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Weekly Drug News Round Up - May 14, 2014

Merck’s Zontivity Approved to Lower Heart Attack and Stroke Risk

Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist Read More...

Anti-platelet drugs decrease the ability of platelets to adhere to each other to form a blood clot, lessening the risk of heart attack or stroke. The U.S. Food and Drug Administration (FDA) has approved a new anti-platelet agent, Zontivity (vorapaxar), in tablet form. In a study of roughly 25,000 participants, Zontivity, added to other anti-platelet agents such as aspirin and clopidogrel (Plavix) reduced the rate of heart attack, stroke, cardiovascular death, and urgent procedures to improve blood flow to the heart. Patients using Zontivity may bruise or bleed more easily and should report any unexpected bleeding to their health care provider.

FDA Drug Safety Update: Pradaxa and Warfarin

The FDA still considers Pradaxa to have a favorable benefit to risk profile, and no label changes were introduced Read More...

Pradaxa (dabigatran) and warfarin are blood thinners frequently used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF). The U.S. Food and Drug Administration (FDA) has completed a comparative study of Pradaxa and warfarin in a large population of Medicare patients 65 years of age or older. The study found that use of Pradaxa was linked with a lower risk of stroke, bleeding in the brain, and death, than with warfarin. However, Pradaxa was associated with a great risk for stomach bleeding. Risk for a heart attack was similar between the two drugs.

Osteoporosis Drugs: How Long Should You Take Them?

Bisphosphonates have been successfully used since 1995 to slow or inhibit the loss of bone mass Read More...

According to a study done by the U.S. Food and Drug Administration (FDA), some patients may be able to stop taking the osteoporosis class of drugs known as bisphosphonates after three to five years and still continue to benefit from their use. Doctors commonly prescribe brand name drugs as Actonel, Atelvia, Boniva, and Fosamax (as well as the generic products) for osteoporosis. Studies suggest younger patients who are at a lower risk of fracture may be able to discontinue bisphosphonate therapy after three to five years. However, more research is needed on fracture risk after stopping bisphosphonates, and whether restarting them later could prove beneficial.

Evolocumab May Lower Cholesterol Even Beyond Statin Use

Evolocumab, if approved, is predicted to be very costly as it’s a monoclonal antibody Read More...

Amgen’s investigational drug known as evolocumab may be able to further lower cholesterol levels in people who already take statin drugs like atorvastatin (Lipitor) and rosuvastatin (Crestor), according to the results of a worldwide trial. As reported in the Journal of the American Medical Association, evolocumab taken every two weeks reduced LDL cholesterol levels an additional 66 to 75 percent, compared to placebo, in Phase 3 trials. By comparison, ezetimibe (Zetia) provided an additional cholesterol reduction of up to 24 percent, the investigators found. Evolocumab could be helpful for heterozygous familial hypercholesterolemia or those who cannot take large statin doses.

Apotex Launches First-Time Generic for Rhinocort Aqua

Budesonide nasal spray is approved for seasonal or perennial allergic rhinitis in adults and children 6 years of age and older Read More...

The generic formulation for Rhinocort Aqua (budesonide nasal) spray is now available. Budesonide is an anti-inflammatory corticosteroid agent used frequently in the treatment of allergies. According to Apotex, the generic budesonide nasal spray was launched on May 13, 2014 at a suggested average wholesale price of $160.53 - not much of a savings compared to Rhinocort Aqua - which currently retails between $170 and $215. Apotex may have been entitled to a 180-day exclusivity for marketing, and consumers can usually expect the price to fall after the 180-day exclusivity expires. AstraZenenca makes the brand product Rhinocort Aqua nasal spray.

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