Clinical News

FDA has approved a subcutaneous (SC) formulation of abatacept (Orencia, Bristol-Myers Squibb) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA). It is the first biologic available in both SC and intravenous formulations for the treatment of RA.

The significant decrease in the death rate from the varicella virus, or chickenpox, can be attributed to the effectiveness of the chickenpox vaccine, according to a new study in a recent issue of Pediatrics.

Opponents of a controversial Change Request initiated by the Centers for Medicare and Medicaid Services aired their views to CMS officials earlier this week.

FDA has received reports of serious central nervous system reactions when methylene blue is given to patients taking serotonergic psychiatric medications.

Patients treated with belatacept (Nulojix, Bristol-Myers-Squibb) are at increased risk of developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), which predominantly involves the central nervous system, and progressive multifocal leukoencephalopathy, according to a recent FDA Safety Alert. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV) and therefore is indicated for use only in transplant patients who are EBV seropositive.

Improved glycemic control may help prevent heart failure, according to a study recently published in The Lancet.

FDA has approved the Risk Evaluation and Mitigation Strategy (REMS) for Fentora (fentanyl buccal tablet) [C-II] and Actiq (oral transmucosal fentanyl citrate) [C-II]. Both products, manufactured by Cephalon, are indicated for management of breakthrough pain in opioid-tolerant patients with cancer.

On June 15, 2011, FDA published an online safety communication informing prescribers and patients that pioglitazone (Actos, Takeda Pharmaceuticals America Inc) use may be associated with a 20% to 40% increased hazard of new bladder cancer.

FDA has approved ticagrelor (Brilinta, AstraZeneca) tablets to reduce the rate of heart attack and cardiovascular death in adult patients with acute coronary syndrome.

An increase in methicillin-resistant Staphylococcus aureus (MRSA) has led to a significant increase in cases of children?s pneumonia, a new study has reported.

FDA has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the 6 manufacturers licensed to produce and distribute influenza vaccine for the United States.

The CDC is concerned about the increasing potential in gonorrhea patients for resistance to cephalosporin.

The concentration of the influenza drug oseltamivir phosphate (Tamiflu, Genentech) for oral suspension has been reduced from 12 mg/mL to 6 mg/mL to reduce the possibility of prescribing and dosing confusion that can lead to medication errors, FDA announced.

On April 22, 2011, Menactra was granted FDA approval for use in infants and toddlers as young as 9 months of age.

Experts suggest that pharmacogenomics and personalized medicine may soon change the practice of community pharmacy.

According to new guidelines, researchers at the Alzheimer's Association and the National Institute of Aging of the National Institutes of Health have categorized AD into 3 different stages: preclinical, mild cognitive impairment, and Alzheimer's dementia.

Chronic cluster headaches are debilitating for patients who experience them. A recent study concluded that low-intensity anticoagulation with warfarin was associated with significantly higher incidence of remission and less headache impact on patients' lives.

Polypharmacy is becoming a greater risk factor for elderly cancer patients, resulting in an increased risk of adverse drug reactions and drug interactions, according to a recent study published in The Lancet Oncology.

The involvement of specialty pharmacists and nurses increased medication adherence in patients with hepatitis C (HCV), recent research has reported.

According to a briefing presented to Congress on Tuesday, drug shortages are having an enormous impact on the nation's health systems through delayed treatment, less effective drug treatments provided to patients, and increased drug costs.

In an effort to address the efficacy of various treatment options available to reduce pain and improve physical function and quality of life in patients with painful diabetic neuropathy, a broad literature review was conducted and new guidelines were published online May 17 in Neurology and were presented at the American Academy of Neurology Annual Meeting in Honolulu.

FDA has approved rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee- or hip-replacement surgery. Xarelto is the only new oral anticoagulant with FDA approval for this indication.

The American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP) last week issued a serious medication alert about colistimethate.

Diabetic kidney disease has become more prevalent in the United States over the last 2 decades due to the expansion of the diabetes population, concluded a study published in the June 22/29 issue of JAMA.

Crizotinib, an investigational drug, demonstrated an association with a sharp increase in survival rates for patients with advanced non-small cell lung cancer (NSCLC) with an anaplastic lymphoma kinase (ALK) positive genetic alteration, according to the results of an early-phase study presented at the 2011 annual meeting of the American Society of Clinical Oncology.

FDA has issued a warning that smoking-cessation aid varenicline (Chantix, Pfizer) may be associated with a small, increased risk of certain adverse events in patients who have cardiovascular disease.

Compared with moderate-dose therapy, intensive-dose statin therapy appears to be associated with increased risk of new-onset diabetes, concluded a meta-analysis of data from 5 statin trials published in the June 22/29 issue of JAMA.

FDA approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people aged 18 and older.

Legislators and pharmacists are working to convince the Centers for Medicare and Medicaid Services???????????????????????? to halt its rule change on infusion pumps for pain medications.