Parkinson's Disease -Side Effects of Drugs
Permax
Parkinson's is progressive, patients need to take drugs to manage some
symptoms, but the disease wasn't about to go away. Recently, Permax (pergolide)
and its generic versions used by several thousand patients with Parkinson's
disease are being pulled from the market because of reports of heart valve
damage. [1]
At least 14 patients have needed to replace their heart valves. Indeed, after some
reports of heart valve problems in 2002, its label warnings have been revised. Two
recent studies suggested that up to 20% of the pergolide users developed valve
leakage. Moreover, other dopamine agonists used for Parkinson's disease are not
associated with such high rate of heart valve problems. [1] This article reviews the
side effects of a few popular medicines for Parkinson's disease.
Levodopa
It has been known that low dopamine levels are associated with Parkinson's
disease. Logically, dopamine supplementation should be the first line treatment for
Parkinson's disease. Unfortunately, dopamine cannot get through the body's blood-
brain barrier. Because levodopa can pass through the barrier, levodopa becomes
the gold standard of Parkinson's therapy. Approved in 1970, levodopa helps restore
muscle control when it is converted to dopamine in the brain.
However, only a small amount of levodopa actually makes it into the brain. Most
change to dopamine before reaching the brain. So to relieve symptoms, many
patients need to take fairly large doses, which can cause side effects such as
nausea and dyskinesias (involuntary movements).
Sinemet
To reduce these drawbacks, doctors often prescribe levodopa mixed with
carbidopa, a drug that is marketed as Sinemet or in generic versions. About 80
percent of Parkinson's patients take this drug in 1998. Carbidopa delays the
conversion of levodopa to dopamine until it reaches the brain, often lessening or
even preventing levodopa side effects. Carbidopa also decreases the amount of
levodopa needed. Because each Parkinson's patient reacts differently to treatment,
doctors and patients must work closely to find a tolerable balance between the
drug's benefits and side effects.
Though the levodopa-carbidopa combination can be so effective that some patients
forget for a while that they have Parkinson's, the drug is far from perfect. Side effects
aside, doses typically must be increased over time, and the disease often manifests
an "on-off" syndrome in advanced patients.
In 1996, FDA approved Exelon (rivastigmine tartrate) for the treatment of mild to
moderate dementia (chronic loss or impairment of intellectual capacity) associated
with Parkinson's disease. The use of Exelon has been associated with significant
gastrointestinal adverse side effects. In clinical trials, 47 percent of the patients
treated with the drug developed nausea, and 26 percent of women and 18 percent
of men on high doses of Exelon experienced significant weight loss. Other common
adverse side effects reported by patients on Exelon include vomiting, anorexia,
dyspepsia and asthenia (loss of strength). In some patients with Parkinson's
disease, treatment with Exelon was associated with a worsening of tremor. [3]
Mirapex and Requip
In 1997, FDA approved three drugs to treat Parkinson's disease and they are
Mirapex (pramipexole dihydrochloride), Requip (ropinirole hydrochloride), and
Tasmar (tolcapone). Mirapex and Requip, which mimic dopamine's role in the brain,
allow patients to regain some of their lost muscle control. Both are approved for use
alone or with levodopa drugs. In clinical trials, patients taking Mirapex alone saw as
much as a 30 percent improvement in symptoms. Combining Mirapex with levodopa
drugs allowed advanced patients to reduce those doses by up to 25 percent.
Requip trials showed similar benefits, allowing patients to reduce levodopa doses
by an average of 31 percent.
In the three double-blind, placebo-controlled trials of patients with early Parkinson's
disease, the most commonly observed adverse events (>5%) that were numerically
more frequent in the group treated
with MIRAPEX (pramipexole dihydrochloride) tablets were nausea, dizziness,
somnolence, insomnia, constipation, asthenia, and hallucinations. [6]
Tasmar
Tasmar is a kind of drug called a COMT inhibitor. It also is indicated for use with
levodopa drugs. It seems that Tasmar blocks a key enzyme responsible for
breaking down levodopa before it reaches the brain. In trials, patients with a stable
response to levodopa drugs who took Tasmar experienced significant
improvements in daily activities such as talking, writing, walking, and dressing.
However, on November 16, 1998, FDA and the manufacturer of the drug Tasmar for
patients with Parkinson's Disease, are advising doctors about reports of a new
finding of fatal liver injury associated with use of the drug. The warning calls for
increased liver monitoring (every two weeks) if a prescriber elects to treat patients
with Tasmar. Doctors should also advise their patients to self-monitor for classical
signs of liver disease such as jaundice and nonspecific ones such as fatigue and
loss of appetite and other signs of side effects. [4]
Some doctors also described levodopa together with Parlodel (bromocriptine) or
Permax (pergolide, withdrawn from market) to improve response. Parlodel
(bromocriptine) and Permax (pergolide) can mimic dopamine's role in the brain.
Eldepryl
Doctors may also use Eldepryl (selegiline hydrochloride) or deprenyl to delay the
breakdown of naturally occurring and levodopa-formed dopamine and allow the
chemicals to accumulate in surviving nerve cells. Thus, the levodopa response is
prolonged.
Comtan
1999, FDA approved Comtan together with carbidopa/ levodopa to treat people
with Parkinson’s disease that experience the signs and symptoms of end-of-dose
"wearing-off". The side effects of the treatment include Abnormal jerky movements,
nausea, discolored (brownish orange) urine, diarrhea, abdominal pain, dizziness or
fainting especially upon quickly standing or going from a laying down to an upright
position, confusion and sweating. You should inform your healthcare if you have the
following symptoms: severe diarrhea, hallucinations, muscle pain or prolonged
rigidity and high fever. [5]
FDA approved Azilect (rasagiline) for the treatment of Parkinson's disease. The
drug is a monoamine oxidase type--B (MAO-B) inhibitor that blocks the breakdown
of dopamine.
Azilect
Azilect was approved for use as an initial single drug therapy in early Parkinson's
disease, and as an addition to levodopa in more advanced patients. Levodopa is a
standard treatment for Parkinson's disease. The safety and effectiveness of Azilect
was demonstrated in three 18- to 26-week controlled clinical trials.
In one study, the condition of patients with early Parkinson's on Azilect showed
significantly less worsening on a rating scale that measures the ability to perform
mental and motor tasks as well as daily living activities. compared with patients on
placebo. In the other two studies, patients at advanced stage using Azilect together
with levodopa had significantly less time per day with relatively poor function and
mobility as compared with patients on levodopa and placebo.
However, Azilect may be associated with hypertensive crisis if patients also
consume tyramine-rich foods, beverages (such as cheese and red wine) or dietary
supplements or amines contained in many cough/cold medications. As with most
other medications for Parkinson's, Azilect has the potential to cause involuntary
movements (dyskinesias), hallucinations and lowered blood pressure. Check the
product label for details of side effects. In addition, intake of Azilect may also be
associated with an increased risk for melanoma. [2]
More about Parkinson's Disease
Parkinson's Disease - Supplements
Parkinson's Disease - Herbs
Parkinson's Disease - Side Effects of Drugs
Parkinson's Disease - Symptoms
Reference Parkinson's Disease: New Treatments Slow Onslaught of Symptoms FDA Consumer magazine (July-August 1998)
[1] Parkinson's drug pulled from market, AP, March 29, 2007. FDA Drug Safety Podcasts Pergolide (marketed as Permax)
Transcript March 29, 2007 [2] FDA Approves New Treatment for Parkinson's Disease FDA News May 17, 2006. [3] FDA
Approves the First Treatment for Dementia of Parkinson's Disease FDA News June 27, 2006. [4] NEW WARNINGS FOR
PARKINSON'S DRUG, TASMAR FDA Talk Papers November 16, 1998. [5] Comtan, Consumer Drug Information Sheet
December 29, 2004 [6] Mirapex, Product Insert, NDA 20-667/S-011/S-013
Parkinson's is progressive, patients need to take drugs to manage some
symptoms, but the disease wasn't about to go away. Recently, Permax (pergolide)
and its generic versions used by several thousand patients with Parkinson's
disease are being pulled from the market because of reports of heart valve
damage. [1]
At least 14 patients have needed to replace their heart valves. Indeed, after some
reports of heart valve problems in 2002, its label warnings have been revised. Two
recent studies suggested that up to 20% of the pergolide users developed valve
leakage. Moreover, other dopamine agonists used for Parkinson's disease are not
associated with such high rate of heart valve problems. [1] This article reviews the
side effects of a few popular medicines for Parkinson's disease.
Levodopa
It has been known that low dopamine levels are associated with Parkinson's
disease. Logically, dopamine supplementation should be the first line treatment for
Parkinson's disease. Unfortunately, dopamine cannot get through the body's blood-
brain barrier. Because levodopa can pass through the barrier, levodopa becomes
the gold standard of Parkinson's therapy. Approved in 1970, levodopa helps restore
muscle control when it is converted to dopamine in the brain.
However, only a small amount of levodopa actually makes it into the brain. Most
change to dopamine before reaching the brain. So to relieve symptoms, many
patients need to take fairly large doses, which can cause side effects such as
nausea and dyskinesias (involuntary movements).
Sinemet
To reduce these drawbacks, doctors often prescribe levodopa mixed with
carbidopa, a drug that is marketed as Sinemet or in generic versions. About 80
percent of Parkinson's patients take this drug in 1998. Carbidopa delays the
conversion of levodopa to dopamine until it reaches the brain, often lessening or
even preventing levodopa side effects. Carbidopa also decreases the amount of
levodopa needed. Because each Parkinson's patient reacts differently to treatment,
doctors and patients must work closely to find a tolerable balance between the
drug's benefits and side effects.
Though the levodopa-carbidopa combination can be so effective that some patients
forget for a while that they have Parkinson's, the drug is far from perfect. Side effects
aside, doses typically must be increased over time, and the disease often manifests
an "on-off" syndrome in advanced patients.
In 1996, FDA approved Exelon (rivastigmine tartrate) for the treatment of mild to
moderate dementia (chronic loss or impairment of intellectual capacity) associated
with Parkinson's disease. The use of Exelon has been associated with significant
gastrointestinal adverse side effects. In clinical trials, 47 percent of the patients
treated with the drug developed nausea, and 26 percent of women and 18 percent
of men on high doses of Exelon experienced significant weight loss. Other common
adverse side effects reported by patients on Exelon include vomiting, anorexia,
dyspepsia and asthenia (loss of strength). In some patients with Parkinson's
disease, treatment with Exelon was associated with a worsening of tremor. [3]
Mirapex and Requip
In 1997, FDA approved three drugs to treat Parkinson's disease and they are
Mirapex (pramipexole dihydrochloride), Requip (ropinirole hydrochloride), and
Tasmar (tolcapone). Mirapex and Requip, which mimic dopamine's role in the brain,
allow patients to regain some of their lost muscle control. Both are approved for use
alone or with levodopa drugs. In clinical trials, patients taking Mirapex alone saw as
much as a 30 percent improvement in symptoms. Combining Mirapex with levodopa
drugs allowed advanced patients to reduce those doses by up to 25 percent.
Requip trials showed similar benefits, allowing patients to reduce levodopa doses
by an average of 31 percent.
In the three double-blind, placebo-controlled trials of patients with early Parkinson's
disease, the most commonly observed adverse events (>5%) that were numerically
more frequent in the group treated
with MIRAPEX (pramipexole dihydrochloride) tablets were nausea, dizziness,
somnolence, insomnia, constipation, asthenia, and hallucinations. [6]
Tasmar
Tasmar is a kind of drug called a COMT inhibitor. It also is indicated for use with
levodopa drugs. It seems that Tasmar blocks a key enzyme responsible for
breaking down levodopa before it reaches the brain. In trials, patients with a stable
response to levodopa drugs who took Tasmar experienced significant
improvements in daily activities such as talking, writing, walking, and dressing.
However, on November 16, 1998, FDA and the manufacturer of the drug Tasmar for
patients with Parkinson's Disease, are advising doctors about reports of a new
finding of fatal liver injury associated with use of the drug. The warning calls for
increased liver monitoring (every two weeks) if a prescriber elects to treat patients
with Tasmar. Doctors should also advise their patients to self-monitor for classical
signs of liver disease such as jaundice and nonspecific ones such as fatigue and
loss of appetite and other signs of side effects. [4]
Some doctors also described levodopa together with Parlodel (bromocriptine) or
Permax (pergolide, withdrawn from market) to improve response. Parlodel
(bromocriptine) and Permax (pergolide) can mimic dopamine's role in the brain.
Eldepryl
Doctors may also use Eldepryl (selegiline hydrochloride) or deprenyl to delay the
breakdown of naturally occurring and levodopa-formed dopamine and allow the
chemicals to accumulate in surviving nerve cells. Thus, the levodopa response is
prolonged.
Comtan
1999, FDA approved Comtan together with carbidopa/ levodopa to treat people
with Parkinson’s disease that experience the signs and symptoms of end-of-dose
"wearing-off". The side effects of the treatment include Abnormal jerky movements,
nausea, discolored (brownish orange) urine, diarrhea, abdominal pain, dizziness or
fainting especially upon quickly standing or going from a laying down to an upright
position, confusion and sweating. You should inform your healthcare if you have the
following symptoms: severe diarrhea, hallucinations, muscle pain or prolonged
rigidity and high fever. [5]
FDA approved Azilect (rasagiline) for the treatment of Parkinson's disease. The
drug is a monoamine oxidase type--B (MAO-B) inhibitor that blocks the breakdown
of dopamine.
Azilect
Azilect was approved for use as an initial single drug therapy in early Parkinson's
disease, and as an addition to levodopa in more advanced patients. Levodopa is a
standard treatment for Parkinson's disease. The safety and effectiveness of Azilect
was demonstrated in three 18- to 26-week controlled clinical trials.
In one study, the condition of patients with early Parkinson's on Azilect showed
significantly less worsening on a rating scale that measures the ability to perform
mental and motor tasks as well as daily living activities. compared with patients on
placebo. In the other two studies, patients at advanced stage using Azilect together
with levodopa had significantly less time per day with relatively poor function and
mobility as compared with patients on levodopa and placebo.
However, Azilect may be associated with hypertensive crisis if patients also
consume tyramine-rich foods, beverages (such as cheese and red wine) or dietary
supplements or amines contained in many cough/cold medications. As with most
other medications for Parkinson's, Azilect has the potential to cause involuntary
movements (dyskinesias), hallucinations and lowered blood pressure. Check the
product label for details of side effects. In addition, intake of Azilect may also be
associated with an increased risk for melanoma. [2]
More about Parkinson's Disease
Parkinson's Disease - Supplements
Parkinson's Disease - Herbs
Parkinson's Disease - Side Effects of Drugs
Parkinson's Disease - Symptoms
Reference Parkinson's Disease: New Treatments Slow Onslaught of Symptoms FDA Consumer magazine (July-August 1998)
[1] Parkinson's drug pulled from market, AP, March 29, 2007. FDA Drug Safety Podcasts Pergolide (marketed as Permax)
Transcript March 29, 2007 [2] FDA Approves New Treatment for Parkinson's Disease FDA News May 17, 2006. [3] FDA
Approves the First Treatment for Dementia of Parkinson's Disease FDA News June 27, 2006. [4] NEW WARNINGS FOR
PARKINSON'S DRUG, TASMAR FDA Talk Papers November 16, 1998. [5] Comtan, Consumer Drug Information Sheet
December 29, 2004 [6] Mirapex, Product Insert, NDA 20-667/S-011/S-013
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Discuss with your doctor before taking any alternative medicine. This article is for reference only, it is not a medical advice. All rights
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