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Weekly Drug News Round Up - April 30, 2014

Sylvant is First FDA-Approved Drug for Multicentric Castleman’s Disease

Multicentric Castleman’s Disease is a rare blood disorder resulting in an overgrowth of immune cells in lymph nodes Read More…

The U.S. Food and Drug Administration (FDA) has approved Janssen Biotech’s Sylvant (siltuximab), an orphan drug for patients with multicentric Castleman’s disease (MCD). MCD is a rare disorder resembling cancer of the lymph nodes (lymphoma). Sylvant is an interleukin-6 antagonist that blocks a protein to help slow abnormal growth of immune cells. In clinical trials, a tumor response was seen in 34 percent of 79 participants treated with Sylvant and best supportive care (BSC), but no participant treated with placebo and BSC had a tumor response. Sylvant is used in patients who do not have HIV or human herpes virus 8.

FDA Grants Accelerated Approval to Zykadia for Advanced Lung Cancer

Common side effects include diarrhea, nausea/vomiting, increased liver enzymes, and constipation Read More...

Novartis has received FDA-approval for their new lung cancer treatment Zykadia (ceritinib). Zykadia is to be used in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) that has spread in the body (metastatic). It is classified as a kinase inhibitor and works by inhibiting proteins that advance cancer cell growth. Zykadia is intended to be used in patients who have been previously treated with Xalkori (crizotinib), the only other approved ALK tyrosine kinase inhibitor. Zykadia capsules are taken once daily on an empty stomach, and patients must not consume grapefruit and grapefruit juice during treatment.

Purixan Approved for Adjunctive Treatment of Acute Lymphoblastic Leukemia

The FDA okayed a 20-milligram per milliliter (20 mg/mL) oral suspension Read More...

Purixan (mercaptopurine) is a cancer medication that interferes with the growth and spread of cancer cells in the body and is used to treat certain types of leukemia. Purixan is a new oral suspension of mercaptopurine used for acute lymphoblastic leukemia (ALL) as part of a combination regimen. Mercaptopurine was previously only available as a 50-mg tablet, and was difficult to use in children with ALL who have trouble swallowing tablets. The new suspension will allow easier and more precise dosing, is in a form that is easier for children to swallow, and may be more uniform than pharmacy compounded formulations.

FDA: Stop Prescribing and Dispensing Higher Dose Acetaminophen

Products with over 325 mg of acetaminophen have been voluntarily withdrawn from the U.S. market Read More...

Excessive intake of acetaminophen can lead to severe liver damage. The U.S. Food and Drug Administration (FDA) is reminding health care providers to stop prescribing or dispensing combination drug products that contain over 325 milligrams (mg) of acetaminophen per dosage form; the FDA originally made this recommendation in January. Pharmacists should contact prescribers, if needed, to discuss products with lower amounts of acetaminophen. Pharmacists may return these higher dose products to the wholesaler. A full update of all FDA acetaminophen recommendations can be found here.

Some Statin Users Continue to Eat Unhealthy Food

According to researchers, statins are used by about one-sixth of adults Read More...

Cholesterol-lowering statin drugs like atorvastatin (Lipitor) or rosuvastatin (Crestor) can drastically reduce cholesterol levels and improve heart health. However, patients taking statins should still eat healthy foods. According to one study, some statin users are eating high calorie, high fat food. Researchers have found that statin users in the years 2009 to 2010 consumed 9.6 percent more calories and 14.4 percent more fat than statin users in 1999 to 2000. Healthcare providers should still encourage patients to engage in a healthy diet and exercise, even if cholesterol numbers fall with statin use. Diabetes, obesity and high blood pressure can also lead to a higher cardiac risk.