Skip to Content

Weekly Drug News Round Up - September 5, 2012

FDA Warns Against Pediatric Off-Label Use of Revatio

Revatio use at higher doses for pulmonary arterial hypertension has lead to death in children Read More...

Revatio (sildenafil) is a phosphodiesterase-5 (PDE5) inhibitor approved to treat pulmonary arterial hypertension (PAH) in adults. The U.S. Food and Drug Administration (FDA) considers Revatio use in children “off-label” as it is not approved for this age group. The FDA is warning health care providers and facilities that the use of Revatio in a recent long-term, pediatric PAH clinical trial showed that higher doses are associated with death in children, and that lower doses are not effective for pediatric PAH. This new warning is being added to the Revatio product labeling. Patients and caregivers should not change the dose or stop taking Revatio without first speaking with their healthcare provider.

Bosulif Approved to Treat Chronic Myelogenous Leukemia

Chronic myelogenous leukemia (CML) is a blood and bone marrow disease that usually affects older adults Read More...

Bosulif (bosutinib) has been approved by the U.S. Food and Drug Administration (FDA) for patients with chronic, accelerated or blast phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) who are resistant to or who cannot tolerate other therapies. Patients with CML have a genetic mutation that causes the bone marrow to make an enzyme called tyrosine kinase. Tyrosine kinase triggers the development of abnormal white blood cells normally used for fighting infections. Bosulif works by blocking the tyrosine kinase signal that promotes the development of these defective white blood cells. Other drugs approved by FDA to treat various forms of CML include imatinib, dasatinib, and nilotinib.

New Dose of Exelon Patch Approved for Alzheimer’s Disease

Higher dose results in significant improvement in overall function as measured by the activities of daily living scale Read More...

Roughly 5 million people in the U.S. have Alzheimer’s disease. Alzheimer’s disease is a degenerative neurological disease that leads to memory and behavioral problems that worsen over time. Symptomatic treatment is the only available option for this form of dementia; there is no cure. The U.S. Food and Drug Administration has approved a 13.3 milligram (mg) per 24-hour strength of Exelon (rivastigmine) Patch to provide a new treatment option for patients with mild to moderate Alzheimer's disease who are experiencing a functional and cognitive decline. Exelon, a cholinesterase inhibitor, is also available in a 4.6 mg per 24-hour and 9.5 mg per 24-hour strength patch.

Xtandi Receives Priority Review Approval for Late Stage Prostate Cancer

Xtandi use extends survival in castration-resistant prostate cancer by a median of 4.8 months Read More...

Roughly 28,000 men will die from prostate cancer in 2012. The U.S. Food and Drug Administration (FDA) has approved Xtandi (enzalutamide) under priority review for late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi is approved for patients previously treated with the anti-cancer agent docetaxel. In clinical trials, Xtandi extended the median survival for patients by 18.4 months compared to 13.6 months for patients who received a placebo. In studies, seizures occurred in approximately one percent of patients receiving Xtandi, who then had to stop treatment. The safety of Xtandi in patients with a risk for seizures is unknown.

Linzess Approved for Treatment of Chronic and IBS-Related Constipation

New oral, once-daily treatment for constipation-predominant irritable bowel syndrome approved Read More...

Constipation is a common U.S. problem, with over 78 million people suffering from chronic constipation or irritable bowel syndrome with constipation (IBS-C). Once-daily Linzess (linaclotide) capsules have been approved by the U.S. Food and Drug Administration to offer relief to adult patients with these types of constipation. Linzess has been shown to activate intestinal chloride channels to increase fluid secretion and facilitate bowel movements. The Linzess approved labeling states the drug should not be used in patients less than 17 years of age. The most common side effect reported in studies was diarrhea. Amitiza is another option also approved for chronic constipation and IBS-C.