Tag Archives: mental illness

Is There a Safe Amount of Drinking Over the Holidays?

By Dr. Marc Manseau
JustCareUSA

With the holiday season upon us, there are many opportunities to drink alcohol. Some are undoubtedly tempted to over-indulge, and people who struggle with alcohol may find this time of year particularly challenging and stressful. But what are the benefits and risks of alcohol? Many people can enjoy alcohol without any immediate problems, and may find that it helps them to relax and socialize. In some cultures, it is important for observing traditions or celebrating religious feasts. But does an apparent lack of alcohol-related problems make it safe?

The science on the possible benefits and safety of alcohol use resembles a mudslide more than a crystal-clear glass of chardonnay. Certainly, heavy alcohol use is associated with myriad health problems, from mental illness and dementia, to heart disease and stroke, to cancer and liver disease, to earlier death. But what about light-to-moderate alcohol consumption? Some studies have actually linked moderate alcohol use with health benefits, including decreased risk of ischemic heart disease, ischemic stroke, diabetes, dementia, and mortality.

However, since we can’t randomly assign people to take alcohol or placebo, these studies have numerous limitations. For one, there is the “sick abstainer effect,” whereby a subset of people reporting no alcohol may actually have quit drinking due to a history of problems from past heavy alcohol use, which would put them at elevated long-term risk of certain health problems. Another problem is confounding. For instance, people who moderately consume alcohol have been shown to have higher average socioeconomic status, which is associated with better health and a longer life. Researchers have tried to control for potential confounders, but it isn’t possible to account for all of them; only randomization can do that. Finally, almost all studies are based on self-reports of drinking behavior, which is fraught with potential error and bias. We know that people tend to under-report “undesirable” behaviors like heavy drinking, and studies have attempted to correct for this, but no adjustment strategy is perfect.

Recently, an extremely large, international study tried to get a definitive answer to the question about the safety of alcohol use. Using data from 195 locations across the globe, including 694 data sources about alcohol consumption, 592 studies on the health effects of alcohol use, and a combined study population of 28 million people, the researchers sought to determine the total burden of disease and disability caused by alcohol use between 1990 and 2016. Importantly, they did not solely rely on self-reported drinking, but adjusted alcohol consumption estimates using alcohol sales data, which were further corrected for tourism-related and unrecorded consumption.

In 2016, globally, among people aged 15 to 49 years old, alcohol was the leading risk factor for death and disability, with 3.8% of female deaths and 12.2% of male deaths attributable to alcohol use.

The findings were sobering. In 2016, alcohol was the seventh overall cause of death and disability globally, accounting for 2.2% of deaths among females and 6.8% among males. Among people aged 15 to 49 years old, alcohol was the leading risk factor for death and disability, with 3.8% of female deaths and 12.2% of male deaths attributable to alcohol use. And the study was unable to identify any safe level of alcohol consumption (or in other words, the safest amount of drinking was zero).

But don’t pour your eggnog and brandy down the drain just yet. Even though this was a massive study with key methodological innovations, there were still limits. Like all previous studies, it wasn’t randomized, so confounding remains a possible explanation for some of the links between alcohol and health problems. Further, the findings have more obvious implications for public health than for individual risk. That means that while the study revealed important harms of alcohol use within the population at large, the danger to any individual person remains quite small. For instance, the top three causes of alcohol-related death for younger people were tuberculosis, road injuries, and self-harm. If you don’t live in the developing world, the first basically doesn’t apply to you. And if you never mix your moderate drinking with driving and have never had a problem with suicidal thinking, the next two aren’t relevant either (though someone else’s drinking and driving could still hurt you).

For the older group, cancers were the main causes of alcohol-related deaths. This risk technically applies to everyone who drinks any amount, but the actual increase in cancer risk that an individual would experience from moderate drinking is small. For example, if a man in the United States drinks 3-4 drinks per day (moderate-to-heavy drinking), his risk of developing colorectal cancer would increase from about 4.6% to around 5.7%. Assuming this 1.1% absolute risk increase is entirely due to alcohol (and not confounders), this would mean that alcohol is causing a lot of cancer cases in the overall population, but that it arguably does not present a very significant danger for an individual person.

Finally, especially in wealthier countries, light-to-moderate alcohol consumption was associated with a protective effect against ischemic heart disease for men and against ischemic heart disease and diabetes among women. So you might kick yourself for drinking if you develop a possible alcohol-related cancer at 70 years old, but you’d have no way of knowing whether or not this same alcohol use prevented you from dying of a heart attack at 68.

So, by now you’re likely asking whether you should drink. Unfortunately, I can’t make a strong recommendation. Yes, there are real risks associated with alcohol, but many also find benefits in light-to-moderate drinking, and every decision we make requires some amount of weighing the risks and benefits (e.g., driving a car is fairly risky but also confers many social and economic benefits). Each person’s calculation will be personal and different.

But what we do clearly know is that heavy and/or problematic drinking is very unhealthy. Heavy drinking is defined as more than three standard drinks a day or more than eight a week for a woman, and more than four a day or 14 a week for a man; and a standard drink is much less than you might think (that martini is likely two to three standard drinks). If associated with social, occupational, or health problems, any amount of alcohol can be considered problematic. If your drinking habit matches these definitions, you should consider cutting back and speak with your doctor if you need help. But if you enjoy light-to-moderate drinking without any problems, you may decide that enjoying a little Holiday cheer is worth the risks.

This article was first published by JustCareUSA. Reprinted by permission.

Childhood Infections, Antibiotics Use Linked to Mental Disorders

Children who have infections and are treated with antibiotics are at an increased risk for developing psychiatric disorders, according to a new study.

Researchers in Denmark examined the medical records of about one million children born in the country between 1992 and 2012 and followed their mental history for an average of 10 years. Children who developed a severe infection that required hospitalization had an 84% higher risk of developing a mental illness before turning 18, and a 42% increased risk of filling a prescription for a psychotropic medication, according to results published in JAMA Psychiatry.

The use of an antibiotic to treat an infection was associated with around a 40% increased risk for a future mental disorder and a 22% increased risk for getting a psychiatric medication. The mental illnesses with the highest risk following infection were schizophrenia, obsessive-compulsive disorder, personality disorders, mental retardation, autism and ADHD (attention-deficit/hyperactivity disorder).

The researchers suggested several reasons for the association between infections, antibiotics and mental illnesses. The first is that an infection may impact the brain, increasing the risk for a mental disorder. Another theory is that antibiotics can negatively impact the “good” bacteria in the gut, which can subsequently alter the brain and increase the risk for mental disorders. Also, some people have a genetically higher risk of getting more infections and mental illnesses.

Quick Hits: Older Adults Want To Take Fewer Drugs, Talk Therapy Side Effects & More

Two out of three older adults would like to decrease the number of medications they are taking, according to a new survey. Also, nine out of 10 of them would stop taking one or more medicines if their doctor told them it was okay. Researchers based their findings on results from the National Health and Aging Trends Study, which includes adults 65 and older. Almost 50% of seniors take five or more medications. Taking many medications simultaneously, commonly known as polypharmacy, can lead to an increased risk of side effects and drug interactions. The survey also showed that those with chronic medical conditions were more likely to want to cut back on the number of drugs they take. The researchers said the results indicate that doctors should be comfortable bringing up the idea of deprescribing with senior patients. Posted October 15, 2018. Via JAMA Internal Medicine.

Cognitive behavioral therapy (CBT), one of the most popular treatments for various kinds of mental illnesses, is not without unwanted effects, according to a new study. These unwanted effects include distress, strains in relations with family, feelings of guilt and shame and intense emotions. Researchers interviewed 100 therapists and asked them to think about a client they had seen for at least 10 sessions. The therapists were then asked if the client had experienced any of 17 unwanted effects from therapy. Based on the interviews, researchers say about 40% of those undergoing CBT experience at least one unwanted event. They added that the unwanted effects may be an inevitable part of dealing with difficult thoughts and events. Posted October 7, 2018. Via Cognitive Therapy and Research.

Drugmakers would be required to disclose the price of a medication in television drug ads under a new proposal from the Trump administration. The proposed rule would mandate that the ad mention the wholesale or list price for a typical course of treatment, or a 30-day supply if the drug is a long-term medication. This is the price of a drug before insurance coverage picks up at least part of the cost. The administration is pushing the requirement as part of an effort to increase price transparency of drugs. Medications with a list price of less than $35 per month would be exempt from the price disclosure requirement. The top 10 most advertised drugs on television have list prices ranging from $535 to $11,000 per month, according to the Department of Health and Human Services (HHS). Posted October 15, 2018. Via Centers for Medicare and Medicaid Services.

Suicide and Mental Illness: The Forgotten Health Crises in America

Last week, mental health was front and center in the news for several reasons. First, the suicides of two high-profile individuals, fashion designer Kate Spade and celebrity chef Anthony Bourdain, captured headlines.

But you may have missed a CDC (Centers for Disease Control and Prevention) report that came out last Thursday that found suicide rates have skyrocketed in the US between 1999 and 2016. Twenty-five states saw suicide rates increase by at least 30%. Montana had the highest rate. Suicide rates rose in every state except 1: Nevada.

Just how serious a problem is suicide? According to the CDC, in 2016, about 45,000 Americans 10 years old and older died by suicide. Taking one’s life is the 10th leading cause of death and is 1 of only 3 leading causes that are on the rise, the CDC says.

These figures are a major wake-up call that we need a multi-faceted approach to not only stem – and hopefully reduce – the rising rates of suicide. It is also an indication that the way mental illness is considered, approached, treated and funded in this country is not right.

Why Now?

The drastic rise in suicide rates is all the more shocking considering that since the early 1990s, access to mental health care has – on the surface — actually increased. The Mental Health Parity and Addiction Equity Act (MHPA), signed into law in September 1996, requires that annual or lifetime dollar limits or benefits on an individual’s health insurance not be lower than limits for medical care.

And in 2014, the major provisions of the Patient Protection and Affordable Care Act (PPACA), also known as Obamacare, that went into effect included mental health care as an essential health benefit that all insurance plans on health insurance exchanges must cover.

Despite MHPA and PPACA, we have a mental health crisis in our midst. Why? It’s hard to say, and it is likely a combination of many things.

Can Antidepressants Make the Problem Worse?

One thing is for sure: An increasing number of Americans are depressed – or at least unhappy. Many of them are turning to their doctors and they are receiving prescriptions for antidepressants. And those drugs could actually be doing more harm than good.

A CDC report that came out in August of last year found that between 1999 and 2014, the number of Americans that had taken an antidepressant rose by 65%. That’s not a typo. In 2014, about 1 in 8 Americans over the age of 12 said that they had recently used an antidepressant.

Why is the relatively high use of antidepressants a concern? While antidepressants may well help a lot of people, there’s a mountain of evidence indicating they are no better than a placebo. They also come with a “black box” warning – the most serious the FDA can require for a drug – stating that they may increase suicidal thoughts or actions.

Another study, published in 2016, found that when given an antidepressant, people with no prior history of mental illness were twice as likely to become suicidal and violent.

Other drugs are also known to have suicidal thoughts as a potential side effect. Bourdain, for example, was said to be taking the smoking cessation drug Chantix (varenicline), according to news reports. The prescribing information for Chantix notes that “serious neuropsychiatric adverse events” have been reported in people taking the drug, including suicidality. Chantix used to have a “black box” warning regarding suicidality, but following an intense lobbying campaign from the med’s manufacturer, Pfizer, the FDA agreed to drop that boxed warning from Chantix’s labeling in December 2016.

We don’t know exactly how much impact antidepressant use has had on the increase in suicide rates (If any mental health researchers are reading this, it would be a good idea to investigate this, if you aren’t doing so already), but the evidence seems to point it could have a significant effect.

We also don’t know exactly what drives people to suicide. It’s likely a combination of factors. But there are roles both governments and society can play in helping to turn the tide of rising suicides.

Federal and State Government Funding Failures

Our federal government — as well as state ones — have a role to play by adequately funding mental health programs, especially for the poor and elderly. Yet, they have largely failed. Under the Trump administration, the situation is getting even more grim. Trump’s proposed fiscal 2019 budget calls for massive cuts to Medicaid and Medicare. It also reduces funding for the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Mental Health and Substance Abuse Treatment Programs of Regional and National Significance by about $600 million, according to the non-profit group Mental Health America.

Inadequate investing of mental health can have severe consequences. “Failure to invest in mental health as a matter of urgency will have health, social and economic costs on a scale that we have rarely seen before,” a World Health Organization (WHO) report on mental health released this year stated.

The WHO report also found that spending on mental health makes economic sense. The organization projects that every $1 invested in mental health treatment leads to a return of $4 in improved health and the ability to work.

Society’s Role in Making Change Happen

Having a mental illness carries a lot of stigma in our society. Many people that could be helped with mental health treatment often don’t get it because they think it will reflect badly on them by their friends, family or co-workers.

This mentality held by far too many among us needs to end and we can help doing so by treating mental illness exactly the same as someone who has a medical condition, such as diabetes or cancer. There is absolutely no shame in having a mental illness.

We need to talk openly about mental illness much more than we do now. We also need to raise awareness that if someone is depressed, is suffering from bipolar disorder, schizophrenia or any other mental illness, there is help available and they shouldn’t feel afraid to seek it.

Together, we can help stop the rise in suicides. Speak up and advocate for greater mental health awareness and funding. It may just save someone’s life.

Why School Shootings Are as Much Public Health Issues as They Are Gun Control Ones

For students at Santa Fe High School in Santa Fe, Texas, life changed forever on Friday morning. Armed with a handgun and a sawed-off shotgun, 17-year-old Dimitrios Pagourtzis methodically walked through the school and killed 9 students and 1 teacher. He planned on shooting himself after the bloodbath, but apparently didn’t have the courage to do it in the end.

And then what always is the case after school shootings of late happened: President Trump and Vice President Pence offered condolences to the Santa Fe community, offered federal support, and didn’t do much else. Talking heads on cable TV news networks began the gun control debate. And then, late Friday afternoon, the networks shifted attention to something apparently more newsworthy – the following day’s wedding of Prince Harry and Meghan Markle.

Is there something wrong with this picture? Of course. While we try to “fix” the issue of school shootings, it seems like too many people think there is only one approach, or that some are better than others, or that we don’t want to infringe on the rights of others in order to do so.

This is wrong and why, if it continues, school shootings will continue. It’s time to face the reality that the epidemic of school shootings is as much a public health issue as it is a gun control issue. It will take a combination of approaches to end. And the sooner those in positions of power to make changes realize this, the sooner these tragedies can finally come to an end and no more innocent lives will be lost.

What public health issues in particular? First and foremost is mental health. In almost every school shooting, mental illness in some form played a role in the tragedy. Mental illness is still widely stigmatized in our society, especially among teens. This may give pause to young people who may realize they need help, but don’t seek treatment out fear of embarrassment from their peers. This mentality must change, and change immediately. In addition, every school should have a trusted mental health professional available for students to consult.

You should also know that statistics show people with mental illness are much more likely to be the victims of gun — and other — violence than to perpetrate it.

The second is bullying. Some of us were likely bullied in our youth. While many of us are resilient and/or didn’t get bullied constantly, there is only so much getting picked on that some adolescents or teens can take before they can’t take it anymore. Anti-bullying education should be required in every school, and reinforced by parents.

The argument for gun control of some sort seems to be obvious to everyone except too many who seem to care more about their weapons than reasonable measures — whatever the cost to society. And there is a public health issue with guns themselves. In many school shootings — including the most recent at Santa Fe — the guns used by the teen perpetrators came from within their own homes, and were legally obtained. More education on how to safeguard weapons within the home is imperative to prevent future shootings.

If all of this sounds sensible, it’s because it is. The main problem? Politicians not wanting to risk contributions from powerful political contributors — such as the National Rifle Association — to do so. If children really are our future, then politicians have to do what is right, no matter the financial costs. Children’s lives are in the balance.

And what can the general public do? Follow what has happened since the school shooting in Parkland, Florida. Speak out. Attend rallies. Write letters to elected officials. Eventually, they will hear you and make the long-needed changes to save lives. I pray they will.

Mariah Carey: An Unexpected Mental Health Advocate

Superstar singer Mariah Carey has had a rough few years. She has been dragged through the media and been the target of many a late-night talk show host’s jokes. And this was even before her near meltdown on Dec. 31, 2016, during a nationally televised New Year’s Eve performance.

However, no one should be making fun of Ms. Carey now. In fact, we should be applauding her. Why?

Last month she gave an exclusive interview to PEOPLE magazine detailing her struggle with bipolar disorder. Anyone going through bipolar — I know several — is battling demons. Ms. Carey is fighting those monsters while in the public limelight and performing.

Yes, Ms. Carey is famous. Some may argue that we should have more sympathy for those struggling with bipolar disorder who aren’t a celebrity. They may have a point.

However, her bravery — particularly as a celebrity admitting she has a serious mental illness while knowing the consequences that can come with such a revelation — can be useful to mental-health awareness and treatment. Like most mental illnesses, there is a severe stigma attached to many in our society to bipolar disorder. Perhaps Ms. Carey’s interview will educate some people on bipolar, or at the very least get a conversation started.

When it comes to health and medicine, you are more likely to see a celebrity talking about an illness if they are shilling for a drug or medical product. Ms. Carey is opening up about an illness she is personally suffering from. This is exactly why she should be lauded and why I personally applaud her for her bravery, considering my own history with mental illness.

Will ridiculing of Ms. Carey continue? Undoubtedly, as that is what gets people to read articles and watch late-night comedians. But I see her as an advocate for mental-health awareness – and as an example other celebrities could learn from. Thank you, Mariah.

Quick Hits: Americans Open to Non-Drug Pain Treatments, Psychiatric Drugs’ Impact on Cognition & More

More than three-quarters of Americans — 78% — say they are willing to try non-drug alternatives for pain before turning to prescription painkillers. Results from the Gallup-Palmer College of Chiropractic Annual Study of Americans show that 40% of Americans consider prescription painkillers such as opioids a “crisis” or “very serious problem.” And 55% of those who know about the nation’s opioid epidemic place some of blame on the drug industry’s encouraging physicians to prescribe opioids. Another 53% place a lot of blame on doctors overprescribing painkillers to patients. About 23% of those polled said prescription pain meds such as opioids are not very safe, and 8% said opioids are not safe at all. In 2015, more than two-thirds of the opioid deaths reported involved prescription opioids such as oxycodone, hydrocodone, morphine and fentanyl. Posted Sept. 13, 2017. Via Gallup.

Taking high doses of antipsychotic drugs over an extended period may be associated with poorer cognition in schizophrenia. However, taking low doses of antipsychotics such as benzodiazepines and antidepressants over a long time doesn’t affect cognition, according to a new study published in the journal European Psychiatry. The research also found that schizophrenia patients who took a long break from using antipsychotic drugs tended to see their cognitive function improve. Posted Sept. 5, 2017. Via EurekAlert/European Psychiatry.

Women who take antiepileptic drugs (AEDs) during pregnancy have a higher risk of having premature babies or babies that have a low birth weight for their age in the womb. Women with epilepsy who took AEDs while pregnant had a 9.3% increased risk of having a premature baby, while women without epilepsy who took an AED had a 10.5% increased risk, according to results published in the Annals of Neurology. Women who did not take a medication and didn’t have epilepsy had only a 6.2% increased risk of a premature baby. Compared to women who didn’t take an AED and didn’t have epilepsy, women with epilepsy who took one of the drugs gave birth to a child with a mean lower birth weight of 3.9 ounces. For women who took an AED and didn’t have epilepsy, the figure was 4.8 ounces. Common AEDs include Lamictal (lamotrigine), Topamax (topiramate), Tegretol (carbamazepine), Keppra (levetiracetam) and Neurontin (gabapentin). Posted Sept. 11, 2017. Via Medical Express/Annals of Neurology.

Quick Hits: New Breast Cancer Drugs Have Fewer Side Effects, Antidepressant Use in Pregnancy and Autism & More

A new class of oral drugs for treating the most common type of breast cancer, known as cyclin-dependent kinase (CDK) inhibitors, appears to have fewer adverse events and side effects for most patients compared to other treatments. There are 2 CDK inhibitors currently on the market: Ibrance (palbociclib), approved in February 2015, and Kisqali (ribociclib), which was just approved in March. Both are used to treat hormone receptor-positive (HR+) metastatic breast cancer. A third CDK inhibitor, abemaciclib, is in late-stage development. Researchers examined all publicly available trials for the 3 drugs. The most common side effect was low white blood cells, a condition known as neutropenia that can lead to infection, though it was seen less in abemaciclib. However, neutropenia was usually temporary or resolved with a dose reduction. Other, more common side effects seen with the medications were diarrhea and fatigue. Less common side effects observed were nausea and alopecia (hair loss), though these were mild and treated through a dose reduction or a break from the drug. Posted July 14, 2017. Via The Oncologist.

Children exposed to antidepressants during pregnancy may have a slightly higher risk of developing autism than children of mothers with mental illness who didn’t receive the drugs. Researchers, however, stress that the absolute risk of autism was small, so the results should not be considered alarming. A team at the University of Bristol (UK) analyzed data from 254,610 individuals aged 4-17 of which 5,378 had autism. Of the 3,342 children exposed to antidepressants during pregnancy, 4.1% (136) had a diagnosis of autism compared with 2.9% (353) in 12,325 children not exposed to antidepressants whose mothers had a history of a psychiatric disorder. Researchers noted that overall, 95% of women who took antidepressants did not have a child with autism. An accompanying editorial noted that the results should not dissuade women with depression from using antidepressants in pregnancy since untreated depression can lead to “ substantial health consequences.” Posted July 19, 2017. Via The BMJ.

The FDA has approved a new hepatitis C (HCV) medication, Vosevi. The drug is actually a combination of two existing anti-viral treatments, sofosbuvir and velpatasvir (sold as Epclusa), and a new drug, voxilaprevir. Vosevi is for patients with HCV without liver disease (cirrhosis) or with a mild form of cirrhosis. Results from 2 late-stage trials demonstrated that 96-97% of patients who received Vosevi had no HCV detected in their blood 12 weeks after finishing treatment, an indication the infection has been cured. The most common side effects in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Posted July 18, 2017. Via FDA.

 

Half of Opioid Prescriptions Given To Those With Mental Illness

Slightly more than half of all of the opioid prescriptions written each year are given to people with mood disorders, depression and anxiety, a troubling statistic since those with mental illness face a higher risk of overdose and abuse.

About 115 million opioids prescriptions are given each year, and 51.4% of them went to people who also had a mental health disorder, according to research published in the Journal of the American Board of Family Medicine. Opioid use was defined as patients that received 2 or more opioid prescriptions in a year.

Results also showed that 18.7% of adults with a mental illness are given opioids. But just 5% of adults without a mental disorder are prescribed one.

As to why those with mental illness are more likely to receive an opioid, there are several potential reasons. Study co-author Brian Sites, MD, of the Dartmouth-Hitchcock Medical Center, told STAT that some physicians may be sympathetic to patients who have both a mental illness and another condition, making them more likely to prescribe an opioid. Also, people with mood disorders may experience pain differently. He also noted that opioids may have antidepressant effects in the short-term, prompting those with depression to ask their doctor for a prescription.

“The high prevalence of mental health disorders coupled with prescription opioid use suggests that this population is critical to consider when addressing the issue of opioid use from a health system or policy perspective,” the study authors wrote.

Can You Trust a New Drug?

The US prides itself on the fact that the FDA is arguably the best drug regulatory organization in the world. Yet in less than 5 years of being on the market, 32% of new drugs have bad enough side effects and adverse events that the FDA has had to send doctors warnings about safety and/or put “black box” labels on the drugs. And this was after drugs were on the market a median of 4.2 years.

A new study from the Yale University School of Medicine published in JAMA looked at the 222 new medicines that the FDA approved from 2001-2010. Of those drugs, 3 had to be withdrawn from the market because of safety concerns, about 20% received safety communications from the FDA, and 20% had “black box” warnings slapped on their label, the FDA’s most serious warning. Some drugs received both black box and safety communications, most often for different safety issues.

Are we safe taking new drugs? Pretty much. The good news is that few drugs get pulled from the market because they aren’t effective. The bad news is that we don’t know what the actual health risks are from new drugs. We don’t know what new side effects are or even if adverse events can be caused because the length of clinical trials is short and the number of people the drug is tested on is usually small.

Short Trials With Relatively Few Patients

Most new drugs are tested for only 6 months and on fewer than 1,000 people. Consider that a side effect considered “common” would happen in 1 in 100 people. If there were 700 people in a trial, 7 would have to complain of the same side effect. If it was an “uncommon” — but not “rare” — side effect, then 1 person in 1,000 might report it, and there aren’t even 1,000 people in many trials. That’s why so many side effects are found after the medicine is approved.

There might be a way to predict which new drugs are most likely to have safety problems — which was the goal of the study. If we could predict problem drugs, than patients could be warned of the likely possibility of unknown safety issues and follow-up studies could be more rigorous.

The researchers were able to classify most of the drugs that had postmarket safety events into 4 categories. They are drugs that received:

  • “Priority Review” status: Drugs with that designation have to be reviewed within a 6-month window rather than the standard 10-month time frame.
  • “Accelerated Approval” status: Drugs being developed for a serious unmet medical need can get this designation and use surrogate markers of disease in their clinical trials instead of actual outcomes (true endpoints). Surrogate markers have been helpful, but can be misleading. For example, Vytorin, a combination of Zocor and Zetia used to lower cholesterol, was shown to decrease LDL (bad) cholesterol and C-reactive protein, both considered “markers” of heart disease. Vytorin was approved based on this surrogate marker. The true endpoint is survival, and out in the real world it was found that patients using Vytorin did not live longer, even though their LDL was lower.
  • “Orphan Drug” status: Drugs that treat a rare disease gain a longer period of exclusivity in the marketplace, which prolongs a generic competition. For this study, researchers examined if a drug received an orphan designation for the indication for which it was initially approved.
  • Near-Regulatory Deadline Approvals: The FDA has strict deadlines for approving drugs. Those drugs that were approved within 60 days of the deadline were more likely to end up with postmarketing safety problems.

Drugs used to treat psychiatric illnesses or ones known as biologics (genetically-engineered proteins derived from human genes instead of chemical components) had more frequent safety events than others.

Increasing Drug Review Time

We need to consider taking more time to review drugs. Notice that 2 of the red flags have to do with rushing the drug through the review process: Priority Review and Near-Regulatory Deadline Approvals. The difference between a thorough, considered review and one that leads to expensive and time-consuming drug fact label changes and warnings is only days.

A third (Accelerated Approval) allows for shorter study times because of the use of surrogate markers in place of true endpoints.

We need to have rigorous and ongoing postmarket studies of drugs. It’s the only way to keep people safe and to give doctors the information they need to prescribe appropriately.

As for your own health, ask your doctor how long a drug has been on the market. When you consider taking a medicine to improve your health, don’t ask for the newest drug on the block. Unless there is a compelling reason to use a new drug, you may well be better off with older medicines that have proven themselves safe over time.

Do Your Psychiatric Drugs Keep You Up at Night?

If you take a medication for a psychiatric condition, you may have experienced troubled sleep — insomnia, daytime sleepiness, or any other numbers of sleep-related disorders. I have treated patients with myriad sleep difficulties who take antidepressants, antipsychotics and even medications to treat attention deficit/hyperactivity disorder (ADHD).

While no one wants to experience a poor night of sleep, it’s important to recognize whether the sleep problem you are having is a result of a side effect of a drug (or drugs) you are taking, or something completely independent of medication. That is why if you are on psychiatric medication – or any drug for that matter – and you find yourself having difficulty catching some Zs, it’s important to talk to your primary doctor, who may change your medication or refer you to a sleep specialist for further evaluation. In many cases, the benefits of a drug may outweigh the sleep-deficit side effects. Your physician can work with you to minimize the impact of them.

However, it’s a good idea to know what some of the sleep-related side effects are that have been reported with different types of drugs which act upon the brain. Let’s start with antidepressants. The most commonly prescribed ones are known as SSRIs (selective serotonin reuptake inhibitors) and have names including Prozac (fluoxetine), Zoloft (sertraline), and Paxil (paroxetine). Complaints of both insomnia and daytime sleepiness have been reported in patients with depression on SSRIs. Prozac’s impact on sleep has been the most widely studied. Interestingly, it has been shown to have both a sedating and energizing effect depending on the individual. Prozac can also cause decreased sleep efficiency, awakenings during the night, and interrupted REM (rapid eye movement) sleep, an important period during the sleep cycle that allows a person to dream vividly.

Antidepressants and Vivid Dreams

Another class of antidepressants, SNRIs (serotonin norepinephrine reuptake inhibitors), are known to cause sleep problems similar to those in SSRIs, as well as vivid dreams. Common SNRIs are Effexor (venlafaxine), Pristiq (desvenlafaxine) and Cymbalta (duloxetine).

Treatment with Effexor has also been associated with a condition known as dyskinesia that is characterized by occasional movement of one’s limbs, repetitive and involuntary movements of the extremities – typically the legs – usually during or just before falling asleep. There have also been cases where these involuntary movements have been seen a week after a person stopped taking Effexor.

One antidepressant, Wellbutrin (bupropion), has been associated with insomnia. However, studies that have examined electrical activity of the brain in patients taking bupropion indicate the drug actually increases REM sleep time.

It’s important to recognize whether the sleep problem you are having is a result of a side effect of a drug (or drugs) you are taking, or something completely independent of medication.

Antipsychotics are usually prescribed for schizophrenia and other psychotic disorders, though they are also prescribed for bipolar disorder and to supplement antidepressants in the treatment of depression. One of the most popular antipsychotics, Seroquel (quetiapine), has been associated with faster sleep onset and longer overall sleep time. A typical antipsychotic, Clozaril (clozapine) has also been associated with improving sleep onset and sleep time.

RLS (restless legs syndrome) can ruin a good night’s sleep and antipsychotics and antidepressants have been known to lead to cause it. The strong urge that RLS causes to uncontrollably move one’s legs can make it hard to sleep, lead to sleeplessness, irritability and depressed mood. Remeron (mirtazapine), an older, atypical antidepressant, is most likely to cause RLS. A case study found that RLS appeared to be provoked in patients on a low-dose of Seroquel. Interestingly, some evidence has shown that Wellbutrin may actually help to alleviate RLS.

Lifestyle Changes May Help Curb Sleep-Related Side Effects

However, you might find relief from RLS through lifestyle changes and/or taking certain vitamins. For example, going to the bed at the same time every night and getting up at the same time each morning can help. Also, there are some indications that a lack of some vitamins and minerals, such as iron, folic acid, magnesium, and vitamin B, can contribute to RLS.

Not surprisingly, insomnia and delayed sleep onset are associated with stimulants such as Adderall and Ritalin (methylphenidate), that are used in the treatment of ADHD. However, the effect of Ritalin on sleep may depend on the amount of time a child has been on the drug and when the medication is given. There have also been reports of children having difficulty falling asleep as they are being weaned off the medication.

Sleep is an important part of staying healthy and feeling good. Again, if you feel you are experiencing sleep issues as a result of medication, speak to your doctor without delay. Sleep-related side effects due to drugs impact relatively few patients. And if it ends up your sleep problems are not drug-related, the good news is there are steps you can take to rectify the situation. Changes in sleep hygiene and even in your bedroom environment can provide some of the most effective improvements, as can making sure you are getting enough sleep in the first place. As we are in the middle of Sleep Awareness Week, I recommend visiting the National Sleep Foundation’s website for more helpful tips.

This piece is based on an article, Adverse Effects of Psychotropic Medications on Sleep, published in the journal Psychiatric Clinics of North America in 2016.

Quick Hits: Nighttime Urination Treatment Approved, Using Aricept & More

Noctiva (desmopressin acetate), a prescription nasal spray for adults who urinate frequently throughout night, was approved by FDA. The drug is the first FDA-approved treatment for the condition known as nocturnal polyuria, which is overproduction of urine during the night. Patients who plan to take this Noctiva should take precautions since the drug has a boxed warning. Noctiva can cause hyponatremia, which is low sodium levels in the blood. If it is not promptly diagnosed and treated, hyponatremia can be fatal — leading to seizures, coma, respiratory arrest or death. Doctors should ensure that a patient’s sodium level is normal before prescribing Noctiva, and should check sodium levels within 1 week and approximately 1 month after starting treatment and periodically thereafter. Posted March 3, 2017. Via FDA.

People with milder cognitive impairment should be given a genetic test before using Aricept (donepezil) to treat Alzheimer’s disease. Researchers at the UCLA School of Nursing found Aricept could speed mental decline in someone with mild cognitive impairment who has a specific genetic variation, they reported in the Journal of Alzheimer’s Disease. Patients with the K-variant of the butyrylcholinesterase (BChE) gene who took Aricept deteriorated faster than those who took a placebo. Posted March 7, 2017. Via Medline Plus.

Patients who have psychiatric ailments are more likely to reject treatment if only medication is involved. Researchers analyzed 186 studies of patients who sought help for mental health conditions. The results, published in the journal Psychotherapy, found that the treatment refusal rate was more than 8% on average. Patients were almost twice as likely to refuse drug treatment alone compared to those offered talk therapy alone. Patients with depression were more than 2 times more likely to refuse drug therapy alone and patients with panic disorders were nearly 3 times more likely to refuse drug therapy alone. Researchers explained that patients usually prefer talking with a caring individual who could talk them through their emotional distress. Posted March 6, 2017. Via Medline Plus.