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  1. Up to 45 percent of antidepressant prescriptions are for another condition entirely. 05/27/2016 02:37 pm ET Anna Almendrala Senior Healthy Living Editor There’s been a lot of concern over the “skyrocketing” use of antidepressants over the last 20 years. Many experts believe that these rising numbers indicate either higher depression rates or an over-diagnosis of mental illness. But there is at least one more factor, courtesy of a new study published in the journal JAMA: An increasing number of people are taking antidepressant medications for completely separate conditions, according to an analysis of nine years of prescription data in Quebec, Canada. Only about 55 percent of antidepressant prescriptions were written to alleviate depression symptoms, while the rest were written for a wide variety of other conditions that aren’t related to depression. Some of these were prescribed in what’s known as “off-label” use — when a medicine is prescribed to treat a condition for which it wasn’t officially approved, or when a medicine is taken in a different dose or method than the manufacturers originally intended. While using medications for unapproved conditions is common and perfectly safe under the care of a doctor, the increasing rate of off-label antidepressant use is an important reminder for experts not to assume that patients who are taking antidepressants have depression, said lead study author Jenna Wong, a PhD student with the department of epidemiology and biostatistics at McGill University in Montreal. Other reasons people take antidepressants We’ve known for a while that there are an increasing number of reasons to use antidepressants off-label, but Wong’s study is among the first to break down the most common reasons by percentage. Wong and her colleagues analyzed over 100,000 antidepressant prescriptions written from 2006 to 2015 for approximately 20,000 patients in prescription databases in Quebec. These databases are unique because they contain a field that allows the doctor explain why the medication is being prescribed — a feature Wong says should spread to more prescription databases. Though the study data came from Canada, off-label use was determined using both Health Canada and U.S. Food and Drug Administration classifications. The FDA has given approval for antidepressant use in treating some of the other conditions, but interestingly, doctors also prescribed antidepressants for conditions which are off-label for all antidepressants as a class. In all, 29 percent of antidepressant prescriptions were prescribed for off-label use, Wong notes. Here are the most common alternate uses: 1. Anxiety Certain classes of antidepressants are FDA-approved for anxiety disorder treatment. And Wong found that 18.5 percent of antidepressant prescriptions were in fact written to address anxiety, instead. 2. Insomnia About 10 percent of prescriptions were written to address insomnia. People with insomnia have a ten-fold risk of developing depression, while insomnia or other sleep problems are a common symptom in people with depression. That’s why they sometimes share the same treatment, notes the Sleep Foundation. Doctors in Wong’s study tended to prescribe mostly off-label antidepressants for insomnia and pain; though there is one FDA-approved antidepressant for insomnia, about 97 percent of the prescriptions written for insomnia were off-label. 3. Pain The Mayo Clinic calls antidepressants a “mainstay” in chronic pain treatment for their ability to dull the perception of pain — an ability that is not fully understood by researchers. Pain disorders made up six percent of the antidepressant prescriptions in Wong’s study. A few antidepressants are FDA-approved to help alleviate chronic pain, but 83 percent of the antidepressants prescribed for pain were off-label, according to Wong’s analysis. 4. Panic disorders Four percent of antidepressant prescriptions were indicated for panic disorder, which includes agoraphobia, social phobia and widespread anxiety and can lead to physical symptoms like a racing heart rate, trembling, chest pain and shortness of breath. The American Academy of Family Physicians notes that antidepressant medication can alleviate some of these symptoms and can even stop the recurrence of panic attacks. Several antidepressants are FDA-approved for treating panic attacks. 5. Fibromyalgia The treatment of fibromyalgia, a disorder with symptoms like musculoskeletal pain, fatigue and sleep issues, made up 1.5 percent of antidepressant descriptions. Antidepressants can help with the pain and fatigue that fibromyalgia can cause, the Mayo Clinic notes, and some of them are approved by the FDA for treatment of the condition. 6. Migraine Migraines, which are severe headaches that can be accompanied by nausea, vomiting and what’s known as “aura” (dizziness, visual hallucinations and light sensitivity), can sometimes be treated with a certain class of antidepressant known as a tricyclic antidepressant. Using any antidepressant to treat migraines is an off-label use of the medication, but experts believe that it changes chemical levels in the brain, which in turn helps prevent migraines. Prescriptions for migraines made up 1.5 percent of the prescriptions in Wong’s study. 7. Obsessive-Compulsive Disorder Obsessive-compulsive disorder made up 1.1 percent of the prescriptions analyzed in Wong’s study. Several antidepressants have been approved by the FDA to treat OCD because it can help make symptoms more manageable. They are a first-line pharmaceutical treatment for the disorder, the Mayo Clinic notes. 8. Menopause symptoms Just 0.8 percent of the prescriptions in Wong’s study were written to address vasomotor symptoms of menopause like hot flashes or night sweats. Treating these menopausal symptoms are off-label use for all antidepressants, but recent research from 2014 has shown that taking antidepressants was more effective than a placebo at treating them. However, antidepressants did not outperform the standard of care for hot flashes and night sweats, which is estrogen supplements. Off-label use is perfectly safe While “off-label” use might seem alarming, the FDA notes that it can be an option when approved treatments don’t work, or when prescribed for people with conditions that don’t have an approved treatment. Many off-label uses are backed by scientific evidence from clinical trials, just not full government approval, as the list above demonstrates. Off-label drug use is also common in certain populations, especially among children, because most drugs prescribed to pediatric patients were never tested in children. This makes many pediatric prescriptions necessarily off-label. Why antidepressants are so commonly used for other conditions While she didn’t talk to doctors about why they prescribed so many antidepressants off-label, Wong’s team has two theories about why this is such a common application. The first is that pharmaceutical companies may be aware of clinical trials that test their drugs beyond approved use, and could be promoting and marketing the findings to doctors, Wong said. The second theory is that doctors are simply observing changes in their patients after they start taking certain medicines, and then applying these insights to other patients in their practices. Neither of those two drivers of off-label use are unique to Quebec or Canada, Wong concluded, which means that even though this database only has information about patients in Quebec, there’s no reason to think that this is a Quebec-only phenomenon. But her research does underscore the need for more experts to recognize that simply having an antidepressant prescription is not a proxy for a depression diagnosis or depression treatment. Wong also called for more research on the off-label uses of antidepressants. Source: HuffPost
  2. Melissa Healy April 29, 2014, 5:23 p.m. About a decade after the Food and Drug Administration first warned that antidepressant medications increase the risk of suicidal thoughts and behaviors in children, new research has found that kids and young adults starting on high doses of antidepressants are at especially high risk, especially in the first three months of treatment. Among patients 24 and younger, those who started treatment for depression or anxiety with a higher-than-usual dose of selective serotonin reuptake inhibitor (SSRI) were more than twice as likely to harm themselves intentionally than those whose treatment began at the customary dose and increased slowly, the study found. For every 150 such patients treated with high initial doses of SSRIs -- antidepressants marketed under such commercial names as Zoloft, Paxil, Prozac, Celexa and Lexapro -- the study suggests one additional suicide would be attempted. By contrast, young patients starting SSRI therapy at doses considered customary were at only slightly elevated risk of self-harm, about 12% above the level of their depressed peers not taking medication. The latest research on depression treatment, conducted by epidemiologists at Harvard University and the University of North Carolina, was published Tuesday in JAMA Internal Medicine. The researchers found no increased risk of suicidal behavior among adults older than 24 who started medical treatment for depression or anxiety at larger initial doses. About 18% of young people diagnosed with depression were prescribed an initial antidepressant dose that was higher than that recommended by clinical guidelines: For the antidepressant fluoxetine (better known by its commercial name, Prozac), for instance, a standard dose would be 10 milligrams daily for the first week, increasing to 20 milligrams for the next three weeks, and only then considering any increased dose. Given that antidepressants appear to be less effective in young people than in older patients, and that higher doses do not appear to bring more or faster relief, the author of an invited commentary in JAMA Internal Medicine suggested that prescribing physicians should abide by the well-worn maxim "start low, go slow," and monitor patients closely during their first several months of treatment. The study used medical records to track 162,625 U.S. residents, ages 10 to 64, who were diagnosed with depression and prescribed SSRI between 1998 and 2010. It found that more than half of antidepressants in that period were prescribed by primary care doctors, and about an additional quarter by practitioners not specialized in mental health. Even in children, fewer than 30% of antidepressant prescriptions were issued by psychiatrists. The authors acknowledged that they could not discern why younger patients on high initial doses of antidepressant were more likely to try to harm themselves. Although it could have been the dose at which these young patients began their therapy, it is equally plausible that younger patients who are correctly perceived to be in a mental health crisis are more likely to be treated more aggressively, but not more likely to get better with SSRIs. It might also be that those started on high-dose SSRIs are more likely to discontinue their therapy and to suffer from "discontinuation syndrome," which can bring physical symptoms of anxiety and is sometimes linked to unpredictable behavior.
  3. Today in JAMA Pediatrics, researchers from The Children's Hospital of Philadelphia's (CHOP) PolicyLab published the largest study to date documenting the significant risks to children's health associated with prescription antipsychotics, a powerful a class of medications used to treat mental and behavioral health disorders. The results suggest that initiating antipsychotics may elevate a child's risk not only for significant weight gain, but also for type II diabetes by nearly 50 percent; moreover, among children who are also receiving antidepressants, the risk may double. Previous PolicyLab research showed that one in three youth receiving antidepressants in the Medicaid program were receiving an antipsychotic at the same time. Traditionally, antipsychotics have been narrowly prescribed to children with a diagnosis of schizophrenia or bipolar disorder, or to those with significant developmental delays who were displaying aggressive behaviors that were potentially injurious to themselves or others. However, in recent years, these medications are increasingly being prescribed in the absence of strong supporting safety and efficacy data to treat healthier children and adolescents with disruptive behaviors, such as those who are diagnosed with attention deficit hyperactivity disorder (ADHD). The new study, which used national Medicaid data on more than 1.3 million youth ages 10 to 18 with a mental health diagnosis from the Centers for Medicare and Medicaid Services, must be interpreted in the context of emerging evidence that Medicaid-enrolled children are far more likely than privately insured children to be prescribed antipsychotic medications. Overall, over 25 percent of Medicaid-enrolled children receiving prescription medications for behavioral problems were prescribed antipsychotics by 2008, largely for less severe disorders. "With such vast numbers of children being exposed to these medications, the implications for potential long-lasting harm can be jarring," said David Rubin, MD, MSCE, the study's lead author and co-director of PolicyLab at CHOP. Nevertheless, Rubin and his co-authors remain cautious in over-reacting to these findings. The baseline risk for diabetes among youth who were not exposed to antipsychotics in the study was only 1 in 400, rising to 1 in 260 among those initiating antipsychotics, and at most to 1 in 200 among those who initiated antipsychotics while they were simultaneously receiving antidepressants. "Although these findings should certainly give us pause," Dr. Rubin added, "we should not reflexively over-react to them. Rather, we need to incorporate these new revelations about the risk for diabetes into a more thoughtful consideration of the true risks and benefits of prescribing an antipsychotic to a child. Yes, we should try, by all means possible, to minimize the numbers of children and adolescents exposed to these powerful medications. But for some children in immediate crisis, we must also concede that the benefit of the antipsychotic for acute management may still outweigh the risk." The study's authors recommend that clinicians and families who are making medication decisions periodically revisit the treatment strategy to address challenging behaviors. For example, when planning to prescribe antipsychotics to a child, professional organizations recommend beginning cautiously with the lowest dose possible, while strictly monitoring for early evidence of weight gain or abnormal lab tests that often predict later onset of diabetes. Dr. Rubin, who is also an attending pediatrician at CHOP, notes, "Once a child is on the antipsychotic drug, a plan should be agreed upon and periodically revisited to see whether or not an evidence-based counseling service, such as trauma-focused cognitive therapy, could address underlying emotional trauma, which is often the root cause for the behavior. That same periodic review would also seek to transition the child off the antipsychotic as soon as possible, once these problems are more suitably addressed. " Ultimately, say Rubin and his co-authors, the prescription of antipsychotics to children and adolescents is likely to continue, reflecting a growing demand to address very challenging behaviors in children "At the end of the day, the approach to the individual child who is in crisis is still a case-by-case decision between a family and the treating provider," said Dr. Rubin. "We can only hope that those decisions are made in full recognition of our findings, and that for some children, alternatives to these powerful medications--such as counseling or other supportive services, will be considered first." Source:Children's Hospital of Philadelphia
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