Health Highlights: Sept. 30, 2013
FDA Approves New AntidepressantNew Lung Cancer Drug Shows Promise: Study House Passes Bill to Improve Safety of Drugs Made by Compounding Pharmacies FDA Warns That Antibiotic Tygacil Shows Raised Death Risk
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Approves New Antidepressant
The drug Brintellix has been approved to treat depression, the U.S. Food and Drug Administration announced Monday.
"Major depressive disorder can be disabling and can keep a person from functioning normally," Dr. Mitchell Mathis, acting director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, said in a news release. "Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression."
The approval was based on the results of six clinical trials where Brintellix (vortioxetine) was pitted against a placebo medication, the agency said. FDA officials also looked at a seventh study that found the medication lowered the chances of a recurrence after patients were treated successfully for an initial bout of depression.
Side effects seen during the trials included nausea, constipation and vomiting. Like other antidepressants already on the market, Brintellix will carry a "black box" warning that states these medications can raise the risk of suicidal thoughts and behavior in adolescents and young adults who take them, the FDA said.
The hallmarks of depression include loss of interest in daily activities, weight changes, insomnia or the opposite, restlessness, slowed thinking or impaired concentration and suicidal thoughts and behaviors.
Marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, Ill., Brintellix will be sold in 5 milligram (mg), 10 mg, 15 mg and 20 mg tablets. Doctors should watch any patients starting on antidepressants for a worsening of symptoms, according to the FDA.
New Lung Cancer Drug Shows Promise: Study
A experimental drug shows promise in fighting lung cancer in difficult-to-treat patients, according to a new study.
An early-stage clinical trial of 53 patients who took Roche's MPDL3280A found that those whose tumors were reduced had a median response of 48 weeks, and all but one are "still in response," said Jean-Charles Soria, who led the research at the Gustave Roussy Institute in Paris, Bloomberg News reported.
The drug -- which is given by infusion once every three weeks -- was most effective in patients with the highest levels of a protein called PD-L1. The drug blocks PD-L1, which prevents the immune system from attacking cancer cells.
The study findings were presented at the European Cancer Congress. Roche has started late-stage trials of MPDL3280A in combination with its own test for identifying which patients would benefit most from the drug, Bloomberg reported.
House Passes Bill to Improve Safety of Drugs Made by Compounding Pharmacies
A bill meant to improve the safety of customized drugs prepared by compounding pharmacies was passed Saturday by the U.S. House of Representatives.
The legislation would improve how drugs made by compounding pharmacies are tracked from production until they're sold at a drug store, and require the Food and Drug Administration to coordinate its safety oversight of the drugs with states, the Associated Press reported.
Compounding pharmacies could voluntarily register as outsourcing facilities, which would place them under FDA authority. Those that remain traditional pharmacies would continue to be watched over mostly by state pharmacy boards.
The Senate is preparing similar legislation.
About a year ago, a meningitis outbreak that killed 64 people and sickened hundreds of others was traced to a compounding pharmacy in Framingham, Mass., the AP reported.
FDA Warns That Antibiotic Tygacil Shows Raised Death Risk
The antibiotic Tygacil is linked to an increased chance of death when used to treat serious infections, the U.S. Food and Drug Administration said Friday.
In issuing a black box warning, the agency asked that physicians limit their use of the intravenous medication.
Labeling for the Pfizer drug will now state that the medicine "should be reserved for use in situations when alternative treatments aren't suitable."
The warning is based on a new analysis that showed 2.5 percent of patients receiving Tygacil died, compared with 1.8 percent of patients receiving other antibiotics.
Pfizer said in a statement it will update the labeling, Dow Jones reported. "Pfizer encourages health care professionals to review all available information to find an antibiotic therapy that works best for each patient's clinical situation," the company said.
Approved for the treatment of a specific type of pneumonia and certain skin and intra-abdominal infections, Tygacil is not approved to treat diabetic foot infections or for hospital-acquired or ventilator-associated pneumonia. In 2012, sales of the drug surpassed $335 million, Dow Jones reported.
The agency's concerns with Tygacil first surfaced in 2010, when the FDA warned of an increased risk of death in clinical studies. Since then, the agency has analyzed data from 10 trials to arrive at the decision to issue a black box warning.
"In general, the deaths resulted from worsening infections, complications of infection or other underlying medical conditions," the agency said.