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Weekly Drug News Round Up - November 13, 2013

Statins The Go-To Drug in New Heart Disease Guidelines

At the very least, patients 40-75 years should know their 10-year risk of heart attack and stroke and discuss this number with their doctor Read More...

It’s been almost a decade-long wait, but new guidelines addressing heart health, obesity and risk factors were released this week. According to the guidelines, patients should use statin drugs to lower cholesterol if they have cardiovascular disease, are 21 or over with bad (LDL) cholesterol 190 mg/dL or higher, if they are 40 to 75 years of age with type 2 diabetes or 40 to 75 years of age with an estimated 10-year risk of cardiovascular disease of 7.5% or more. In addition, heart healthy diets are recommended - not necessarily low-calorie diets - and exercise to reduce the risk for cardiovascular disease by lowering blood pressure and cholesterol. A calculated BMI and waist measurement can help uncover obesity risk factors, too.

FDA Approves Sunovion’s Aptiom for Seizure Control

Common side effects with Aptiom include dizziness, drowsiness, nausea, headache, double-vision, vomiting, fatigue and loss of coordination Read More…

Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain’s nerve cells. The U.S. Food and Drug Administration (FDA) has approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat partial seizures associated with epilepsy. In clinical trials in over 1,400 patients with partial-onset seizures uncontrolled by one to three other antiepileptic drugs (including carbamazepine, lamotrigine, valproic acid and levetiracetam), Aptiom led to significant reductions in standardized seizure frequency versus placebo. Sunovion expects Aptiom to be available in the second quarter of 2014.

Imbruvica: Breakthrough Therapy FDA-Approved for Mantle Cell Lymphoma

MCL spreads rapidly and by the time it is diagnosed it has usually spread to the lymph nodes, bone marrow and other organs Read More...

Mantle cell lymphoma (MCL) is a rare and aggressive type of blood cancer - a form of non-Hodgkin lymphoma - and represents about 6 percent of all non-Hodgkin lymphoma cases in the U.S. The U.S. Food and Drug Administration has approved Imbruvica (ibrutinib), a new treatment for patients with this rapidly spreading blood cancer who have received at least one prior therapy. Imbruvica was evaluated in a study of 111 participants. Of those who took the drug daily, 66 percent had their cancer shrink or disappear. Velcade (bortezomib) and Revlimid (lenalidomide) are also approved for MCL treatment.

Aciphex: Generic Version of Heartburn Drug Approved

Generic drugs are the equivalent to the brand-name versions in strength and quality, per the FDA Read More...

The first generic versions of the acid suppressing drug Aciphex (rabeprazole sodium) have been approved by the U.S. Food and Drug Administration (FDA) for people aged 12 years and older.  Rabeprazole is used for gastroesophageal reflux disease (GERD), also known as chronic heartburn, a common disorder characterized by backward flow of stomach acid to the esophagus. The drug is in the class called proton-pump inhibitors (PPIs), which are designed to reduce the amount of stomach acid produced. Over-the-counter (OTC) proton-pump inhibitors are also available and include Prilosec OTC (omeprazole), Prevacid 24-Hour (lansoprazole), and Zegerid OTC (omeprazole with sodium bicarbonate). Rabeprazole is not yet available OTC.

Orencia Shows Early Promise in Kidney Disease

Additional research is needed, but Orencia may prove effective for certain forms of kidney disease Read More...

New research published in the the New England Journal of Medicine suggests that the biologic agent abatacept (Orencia), a treatment used to decrease inflammation in rheumatoid arthritis, may have beneficial effects in the treatment of a common form of kidney disease. The kidney disease - focal segmental glomerulosclerosis (FSGS) - is difficult to treat and often leads to kidney failure. Orencia has prevented four patients from losing a transplanted kidney to FSGS. Another patient with a treatment-resistant FSGS who was at high risk for kidney failure went into remission for the first time in more than a year after being treated with the drug.