T
TC
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http://www.usatoday.com/news/health/2006-01-20-fat-blocking-pill_x.htm
FDA to consider over-the-counter sales of fat-blocking pill
WASHINGTON (AP) - A pharmaceutical company that seeks federal
approval for over-the-counter sales of a prescription diet pill that
blocks the absorption of fat faces questions on the pill's potential
for creating vitamin deficiencies and encouraging abuse.
A Food and Drug Administration advisory committee is to discuss on
Monday allowing over-the-counter sales of orlistat, which
GlaxoSmithKline Consumer health care proposes to market as Alli
(pronounced "ally"). That version would be half the dose of the
prescription form of the drug, known as Xenical, which won FDA approval
in 1999.
An FDA reviewer found the drug is a "safe and effective weight loss
agent," but held off on recommending whether the Endocrinologic and
Metabolic Drugs Advisory Committee should in turn recommend to the FDA
that it approve the drug for sale without a prescription.
The drug acts by blocking the absorption of about one-quarter the fat a
patient consumes. That fat is then passed out of the body in stools,
which can be loose or oily as a result.
In six-month clinical trials, obese subjects who took orlistat lost on
average 5.3 pounds to 6.2 pounds more than did those who were given
dummy pills, according to FDA documents released Friday.
FDA reviewer Dr. Karen Feibus said the primary concern with the drug is
its potential to create vitamin deficiencies, since its use also would
block absorption of fat-soluble vitamins like D, E, K and
beta-carotene.
The company recommends patients take multivitamins when using the drug,
said Steve Burton, GlaxoSmithKline's vice president of weight control.
Whether that would happen remains unclear: at least 47% of the people
involved in trials of the drug did not take multivitamins as
recommended, the FDA said.
Orlistat may also block some drugs, including cyclosporine, used to
prevent rejection of kidney, liver and heart transplants. Orlistat
shouldn't be taken with that drug, the FDA said.
Furthermore, just 35% of diabetes patients in a study correctly stated
the drug was not appropriate for them to use, according to agency
documents.
The regulatory agency also is concerned about increased potential for
abuse or misuse of the prescription-free version of the drug,
especially among bulimics or binge-eaters who could develop vitamin
deficiencies due to chronic use of the drug. There are at least four
published reports of women suffering from bulimia using the
prescription form of the drug as a purgative. An estimated 22 million
people worldwide have used the drug.
"We believe there is a very low potential for misuse and abuse. But we
need to be vigilant," Burton said.
The company plans to limit sales of the drug to adults. It expects
women to make up 80% of the expected market for the drug, which would
cost consumers an estimated $12 to $25 a week.
The company intends to package Alli as part of an overall diet and
fitness program. The program would emphasis eating a lower-fat diet, to
both cut calories and curtail the drug's effect on a user's stools.
United Kingdom-based GlaxoSmithKline's U.S. operations are based in
Philadelphia and Research Triangle Park, N.C.
The company declined to share sales projections, but said that 130
million Americans are overweight or obese and that consumers spend $23
billion each year on weight-loss strategies.
*******
Safe?
http://www.drugs.com/Xenical/
XENICAL
Generic Name: orlistat (OR lih stat)
Brand Names: Xenical
What is the most important information I should know about orlistat?
· Orlistat may decrease your body's absorption of some fat-soluble
vitamins. To ensure adequate nutrition, your doctor may recommend
taking a multivitamin that contains vitamins D, E, K, and
beta-carotene. Take your vitamin supplement once a day, at least 2
hours before or after a dose of orlistat.
· Do not take more of this medication than has been prescribed for
you. Doses greater than 120 mg three times a day have not been shown to
provide any additional weight-loss benefit.
What is orlistat?
· Orlistat blocks some of the fat that you eat from being absorbed
by your body.
· Orlistat is used in the management of obesity including weight
loss and weight maintenance when used with a reduced-calorie diet.
· Orlistat may also be used for purposes other than those listed in
this medication guide.
What should I discuss with my healthcare provider before taking
orlistat?
· Do not take orlistat without first talking to your doctor if you
have
· chronic malabsorption syndrome (an inability to absorb food
and nutrients properly), or
· gallbladder problems.
· You may not be able to take orlistat if you have any of the
conditions listed above.
· Before taking orlistat, talk to your doctor if you
· have a history of kidney stones,
· have diabetes,
· have anorexia or bulimia,
· take any other weight-loss medicine, or
· take cyclosporine (Sandimmune, Neoral).
· You may not be able to take orlistat, or you may require a dosage
adjustment or special monitoring during your treatment if you have any
of the conditions listed above.
· Orlistat is in the FDA pregnancy category B. This means that it
is not expected to harm an unborn baby. Do not take orlistat without
first talking to your doctor if you are pregnant.
· It is not known whether orlistat passes into breast milk. Do not
take orlistat without first talking to your doctor if you are
breast-feeding a baby.
How should I take orlistat?
· Take orlistat exactly as directed by your doctor. If you do not
understand these directions, ask your pharmacist, nurse, or doctor to
explain them to you.
· Take each dose with a full glass of water.
· Orlistat is usually taken with each main meal that contains fat.
Orlistat can be taken during meals or up to one hour after a meal.
· Each time you take orlistat, your meal should contain no more
than about 30% of calories from fat. Evenly divide your daily intake of
fat, carbohydrates, and protein over three main meals a day. Talk to
your doctor about following a healthy eating plan.
· If you miss a meal, or if you have a meal without fat, you can
skip your dose of orlistat for that meal also.
· If orlistat is taken with any one meal that is very high in fat,
there is an increased chance of digestive side effects.
· Do not take more of this medication than has been prescribed for
you. Doses greater than 120 mg three times a day have not been shown to
provide an additional weight-loss benefit.
· Orlistat may decrease your body's absorption of some fat-soluble
vitamins. To ensure adequate nutrition, your doctor may recommend
taking a multivitamin that contains vitamins D, E, K, and
beta-carotene. Take your vitamin supplement once a day, at least 2
hours before or after a dose of orlistat.
· Store orlistat at room temperature away from moisture and heat.
What happens if I miss a dose?
· Take the missed dose up to one hour after a meal. If more than
one hour has passed since your last meal, skip the dose you missed and
take only your next regularly scheduled dose as directed. Do not take a
double dose of this medication.
· If you miss a meal, or if you have a meal without fat, you can
skip your dose of orlistat for that meal also.
What happens if I overdose?
· Seek emergency medical attention.
· Symptoms of an orlistat overdose are not known.
What should I avoid while taking orlistat?
· Each time you take orlistat, your meal should contain no more
than about 30% of calories from fat. Evenly divide your daily intake of
fat, carbohydrates, and protein over three main meals a day. Talk to
your doctor about following a healthy eating plan.
What are the possible side effects of orlistat?
· Stop taking orlistat and seek emergency medical attention if you
experience a rare allergic reaction including shortness of breath;
closing of your throat; swelling of your lips, tongue, or face; or
hives.
· Other, less serious side effects are more likely to occur.
Continue to take orlistat and talk to your doctor if you experience
· oily spotting;
· oily or fatty stools;
· orange or brown colored oil in your stool;
· gas with discharge, an oily discharge;
· an urgent need to go to the bathroom;
· an inability to control bowel movements, or;
· an increased number of bowel movements.
· The bowel changes listed above are a natural effect of blocking
fat and indicate that orlistat is working. They generally occur early
in treatment, particularly after meals containing higher amounts of fat
than are recommended. These symptoms are usually temporary and lessen
or disappear as you continue treatment and keep to your recommended
diet of meals containing 30% fat.
· Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome.
What other drugs will affect orlistat?
· Do not take orlistat without first talking to your doctor if you
are taking any of the following medicines:
· cyclosporine (Neoral, Sandimmune), or
· warfarin (Coumadin).
· You may not be able to take orlistat, or you may require a dosage
adjustment or special monitoring during your treatment if you are
taking any of the medicines listed above.
· Orlistat may decrease your body's absorption of some fat-soluble
vitamins. To ensure adequate nutrition, your doctor may recommend
taking a multivitamin that contains vitamins D, E, K, and
beta-carotene. Take your vitamin supplement once a day, at least 2
hours before or after a dose of orlistat.
· Drugs other than those listed here may also interact with
orlistat. Talk to your doctor and pharmacist before taking or using any
other prescription or over-the-counter medicines including vitamins,
minerals, and herbal products.
Where can I get more information?
· Your pharmacist has more information about orlistat written for
health professionals that you may read.
--------------------------------------------------------------------------------
· Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed.
· Every effort has been made to ensure that the information
provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and
complete, but no guarantee is made to that effect. Drug information
contained herein may be time sensitive. Multum information has been
compiled for use by healthcare practitioners and consumers in the
United States and therefore Multum does not warrant that uses outside
of the United States are appropriate, unless specifically indicated
otherwise. Multum's drug information does not endorse drugs, diagnose
patients or recommend therapy. Multum's drug information is an
informational resource designed to assist licensed healthcare
practitioners in caring for their patients and/ or to serve consumers
viewing this service as a supplement to, and not a substitute for, the
expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way
should be construed to indicate that the drug or drug combination is
safe, effective or appropriate for any given patient. Multum does not
assume any responsibility for any aspect of healthcare administered
with the aid of information Multum provides. The information contained
herein is not intended to cover all possible uses, directions,
precautions, warnings, drug interactions, allergic reactions, or
adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist.
*********
Safe my eye.
TC
FDA to consider over-the-counter sales of fat-blocking pill
WASHINGTON (AP) - A pharmaceutical company that seeks federal
approval for over-the-counter sales of a prescription diet pill that
blocks the absorption of fat faces questions on the pill's potential
for creating vitamin deficiencies and encouraging abuse.
A Food and Drug Administration advisory committee is to discuss on
Monday allowing over-the-counter sales of orlistat, which
GlaxoSmithKline Consumer health care proposes to market as Alli
(pronounced "ally"). That version would be half the dose of the
prescription form of the drug, known as Xenical, which won FDA approval
in 1999.
An FDA reviewer found the drug is a "safe and effective weight loss
agent," but held off on recommending whether the Endocrinologic and
Metabolic Drugs Advisory Committee should in turn recommend to the FDA
that it approve the drug for sale without a prescription.
The drug acts by blocking the absorption of about one-quarter the fat a
patient consumes. That fat is then passed out of the body in stools,
which can be loose or oily as a result.
In six-month clinical trials, obese subjects who took orlistat lost on
average 5.3 pounds to 6.2 pounds more than did those who were given
dummy pills, according to FDA documents released Friday.
FDA reviewer Dr. Karen Feibus said the primary concern with the drug is
its potential to create vitamin deficiencies, since its use also would
block absorption of fat-soluble vitamins like D, E, K and
beta-carotene.
The company recommends patients take multivitamins when using the drug,
said Steve Burton, GlaxoSmithKline's vice president of weight control.
Whether that would happen remains unclear: at least 47% of the people
involved in trials of the drug did not take multivitamins as
recommended, the FDA said.
Orlistat may also block some drugs, including cyclosporine, used to
prevent rejection of kidney, liver and heart transplants. Orlistat
shouldn't be taken with that drug, the FDA said.
Furthermore, just 35% of diabetes patients in a study correctly stated
the drug was not appropriate for them to use, according to agency
documents.
The regulatory agency also is concerned about increased potential for
abuse or misuse of the prescription-free version of the drug,
especially among bulimics or binge-eaters who could develop vitamin
deficiencies due to chronic use of the drug. There are at least four
published reports of women suffering from bulimia using the
prescription form of the drug as a purgative. An estimated 22 million
people worldwide have used the drug.
"We believe there is a very low potential for misuse and abuse. But we
need to be vigilant," Burton said.
The company plans to limit sales of the drug to adults. It expects
women to make up 80% of the expected market for the drug, which would
cost consumers an estimated $12 to $25 a week.
The company intends to package Alli as part of an overall diet and
fitness program. The program would emphasis eating a lower-fat diet, to
both cut calories and curtail the drug's effect on a user's stools.
United Kingdom-based GlaxoSmithKline's U.S. operations are based in
Philadelphia and Research Triangle Park, N.C.
The company declined to share sales projections, but said that 130
million Americans are overweight or obese and that consumers spend $23
billion each year on weight-loss strategies.
*******
Safe?
http://www.drugs.com/Xenical/
XENICAL
Generic Name: orlistat (OR lih stat)
Brand Names: Xenical
What is the most important information I should know about orlistat?
· Orlistat may decrease your body's absorption of some fat-soluble
vitamins. To ensure adequate nutrition, your doctor may recommend
taking a multivitamin that contains vitamins D, E, K, and
beta-carotene. Take your vitamin supplement once a day, at least 2
hours before or after a dose of orlistat.
· Do not take more of this medication than has been prescribed for
you. Doses greater than 120 mg three times a day have not been shown to
provide any additional weight-loss benefit.
What is orlistat?
· Orlistat blocks some of the fat that you eat from being absorbed
by your body.
· Orlistat is used in the management of obesity including weight
loss and weight maintenance when used with a reduced-calorie diet.
· Orlistat may also be used for purposes other than those listed in
this medication guide.
What should I discuss with my healthcare provider before taking
orlistat?
· Do not take orlistat without first talking to your doctor if you
have
· chronic malabsorption syndrome (an inability to absorb food
and nutrients properly), or
· gallbladder problems.
· You may not be able to take orlistat if you have any of the
conditions listed above.
· Before taking orlistat, talk to your doctor if you
· have a history of kidney stones,
· have diabetes,
· have anorexia or bulimia,
· take any other weight-loss medicine, or
· take cyclosporine (Sandimmune, Neoral).
· You may not be able to take orlistat, or you may require a dosage
adjustment or special monitoring during your treatment if you have any
of the conditions listed above.
· Orlistat is in the FDA pregnancy category B. This means that it
is not expected to harm an unborn baby. Do not take orlistat without
first talking to your doctor if you are pregnant.
· It is not known whether orlistat passes into breast milk. Do not
take orlistat without first talking to your doctor if you are
breast-feeding a baby.
How should I take orlistat?
· Take orlistat exactly as directed by your doctor. If you do not
understand these directions, ask your pharmacist, nurse, or doctor to
explain them to you.
· Take each dose with a full glass of water.
· Orlistat is usually taken with each main meal that contains fat.
Orlistat can be taken during meals or up to one hour after a meal.
· Each time you take orlistat, your meal should contain no more
than about 30% of calories from fat. Evenly divide your daily intake of
fat, carbohydrates, and protein over three main meals a day. Talk to
your doctor about following a healthy eating plan.
· If you miss a meal, or if you have a meal without fat, you can
skip your dose of orlistat for that meal also.
· If orlistat is taken with any one meal that is very high in fat,
there is an increased chance of digestive side effects.
· Do not take more of this medication than has been prescribed for
you. Doses greater than 120 mg three times a day have not been shown to
provide an additional weight-loss benefit.
· Orlistat may decrease your body's absorption of some fat-soluble
vitamins. To ensure adequate nutrition, your doctor may recommend
taking a multivitamin that contains vitamins D, E, K, and
beta-carotene. Take your vitamin supplement once a day, at least 2
hours before or after a dose of orlistat.
· Store orlistat at room temperature away from moisture and heat.
What happens if I miss a dose?
· Take the missed dose up to one hour after a meal. If more than
one hour has passed since your last meal, skip the dose you missed and
take only your next regularly scheduled dose as directed. Do not take a
double dose of this medication.
· If you miss a meal, or if you have a meal without fat, you can
skip your dose of orlistat for that meal also.
What happens if I overdose?
· Seek emergency medical attention.
· Symptoms of an orlistat overdose are not known.
What should I avoid while taking orlistat?
· Each time you take orlistat, your meal should contain no more
than about 30% of calories from fat. Evenly divide your daily intake of
fat, carbohydrates, and protein over three main meals a day. Talk to
your doctor about following a healthy eating plan.
What are the possible side effects of orlistat?
· Stop taking orlistat and seek emergency medical attention if you
experience a rare allergic reaction including shortness of breath;
closing of your throat; swelling of your lips, tongue, or face; or
hives.
· Other, less serious side effects are more likely to occur.
Continue to take orlistat and talk to your doctor if you experience
· oily spotting;
· oily or fatty stools;
· orange or brown colored oil in your stool;
· gas with discharge, an oily discharge;
· an urgent need to go to the bathroom;
· an inability to control bowel movements, or;
· an increased number of bowel movements.
· The bowel changes listed above are a natural effect of blocking
fat and indicate that orlistat is working. They generally occur early
in treatment, particularly after meals containing higher amounts of fat
than are recommended. These symptoms are usually temporary and lessen
or disappear as you continue treatment and keep to your recommended
diet of meals containing 30% fat.
· Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome.
What other drugs will affect orlistat?
· Do not take orlistat without first talking to your doctor if you
are taking any of the following medicines:
· cyclosporine (Neoral, Sandimmune), or
· warfarin (Coumadin).
· You may not be able to take orlistat, or you may require a dosage
adjustment or special monitoring during your treatment if you are
taking any of the medicines listed above.
· Orlistat may decrease your body's absorption of some fat-soluble
vitamins. To ensure adequate nutrition, your doctor may recommend
taking a multivitamin that contains vitamins D, E, K, and
beta-carotene. Take your vitamin supplement once a day, at least 2
hours before or after a dose of orlistat.
· Drugs other than those listed here may also interact with
orlistat. Talk to your doctor and pharmacist before taking or using any
other prescription or over-the-counter medicines including vitamins,
minerals, and herbal products.
Where can I get more information?
· Your pharmacist has more information about orlistat written for
health professionals that you may read.
--------------------------------------------------------------------------------
· Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed.
· Every effort has been made to ensure that the information
provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and
complete, but no guarantee is made to that effect. Drug information
contained herein may be time sensitive. Multum information has been
compiled for use by healthcare practitioners and consumers in the
United States and therefore Multum does not warrant that uses outside
of the United States are appropriate, unless specifically indicated
otherwise. Multum's drug information does not endorse drugs, diagnose
patients or recommend therapy. Multum's drug information is an
informational resource designed to assist licensed healthcare
practitioners in caring for their patients and/ or to serve consumers
viewing this service as a supplement to, and not a substitute for, the
expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way
should be construed to indicate that the drug or drug combination is
safe, effective or appropriate for any given patient. Multum does not
assume any responsibility for any aspect of healthcare administered
with the aid of information Multum provides. The information contained
herein is not intended to cover all possible uses, directions,
precautions, warnings, drug interactions, allergic reactions, or
adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist.
*********
Safe my eye.
TC