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Weekly Drug News Round Up - December 17, 2014

Orphan Drug Signifor LAR Approved for Acromegaly

Novartis’ Signifor LAR is a next-generation somatostatin analog addressing a critical unmet need Read More...

The US Food and Drug Administration (FDA) has approved Signifor LAR (long-acting release pasireotide), an intramuscular injection for the treatment of acromegaly in patients who have had an inadequate response or are not candidates for surgery. Acromegaly is a excessive growth hormone (GH) disorder. In the majority of cases, the disease is caused by a non-cancerous tumor on the pituitary gland. Acromegaly, which usually affects middle-aged adults, leads to an increase in your bone size. In Phase III clinical trials, higher rates of full biochemical control were achieved with Signifor LAR compared to a first generation SSA.

Somatuline Depot Wins New Indication for Neuroendocrine Tumors

Common side effects with lanreotide include stomach pain, muscle pain, vomiting, headache, and high blood pressure Read More...

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) rare neoplasms that secrete peptides and neuroamines that cause distinct clinical syndromes, including carcinoid syndrome. The US Food and Drug Administration (FDA) has approved Ipsen Pharma’s Somatuline Depot Injection (lanreotide) for the treatment of patients with GEP-NETs to improve progression-free survival. Lanreotide was previously approved for the long-term treatment of acromegalic patients who can’t use surgery or radiotherapy. In clinical trials, the progression-free survival (PFS) in the lanreotide arm had not been reached at the time of the final analysis and will exceed 22 months. The median PFS in the placebo arm was 16.6 months.

FDA Approves Kitabis Pak for Cystic Fibrosis

Patients may obtain a compressor through the PARI PROVIDE access program Read More...

Cystic fibrosis (CF) is a life-threatening disease affecting 30,000 Americans. CF involves a genetic mutation that results in poorly hydrated, thickened mucous secretions in the lungs, as well as severely impaired mucociliary clearance. PulmoFlow’s co-packaging of generic tobramycin inhalation solution with a PARI LC Plus Nebulizer has been FDA-approved for patients with cystic fibrosis. It is approved for use in adults and pediatric patients 6 years of age and older with P. aeruginosa. The price of Kitabis Pak will be similar to the price of the generic tobramycin drug alone; however, a compressor is required to deliver the tobramycin inhalation solution through the mouthpiece.

Ziprasidone Linked With Rare, Serious Skin Reactions

New warnings for DRESS will be added to ziprasidone drug labeling Read More...

Ziprasidone (Geodon) is an atypical antipsychotic used to treat schizophrenia and bipolar disorder. The U.S. Food and Drug Administration is warning that a rare and potentially fatal serious reaction known as DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms - can occur on the skin and spread to other areas. DRESS may start as a rash, and can include fever, swollen glands, organ inflammation, and high white blood cell count. Six case reports have been noted but no deaths. Patients taking ziprasidone who develop a fever with a rash and/or swollen lymph glands should seek urgent medical care.

Are Drug Interactions Addressed in Hospitalized Kids?

A patient's med profile should be screened for drug interactions with any medication change Read More...

Harmful drug interactions should be a concern for parents when their kids are hospitalized. In a study published in Pediatrics, researchers found that among nearly 500,000 children and teenagers who were hospitalized in 2011, nearly half were given a combination of drugs that could interact. However, it’s not clear if the drug interactions caused harmful or clinically significant events. The bottom line - hospitalized children should still get the drug they require. But the findings suggest vigilance and more rational systems of alerting docs to potential drug interactions are needed to boost true meaningful use. Learn more about drug interaction prevention here.