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Weekly Drug News Round Up - September 23, 2015

Taiho Oncology’s Lonsurf Approved for Advanced Colorectal Cancer

Patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo Read More...

This week, the US Food and Drug Administration (FDA) approved the oral drug Lonsurf (trifluridine and tipiracil) for patients with advanced (metastatic) colorectal cancer who are no longer responding to other therapies, such as chemotherapy and biological therapy. Lonsurf is a nucleoside metabolic inhibitor, which is incorporated directly into DNA and interferes with its function. The blood level of trifluridine is maintained via tipiracil, which is an enzyme inhibitor of thymidine phosphorylase. Common side effects with Lonsurf include anemia, neutropenia, thrombocytopenia, physical weakness, extreme tiredness and lack of energy (fatigue).

Forest’s Vraylar Given the Nod to Treat Two Mental Health Disorders

The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2700 patients Read More...

Schizophrenia and bipolar disorder are highly disabling disorders that can interfere with a normal lifestyle, ability to work, and social functioning. This week the FDA approved Vraylar (cariprazine) to treat both of these conditions. Vraylar is an atypical antipsychotic, and like other antipsychotics, contains a Boxed Warning against use in the elderly with dementia-related psychosis. Neither Vraylar nor any other drug in the atypical antipsychotic class is approved to treat such patients. In clinical trials, common side effects reported with Vraylar included extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence) and restlessness.

Off-label Use of Tramadol May Interfere With Breathing in Children

FDA will communicate final tramadol recommendations once the review is complete Read More...

FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger due to the risk of slowed or difficult breathing, especially after surgery to remove their tonsils and/or adenoids. Tramadol is not FDA-approved for use in children but has been used as an “off-label” narcotic analgesic in the pediatric population. Children with a genetic predisposition to more rapidly break down tramadol in the body may be at higher risk. Caregivers of children taking tramadol who notice slow or noisy breathing, confusion, or unusual sleepiness should stop tramadol and call 911 or go to the emergency room.

FDA Warns About Possible Dosing Errors With Avycaz

Confusion stemmed from the drug strength displayed on the vial and carton labels Read More...

The FDA is warning healthcare professionals about the risk for dosing errors with the intravenous antibacterial agent Avycaz (ceftazidime and avibactam). Label errors have caused confusion and caused at least one patient medication error. Therefore, FDA has revised labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram. Avycaz labels originally displayed the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram). Avycaz is approved to treat complicated infections in the urinary tract, or in combination with metronidazole to treat complicated abdominal infections.

Early Studies Show Antibiotic Resistance May Soon Meet Its Match

New organometallic antibiotics are coming at a time when bacteria have not evolved to resist them Read More...

Studies in the beginning phases are making new inroads to develop robust drug therapy to treat antibiotic resistance. A study this week reports on new drugs containing  iridium, a transition metal that doesn't break down easily. This may one day help the antibiotics to treat superbugs, such as potentially fatal MRSA (methicillin-resistant Staphylococcus aureus). The team is currently testing the compounds in human cells, and so far, the cells have remained healthy and normal. In 2013 alone, MRSA caused nearly 10,000 deaths in the US, according to the U.S. Centers for Disease Control and Prevention.