Tag Archives: mental illness

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.

High Percentage of Americans Taking Psychiatric Drugs

Nearly 17% of Americans — 1 in 6 adults — took a drug to treat a mental illness at least once in 2013, with antidepressants as the most common prescription filled.

About 12% of adults said they used antidepressants; 8.3% filled a prescription for an anxiolytic, sedatives or hyponotic; and 1.6% reported taking an antipsychotic.

White adults were the most likely to have taken a psychiatric medication. Nearly 21% of them did. Next were black adults at 8.7%, followed by Hispanic and Asian adults at, respectively, 8.7% and 4.8%

The analysis, published Dec. 12 in JAMA Internal Medicine, was based on data from the 2013 Medical Expenditure Panel Survey. The authors said that the use of these drugs could even be much higher as the prescription use data was self-reported.

Older age was also associated with higher psychiatric drug use. About 25% of adults 60 to 85 reported use compared with 9% of adults 18 to 39 years of age. Also, women were significantly more likely than men to take medication for a mental health issues.

“Safe use of psychiatric drugs could be improved by increasing emphasis on prescribing these agents at the lowest effective dose and systematically reassessing the need for continued use,” the authors noted.

If you are experiencing side effects with antidepressants, check out MedShadow’s feature on how to cope with them.