Skip to Content

Weekly Drug News Round Up - October 15, 2014

Gilead’s Harvoni Approved for Hepatitis C Virus

The new hepatitis C combo will cost over $94,000 for a 12-week supply Read More…

The U.S. Food and Drug Administration (FDA) has approved Gilead’s Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni (ledipasvir and sofosbuvir) is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor; both drugs interfere with HCV enzymes. Harvoni contains sofosbuvir, previously approved for HCV as Sovaldi, and a new drug called ledipasvir. Harvoni is the first combination pill approved to treat HCV genotype 1 that does not require administration with interferon or ribavirin, two HCV medications that can be associated with difficult side effects. The FDA also approved Olysio (simeprevir) in November 2013.

Akynzeo OK’d for Prevention of Chemotherapy-Induced Nausea and Vomiting

Common side effects of Eisai’s Akynzeo included headache, weakness, fatigue, indigestion, and constipation Read More...

The U.S. Food and Drug Administration (FDA) has approved Akynzeo (netupitant and palonosetron), an oral NK1 receptor antagonist and 5-HT3 receptor antagonist fixed-dose drug used to help prevent chemotherapy-induced nausea and vomiting. Palonosetron, approved in 2008, works on the acute phase of nausea vomiting in chemotherapy patients, while netupitant, a new drug, prevents nausea and vomiting during both the acute phase and from 25 to 120 hours after the start of chemotherapy. Clinical trials showed that 90 percent or more of Akynzeo-treated patients did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases. One Akynzeo capsule is taken one hour before the start of chemotherapy.

Breakthrough Drugs Approved for Idiopathic Pulmonary Fibrosis

The FDA granted Esbriet and Ofev fast track, priority review, orphan product, and breakthrough designations Read More…

Idiopathic pulmonary fibrosis (IPF) is an incurable lung disease in which the cause is not known and few treatment options exist. This week, the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) and Esbriet (pirfenidone), two novel new drugs for the treatment of patients with IPF. Both drugs are known as “first-in-class” products for patients with IPF. The new approvals appear to prevent lung scarring that worsens the ability to breath, and they also slow IPF progression, but are not considered a cure.

Lumason: A New Contrast Agent for Echocardiograms

The most commonly reported side effects associated with Lumason were headache and nausea Read More...

The contrast agent Lumason (sulfur hexafluoride lipid microsphere) has been FDA-approved for patients whose ultrasound image of the heart (echocardiogram) is hard to see with ultrasound waves. Lumason is made up of gas-filled microbubbles that reflect the sound waves to enhance the heart image. All microbubble contrast agents, including Lumason, carry a boxed warning about the risk of serious side effects, including fatal cardiac or respiratory arrest. The risk of these reactions may be increased among patients with certain heart conditions; most serious reactions occur within 30 minutes of administration.

Meds, Not Food, Often to Blame for Deadly Allergic Reactions

Symptoms of a serious allergic reaction include swelling, wheezing, shortness of breath, hives and passing out Read More...

A recent study published in the Journal of Allergy and Clinical Immunology reports that medications are actually the biggest cause of sudden deaths related to allergy. In the study, researchers found 2,500 deaths related to life-threatening anaphylaxis; medications were the cause in 59 percent of these cases. Food accounted for just under 7 percent of deaths, and 15 percent of deaths were due to venom from an insect bite or sting. Medications found to lead to reactions most commonly included antibiotics, contrast media, and chemotherapy. Learn to use an injectable epinephrine autoinjector and call 911 for emergency help in a suspected serious allergic reaction.