October 12, 2011
The Huffington Post
By: Dr. Peter Breggin
My October 3, 2011 blog on The Huffington Post described a recent precedent-setting criminal case in which a Winnipeg, Manitoba judge confirmed my written opinion and courtroom testimony that Prozac adverse drug effects drove a 16-year-old boy to stab a friend to death. I have now made the judge’s opinion available online and also as a part of my more extensive report on the case on my website.
In the case of “C.J.P,” Judge Robert Heinrichs concluded, “Dr. Breggin’s explanation of the effect Prozac was having on C.J.P.’s behavior both before that day and in committing an impulsive, inexplicable violent act that day corresponds with the evidence” (p. 18). My written report in the case stated, “At the time of the assault, [C.J.P] was suffering from a Prozac-Induced Mood Disorder (292.84) with manic features (especially extreme irritability) caused by Prozac. I want to emphasize that, within a reasonable degree of medical certainty, he would not have become violent without the exposure to Prozac, and he will not become violent again.”
Judge Heinrichs also found, “There is clear medical and collateral evidence that the Prozac affected his behavior and judgment, thereby reducing his moral culpability” (p. 20). In my report I observed that C.J.P.’s adverse reactions to Prozac exactly paralleled the description of adverse drug reactions contained in the FDA-approved label for Prozac, including the “emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down” (p. 8). C.J.P. had deteriorated emotionally over a three month period on Prozac, including an increase in dosage 17 days prior to the assault.
The case of C.J.P. and its violent outcome can be compared to a similar case that I describe in “Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime.” A very gentle teenage girl whom I called Emily Ashton developed a sudden urge to thrust a knife into her mother’s back during her second week of taking Prozac. Like C. J. P., she was 16 years old; but unlike him, she showed no outward signs of a worsening mental condition and displayed no anger at all until the sudden compulsive urge to stab her mother began to overtake her. At the time, there were no angry conflicts in the family. Fortunately, Emily told her mother about the bizarre and violent compulsion. As in C.J.P.’s case, Emily’s mother knew that violence was wholly out of character for her daughter and she suspected the Prozac.
Again as in C.J.P.’s case, Emily’s mother took her back to her prescribing family doctor who then referred her to a psychiatrist. There the comparison ends. Unlike C.J.P.’s tragic case, the consultant psychiatrist recognized the problem as Prozac-induced and immediately stopped the anti-depressant, after which the compulsion gradually subsided. Emily went on to live a normal, productive adult life and to raise a family. Nonetheless, she continued to feel guilty about her violent impulse that overcame her at the age of 16. She felt relieved many years later when we talked and I was able to reassure her that the impulse had been chemically-driven by the drug.
All of the newer anti-depressants carry the same warnings as Prozac concerning “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression and suicidal ideation.” These drugs include Celexa, Lexapro, Luvox, Prozac or Serafem, Paxil, Cymbalta, Effexor, Wellbutrin or Zyban, and Pristiq.
Many tragic acts of suicide and violence could be averted by reducing or stopping the use of anti-depressant drugs, by greater professional and public awareness of the dangers associated with these drugs, by withdrawal from the drugs at the earliest sign of mental and behavioral deterioration, and by greater reliance on individual and family psychotherapy.
The effectiveness of anti-depressants has been increasingly called into question. At the same, the risk of withdrawing from them has become more obvious, and cutting back or stopping them requires experienced clinical supervision and a slow, cautious taper. Many psychotherapists successfully treat depressed patients without resort to these drugs.
Click here for the full report from The Huffington Post
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.
September 20, 2010
A major U.S. drug company, Forest Pharmaceuticals, has agreed to plead guilty to three charges related to selling an unapproved drug, promoting an antidepressant to children and obstructing federal agents.
The company is facing fines and criminal penalties of over $300 million.
The charges date back more than 10 years when Forest was promoting its antidepressant, Celexa, for pediatric use when it was only approved for use in adults. Celexa is a selective serotonin reuptake inhibitor. In some children and teens it’s been linked to suicide and suicidal thoughts.
Forest was also convicted of marketing its thyroid drug Levothroid without getting FDA approval. When the company was ordered to stop selling the drug in 2003, it increased production rather than scaling down. It also ignored a subsequent warning letter.
A new formulation of Levothroid is now on the market with full approval. In Canada it’s sold under the name Levothyroxine. The drug was approved by Health Canada in 2002.
The third count, a felony charge of obstruction, relates to false statements company employees made to federal inspectors during a 2003 FDA inspection at a Forest Pharmaceuticals plant.
“These charges should serve as a warning to industry,” said Deborah Autor, director of the compliance office at the FDA’s centre for drug evaluation and research.
“Any company that operates in violation of the FDCA [Food Drug and Cosmetics Act] and ignores FDA’s warnings should be aware that a criminal action could follow.”
Forest has also agreed to settle civil claims related to the disribution of Levothroid and the promotion of Celexa to children.
The drug company will pay $149 million to the U.S. government and state Medicaid agencies. In settling the claims Forest denies the allegations made in the suit.
“We are pleased to bring closure to this long-running investigation,” said Howard Soloman, the chairman and CEO of Forest.
“We have continued to enhance our compliance program since the events at issue in this investigation, which occurred a number of years ago,” he said.
Click Here For Full Reports
August 13th, 2010
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
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.
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
August 26, 2009
By David Gutierrez
The antidepressant Celexa, commonly prescribed to alleviate some symptoms of autism in children, has no medical benefit in such patients, while exposing them to a significant risk of side effects.
Researchers treated 149 autistic children between the ages of five and 17 with either Celexa (generic name citalopram) or a placebo for 12 weeks. While one third of the patients who took Celexa showed improvement in symptoms over the study period, just as many patients showed improvement on the placebo. Children who took Celexa were twice as likely to suffer from side effects, including insomnia and impulsiveness, as children who took a placebo.
Lead researcher Bryan King noted that doctors prescribing drugs for “off-label” uses not approved by the FDA — often uses for which few studies of effectiveness or safety have been done — may think the treatment is actually working because of strong placebo effects like that seen in this study.
Celexa is an antidepressant in the selective serotonin reuptake inhibitor (SSRI) class. Because many SSRIs have shown some effectiveness in treating the symptoms of obsessive compulsive disorder in adults, growing numbers of pediatricians are turning to the drugs to treat obsessive, repetitive behaviors in autistic children. Many autistic children are prone to carry out repetitive behaviors like counting or arm flapping almost uncontrollably, often flying into a tantrum if interrupted.
The only drug approved by the FDA to treat irritability and aggression in autistic children is the atypical antipsychotic risperidone. Federal law allows doctors to prescribe drugs for any use they wish, however.
Treatment of obsessive symptoms in autistic children with Celexa or other SSRIs has been premised on the untested assumption that such symptoms stem from similar neurological pathways as those of adult obsessive compulsive disorder. The new study has cast serious doubt onto that hypothesis.
Click here for the full report from Natural News
August 11, 2009
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