Clinical News

FDA has approved Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one combination product taken once daily for the treatment of hypertension in patients who are not adequately controlled on any 2 of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers, and diuretics, according to Daiichi Sankyo Inc.

Patients taking newer antiepileptic drugs (AEDs) that are associated with a high risk of depression may have an elevated risk of self-harm or suicidal behavior, but other groups of AEDs do not appear to carry the same risk, according to research published in the July 27 issue of Neurology and reported in HealthDay News.

Oral antidiabetic (OAD) agents generally result in a maximum 1.5% drop in hemoglobin (Hb) A1C levels, with sulfonylureas and thiazolidinediones having a slightly more beneficial effect than other classes of oral agents, according to research published in the August issue of Diabetes Care and reported by HealthDay News.

Investigational combination treatment with sustained-release (SR) naltrexone and bupropion (Contrave, Orexigen Therapeutics) combined with lifestyle modification, appears effective in helping people lose 5% or more of their excess body weight, according to research published online July 30 in The Lancet and reported by HealthDay News.

No sooner did Sandoz begin shipping its generic version than Sanofi-Aventis, manufacturer of Lovenox, filed a federal lawsuit to reverse the FDA's approval of the generic.

The generic market is likely to remain very strong between now and 2015, but the combination of healthcare reform and a lack of significant drugs coming off patent means that the outlook between 2015 and 2020 is murkier.

There are some big names among the brand drugs that have recently come off patent and joined the burgeoning generics market.

In a recent survey by Medco Health Solutions Inc., only 66% of 1,092 patients with insurance surveyed "agreed that a generic drug is the same as the brand-name medication - many patients are still not comfortable using a generic and others still consider brand-name drugs to be superior."

Pharmacists are in a good position to tell patients that sand, water, snow, and clouds reflect and intensify the sun's rays, causing unsuspected sun damage, even in shade, and that protecting skin from sun damage should be incorporated into a daily routine.

An FDA advisory panel voted 20 to 12 to recommend that the agency allow rosiglitazone (Avandia, GlaxoSmithKline) to remain on the market.

Many pharmacies across the country have adopted new policies and procedures that focus more on patient care and outcomes. Included among these new options is administration of vaccines.

Although the Patient Protection and Affordable Care Act (PPACA) creates an abbreviated approval pathway for biological products that are demonstrated to be ?highly similar? (biosimilar) to or ?interchangeable? with an FDA-approved biological product, only time will tell how long it will take for these biosimilars to reach the marketplace.

Recent clinical practice guidelines offer similar recommendations for assessing and managing low back pain, and clinicians can improve patient care by adopting these recommendations, according to a review published in the June issue of The Spine Journal, reported HealthDay News.

Written confirmation is now available from the Centers for Medicare and Medicaid Services indicating that Fluzone High-Dose (Sanofi Pasteur) influenza virus vaccine for patients 65 years or older is a benefit covered by Medicare Part B and will be reimbursed for the upcoming 2010?11 influenza season.

The Centers for Medicare & Medicaid Services (CMS) issued a proposed regulation on June 25 that would exempt community pharmacies from the upcoming bidding process for Medicare Part B diabetes-testing supplies, along with instructions that exempt most independent community pharmacies from accreditation requirements.

Long-term data from a retrospective cohort study showed that hyperlipidemic obese patients had more than a 90% reduction in their need of lipid-lowering therapy following laparoscopic gastric-bypass surgery, MedPage Today reported.

Women who suffer from endometriosis-related pain should be treated first with conservative, nonsurgical approaches and then with more invasive options if pain does not resolve, and with hysterectomy only as a last resort, according to a practice bulletin issued by the American College of Obstetricians and Gynecologists and published in the July issue of Obstetrics & Gynecology, reported HealthDay News.

The Drug Enforcement Administration (DEA) has issued a notice in the Federal Register requesting input about the dispensing of controlled substances for residents in long-term-care (LTC) facilities.

A recall of 3 lots of physician sample blister packs of Coumadin 1-mg tablets and 5 lots of Coumadin 1-mg tablet hospital unit dose blister packs has been initiated by Bristol-Myers Squibb.

The use of nutraceuticals and nonprescription over-the-counter (OTC) drugs may be high; however, the use of these agents may largely be ignored by cardiovascular clinicians, according to research published in the July 6 issue of the Annals of Internal Medicine.

Supplementation with folic acid and vitamin B12 over an extended period does not have a beneficial effect on vascular outcomes in individuals who have had a myocardial infarction, but it also poses no excess cancer risk, according to a study in the June 23/30 issue of the Journal of the American Medical Association, HealthDay News reported.

A systematic review assessing the comparative effectiveness of oral anti-diabetic drugs for preventing patients at high risk from progressing to type 2 diabetes has found glitazones (pioglitazone, rosiglitazone), biguanides (metformin), and alpha-glucosidase inhibitors (AGIs; acarbose, voglibose) reduced the relative risk of diabetes by as much as 63%, whereas insulin secretagogues (sulfonylureas and glinides) had no effect.

Sens. Kay R. Hagan (D-N.C.) and Al Franken (D-Minn.) have introduced The Medication Therapy Management (MTM) Expanded Benefits Act, a bill that will allow seniors with one chronic illness to thoroughly review all their medications with a pharmacist in a one-on-one session.

FDA has announced that the agency is currently evaluating whether the use of the angiotensin II receptor blocker (ARB) olmesartan (Benicar, Daiichi Sankyo; also sold in combination with hydrocholorothiazide as Benicar HCT) was associated with increased cardiovascular mortality.

The Dietary Supplement Health and Education Act of 1994 greatly reduced FDA involvement in assessing the safety of dietary supplements, leaving pharmacists with the problem of obtaining accurate information with which to advise patients.

Hormone replacement therapy (HRT) skin patches containing low doses of estrogen carry less risk of stroke than oral therapy and may represent a safer alternative.

Switching from branded to generic drugs for epilepsy did not cause increased incidents or utilization changes among patients, according to new study results.

Inhaled insulin may be making a comeback. That's the hope at MannKind, a California-based biopharmaceutical company developing a rapid-acting inhaled insulin known as Afrezza (insulin human rDNA origin).

The Drug Enforcement Administration has released its long-awaited interim final rule for electronic prescribing of controlled substances.

The first non-drug treatment for severe asthma that is not well controlled by anti-inflammatory medicines won FDA approval April 27.