August 22nd, 2011
Daily Finance
By: Melly Alazraki
Does the market have you thinking about getting a little pharmacological help to ease your jitters and lift your mood? Getting a prescription for Prozac is easier than you think. In fact, you can skip the appointment with a psychiatrist altogether.
A study released last week in Health Affairs journal found a growing trend of doctors who aren’t psychiatrists offering antidepressants to patients. The meds often get prescribed without any psychiatric diagnosis, simply to boost someone’s mood, relieve mild anxiety, or improve sleep. Worse yet, there’s no evidence these drugs actually help such patients.
All these questionable prescriptions helped make this class of drugs one of the most commonly prescribed in the U.S. In 2010, according to IMS Health data, antidepressants spending grew to $11.6 billion. The class was the second most prescribed after cholesterol regulators and heart meds, with nearly 254 million prescriptions.
It’s No Secret Who’s Really Smiling
The growth in antidepressant use brings a smile to at least one group of people: Big Pharma.
While Eli Lilly’s (LLY) Prozac has long lost its patent protection, U.S. Cymbalta sales for 2010 grew 9% to $2.8 billion, topping the $758 million mark in the most recent second quarter. Bristol-Myers Squibb’s (BMY) Abilify U.S. sales grew by 5% in the recent quarter, to 517 million. AstraZeneca’s (AZN) second-quarter U.S. sales of Seroquel XR grew 14% to $205 million. (Both Seroquel XR and Abilify are atypical antipsychotics approved by the FDA as adjunct treatments for depression that doesn’t respond to a selective serotonin re-uptake inhibitor like Prozac or Zoloft alone.)
The study made no mention of any illegal marketing practices by pharmaceuticals that may have contributed to this trend, although such allegations regarding off-label marketing are certainly not foreign to AstraZeneca or Eli Lilly, among many others.
However, the study said that direct-to-consumer advertising could be causing patients to request the drugs. The U.S. and New Zealand are the only countries that allow advertising for prescription medications.
Do We Have a Drug Problem?
The researchers are concerned that this growing trend of non-psychiatrists prescribing antidepressants could mean that the drugs get prescribed inappropriately. They worry that patients who haven’t been properly diagnosed are not receiving the best care they need. The study suggests starting by educating physicians on mental disorders, the drugs, and their appropriate use.
The researchers also encourage patients to ask questions — lots of them, including questions about the diagnoses, the side effects, possible alternative treatments, and whether antidepressants are the right treatment for their problems in the first place.
Click here for the full report from Daily Finance
Tags: antidepressant prescriptions, antidepressants, anxiety, AstraZeneca, Big Pharma, Bristol-Myers Squibb, cholesterol, doctors, Eli Lilly, jitters, mood, patients, pharmacological, prescription, Prozac, psychiatrist, Zoloft
July 11, 2011
New York Times
By Laurie Tarkan
A new study found an elevated risk of autism in children whose mothers took a popular type of antidepressant during the year before delivery. But the authors reassured women taking these drugs — so-called S.S.R.I.’s like Prozac, Zoloft, Celexa and Lexapro — that the risk was still quite low: 2.1 percent in children whose mothers used them in the year before delivery, and 2.3 percent in the first trimester of pregnancy.
Dr. Joseph Coyle, the editor in chief of the psychiatry journal, called the two studies “game changers.”
Clara Lajonchere, an author of the twin study and vice president of clinical programs for the research and advocacy organization Autism Speaks, said that “much more emphasis is going to be put on looking at prenatal and perinatal factors with respect to autism susceptibility.”
She added, “We need to not just study the environmental factors, but the relation between the genes and the environment.”
“For pregnant women or those thinking about having a family,” she said, “prenatal care is critical, and if a pregnant woman is taking any kinds of medication, she should work closely with a physician.”
Click here for the full report from the New York Times.
Tags: antidepressants, autism, babies, Celexa, children, drugs, Lexapro, pregnancy, Prozac, risk, Zoloft
August 13th, 2010
Natural News
By: Jonathan Benson
A new report published in the Cochrane Database of Systematic Reviews has once again found that the antidepressants commonly prescribed to children with autism are not effective at improving behavior. After evaluating seven different studies about selective serotonin reuptake inhibitors (SSRIs) and autism, the team says there is no evidence that they work any better than a placebo at helping autistic children.
The U.S. Food and Drug Administration (FDA) has not approved any medications to specifically treat autism, but they have approved three SSRIs — sertraline (Zoloft), fluoxetine (Prozac) and fluvoxamine (Luvox) — to alleviate certain symptoms of the illness. But according to the research, it appears these drugs are being needlessly prescribed because they do not provide any benefits.
The new study hinges upon a government-funded investigation last year that found that the antidepressant citalopram (Celexa) is no better than a placebo at alleviating autism symptoms. Upon further investigation, researchers came to realize that all related studies on other antidepressants revealed the same thing.
Besides not working, these antidepressants often cause major side effects, especially in young people. In the citalopram study, one child participant developed severe seizures from taking the drug. Even after being taken off it, the child continued to have seizures. Other children taking it had a hard time sleeping and concentrating.
The team recommends that children continue to take these medications if they seem to be helping and are not inducing side effects, but it remains to be seen whether or not the findings will affect how doctors prescribe SSRIs to autistic children going forward.
Click Here For The Full Article
Tags: antidepressants, autism, behavior, Celexa, citalopram, Cochrane Database of Systematic Reviews, drug, evidence, FDA, fluoxetine, fluvoxamine, government-funded, illness, luvox, major side effects, placebo, prescription, Prozac, seizures, selective, serotonin reuptake inhibitors, sertraline, severe, SSRIs, studies, young people, Zoloft
June 10, 2010
Natural News
By S.L. Baker
(NaturalNews) Of the 35 million Americans who are age 65 or older, the National Institutes of Health (NIH) claims about 7 million of them suffer from clinical depression — and millions are on the prescription antidepressant drugs known as selective serotonin reuptake inhibitors (SSRIs) such as Prozac, Paxil, Lexapro and Zoloft. Hyped by Big Pharma as the way to solve depression problems in all age groups, these medications come with a litany of serious side effects, including some that are particularly dangerous for elders.
For example, a University of Minnesota study found SSRIs increase the rate of bone loss in older men and women. And now there’s even more reason for seniors to be wary of taking SSRIs. New research just published in Ophthalmology, the journal of the American Academy of Ophthalmology, concludes taking these antidepressants substantially raises the risk of sight-threatening cataracts.
A cataract is a clouding of the lens in the eye that affects vision. In fact, as cataracts progress, they can cause enough deterioration of eyesight that surgery is needed to remove them. Although cataracts are common in older people, there are many factors that can increase a person’s risk of actually developing the eye problem, including exposure to cigarette smoke, air pollution, and heavy alcohol consumption. And now you can add taking SSRIs to that list.
Click here for the full report.
Tags: alcohol, antidepressants, cataracts, Cigarette, Clinical, consumption, depression, Health, inhibitors, Lexapro, million, ophthamology, Paxil, pollution, Prozac, risk, SSRIs, substantially, Zoloft
April 5, 2010
Wall Street Journal
By Shirley S. Wang and Melanie Trottman
The Federal Aviation Administration will let some pilots who take four popular antidepressants return to the skies, saying Friday that it is easing its long-standing ban on psychiatric medications.
The old policy stemmed in part from concerns over possible side effects of psychiatric drugs, including sedation. But newer medications have fewer side effects, and pilots’ associations have pressured the agency to reconsider the ban.
FAA Administrator Randy Babbitt said some pilots with depression likely weren’t being treated or were doing so in secret out of fear of losing their jobs. “We need to change the culture and remove the stigma associated with depression,” said Mr. Babbitt.
Starting Monday, the agency will consider granting waivers that will allow pilots to fly while taking Prozac, Zoloft, Celexa or Lexapro, as well as their generic equivalents.
Medical experts and mental-health organizations supported the move, noting that untreated depression itself has an impact on job performance. They cautioned that the FAA needed to monitor the changes and keep pilots’ confidentiality in mind.
Another risk: If some pilots who come forward aren’t granted waivers, the agency may inadvertently discourage others from doing so, said Ken Duckworth, a psychiatrist and medical director of the National Alliance on Mental Illness, an advocacy organization.
The Air Line Pilots Association, the world’s largest pilot union, backed the move. “This policy change should improve aviation safety and pilot health,” it said in a statement.
The FAA says it can’t estimate how many pilots might come forward but believes pilots’ depression rate doesn’t differ much from that of the general population, about 10%.
Antidepressants are the fourth biggest-selling class of drugs in the U.S., netting nearly $10 billion in sales in 2009. For the four antidepressants, nearly 75 million prescriptions were dispensed in the U.S. last year, according to IMS Health, which tracks prescription-drug sales.
The new policy doesn’t mean pilots who want to begin taking one of the medications can get in the cockpit right away. Before being granted a waiver by a physician certified by the FAA, a pilot must be considered “satisfactorily treated” for 12 months; in the meantime, he or she will be grounded.
For pilots who have been secretly taking antidepressants, the FAA is offering a grace period. The agency said it wouldn’t take action against such pilots if they come forward within six months. However, pilots with a recent case of depression or who want to begin a new medication regimen will be subject to the one-year waiting period, according to FAA spokeswoman Alison Duquette. “We’re really looking for stability,” she said.
Pilots must be examined by an aviation medical examiner every six months to one year to be recertified. They are required disclose what medications they are taking; lying on the form is considered a federal offense. The FAA says it doesn’t track the number of pilots who have been grounded because they are taking psychiatric medications.
Psychiatrists said it usually takes three to six weeks for an antidepressant to begin taking effect, and doctors should have a good sense of how people are responding within three months. It takes an additional six months or so to get a sense of whether the depression will recur while on the medication.
The four medications that are allowed by the new policies are part of the so-called SSRI family. They work by preventing a brain chemical called serotonin from being reabsorbed by neurons. Their most common side effects are nausea and sexual dysfunction, said psychiatrists.
The FAA said it would consider allowing other psychiatric medicines in the future.
Psychiatrists say that it is far better to encourage pilots to get help than allow them to fly with untreated mental illness. “Untreated depression affects cognition probably more than any possible detrimental effect of any of these antidepressants,” said P. Murali Doraiswamy, a professor of biological psychiatry at Duke University Medical Center.
Click here for the full report.
Tags: Air Line Pilots Association, antidepressants, ban, Celexa, FAA, Federal Aviation Administration, Lexapro, lifted, piolots, Prozac, psychiatric drugs, side effects, Zoloft
March 26, 2010
ABC News
By: Martha Raddatz and Michael Murray
After years on the battlefield or in the trenches, many American soldiers are showing signs of psychological distress. An increasing number of soldiers are turning to medication to alleviate their symptoms.
From the isolated outposts of Afghanistan to the bloody streets of Fallujah in Iraq, U.S. troops have been fighting, dying and suffering unbearable emotional scars. A 2008 Rand Corporation study found under 20 percent of soldiers reported psychological distress in some form.
Some have unfortunately committed suicide, but ABC News has been told that an increasing number — at least 8 percent of the force — are now using pills to treat themselves. Some are turning to antidepressants, such as Prozac, Zoloft and Paxil, which are prescribed right on the front lines.
“We are sending soldiers into the field, into combat missions, who are suicidal,” said former Air Force psychologist Jason Prinster. “And we are prescribing medication that has significant side effects.”
He also told ABC News that the Army’s culture of treating physical injuries as more serious than psychological ones can lead to bad operating procedure, in his opinion. “If your leg is broken, if you have a physical problem, you can stay inside the wire. If you are anxious, afraid, hopeless, it’s not OK,” he said.
Soldiers say the side effects can affect their combat readiness; some medications cause sluggishness and disorientation. Army Sgt. Chuck Luther told ABC News that “some would make me more depressed, some would make me jittery.”
Soldier Said He Was Given Prescriptions, No Therapy
Luther was an Army sergeant based in Taji, Iraq. He told ABC News he didn’t get therapy for his emotional problems, just drugs to help him make it through his deployment.
“Mortars would come in & suicide bombers. It was taking a toll on me and then seeing fellow soldiers being killed in front of you.”
ABC News asked Col. John Looper, an Army psychologist stationed in Iraq, what he thought of the prescriptions. “If the treating clinician feels that a given service member might be restored to full functioning with a course of antidepressant medication or anti-anxiety medication, we have the wherewithal to do that,” he told us.
The military is making an effort to provide therapy to service members having mental health issues, but given the remoteness of some bases, it is not always possible, and remains a real concern.
Click here for the full report.
Tags: Afghanistan, American soldiers, antidepressants, Chuck Luther, Fallujah, Iraq, Jason Prinster, John Looper, Paxil, Prozac, psychological distress, Rand Corporation, Taji, Zoloft
March 24, 2010
ABC World News
By Martha Raddatz and Michael Murray
After years on the battlefield or in the trenches, many American soldiers are showing signs of psychological distress. An increasing number of soldiers are turning to medication to alleviate their symptoms.
From the isolated outposts of Afghanistan to the bloody streets of Fallujah in Iraq, U.S. troops have been fighting, dying and suffering unbearable emotional scars. A 2008 Rand Corporation study found under 20 percent of soldiers reported psychological distress in some form.
Some have unfortunately committed suicide, but ABC News has been told that an increasing number — at least 8 percent of the force — are now using pills to treat themselves. Some are turning to antidepressants, such as Prozac, Zoloft and Paxil, which are prescribed right on the front lines.
“We are sending soldiers into the field, into combat missions, who are suicidal,” said former Air Force psychologist Jason Prinster. “And we are prescribing medication that has significant side effects.”
He also told ABC News that the Army’s culture of treating physical injuries as more serious than psychological ones can lead to bad operating procedure, in his opinion. “If your leg is broken, if you have a physical problem, you can stay inside the wire. If you are anxious, afraid, hopeless, it’s not OK,” he said.
Soldiers say the side effects can affect their combat readiness; some medications cause sluggishness and disorientation. Army Sgt. Chuck Luther told ABC News that “some would make me more depressed, some would make me jittery.”
Soldier Said He Was Given Prescriptions, No Therapy
Luther was an Army sergeant based in Taji, Iraq. He told ABC News he didn’t get therapy for his emotional problems, just drugs to help him make it through his deployment.
“Mortars would come in … suicide bombers. It was taking a toll on me … and then seeing fellow soldiers being killed in front of you.”
ABC News asked Col. John Looper, an Army psychologist stationed in Iraq, what he thought of the prescriptions. “If the treating clinician feels that a given service member might be restored to full functioning with a course of antidepressant medication or anti-anxiety medication, we have the wherewithal to do that,” he told us.
The military is making an effort to provide therapy to service members having mental health issues, but given the remoteness of some bases, it is not always possible, and remains a real concern.
Click here for the full report
Tags: antidepressants, drugs, dying, emotional scars, fighting, Paxil, Prozac, psychiatric problems, side effects, suffering, troops, Zoloft
January 27th, 2010
WebMD Health News
By Salynn Boyles
Early research suggests a link between antidepressant use and breastfeeding difficulties in new moms.
The risk of delayed lactation after giving birth was twice as great among women in the study taking selective serotonin reuptake inhibitor (SSRI) antidepressants as among new mothers who did not take the drugs.
Just eight, or about 2%, of the 431 study participants were taking the antidepressants, however, so the findings are far from conclusive.
But the study is the first to explore the impact of antidepressant use on lactation in humans.
“Delayed lactation is very common in the United States, but we don’t really understand the reasons for it,” researcher Nelson D. Horseman, PhD, of the University of Cincinnati College of Medicine tells WebMD. “This may end up being one of the few concrete explanations for at least some of the delayed lactation we see.
“Earlier research in Nelson’s lab found that the hormone serotonin plays a role in breast function, including the ability to secrete milk when needed.
The finding led the researchers to wonder if drugs that affect serotonin levels, such as SSRI antidepressants, would also affect the ability of the breasts to secrete milk when needed.
SSRIs are the most widely prescribed antidepressants. They include the drugs Zoloft, Celexa, Prozac, Paxil, and Lexapro.
In an effort to answer the question, Nelson and colleagues followed 431 first-time mothers from childbirth through the first days of motherhood.
For the purposes of the study, the researchers considered breastfeeding delayed when a woman did not have copious milk production within three days, or 72 hours, of giving birth.
All the women in the study were eventually able to breastfeed, whether they were taking antidepressants or not.
But the average time to lactation for the eight women taking SSRIs was almost 86 hours after childbirth, which was almost a day later than the average time it took women who did not take the antidepressants to establish a milk supply.
Lactation specialist Laurie Nommsen-Rivers, PhD, tells WebMD that this extra day can be the difference between success or failure for women anxious to provide their babies nutrition.
A co-author of the study, Nommsen-Rivers is also an epidemiologist with Cincinnati Children’s Hospital Medical Center. “That delay can be the point where many women throwing in the towel and decide they can’t breastfeed,” she says. “It is important to point out that all the women in our study eventually lactated. SSRI use doesn’t prevent women from breastfeeding, but it might take SSRI users a little longer.
“Nommsen-Rivers says that while all new moms should have access to breastfeeding support, such support may be especially important for new moms who take antidepressants.
The study appears in the February issue of the Journal of Clinical Endocrinology and Metabolism.
“These women need to know that delay doesn’t mean it isn’t going to happen,” she says.
Texas Tech University Medical School health psychologist and lactation consultant Kathleen Kendall-Tackett, PhD, points to numerous studies that have explored the impact of SSRIs on babies born to women who use them.
“To my knowledge this lactation delay has not been documented before,” she tells WebMD. “I would guess that if this is happening, it is rare.”
She points out that pregnant women are at the highest risk for depression in their last trimester and in the early weeks after giving birth.
While she feels too many women may be taking antidepressants when other treatments might work for them, Kendall-Tackett also warns that moms-to-be and new moms should never stop taking SSRIs or any other prescribed antidepressant without their doctor’s approval.
“Generally speaking, if a woman is on an antidepressant during the last trimester of pregnancy she probably needs to stay on it, and she should never go off it on her own,” she says.
Click here for the full report
Tags: Antidepressant, breast-feeding, Celexa, endocrinology, Lexapro, metabolism, Paxil, PhD, pregnancy, Prozac, SSRI, Zoloft
August 19, 2009
ABC News
By Matthew Perrone
Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.
An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.
Known as the CASPPER program, the paper explains how the company can help physicians with everything from “developing a topic,” to “submitting the manuscript for publication.”
The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.
A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.
“The program was not heavily used and was discontinued a number of years ago,” said Mary Anne Rhyne.
According to the memo, which dates from April 2000, the CASPPER program was designed to “strengthen the product positioning and overcome competitive issues.”
At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly’s Prozac and Pfizer’s Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.
Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.
But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry’s influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.
According to ghostwriting expert Dr. Leemon McHenry, Glaxo’s program was unusually intertwined with its internal sales and marketing department.
“We know that GSK has engaged in ghostwriting for many years,” said McHenry, who works as a research consultant for Baum Hedlund. “But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients.”
McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.
“If these ghostwritten publications are contributing to the harm of patients because they’re making false claims, then that’s illegal,” McHenry said.
Articles from the company’s program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.
Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.
Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo’s memo seems to acknowledge: “Physicians will be eager to participate in CASPPER regardless of their professional stature,” the brief notes.
Click here for the full report from ABC News
Tags: Antidepressant, birth defects, CASPPER, ghostwriting, Glaxo, GlaxoSmithKline, medical journal articles, Paxil, Prozac, suicidal behavior, Zoloft
August 11, 2009
Reuters
By Julie Steenhuysen
People under age 25 who take antidepressants have a higher risk of suicide, but adults older than that do not, an analysis by U.S. Food and Drug Administration researchers released on Tuesday showed.
The report by the FDA scientists confirms earlier studies and supports the agency’s age-related warnings on the drugs’ labeling.
U.S. and European regulators have been sounding alarms on the use of antidepressant drugs since 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in those under age 18.
In February 2005, the FDA added a so-called black box warning — the agency’s strongest warning — on the use of all antidepressants in young children and teens to draw attention to the possible risks of these medications. In May 2007, it extended the warnings to young adults aged 18 to 24.
Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment for depression, the leading cause of suicide. In fact, recent studies have suggested the warnings triggered an 8 percent rise in suicide among youth and teens in 2004, the biggest one-year gain in 15 years.
A LASTING DECLINE
A study published in June in the journal Archives of General Psychiatry said the FDA’s decision to impose black box warnings for children and young adults had a spillover effect on depression care in older adults, resulting in a lasting decline in depression diagnosis and treatment.
Those researchers urged the FDA to revise its policy.
The FDA analysis by Dr. Marc Stone, Dr. Thomas Laughren and colleagues involved a review of data from eight drug makers on 372 clinical trials involving nearly 100,000 adults.
Overall, they found the risk of suicide was “strongly age-dependent,” with higher risks in people under 25, no difference among those 25 to 64, and lower risks in people 65 and older.
The researchers said the findings, published on the British Medical Journal website, support the agency’s warnings on antidepressant drug labeling for people under 25, and they also support the notion that antidepressant drugs can have two distinct effects.
In some patients, they can promote suicidal thoughts or behavior — but this risk appears to diminish with age. In others, the drugs provide relief from depression, reducing the risk of suicide. They said more research is needed to understand these differences.
John Geddes from the University of Oxford and colleagues said in a commentary the findings were not new and noted that the trials studied by the FDA excluded sicker patients. The study did, however, make clear differences in risks among specific antidepressants, they said.
They noted specific differences in commonly used drugs called selective serotonin reuptake inhibitors, or SSRIs.
For example, the odds of suicidal behavior by people taking Pfizer Inc’s Zoloft, or sertraline, were around half of those who took placebo. By comparison, Forest Laboratories Inc’s Celexa, or citalopram, and Lexapro, or escitalopram, “seem to increase the risk of suicidal events,” Geddes and colleagues wrote.
“Increased risk is probably restricted to younger people and varies greatly between individual medicines.”
Click here for the full report from Reuters
Tags: antidepressants, black box warning, Celexa, citalopram, depression, escitalopram, FDA, Lexapro, regulators, selective serotonin reuptake inhibitors, sertraline, SSRIs, suicide, Zoloft
Next Page »
