Here are some of the latest health and medical news
developments, compiled by the editors of HealthDay:
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,
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,
House Passes Bill to Improve Safety of Drugs Made by Compounding
A bill meant to improve the safety of customized drugs prepared
by compounding pharmacies was passed Saturday by the U.S. House of
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
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
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 Jonesreported. "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,
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.
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