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Weekly Drug News Round Up - February 18, 2015

FDA Approves Lenvima for Thyroid Cancer

Lenvima, a kinase inhibitor, blocks certain proteins that help cancer cells grow and divide Read More...

This past week the U.S. Food and Drug Administration (FDA) approved Eisai’s Lenvima (lenvatinib), an oral multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of progressive, differentiated thyroid cancer (DTC) in patients whose disease progressed despite receiving radioactive iodine therapy. DTC is a cancerous growth of the thyroid gland in the neck that helps to regulate the body’s metabolism. Study results showed Lenvima-treated participants lived a median of 18.3 months without their disease progressing (progression-free survival), compared to a median of 3.6 months for participants who received a placebo. Lenvima was approved under the FDA’s priority review program.

Banzel Use Expanded for Younger Children With Seizures

The most frequently reported adverse reactions with Banzel were vomiting and somnolence Read More...

Eisai’s antiepileptic drug (AED) Banzel (rufinamide) has been approved by the FDA for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in pediatric patients from one to less than four years of age. Previously, Banzel was approved for use in children four years and older and adults for the same indication. LGS is a severe form of epilepsy that affects 1 to 4 percent of all U.S. children with epilepsy. Characterized by multiple seizure types, the disorder is extremely difficult to control, with patients normally having to take several different AEDs.

Women's Libido Pill Flibanserin Resubmitted for FDA Approval

There is no drug currently on the market for women with low libido Read More...

An investigational drug meant to boost sexual desire in women is being resubmitted to the U.S. Food and Drug Administration (FDA), after two previous FDA rejections. The FDA refused to approve flibanserin in 2010 and again in 2013 due to low levels of effectiveness and side effects such as nausea, dizziness and fatigue. The latest application by Sprout Pharmaceuticals includes new information about how the pill affects driving ability. FDA requested the data because clinical trials found that sleepiness occurred in nearly 10 percent of women. Flibanserin is a non-hormonal, multifunctional serotonin agonist-antagonist (MSAA).

Study Links Antibiotics to Digestive Complications in Infants

Vomiting is the first symptom of pyloric stenosis in most children Read More...

Pyloric stenosis occurs when an opening to small intestine becomes narrowed and blocks stomach contents. Pyloric stenosis is a risk for infants who receive certain antibiotics in the early weeks of life, according to a new study published this week in the journal Pediatrics. Doctors have known that using the antibiotic erythromycin can increase the risk of pyloric stenosis in infants. The new findings confirmed that link, and also found that the antibiotic azithromycin (Zithromax) is associated with a higher risk of pyloric stenosis when given to infants under 6 weeks of age. If it occurs, surgery is often needed to treat pyloric stenosis.

Fondaparinux an Alternative to Heparin for Certain Heart Attacks

FDA approved fondaparinux (Arixtra) in 2001, and it became available generically in 2011 Read More...

According to a new study published in JAMA this week, patients who received the blood thinner fondaparinux (Arixtra) to treat a specific type of heart attack called non-ST-segment elevation myocardial infarction (NSTEMI) had a lower risk of major bleeding and death compared to patients who received heparin. Fondaparinux is already used to treat dangerous blood clots in the limbs (deep vein thrombosis) and lungs (pulmonary embolism). The investigators found fewer severe bleeding events occurred with fondaparinux -- 1.1 percent compared with 1.8 percent for heparin.