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clinpsyc.blogspot.com/2007/03...tiq.html
Thursday, March 01, 2007
More on Pristiq
Marissa Miller has a fine post about desvenlafaxine (Pristiq), Wyeth's attempt to cover up for their bestseller Effexor coming off patent in the near future. Coverup? Considering that desvenlafaxine is a clear knockoff of Effexor (venlafaxine), yes, I'm sticking with that descriptor. Why do research to develop an innovative medication when you can just sell one that is quite highly similar to the one that is already a sales blockbuster?
The idea is not new – make a drug that very closely resembles your existing product, then get it FDA-approved slightly before the old one goes off patent. Lexapro-Celexa, Invega-Risperdal, and now Effexor-Pristiq. The new drug offers no advantage over the drug that is about to go generic, and why would it – if you have a red 1975 Ford Pinto or a green 1975 Pinto, you still have the same crappy car.
Aren’t patents supposed to protect inventions that possess the potential to benefit people? Aren’t patents supposed to reward creativity? There is no creativity here – we’re talking a slight manipulation of a molecule to create a new compound that is no better than the first one.
But the blame does not just lie with the patent process. Why are physicians prone to fall for this game? Why do so many physicians prescribe Lexapro (escitalopram), which is pert-near a clone of Celexa (citalopram), when Lexapro is much more pricey? In fact according to Walgreens, 90 pills of 10mg generic citalopram will run $127.59, whereas the same supply of Lexapro costs $210.79. The marketing miracle that constitutes the heart and soul of modern psychiatry is damn good at convincing physicians that newer equals better.
Perhaps if physicians received adequate training in research methods and statistics during medical school, they could actually learn to critically review clinical trial data to discover that the ploy of near-clone medicines usually does nothing but increase costs. Then doctors could also laugh their way through continuing medical education or, better yet, insist that CME start to resemble education rather than advertising.
Thursday, March 01, 2007
More on Pristiq
Marissa Miller has a fine post about desvenlafaxine (Pristiq), Wyeth's attempt to cover up for their bestseller Effexor coming off patent in the near future. Coverup? Considering that desvenlafaxine is a clear knockoff of Effexor (venlafaxine), yes, I'm sticking with that descriptor. Why do research to develop an innovative medication when you can just sell one that is quite highly similar to the one that is already a sales blockbuster?
The idea is not new – make a drug that very closely resembles your existing product, then get it FDA-approved slightly before the old one goes off patent. Lexapro-Celexa, Invega-Risperdal, and now Effexor-Pristiq. The new drug offers no advantage over the drug that is about to go generic, and why would it – if you have a red 1975 Ford Pinto or a green 1975 Pinto, you still have the same crappy car.
Aren’t patents supposed to protect inventions that possess the potential to benefit people? Aren’t patents supposed to reward creativity? There is no creativity here – we’re talking a slight manipulation of a molecule to create a new compound that is no better than the first one.
But the blame does not just lie with the patent process. Why are physicians prone to fall for this game? Why do so many physicians prescribe Lexapro (escitalopram), which is pert-near a clone of Celexa (citalopram), when Lexapro is much more pricey? In fact according to Walgreens, 90 pills of 10mg generic citalopram will run $127.59, whereas the same supply of Lexapro costs $210.79. The marketing miracle that constitutes the heart and soul of modern psychiatry is damn good at convincing physicians that newer equals better.
Perhaps if physicians received adequate training in research methods and statistics during medical school, they could actually learn to critically review clinical trial data to discover that the ploy of near-clone medicines usually does nothing but increase costs. Then doctors could also laugh their way through continuing medical education or, better yet, insist that CME start to resemble education rather than advertising.
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Re: Beware of Prestiq
Mon, May 11, 2009 - 10:24 AM1
MEDICATION GUIDE
PristiqTM (pris-TEEK) Extended-Release Tablets
(desvenlafaxine)
Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal
Thoughts or Actions
Read the Medication Guide that comes with you or your family member's antidepressant
medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with
antidepressant medicines. Talk to your, or your family member's, healthcare provider about:
all risks and benefits of treatment with antidepressant medicines
all treatment choices for depression or other serious mental illness
What is the most important information I should know about antidepressant medicines,
depression and other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions in some
children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of
suicidal thoughts and actions. Some people may have a particularly high risk of
having suicidal thoughts or actions. These include people who have (or have a family
history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or
actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a
family member?
Pay close attention to any changes, especially sudden changes, in mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant medicine is
started or when the dose is changed.
Call the healthcare provider right away to report new or sudden changes in mood,
behavior, thoughts, or feelings.
Keep all follow-up visits with the healthcare provider as scheduled. Call the
healthcare provider between visits as needed, especially if you have concerns about
symptoms.
2
Call a healthcare provider right away if you or your family member has any of the
following symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying • trouble sleeping (insomnia)
• attempts to commit suicide • new or worse irritability
• new or worse depression • acting aggressive, being angry, or violent
• new or worse anxiety • acting on dangerous impulses
• feeling very agitated or restless • an extreme increase in activity and talking (mania)
• panic attacks • other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
Never stop an antidepressant medicine without first talking to a healthcare provider.
Stopping an antidepressant medicine suddenly can cause other symptoms.
Antidepressants are medicines used to treat depression and other illnesses. It is
important to discuss all the risks of treating depression and also the risks of not treating it.
Patients and their families or other caregivers should discuss all treatment choices with
the healthcare provider, not just the use of antidepressants.
Antidepressant medicines have other side effects. Talk to the healthcare provider about
the side effects of the medicine prescribed for you or your family member.
Antidepressant medicines can interact with other medicines. Know all of the
medicines that you or your family member takes. Keep a list of all medicines to show the
healthcare provider. Do not start new medicines without first checking with your
healthcare provider.
Not all antidepressant medicines prescribed for children are FDA approved for use
in children. Talk to your child's healthcare provider for more information.
This Medication Guide has been approved by the U.S. Food and Drug Administration for all
antidepressants.
Important Information about Pristiq
Read the patient information that comes with Pristiq before you take Pristiq and each time you
refill your prescription. There may be new information. If you have questions, ask your
healthcare provider. This information does not take the place of talking with your healthcare
provider about your medical condition or treatment.
3
What is Pristiq?
Pristiq is a prescription medicine used to treat depression. Pristiq belongs to a class of
medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).
Pristiq has not been studied or approved for use in children and adolescents.
Who should not take Pristiq?
Do not take Pristiq if you:
are allergic to desvenlafaxine, venlafaxine or any of the ingredients in Pristiq. See the end
of this Medication Guide for a complete list of ingredients in Pristiq.
currently take or have taken within the last 14 days, any medicine known as an MAOI.
Taking an MAOI with certain other medicines, including Pristiq, can cause serious or
even life-threatening side effects. Also, you must wait at least 7 days after you stop
taking Pristiq before you take any MAOI.
What should I tell my healthcare provider before taking Pristiq?
Tell your healthcare provider about all your medical conditions, including if you:
have high blood pressure
have heart problems
have high cholesterol or high triglycerides
have a history of a stroke
have glaucoma
have kidney problems
have liver problems
have or had bleeding problems
have or had seizures or convulsions
have mania or bipolar disorder
have low sodium levels in your blood
are pregnant or plan to become pregnant. It is not known if Pristiq will harm your unborn
baby.
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are breastfeeding. Pristiq can pass into your breast milk and may harm your baby. Talk
with your healthcare provider about the best way to feed your baby if you take Pristiq.
Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions
Rare, but potentially life-threatening, conditions called serotonin syndrome or Neuroleptic
Malignant Syndrome (NMS)-like reactions can happen when medicines such as Pristiq are taken
with certain other medicines. Serotonin syndrome or NMS-like reactions can cause serious
changes in how your brain, muscles and digestive system work. Especially tell your healthcare
provider if you take the following:
medicines to treat migraine headaches known as triptans
medicines used to treat mood disorders, including tricyclics, lithium, selective serotonin
reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs)
silbutramine
tramadol
St. John's Wort
MAOIs (including linezolid, an antibiotic)
tryptophan supplements
Ask your healthcare provider if you are not sure if you are taking any of these medicines.
Before you take Pristiq with any of these medicines, talk to your healthcare provider about
serotonin syndrome. See “What are the possible side effects of Pristiq?”
Pristiq contains the medicine desvenlafaxine. Do not take Pristiq with other medicines
containing venlafaxine or desvenlafaxine.
How should I take Pristiq?
Take Pristiq exactly as your healthcare provider has told you.
Take Pristiq at about the same time each day.
Pristiq may be taken either with or without food.
Swallow Pristiq tablets whole, with fluid. Do not crush, cut, chew, or dissolve Pristiq
tablets because the tablets are time-released.
When you take Pristiq, you may see something in your stool that looks like a tablet. This
is the empty shell from the tablet after the medicine has been absorbed by your body.
5
It is common for antidepressant medicines such as Pristiq to take several weeks before
you start to feel better. Do not stop taking Pristiq if you do not feel results right away.
Do not stop taking or change the dose of Pristiq without talking with your healthcare
provider, even if you feel better.
Talk with your healthcare provider about how long you should use Pristiq. Take Pristiq
for as long as your healthcare provider tells you to.
If you miss a dose of Pristiq, take it as soon as you remember. If it is almost time for your
next dose, skip the missed dose. Do not try to “make up” for the missed dose by taking
two doses at the same time.
Do not take more Pristiq than prescribed by your healthcare provider. If you take more
Pristiq than the amount prescribed, contact your healthcare provider right away.
In case of an overdose of Pristiq, call your healthcare provider or poison control center,
or go to the emergency room right away.
What should I avoid while taking Pristiq?
Do not drive a car or operate machinery until you know how Pristiq affects you.
Avoid drinking alcohol while taking Pristiq.
What are the possible side effects of Pristiq?
Pristiq can cause serious side effects, including:
See the beginning of this Medication Guide - Antidepressant Medicines, Depression
and other Serious Mental Illnesses, and Suicidal Thoughts or Actions.
Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions. See
“What should I tell my healthcare provider before taking Pristiq?”
Get medical help right away if you think that you have these syndromes. Signs and
symptoms of these syndromes may include one or more of the following:
• restlessness • increase in blood pressure
• hallucinations (seeing and hearing things that are not real) • diarrhea
• loss of coordination • coma
• fast heart beat • nausea
• increased body temperature • vomiting
• muscle stiffness • confusion
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Pristiq may also cause other serious side effects, including:
New or worsened high blood pressure (hypertension). Your healthcare provider
should monitor your blood pressure before and while you are taking Pristiq. If you have
high blood pressure, it should be controlled before you start taking Pristiq.
Abnormal bleeding or bruising. Pristiq and other SNRIs/SSRIs may cause you to have
an increased chance of bleeding. Taking aspirin, NSAIDs (non-steroidal antiinflammatory
drugs), or blood thinners may add to this risk. Tell your healthcare provider
right away about any unusual bleeding or bruising.
Glaucoma (increased eye pressure)
Increased cholesterol and triglyceride levels in your blood
Symptoms when stopping Pristiq (discontinuation symptoms). Side effects may occur
when stopping Pristiq (discontinuation symptoms), especially when therapy is stopped
suddenly. Your healthcare provider may want to decrease your dose slowly to help avoid
side effects. Some of these side effects may include:
• dizziness • anxiety
• nausea • abnormal dreams
• headache • tiredness
• irritability • sweating
• sleeping problems (insomnia) • diarrhea
Seizures (convulsions)
Low sodium levels in your blood. Symptoms of this may include: headache, difficulty
concentrating, memory changes, confusion, weakness and unsteadiness on your feet. In
severe or more sudden cases, symptoms can include: hallucinations (seeing or hearing
things that are not real), fainting, seizures and coma. If not treated, severe low sodium
levels could be fatal.
Contact your healthcare provider if you think you have any of these side effects.
7
Common side effects with Pristiq include:
• nausea • tiredness
• headache • diarrhea
• dry mouth • vomiting
• sweating • anxiety
• dizziness • tremor
• insomnia • dilated pupils
• constipation • decreased sex drive
• loss of appetite • delayed orgasm and ejaculation
• sleepiness
These are not all the possible side effects of Pristiq. Tell your healthcare provider about any side
effect that bothers you or does not go away. Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088. For more information on these
and other side effects associated with Pristiq, talk to your healthcare provider, visit our web site
at www.pristiq.com or call our toll-free number at 1-888-Pristiq.
How should I store Pristiq?
Store Pristiq at 68° to 77°F (20° to 25°C).
Do not use Pristiq after the expiration date (EXP), which is on the container. The
expiration date refers to the last day of that month.
Keep Pristiq and all medicines out of the reach of children.
General Information about the safe and effective use of Pristiq
Medicines are sometimes used for conditions that are not mentioned in Medication Guides. Do
not use Pristiq for a condition for which it was not prescribed. Do not give Pristiq to other
people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Pristiq. If you would
like more information, talk with your healthcare provider. You can ask your pharmacist or
healthcare provider for information about Pristiq that is written for healthcare professionals. For
more information, go to www.pristiq.com or call 1-888-Pristiq (774-7847).
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What are the ingredients in Pristiq?
Active ingredient: desvenlafaxine
Inactive ingredients: hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film
coating which consists of sodium carboxymethylcellulose, maltodextrin, dextrose, titanium
dioxide, stearic acid and iron oxide(s).
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued February 2009.
Contact Information
Please visit our web site at www.pristiq.com, or call our toll-free number 1-888-Pristiq to receive
more information.
This product's label may have been updated. For current package insert and
further product information, please visit www.wyeth.com or call our medical
communications department toll-free at 1-800-934-5556.
Wyeth®
Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101
W10530P003
ET01
Rev 02/09
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Re: Beware of Prestiq
Wed, June 10, 2009 - 3:12 PMHad to get off Prestiq after 3 months(getting irritable and more depressed). My shrink now has me on tryptophan and SAM-e. Is helping as much as the the big drug companies poison without all the side effects. I will keep using these for maintenence when the depression is gone, something I would never do with the antidepressant poison. -
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Re: Beware of Prestiq
Sat, June 13, 2009 - 3:45 PMThank you for the imput Ron. Because Prestiq is so new it will be quite awile befor the truth gets out on this one.
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