- Thread starter Angry Me
- Start date
Re: Prestiq
Pristiq is an antidepressant medication just recently released by Wyeth. It is intended as a follow up to Effexor, which will be eligible for generic manufacturers in the near future.
We don't have information on Pristiq at the moment, but I will do some research and get back to you in a few days.
Please return to this thread in a couple of days.
In the meantime, would you share some information?
Is this the first antidepressant you have ever taken or was it a switch?
What has been your experience with Pristiq so far from the point of view of bothersome adverse effects?
In what Country are you located?
Thank you for bringing Pristiq to our attention.
Pristiq is an antidepressant medication just recently released by Wyeth. It is intended as a follow up to Effexor, which will be eligible for generic manufacturers in the near future.
We don't have information on Pristiq at the moment, but I will do some research and get back to you in a few days.
Please return to this thread in a couple of days.
In the meantime, would you share some information?
Is this the first antidepressant you have ever taken or was it a switch?
What has been your experience with Pristiq so far from the point of view of bothersome adverse effects?
In what Country are you located?
Thank you for bringing Pristiq to our attention.
Re: Prestiq
Prestiq is one of many in a line of anti-depressants I've taken over the last 20 years. I've always had side effects from everything else so we've made changes and tried combinations and recently thought I could be weaned down or off of my meds. However, I found out that I will always need something no matter how hard I try. So because of all of the issues with other drugs I was asked to try Prestiq. Just an FYI I take Lamictal in addition.
I live in the United States. The side affects are relatively minor compared to other meds I've been on. A little sleepy but not serious and seems to be subsiding. Basically I don't 'feel'. I'm not angry and I'm not crying because of sadness. I just feel like I don't care. Not happy and disinterested in doing things like being social, going to church, cleaning house, going to work. I do go to work but its very stressful. I know circumstances (divorce, effects of Katrina, financial stress, bad job) add to the equation but I can't seem to feel happiness. I get excited about nothing...even for things that would have previously made me happy or excited. Just wondering if my feelings are being blunted by meds or if I've just learned not to allow myself to feel.
Prestiq is one of many in a line of anti-depressants I've taken over the last 20 years. I've always had side effects from everything else so we've made changes and tried combinations and recently thought I could be weaned down or off of my meds. However, I found out that I will always need something no matter how hard I try. So because of all of the issues with other drugs I was asked to try Prestiq. Just an FYI I take Lamictal in addition.
I live in the United States. The side affects are relatively minor compared to other meds I've been on. A little sleepy but not serious and seems to be subsiding. Basically I don't 'feel'. I'm not angry and I'm not crying because of sadness. I just feel like I don't care. Not happy and disinterested in doing things like being social, going to church, cleaning house, going to work. I do go to work but its very stressful. I know circumstances (divorce, effects of Katrina, financial stress, bad job) add to the equation but I can't seem to feel happiness. I get excited about nothing...even for things that would have previously made me happy or excited. Just wondering if my feelings are being blunted by meds or if I've just learned not to allow myself to feel.
Re: Prestiq
Thanks for the additional info, and that you are in the U.S. I'll check to see if Wyeth has launched in Canada yet.
Give me a couple of days to do my research.
In the meantime perhaps someone else would comment on the way your feelings are responding.
I gather you were adversely affected by Katrina.
Thanks for the additional info, and that you are in the U.S. I'll check to see if Wyeth has launched in Canada yet.
Give me a couple of days to do my research.
In the meantime perhaps someone else would comment on the way your feelings are responding.
I gather you were adversely affected by Katrina.
Cat Dancer
MVP
Re: Prestiq
I've been on Prozac for over a year and I have similar feelings, numbness, lack of reaction to anything, lack of emotion. I don't cry over the things I used to cry over. I don't really laugh or feel happy. I just kind of exist. But it's really better than the overload of emotion I used to feel. I just keep hoping it will level out and I will feel something again.
I've been on Prozac for over a year and I have similar feelings, numbness, lack of reaction to anything, lack of emotion. I don't cry over the things I used to cry over. I don't really laugh or feel happy. I just kind of exist. But it's really better than the overload of emotion I used to feel. I just keep hoping it will level out and I will feel something again.
I believe this medication is available in the U.S. for the time being and has not been launched in Canada yet.
We are hoping for more information, but in the meantime here is the Wyeth press release:
02 / 29 / 2008
FDA Approves Pristiq for the Treatment of Adult Patients with Major Depressive Disorder
Madison, N.J., February 29, 2008 ? Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the U.S. Food and Drug Administration (FDA) has approved PRISTIQ? (desvenlafaxine),
a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD). Wyeth expects to begin shipping PRISTIQ to wholesalers beginning in the second quarter of 2008.
?We are pleased to be able to bring PRISTIQ to patients,? says Bernard Poussot, President and Chief Executive Officer of Wyeth. ?PRISTIQ is Wyeth?s fourth new drug to receive approval in the last twelve months, demonstrating our ability to achieve success through the rigorous scientific process of discovery and development. We look forward to working with FDA and other regulatory authorities around the world to continue to bring important new medicines to patients who need them.?
?PRISTIQ is an important new therapeutic option for patients and clinicians because no single therapy works for all people with major depression,? says Philip Ninan, M.D., Vice President of Wyeth Medical Affairs, Neuroscience. ?PRISTIQ is approved at a once-daily 50-mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose. We are encouraged by the tolerability profile seen in clinical studies.?
FDA approval was subject to several post-marketing commitments, including conducting and submitting data from a new long-term maintenance (relapse prevention) study, a sexual dysfunction study, pediatric studies and a study exploring lower doses. The agency also requested an additional non-clinical toxicity study.
The efficacy of PRISTIQ as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for MDD. At the recommended dose of 50 mg, the discontinuation rate due to an adverse experience for PRISTIQ (4.1 percent) was similar to the rate for placebo (3.8 percent).
Side effects of many antidepressant therapies can cause some patients to stop taking their medication. The most commonly observed adverse reactions in patients taking PRISTIQ for MDD in short-term, fixed-dose studies (incidence >5 percent and at least twice the rate of placebo in the 50 or 100 mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence (sleepiness), decreased appetite, anxiety, and specific male sexual function disorders.
About PRISTIQ
PRISTIQ delivers the major active metabolite of EFFEXOR XR? (venlafaxine HCl) in its active state without going through the CYP2D6 metabolic pathway. This could be beneficial when PRISTIQ is
coadministered with other commonly prescribed medications metabolized through that pathway. EFFEXOR XR, discovered and developed by Wyeth, was the first SNRI approved by the FDA for MDD and is currently the most widely prescribed antidepressant in the world.
PRISTIQ, also discovered and developed by Wyeth, demonstrates the Company?s significant and continued commitment to developing new therapies in the field of neuroscience.
About Major Depressive Disorder
Major depressive disorder (MDD) is a common mental disorder, affecting about 121 million people worldwide. In the United States, MDD affects approximately 15 million adults, or 6.7 percent of the U.S. population age 18 and older in a given year. In fact, depression is among the leading causes of disability and the fourth leading contributor to the global burden of disease. Further, a research study estimated that the total economic burden of depression was $83.1 billion in 2000, including direct treatment costs and suicide- and work-related costs.
MDD is a serious medical condition that is different from ?feeling blue? and is not something that people just ?get over.? Criteria for MDD include five or more of the following symptoms that have been present for at least two weeks, and at least one of the symptoms must be either depressed mood or loss of interest or pleasure: depressed mood; loss of interest or pleasure; changes in appetite or weight; changes in sleeping patterns; psychomotor agitation or retardation; fatigue or low energy; feeling worthless or guilty for no reason; difficulty thinking or concentrating; or thoughts of death or suicide. Further, people with MDD must experience clinically significant distress or impairment in social, occupational or other important areas of functioning.
Important Treatment Considerations for Antidepressants
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially when starting therapy or at times of dose changes.
PRISTIQ is not approved for use in pediatric patients.
Important Treatment Considerations for PRISTIQ
PRISTIQ is indicated for the treatment of major depressive disorder in adults.
Contraindications
PRISTIQ is contraindicated in patients with a known hypersensitivity to PRISTIQ or venlafaxine.
PRISTIQ must not be used concomitantly with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI.
Warnings and Precautions
All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients.
Development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including PRISTIQ, particularly with concomitant use of serotonergic drugs, including triptans. If concomitant use is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Concomitant use of PRISTIQ with serotonin precursors is not recommended.
Patients receiving PRISTIQ should have regular monitoring of blood pressure since sustained increases in blood pressure were observed in clinical studies. Pre-existing hypertension should be controlled before starting PRISTIQ. Caution should be exercised in treating patients with pre-existing hypertension or other underlying conditions that might be compromised by increases in blood pressure. Cases of elevated blood pressure requiring immediate treatment have been reported.
SSRIs and SNRIs, including PRISTIQ, may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to this risk.
Mydriasis has been reported in association with PRISTIQ; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
As with all antidepressants, PRISTIQ should be used cautiously in patients with a history or family history of mania or hypomania.
Caution is advised in administering PRISTIQ to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders. Increases in blood pressure and small increases in heart rate were observed in clinical studies with PRISTIQ.
Dose-related elevations in fasting serum total cholesterol, LDL (low density lipoprotein) cholesterol, and triglycerides were observed in clinical studies. Measurement of serum lipids should be considered during PRISTIQ treatment.
Symptoms associated with discontinuation of PRISTIQ have been reported. Patients should be monitored for symptoms when discontinuing treatment. A gradual reduction in dose rather than abrupt cessation is recommended whenever possible.
Dosage adjustment (50 mg every other day) is necessary in patients with severe renal impairment or end-stage renal disease (ESRD). The dose should not be escalated in patients with moderate or severe renal impairment or ESRD.
Products containing desvenlafaxine and products containing venlafaxine should not be used concomitantly with PRISTIQ.
Adverse Reactions
The most commonly observed adverse reactions in patients taking PRISTIQ for MDD in short-term fixed-dose premarketing studies (incidence >5% and twice the rate of placebo in the 50- or 100-mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.
Full prescribing information for PRISTIQ will be available at Pristiq.com.
Important Treatment Considerations for EFFEXOR XR
EFFEXOR XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs).
Adult and pediatric patients taking antidepressants can experience worsening of their depression and/or the emergence of suicidality. All patients should be monitored appropriately and observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms.
The development of potentially life-threatening serotonin syndrome may occur when EFFEXOR XR is coadministered with other drugs that may affect the serotonergic neurotransmitter systems. Concomitant use of EFFEXOR XR with MAOIs is contraindicated. If concomitant use of EFFEXOR XR with an SSRI, SNRI, or a triptan is clinically warranted, careful observation of the patient is advised. Concomitant use of EFFEXOR XR with tryptophan supplements is not recommended.
Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Postmarketing cases of elevated BP requiring immediate treatment have been reported. Pre-existing hypertension should be controlled. Regular BP monitoring is recommended.
SSRIs and SNRIs, including EFFEXOR XR, may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to this risk.
Mydriasis has been reported in association with venlafaxine; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually.
The most common adverse events reported in EFFEXOR XR short-term placebo-controlled MDD, generalized anxiety disorder (GAD), social anxiety disorder (SAD), and/or panic disorder (PD) trials (incidence >10% and >2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating.
For full prescribing information for EFFEXOR XR, please go to EFFEXOR XR: A Depression and Anxiety Disorders Treatment
.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women?s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world?s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company?s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, there can be no assurance that PRISTIQ will be commercially successful in the highly competitive market for antidepressants in the United States, or that PRISTIQ will be approved in the future for other indications (including treatment of vasomotor symptoms associated with menopause) and/or in other countries. Other risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and our pipeline products (including future regulatory action regarding our other pending applications for desvenlafaxine for the treatment of major depressive disorder and the treatment of vasomotor symptoms, as to which no assurance can be given); government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption ?Item 1A, RISK FACTORS.? The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
We are hoping for more information, but in the meantime here is the Wyeth press release:
02 / 29 / 2008
FDA Approves Pristiq for the Treatment of Adult Patients with Major Depressive Disorder
Madison, N.J., February 29, 2008 ? Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the U.S. Food and Drug Administration (FDA) has approved PRISTIQ? (desvenlafaxine),
a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD). Wyeth expects to begin shipping PRISTIQ to wholesalers beginning in the second quarter of 2008.
?We are pleased to be able to bring PRISTIQ to patients,? says Bernard Poussot, President and Chief Executive Officer of Wyeth. ?PRISTIQ is Wyeth?s fourth new drug to receive approval in the last twelve months, demonstrating our ability to achieve success through the rigorous scientific process of discovery and development. We look forward to working with FDA and other regulatory authorities around the world to continue to bring important new medicines to patients who need them.?
?PRISTIQ is an important new therapeutic option for patients and clinicians because no single therapy works for all people with major depression,? says Philip Ninan, M.D., Vice President of Wyeth Medical Affairs, Neuroscience. ?PRISTIQ is approved at a once-daily 50-mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose. We are encouraged by the tolerability profile seen in clinical studies.?
FDA approval was subject to several post-marketing commitments, including conducting and submitting data from a new long-term maintenance (relapse prevention) study, a sexual dysfunction study, pediatric studies and a study exploring lower doses. The agency also requested an additional non-clinical toxicity study.
The efficacy of PRISTIQ as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for MDD. At the recommended dose of 50 mg, the discontinuation rate due to an adverse experience for PRISTIQ (4.1 percent) was similar to the rate for placebo (3.8 percent).
Side effects of many antidepressant therapies can cause some patients to stop taking their medication. The most commonly observed adverse reactions in patients taking PRISTIQ for MDD in short-term, fixed-dose studies (incidence >5 percent and at least twice the rate of placebo in the 50 or 100 mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence (sleepiness), decreased appetite, anxiety, and specific male sexual function disorders.
About PRISTIQ
PRISTIQ delivers the major active metabolite of EFFEXOR XR? (venlafaxine HCl) in its active state without going through the CYP2D6 metabolic pathway. This could be beneficial when PRISTIQ is
coadministered with other commonly prescribed medications metabolized through that pathway. EFFEXOR XR, discovered and developed by Wyeth, was the first SNRI approved by the FDA for MDD and is currently the most widely prescribed antidepressant in the world.
PRISTIQ, also discovered and developed by Wyeth, demonstrates the Company?s significant and continued commitment to developing new therapies in the field of neuroscience.
About Major Depressive Disorder
Major depressive disorder (MDD) is a common mental disorder, affecting about 121 million people worldwide. In the United States, MDD affects approximately 15 million adults, or 6.7 percent of the U.S. population age 18 and older in a given year. In fact, depression is among the leading causes of disability and the fourth leading contributor to the global burden of disease. Further, a research study estimated that the total economic burden of depression was $83.1 billion in 2000, including direct treatment costs and suicide- and work-related costs.
MDD is a serious medical condition that is different from ?feeling blue? and is not something that people just ?get over.? Criteria for MDD include five or more of the following symptoms that have been present for at least two weeks, and at least one of the symptoms must be either depressed mood or loss of interest or pleasure: depressed mood; loss of interest or pleasure; changes in appetite or weight; changes in sleeping patterns; psychomotor agitation or retardation; fatigue or low energy; feeling worthless or guilty for no reason; difficulty thinking or concentrating; or thoughts of death or suicide. Further, people with MDD must experience clinically significant distress or impairment in social, occupational or other important areas of functioning.
Important Treatment Considerations for Antidepressants
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially when starting therapy or at times of dose changes.
PRISTIQ is not approved for use in pediatric patients.
Important Treatment Considerations for PRISTIQ
PRISTIQ is indicated for the treatment of major depressive disorder in adults.
Contraindications
PRISTIQ is contraindicated in patients with a known hypersensitivity to PRISTIQ or venlafaxine.
PRISTIQ must not be used concomitantly with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI.
Warnings and Precautions
All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients.
Development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including PRISTIQ, particularly with concomitant use of serotonergic drugs, including triptans. If concomitant use is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Concomitant use of PRISTIQ with serotonin precursors is not recommended.
Patients receiving PRISTIQ should have regular monitoring of blood pressure since sustained increases in blood pressure were observed in clinical studies. Pre-existing hypertension should be controlled before starting PRISTIQ. Caution should be exercised in treating patients with pre-existing hypertension or other underlying conditions that might be compromised by increases in blood pressure. Cases of elevated blood pressure requiring immediate treatment have been reported.
SSRIs and SNRIs, including PRISTIQ, may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to this risk.
Mydriasis has been reported in association with PRISTIQ; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
As with all antidepressants, PRISTIQ should be used cautiously in patients with a history or family history of mania or hypomania.
Caution is advised in administering PRISTIQ to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders. Increases in blood pressure and small increases in heart rate were observed in clinical studies with PRISTIQ.
Dose-related elevations in fasting serum total cholesterol, LDL (low density lipoprotein) cholesterol, and triglycerides were observed in clinical studies. Measurement of serum lipids should be considered during PRISTIQ treatment.
Symptoms associated with discontinuation of PRISTIQ have been reported. Patients should be monitored for symptoms when discontinuing treatment. A gradual reduction in dose rather than abrupt cessation is recommended whenever possible.
Dosage adjustment (50 mg every other day) is necessary in patients with severe renal impairment or end-stage renal disease (ESRD). The dose should not be escalated in patients with moderate or severe renal impairment or ESRD.
Products containing desvenlafaxine and products containing venlafaxine should not be used concomitantly with PRISTIQ.
Adverse Reactions
The most commonly observed adverse reactions in patients taking PRISTIQ for MDD in short-term fixed-dose premarketing studies (incidence >5% and twice the rate of placebo in the 50- or 100-mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.
Full prescribing information for PRISTIQ will be available at Pristiq.com.
Important Treatment Considerations for EFFEXOR XR
EFFEXOR XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs).
Adult and pediatric patients taking antidepressants can experience worsening of their depression and/or the emergence of suicidality. All patients should be monitored appropriately and observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms.
The development of potentially life-threatening serotonin syndrome may occur when EFFEXOR XR is coadministered with other drugs that may affect the serotonergic neurotransmitter systems. Concomitant use of EFFEXOR XR with MAOIs is contraindicated. If concomitant use of EFFEXOR XR with an SSRI, SNRI, or a triptan is clinically warranted, careful observation of the patient is advised. Concomitant use of EFFEXOR XR with tryptophan supplements is not recommended.
Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Postmarketing cases of elevated BP requiring immediate treatment have been reported. Pre-existing hypertension should be controlled. Regular BP monitoring is recommended.
SSRIs and SNRIs, including EFFEXOR XR, may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to this risk.
Mydriasis has been reported in association with venlafaxine; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually.
The most common adverse events reported in EFFEXOR XR short-term placebo-controlled MDD, generalized anxiety disorder (GAD), social anxiety disorder (SAD), and/or panic disorder (PD) trials (incidence >10% and >2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating.
For full prescribing information for EFFEXOR XR, please go to EFFEXOR XR: A Depression and Anxiety Disorders Treatment
.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women?s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world?s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company?s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, there can be no assurance that PRISTIQ will be commercially successful in the highly competitive market for antidepressants in the United States, or that PRISTIQ will be approved in the future for other indications (including treatment of vasomotor symptoms associated with menopause) and/or in other countries. Other risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and our pipeline products (including future regulatory action regarding our other pending applications for desvenlafaxine for the treatment of major depressive disorder and the treatment of vasomotor symptoms, as to which no assurance can be given); government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption ?Item 1A, RISK FACTORS.? The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Angry Me said:
I am inclined to think it could be more of the latter since that is my experience.
According to the Health Canada database of approved medications, Pristiq (desvenlafaxine) is not listed at this time.
It is possible they may be planning for a Fall launch.
PS. Updated information on Canadian availability: See Post # 16 in this thread
It is possible they may be planning for a Fall launch.
PS. Updated information on Canadian availability: See Post # 16 in this thread
Last edited:
Steve,
Thanks for the follow up. Prestiq was only recently released here in the U.S. It had only been available publically for a week when my doctor prescribed it to me.
Yes I was adversely affected by Katrina. I really thought I had been really lucky because I didn't lose my house. However, I lost my job and while I thought it would be a brief loss of income, I had to take a 30% cut in pay and still have not found a job of the caliber that matches my expertise.
Janet,
I had been on Prozac years ago but I was married at the time and my husband felt like it made me "zombie-like" and affected my sexual appetite as well so I switched to something else. Just before I went on the Prestiq I went back on Prozac but just for the 10 days prior to my cycle to see if that would eliminate the need for daily medications (for 2 months before that I was medication free but had regressed tremendously especially just prior to my period). After a couple of months of that experiment we determined that I just have too many stressors in my life to expect to be completely free of medications at any time soon. And I think I've finally accepted that - its just finding the right med without the awful side effects that allow me to feel happy and not just a lack of sadness and anger.
Thanks for the follow up. Prestiq was only recently released here in the U.S. It had only been available publically for a week when my doctor prescribed it to me.
Yes I was adversely affected by Katrina. I really thought I had been really lucky because I didn't lose my house. However, I lost my job and while I thought it would be a brief loss of income, I had to take a 30% cut in pay and still have not found a job of the caliber that matches my expertise.
Janet,
I had been on Prozac years ago but I was married at the time and my husband felt like it made me "zombie-like" and affected my sexual appetite as well so I switched to something else. Just before I went on the Prestiq I went back on Prozac but just for the 10 days prior to my cycle to see if that would eliminate the need for daily medications (for 2 months before that I was medication free but had regressed tremendously especially just prior to my period). After a couple of months of that experiment we determined that I just have too many stressors in my life to expect to be completely free of medications at any time soon. And I think I've finally accepted that - its just finding the right med without the awful side effects that allow me to feel happy and not just a lack of sadness and anger.
I assume, Angry Me, you have already tried Wellbutrin and Lexapro?
suewatters1
Member
I was just given 2 weeks worth of Pristiq to try so it must just have gotten approved recently. I have been reading the literature and I can't find the information about when does a person start to feel it working. I know most drugs it takes 8 weeks to get the full effect but it gradually start working at a certain point. I wonder when will I feel the difference with this medication the small improvements?
Sue
Sue
David Baxter PhD
Late Founder
With medications like this, some people start to feel the benefits within the first week; more commonly, it will take a few weeks (up to 4-6 weeks) to recognize benefits.
However, that is true for people just starting on SSRI/SNRI medications. If I remember correctly, you have been already taking medications within this family. If so, you can expect noticeable benefits more quickly.
However, that is true for people just starting on SSRI/SNRI medications. If I remember correctly, you have been already taking medications within this family. If so, you can expect noticeable benefits more quickly.
suewatters1
Member
Thank You DR Baxter. I am taking Generic Wellbutrin Lorazepam Concerta Lyrica Propanalol.
I think with the Welbutrin is it a Norepinephrine Reuptake Inhibitors?
Thanks Again
Sue
I think with the Welbutrin is it a Norepinephrine Reuptake Inhibitors?
Thanks Again
Sue
Based on a query to the Drug Product Database of Health Canada, Pristiq is now available in Canada, manufactured by Wyeth Canada.
This is taken from the Canadian Pristiq Product monograph:
Medications should not be discontinued before consulting with the prescriber, and instructions for discontinuation should be closely followed to avoid adverse reactions.
Attachment:
version Canadian Product Monograph, Source Health Canada DPD
This is taken from the Canadian Pristiq Product monograph:
Medications should not be discontinued before consulting with the prescriber, and instructions for discontinuation should be closely followed to avoid adverse reactions.
Attachment:
version Canadian Product Monograph, Source Health Canada DPD
David Baxter PhD
Late Founder
No. Wellbutrin isn't really in the same family as the SSRI or SNRI medications. It appears to directly affect dopamine rather than serotonin or norepinephrine. It is, however, sometimes used to treat depression or to offset some of the side-effects of SSRIs.
- Lorazepam (Ativan) is a tranquilizer - benzodiazepine family
- Concerta is an ADHD medication
- Lyrica is typically used in the treatment of either fibromyalgia or epilepsy
- Propanalol is a beta blocker used to treat high blood pressure or other heart and circulatory system issues
justhere
Member
I feel for you! i have been there, though on a different med: cymbalta. feeling numb in many ways, well, short term may be necessary to stop the emotional overwhelming feelings, but in my opinion, i switched meds because i no longer felt anything! who wants to live like a breathing zombie
justhere
Member
Update I spoke with my doctor about Pristiq, which after reading this forum and confirmed by my dr, it is not so new, it is Effexor minus some components that could cause adverse side effects. I know when I tried Effexor I had spliting godawful headaches! But for now, my zoloft and lamictal combo, along with therapy and diet management, are what I will continue with
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