n = 321,821]). The researchers categorized treatment with methotrexate a...

February 15, 2012 — The US Food and Drug Administration (FDA) has approved 0.0015% (15 μg/mL) tafluprost ( Zioptan , Merck, under license from Santen Pharmaceutical Co, Ltd) as the first preservative-free prostaglandin analog ophthalmic solution for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. All currently available products contain benzalconium chloride, including travoprost ( Travatan Z , Alcon Pharmaceuticals, Ltd and generics), latanoprost ( Xalatan , Pfizer, Inc and generics), and bimatoprost ( Lumigan , Allergan). "The prostaglandin class has proven over the last 15 years to be very effective and well tolerated, [but] some patients have issues with preservatives and [are] unable to tolerate preserved medications," Jonathan Myers, MD, associate attending surgeon in the glaucoma service at Wills Eye Institute, Philadelphia, Pennsylvania, told Medscape Medical News , noting that the elderly, who are at greate...

February 15, 2012 (Northbrook, Illinois) — New thrombosis guidelines from the American College of Chest Physicians have come down in favor of aspirin use for primary prevention in adults over 50 years old [1]. Lead author of the coronary artery disease chapter of the guidelines, Dr Per Vandvik (Gjøvik Hospital, Oslo, Norway), noted that these are thought to be the first major guidelines to come out after the studies suggesting a reduction in cancer risk and mortality with aspirin were reported, and "incorporating these data pushed us to give aspirin a weak recommendation in primary prevention." Vandvik added: "I would say the cardiovascular benefit and the bleeding risk is pretty much well balanced, but the suggestion of a benefit in mortality may just swing the balance over to taking aspirin." But he stressed that this was not a blanket recommendation. "Doctors need to talk to their patients about it, and it is something they might want to consider." ...

AUDIENCE : Consumer, Pharmacy ISSUE : McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were complaints from consumers who reported difficulty using the Infants’ TYLENOL SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe. BACKGROUND : Infants’ TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. The product was distributed nationwide in the United States. RECOMMENDATION : If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. See the Press Release for lot number and UPC codes of affected product. Consumers can visit www.tylenol.com for additional info...

Today,  February 17, 2012, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women. Prior to FDA’s approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing’s syndrome. Endogenous Cushing’s syndrome is a serious, debilitating and rare multisystem disorder. It is caused by the overproduction of cortisol (a steroid hormone that increases blood sugar levels) by the adrenal glands. This syndrome most commonly affects adults between the ages of 25 and 40. About 5,000 patients will be eligible for Korlym treatment, which received an orphan drug designation by the...

February 9, 2012 — Even small changes in pain intensity may greatly affect quality of life for patients with rheumatoid arthritis (RA). Muscle relaxants and neuromodulators have been tried as agents for improving RA pain control, but 2 Cochrane systematic reviews by Bethan Richards, MBBS, MMed, M Sports Med, and colleagues, published online January 18, conclude that only topical capsaicin merits consideration as add-on therapy. Dr. Richards, who is medical superintendent and staff specialist in rheumatology at the Royal Prince Alfred Hospital Institute of Rheumatology and Orthopedics, Camperdown, Australia, told Medscape Medical News , "It should be stressed that the current evidence available is weak, based on small numbers of patients, and was carried out in a prebiologic era. We found weak evidence (6 trials, 126 participants) in the muscle relaxant paper that neither the benzodiazepine agents (diazepam and triazolam) nor the non-benzodiazepine agent (zopiclone) reduce pai...