A JAMA study by Ellen W Freeman shows that Lexapro is “marginally” more effective than placebo for Hot Flashes
A JAMA study by Ellen W Freeman shows that Lexapro is “marginally” more effective than placebo for Hot Flashes. This is laughable, and surely you must be joking? The authors received money from Forest labs, the makers of Lexapro for a “seeding study”. This is a form of marketing, designed to convince doctors to prescribe the drug for non-approved usage. Last year, Forest Labs paid a 313 million fine for Lexapro fraud. They haven’t learned their lesson or changed their behavior. This Lexapro study is another example of corruption in medical research. The Lexapro study should have been rejected from the start by the NIH and the ethics review board of the hospital. Using an SSRI antidepressant such as Lexapro for women with hot flashes is an outrage and a form of medical victimization. Prescribing Lexapro or any other psycho-active drug for menopauseal hot flashes is NOT FDA approved, and is OFF-Label use. This practice should be discouraged.
Above Left image courtesy of wikimedia commons, Lexapro Pills.
JAMA Says SSRIs are No Better Than Placebos for Depression
Regarding SSRI drugs for depression (drugs like Prozac, Zoloft, Lexapro, Paxil, Wellbutrin, etc) SSRI drugs were shown to be no better than placebo for most people with depression (reference: JAMA 2010;303 ). This disappointing performance of SSRI drugs was discussed in my previous article .
Medical Research Reaches a New Low Point
SSRI antidepressant drugs are addictive, dependency type drugs with adverse side effects including loss of sexual function, agitation, movement disorder, violence and suicide. Abrupty stopping Lexapro (Escitalopram) may cause withdrawal symptoms such as “electric shock” sensations (also known as “brain shivers” or “brain zaps”), dizziness, acute depressions and irritability, as well as akathisia. See this message board to read messages describing Lexapro adverse effects. Lexapro is manufactured by Forest Labs, a company guilty of fraud in marketing of Lexapro.
Forest Labs – Guilty of Lexapro Fraud – Pays $313 Million Settlement
In 2009, Forest Labs was accused of fraud by the US Justice department for illegally marketing Lexapro for unapproved uses in children and teenagers, even though studies showed the drug was ineffective and harmful. The company also ran “seeding studies”, or drug trials that were really a form of marketing to promote Lexapro use by doctors, same as this new JAMA study using the drug for menopausal symptoms of Hot Flashes. Forest labs admitted guilt and settled the criminal and civil complaints for a 313 milion dollar fine in Sept 2010.
Dr Barbara Mintzes of the Therapeutics Inititiative Speaks Out:
A Non-Clinically Significant Difference of Lexapro Compared to Placebo
Barbara Mintzes , an assistant professor with the Therapeutics Initiative at the University of B.C. Mintzes called the results “underwhelming to the extreme.” She also said the difference on the “hot flash bother” scales between the two groups was below a level that would be considered clinically relevant. 55 per cent of the women in the Lexapro drug group versus 36 per cent in the placebo group reported a decrease of at least 50 per cent in “hot flash frequency. These are “manipulated numbers”.
Publicly Funded NIH Study
This JAMA study is an outrage, a cruel farce and a hoax. The funding for this Lexapro JAMA study came from the NIH. Why is the NIH using public funds for this kind of study? What will they study next? Rat poison or drain cleaner for relief of hot flashes? This JAMA study reveals that medical research has reached a new low point in the history of western medicine.
Why spend time effort and money trying to show an ineffective addictive dangerous psych drug is more effective than placebo for a non-FDA approved indication – ie. Treatment for hot flahses? Number one, the SSRI drugs were shown to be no better than placebo for depression. Number two the drug makers are looking for another use for the SSRI family of drugs. Number three: the drug makers are paying a lot of money for this type of nonsense research. Number four: This is a “seeding study”, a form of marketing intended to convince doctors to use the drug for a non-approved use. As such, it is “easy money” from drug makers.
The JAMA Authors Financial Disclosures:
Dr Freeman receives money from Forest Laboratories (maker of Lexapro), Wyeth, Pfizer, Xanodyne Pharmaceuticals. Pherin Pharmaceuticals and Bayer.
Dr Cohen recieves money from Forest Labs , Astra-Zeneca ; Sepracor; Bayer HealthCare; Bristol-Myers; Stanley Foundation; Ortho-McNeill Jansen; Pfizer. Eli Lilly; GlaxoSmithKline; JDS/Noven Pharmaceuticals; Wyeth-Ayerst Pharmaceuticals; Eli Lilly, GlaxosmithKline; Pfizer, Inc, and Wyeth-Ayerst Pharmaceuticals.
Dr Joffer eceives money from Forest Labs, Astra-Zeneca, Bayer HealthCare, Eli Lilly, GlaxoSmithKline, Sanofi-Events, Sepracor, Inc, and Wyeth-Ayerst Pharmaceuticals
Hot Flashes Are Caused By Hormone Deficiency of Menopause
Menopausal symptoms are not caused by a Lexapro deficiency. They are caused by hormone deficiency. SSRI drugs are addictive Psychiatric drugs that do not address the hormone deficiency of menopause. To suggest them as a treatment for hormone deficiency is ludicrous, and creates a new population of women as medical victims.
Safe and Effective Treatment : BioIdentical Hormones
The safest and most effective treatment for menopausal symptoms of hot flashes a biodentical hormone program. Progestins and other synthetic hormones are associated with increased risk of cancer and heart disease. On the other hand, progesterone and Bioidentical Hormones are safe, effective and are not associated with increased risk of cancer or heart disease. That is why bioidentical hormones are the preferred treatment .
Don’t Be a Lexapro Victim
Would you trust a person who admits guilt and pays a fine for fraud? Of course not. The behavior is likely to be repeated. Why take a chance? Why would anyone trust Forest Labs’ Lexapro? Don’t be a medical victim. Avoid the SSRI for menopause trap.
Doctors who can get you off Lexapro SSRI’s and onto Bioidentical Hormones:
Articles with Related Content:
The Safety of Bioidentical Hormones.
Links and References
Use of antidepressant to treat hot flashes raises concern By Sharon Kirkey, Postmedia News
Overall, 55 per cent of the women in the drug group versus 36 per cent taking a placebo reported a decrease of at least 50 per cent in “hot flash frequency,” according to the study, published in the Journal of the American Medical Association.
But the prospect of large numbers of essentially healthy women being treated “off label” with psychiatric drugs for symptoms of menopause is making critics uneasy.
“You’re looking at something that is actually a drug for a fairly serious psychiatric disorder that is being used for something that is a normal part of menopause,” says Barbara Mintzes, an assistant professor with the Therapeutics Initiative at the University of B.C. Mintzes called the results “underwhelming to the extreme.” She also said the difference on the “hot flash bother” scales between the two groups was below a level that would be considered clinically relevant.
Lexapro Feedback and Side Effects
Efficacy of Escitalopram for Hot Flashes in Healthy Menopausal WomenA Randomized Controlled Trial Ellen W. Freeman, PhD;
Context Concerns regarding the risks associated with estrogen and progesterone to manage menopausal symptoms have resulted in its declining use and increased interest in nonhormonal treatments with demonstrated efficacy for hot flashes.
Objective To determine the efficacy and tolerability of 10 to 20 mg/d escitalopram, a selective serotonin reuptake inhibitor, in alleviating the frequency, severity, and bother of menopausal hot flashes.
Design, Setting, and Patients A multicenter, 8-week, randomized, double-blind, placebo-controlled, parallel group trial that enrolled 205 women (95 African American; 102 white; 8 other) between July 2009 and June 2010.
Intervention Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks.
Main Outcome Measures Primary outcomes were the frequency and severity of hot flashes assessed by prospective daily diaries at weeks 4 and 8. Secondary outcomes were hot flash bother, recorded on daily diaries, and clinical improvement (defined as hot flash frequency ≥50% decrease from baseline).
Results Mean (SD) daily hot flash frequency was 9.78 (5.60) at baseline. In a modified intent-to-treat analysis that included all randomized participants who provided hot flash diary data, the mean difference in hot flash frequency reduction was 1.41 (95% CI, 0.13-2.69) fewer hot flashes per day at week 8 among women taking escitalopram (P < .001), with mean reductions of 4.60 (95% CI, 3.74-5.47) and 3.20 (95% CI, 2.24-4.15) hot flashes per day in the escitalopram and placebo groups, respectively. Fifty-five percent of women in the escitalopram group vs 36% in the placebo group reported a decrease of at least 50% in hot flash frequency (P = .009) at the 8-week follow-up. Reductions in hot flash severity scores were significantly greater in the escitalopram group (−0.52; 95% CI, −0.64 to −0.40 vs −0.30; 95% CI, −0.42 to −0.17 for placebo; P < .001). Race did not significantly modify the treatment effect (P = .62). Overall discontinuation due to adverse events was 4% (7 in the active group, 2 in the placebo group). Three weeks after treatment ended, women in the escitalopram group reported a mean 1.59 (95% CI, 0.55-2.63; P = .02) more hot flashes per day than women in the placebo group.
Conclusion Among healthy women, the use of escitalopram (10-20 mg/d) compared with placebo resulted in fewer and less severe menopausal hot flashes at 8 weeks of follow-up.
Antidepressant Lexapro cuts hot flashes: study By Julie Steenhuysen
CHICAGO | Tue Jan 18, 2011 5:33pm EST
While the difference in the effect between the Lexapro and placebo groups was modest, it was statistically significant.
Women in the Lexapro group also were significantly more likely to want to continue on their assigned medication, with 64 percent of women taking Lexapro saying they wanted to stay on the study drug versus 42 percent who took the placebo.
Antidepressants relieve hot flashes By Rob Stein
An antidepressant can help alleviate hot flashes that plague many menopausal women, according to new federally funded research.
Forest’s Lexapro Antidepressant Eases Hot Flashes for Menopausal Women
By Nicole Ostrow – Jan 18, 2011 4:00 PM ET
Antidepressant Might Help Ease Hot Flashes
Lexapro could prove an alternative for women who can’t use hormone therapy, study suggestsBy Serena Gordon
TUESDAY, Jan. 18 (HealthDay News) — The antidepressant medication escitalopram (brand name Lexapro) reduced the frequency and severity of hot flashes in older women, according to new research.
Women in the study experienced nearly 10 hot flashes a day at the start of the study, but those were cut to an average of just over five hot flashes a day in women receiving the antidepressant compared to about 6.5 per day in women receiving a placebo.
“Although hormone treatment is the usual treatment for hot flashes, and it is effective, for women who don’t want to assume the potential risks of hormone therapy, this is another option,” said the study’s lead author, Ellen Freeman, a research professor in the department of obstetrics and gynecology at the University of Pennsylvania School of Medicine.
“We found that after eight weeks of treatment with escitalopram, women had many fewer hot flashes a day compared to those on placebo,” she added.
Results of the study, funded by the U.S. National Institutes of Health, are published in the Jan. 19 issue of the Journal of the American Medical Association.
Hormone therapy has traditionally been the most common treatment offered to women experiencing hot flashes as part of the menopausal transition. However, when the Women’s Health Initiative study reported in 2002 that hormonal therapy had potentially serious risks, many women decided the benefits didn’t outweigh the potential hazards. Since that finding, experts have been able to better identify which women might have a greater risk from hormone therapy, and those for whom hormones are a possible option.
“For some appropriate women — meaning those without contraindications — the short-term use of estrogen or hormone therapy may still be a viable option. And [for these women] we use the lowest dose for the shortest time possible,” explained Dr. Judi Chervenak, a reproductive endocrinologist at Montefiore Medical Center in New York City.
“But, for women for whom hormones aren’t an option, or those who don’t want to take hormones, SSRIs [antidepressants] and SSRI-like medication are another option,” Chervenak said.
Selective serotonin reuptake inhibitors (SSRIs) are approved by the U.S. Food and Drug Administration for the treatment of depression, but doctors sometimes prescribe them for “off-label” (non FDA-approved) uses, such as for treating pain or — as in the study — for the relief of hot flashes. SSRIs include drugs such as Celexa, Lexapro, Paxil, Prozac and Zoloft.
A generic version of Lexapro isn’t yet available in the United States, according to the FDA. The cost of a month’s supply of the drug varies, but a 20-milligram per day dose is approximately $110 for 30 days.
The current trial included 205 women between the ages of 40 and 62 who were either beginning menopause or who had finished the menopause transition in the past year. To be included in the study, the women had to experience at least 28 hot flashes per week that they would classify as bothersome or severe; most women had more than that.
The women were randomly assigned to receive escitalopram (between 10 and 20 milligrams per day) or a placebo for eight weeks.
The researchers found that 55 percent of the women in the escitalopram group reported at least a 50 percent reduction in the frequency of their hot flashes, compared to 36 percent of those in the placebo group. The escitalopram group also reported a decrease in hot flash severity.
Within three weeks of stopping the medication, women in the escitalopram group had an increase of about 1.5 more hot flashes a day than those in the placebo group, the investigators noted.
Side effects were minimal, said Freeman. Just 4 percent of the escitalopram group dropped out due to adverse side effects.
Exactly how escitalopram helps relieve hot flashes isn’t known, according to Freeman. And, she noted, the exact cause of hot flashes still isn’t clear.
“Hot flashes are so distressing to so many women that to have any potential new option is appreciated. This isn’t the be-all, end-all treatment, but it’s another option that we have to offer patients with hot flashes,” said Chervenak.
She added that for women who don’t wish to take medication, one of the best ways to reduce hot flashes is to keep a symptom diary to see if you can figure out what might be causing your hot flashes so you can avoid it. For example, she said, many women experience a hot flash after drinking red wine. Other potential triggers include caffeine, chocolate, spicy foods and stressful situations.
Lexepro for Hot Flashes is merely another example of the medical victimization of women. SSRI antidepressants were shown to be no better than placebo for depression (JAMA2010;303(1):47-53). This new JAMA study shows that Lexepro is “marginally” more effective than placebo for Hot Flashes. This is laughable. Surely you must be joking? SSRI drugs are addictive drugs with adverse side effects including loss of sexual function, akasthesis, agitation, movement disorders and violence and suicide. The proper, correct and effective treatment for hot flashes and all other menopausal symptoms is a biodentical hormone program which is safe and not associated with the increased cancer and heart disease risk found with synthetic hormones. for more information see my blog at jeffreydach (dot) com.
Lexapro Warnings & Precautions
Escitalopram discontinuation, particularly abruptly may cause certain withdrawal symptoms such as “electric shock” sensations (also known as “brain shivers” or “brain zaps”), dizziness, acute depressions and irritability, as well as heightened senses of akathisia.
Forest’s Lexapro Antidepressant Eases Hot Flashes for Menopausal Women
By Nicole Ostrow – Jan 18, 2011 4:00 PM ET
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Freeman reported research support from Forest Laboratories, Inc, Wyeth, Pfizer and Xanodyne Pharmaceuticals; honoraria for consulting and presentations from Wyeth, Forest Laboratories, Inc, Pherin Pharmaceuticals and Bayer Health Care. Dr Cohen reported research support from National Alliance for Research on Schizophrenia and Depression; Astra-Zeneca Pharmaceuticals; Sepracor, Inc; Bayer HealthCare; Bristol-Myers; Stanley Foundation; Ortho-McNeill Jansen; Pfizer, Inc. Advisory/Consulting: Eli Lilly; GlaxoSmithKline; JDS/Noven Pharmaceuticals; Wyeth-Ayerst Pharmaceuticals; Honoraria, Eli Lilly, Forest Laboratories, Inc; GlaxosmithKline; Pfizer, Inc, and Wyeth-Ayerst Pharmaceuticals. Dr Joffe reported research support from Astra-Zeneca Pharmaceuticals, Bayer HealthCare, Eli Lilly, Forest Laboratories, Inc, GlaxoSmithKline, Sanofi-Events (product support only), Sepracor, Inc, and Wyeth-Ayerst Pharmaceuticals; speaking honoraria, Eli Lilly, GlaxoSmithKline; Advisory/Consulting, Abbott Laboratories, Eli Lilly, Forest Laboratories, Inc, JDS-Noven Pharmaceuticals, Sanofi-Events, Sepracor Inc, and Wyeth-Ayerst Pharmaceuticals. No other authors reported having a financial conflict of interest
Dr. Freeman reported research support and honoraria for consulting and presentations from Forest Laboratories Inc (makers of escitalopram), as well as financial arrangements with Wyeth, Pfizer, Xanodyne Pharmaceuticals, Pherin Pharmaceuticals and Bayer Health Care. Among her 14 other coauthors, 2 disclosed consulting or speaking honoraria or research support from Forest Laboratories as well as other companies and the rest reported no conflicts of interest. Dr. McIntyre does not receive any support from Forest Laboratories but he disclosed research grants, CME, advisory board and speakers bureau activity with multiple pharmaceutical companies. Dr. Gass has no personal arrangements with industry; however, NAMS receives unrestricted educational grants from multiple pharmaceutical companies. Forest Research Institute provided the drug and placebo but had no role in the design or conduct of the study, the collection, management, analysis and interpretation of the data, or the preparation of the manuscript.
Disclosure: Ellen W. Freeman, PhD, has disclosed that she owns stock, stock options, or bonds in Pfizer, and that she has received grants for clinical research from Wyeth and Xanodyne. Dr. Freeman has also disclosed that she has served as an advisor or consultant to Wyeth and Pherin Pharmaceuticals. Dr. Freeman has also disclosed that she has received medication for clinical research from Pfizer.
Escitalopram and placebo provided by Forest Research Institute.
Several of the study authors disclosed financial relationships with the pharmaceutical industry, including Forest Laboratories, Inc.
Ellen W. Freeman, PhD, serves on an advisory board or panel for Wyeth, has received grant and research support from Wyeth, Pfizer, and Xanodyne, and is a consultant
for Wyeth and Pherin Pharmaceuticals
Drug names: alprazolam (Xanax and others), bromocriptine (Parlodel
and others), buspirone (BuSpar and others), citalopram (Celexa),
clomipramine (Anafranil and others), danazol (Danocrine and others),
fluoxetine (Sarafem and others), fluvoxamine (Luvox and others),
goserelin (Zoladex), leuprolide (Lupron, Eligard, and others),
mefenamic acid (Ponstel), nafarelin (Synarel), naproxen (Anaprox,
Naprosyn, and others), nefazodone (Serzone), paroxetine (Paxil),
sertraline (Zoloft), spironolactone (Aldactone and others), venlafaxine
Use of antidepressant to treat hot flashes raises concern By Sharon Kirkey, Postmedia News
Facts About Zoloft And Hot Flashes by Menopause defeated on January 23, 2011 in Hot Flashes
By: Patsy Hamilton
Menopause and Antidepressants MENOPAUSE & ANTIDEPRESSANTS – By Frank J. Nuber . With the controversy about hormone replacement therapy, menopausal women and healthcare providers short on time (and often patience) are turning to antidepressants to ease hot flashes in menopause. Such a simplistic, one-size fits all approach may be enticing for all of us….except that menopause is not a mental health disorder. I also find that many physicians that argue that Bioidentical Hormones are not FDA approved are using antidepressants that have not been approved for menopausal symptoms, called off label use.
Forest Labs Maker of Lexepro Accused of Fraud
Drug Maker Is Accused of Fraud By BARRY MEIER and BENEDICT CAREY Published: February 25, 2009
The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.
In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.
From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives, the complaint said.
An official of Forest, which is based in Manhattan, said the company’s lawyers were reviewing the complaint and did not have an immediate comment. Celexa and Lexapro are two versions of the same drug, citalopram. The drugs are currently approved by the Food and Drug Administration only for adults.
By failing to disclose the negative trial results, prosecutors said in the complaint, “Forest told prescribing physicians a half-truth and thereby prevented them and the public from having all potentially available information when making decisions about how to treat a serious medical condition in pediatric patients.”
Doctors are free to prescribe drugs to patients, including children, for whom those drugs are not approved by federal regulators. But it is illegal for companies to actively promote such uses.
The filing follows a long-running federal investigation that began with complaints filed by two former company officials. Under the civil charges brought against Forest, the government is seeking to recover up to three times the amount of money spent by federal programs to pay for pediatric prescriptions of Celexa and Lexapro, but did not specify a figure.
Prosecutors also charged that Forest paid kickbacks, in the form of baseball tickets and gift certificates to expensive restaurants, to doctors who prescribed its drugs, and provided some doctors with paid vacations. The complaint also charges that the company separately ran so-called seeding studies, or trials that were really marketing efforts to promote the drugs’ use by doctors.
Forest, Maker of Celexa, to Pay More Than $313 Million to Settle Marketing CaseBy NATASHA SINGER Published: September 15, 2010
A unit of Forest Laboratories, the maker of the antidepressant Celexa, agreed on Wednesday to pay more than $313 million to settle criminal and civil complaints, including a claim that it had illegally promoted the drug for use in children.
Discussion Board Links:
Disclaimer click here: http://www.drdach.com/wst_page20.html
The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician. Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician — patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur.