Health Highlights: Aug. 20, 201008/20/10
Here are some of the latest health and medical news
developments, compiled by the editors of
Parkinson's Drug May Increase Risk of Cardiovascular Events:
Study data suggest that Parkinson's disease patients taking the
drug Stalevo (a combination of carbidopa/levodopa and entacapone)
may be at greater risk for heart attack, stroke and cardiovascular
death than patients taking the drug Sinemet (carbidopa/levodopa),
the U.S. Food and Drug Administration said Friday.
The FDA is evaluating the data from the STRIDE-PD trial and
recommends that doctors regularly evaluate the cardiovascular
health of patients taking Stalevo, especially if they have a
history of cardiovascular disease.
Patients should not stop taking Stalevo unless told to do so by
their doctor, the FDA said in a news release.
The agency said it's looking at additional ways to assess
whether Stalevo increases the risk of cardiovascular events and
will update the public once it completes its review.
Stalevo was approved by the FDA in June 2003 and about 154,000
patients had received a prescription for the drug through October
FDA Panel Endorses Antidepressant for Back Pain
The antidepressant Cymbalta should be approved to treat lower
back pain, a U.S. Food and Drug Administration advisory panel
However, the panel voted against the use of the drug to treat
The New York Times reported. Cymbalta is made by Eli
While the FDA doesn't have to, it usually follows the
recommendations of its advisory panels.
After the vote, the advisory panel chair criticized Lilly for a
Cymbalta advertising campaign that says "depression is painful."
The ads appeared to be an attempt to "premarket" Cymbalta for a
pain use that has not yet been approved by the FDA, said Dr.
Jeffrey R. Kirsch, chairman of the department of anesthesiology at
the Oregon Health Sciences University, the
Currently, Cymbalta has FDA approval for treatment of major
depression, nerve pain, generalized anxiety disorder, and
fibromyalgia, the newspaper said.
Baseball Pitcher Roger Clemens Denies Steroid Use
Pitching legend Roger Clemens continued Thursday to deny that he
used performance-enhancing drugs, after a federal grand jury
indicted him for allegedly lying to Congress about his use of human
growth hormone and steroids.
"I never took HGH or steroids. And I did not lie to Congress," Clemens said on Twitter, the Associated Press reported. "I look forward to challenging the
government's accusations, and hope people will keep an open mind
until trial. I appreciate all the support I have been getting. I am
happy to finally have my day in court."
Clemens faces a six-count indictment alleging that he obstructed
a congressional inquiry with 15 different statements made under
oath, including saying that he never used human growth hormone or
The seven-time Cy Young winner is the latest baseball superstar
to become embroiled in the steroid scandal that has tainted the
sport. Slugger Mark McGwire has admitted to using steroids and
all-time home run leader Barry Bonds is scheduled to go on trial in
March. Bonds faces charges of lying to a federal grand jury for
stating that he never knowingly used performance-enhancing drugs,
Drug Company Letter About Avandia Misleading: U.S.
A GlaxoSmithKline letter sent to doctors presents misleading
information about a trial involving the diabetes drug Avandia and
could endanger patients, U.S. drug regulators say.
In a July hearing, a U.S. Food and Drug Administration expert
advisory panel discussed the heart risks of Avandia and the ethics
of an ongoing trial comparing Avandia to a similar drug called
Actos, made by Takeda Pharmaceuticals,
The New York Times reported.
The FDA has ordered GlaxoSmithKline to stop recruiting new
patients for the Tide trial but current patients can continue in
the study. At the hearing, Dr. David Graham, an FDA medical
officer, argued that the trial should be stopped because thousands
of participants were being exploited, the newspaper said.
Federal officials ordered GlaxoSmithKline to send a letter
describing the hearing to doctors involved in the Tide trial. But
the letter doesn't mention any of Graham's statements about patient
"This summary is biased, misleading and not truthful," Graham told the Times. "The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced."
Several members of the FDA advisory committee also said the
GlaxoSmithKline letter was biased, the newspaper said.
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