Download Parkinson`s Dementia Drug Gains Approval—September 2006

INSIDE PHARMACIST CARE
Parkinson's Dementia Drug
Gains Approval
drug already sold to treat mild to
moderate dementia in Alzheimer's disease patients has won
federal approval to treat the same condition in Parkinson's patients.
The expanded approval makes Exelon
the first drug for the treatment of the
chronic loss or impairment of intellectual capacity in Parkinson's disease patients, the Food and Drug Administration
said. The drug, whose generic name is
rivastigmine tartrate, is made by
Switzerland-based Novartis AG.
The FDA originally approved Exelon
in 2000 for Alzheimer's patients with
dementia. About 0.2 percent to 0.5 percent of people 65 and older are affected
by Parkinson's dementia and experience
impairments in executive function,
memory and attention, the FDA said.
Parkinson's patients who were treated
with the drug in a 24-week trial scored
higher on a scale that measures mental
processes than did those given placebos,
the FDA said.
There are several side effects associated with the drug. Patients on the drug
can suffer significant gastrointestinal
reactions. In clinical trials, nearly half
the patients developed nausea. Many
also lost significant amounts of weight.
And some patients treated with Exelon
experienced a worsening of the tremors
associated with Parkinson’s, according to
the FDA.
A
Some Sexual Enhancement
Products Pose Risk: FDA
Some sexual enhancement products sold
on the Internet contain the same ingredients as prescription drugs such as
Viagra. These drugs are not only illegal
but are also dangerous, the Food and
Drug Administration (FDA) said.
Erectile dysfunction products can
cause a deadly interaction with many
heart drugs, notably those containing
nitrates. In a statement, the FDA warned
consumers not to purchase or consume
the following drugs: Zimaxx, Libidus,
www.americaspharmacist.net
Neophase, Nasutra, Vigor-25, Actra-Rx,
or 4EVERON.
"These products threaten the public
health because they contain undeclared
chemicals that are similar or identical to
the active ingredients used in several
FDA-approved prescription drug products," added Steven Galson, director of
the FDA's Center for Drug Evaluation
and Research.
Zimaxx contains sildenafil, the active
pharmaceutical ingredient in Viagra,
Pfizer's prescription erectile dysfunction
product. The other products contain
chemical ingredients that are similar
either to sildenafil or to vardenafil, the
active ingredient in Levitra. Levitra is a
prescription erectile dysfunction drug.
The drug is developed and sold jointly by
Bayer AG, GlaxoSmithKline Plc and
Schering-Plough Corp.
Consumers with diabetes, high blood
pressure, high cholesterol, or heart disease often take nitrates, the FDA said.
The FDA also said, “ED (erectile dysfunction) is a common problem in men
with these conditions, and they may seek
products like the ones noted previously
because these products claim that they
are 'all natural' or that they do not contain the active ingredients used in FDAapproved ED drugs."
The agency said it had stopped a shipment of 4EVERON from entry to the
United States and warned the companies
selling the drugs.
HIV/AIDS Patients
Get First Once-Daily Pill
People infected with the virus that causes AIDS can simplify their treatment by
taking a once-a-day pill that combines
three drugs in a "cocktail" therapy that
can be swallowed in a single dose.
Atripla includes three Food and Drug
Administration-approved medicines that
already form one of the most widely prescribed treatments for HIV and AIDS.
The medicine will still be expensive:
more than $1,100 for a month's supply.
October Health Events
Lupus Awareness Month
Lupus Foundation of America
www.lupus.org
Talk About Prescriptions Month
National Council on Patient Information and
Education
www.talkaboutrx.org
National Liver Awareness Month
American Liver Foundation
www.liverfoundation.org
Spina Bifida Awareness Month
Spina Bifida Association of America
www.sbaa.org
Eye Injury Prevention Month
American Academy of Ophthalmology —
The Eye M.D. Association
www.medem.com/eyemd
Atripla can replace the two or more pills
HIV-positive patients now must take
each day to keep the human immunodeficiency virus in check, making it simpler to stick to a treatment regimen.
Atripla won't do away with the multiple other drugs that AIDS patients often
must take to fend off infections and
other complications of their weakened
immune systems, said Frank Oldham Jr.,
executive director of the National Association of People with AIDS. And some
patients will have to take other HIV
drugs along with Atripla to combat the
virus effectively.
Atripla combines Viread (tenofovir),
Emtriva (emtricitabine), and Sustiva (efavirenz). Viread and Emtriva, both made
by Gilead, are now sold in combination
under the brand name Truvada. Sustiva is
made by Bristol-Myers Squibb Co.
About 40 million people worldwide,
including one million Americans, are HIV
positive. o
“Inside Pharmacist
Care®” is the monthly
news report of NCPA’s National Institute
for Pharmacist Care Outcomes division.
September 2006 | america’s PHARMACIST
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