Tag Archives: antidepressants

Is Club Drug Answer for Treatment-Resistant Depression?

With many people suffering from depression not responding to antidepressants despite trying several, there is a critical need for therapies that can treat what is known as treatment-resistant depression. Although it might sound unusual, a medication derived from what is best known as a party drug might just be what millions of people have been looking for.

The drug, esketamine, is closely related to ketamine, a legal anesthetic used in both humans and animals, though it is most popularly known as a party drug due to its hallucinogenic effects. Johnson & Johnson’s Janssen division developed esketamine, which is designed as a nasal spray. The company says the drug is a fast-acting therapy for treatment-resistant depression. While traditional antidepressants can take weeks or months to have any positive effect – if any at all – many people who have taken esketamine report feeling better within a matter of hours.

To me, there is an essential need for a drug like esketamine. About one-third of adults with major depression don’t respond to antidepressants. Given that major depression affects more than 16 million adult Americans – about 6.7% of the US population 18 and older – each year, that’s more than 5 million people who could benefit from esketamine.

As we previously reported in MedShadow, there are plenty of clinics that have popped up across the country offering straight ketamine infusions. The infusions are not cheap, and their efficacy is debatable.

An FDA advisory committee will discuss esketamine at a meeting today, and their decision could well determine if esketamine will ever hit the market. While the FDA is not bound by an advisory committee vote, it usually follows their guidance in making approval decisions.

The FDA is set to render a decision on esketamine on or before March 4. Although the drug has “breakthrough-therapy” designation — meaning it has an expedited review because it treats a serious or life-threatening illness or it represents a significant improvement over existing treatments — that’s not a guarantee a majority of FDA panel members will agree it should be approved.

That’s because of some concerns. The first, which was brought up by FDA staff in review documents, is the potential for abuse, though they admitted this is low and can be mitigated. The other is that since esketamine can cause dissociation, the hallucinogenic feeling I mentioned before, some people who take it could be at risk for accidents or other kinds of harm. Some people have reported this feels like an “out of body” experience. In two late-stage studies, about 27.4% of people taking esketamine experienced dissociation. FDA reviewers say dissociation takes about 90 minutes to go away. That will likely weigh on the minds of many committee members.

There’s also a question about efficacy. In one phase 3 trial, in which patients were given either esketamine plus an antidepressant or a placebo plus antidepressant, there was no difference in change in depression severity between the two groups over four weeks. However, in two other phase 3 trials, the time to relapse of depressive symptoms was slower in the esketamine plus antidepressant group as opposed to the placebo plus antidepressant group.

Esketamine is also under investigation as a treatment for depressed people at heightened risk of suicide. Given that the nation’s suicide rate increased 33% between 1999 and 2017, according to Centers for Disease Control and Prevention data, esketamine could potentially play a role in reversing that trend.

As I see it, the potential benefits of esketamine outweigh some of its concerns. While I don’t believe it will be a solution for everyone suffering from treatment-resistant depression, it could represent the first depression treatment with a new method of action in decades. Given the toll depression and suicides take on society, the FDA should give doctors another treatment option.

Quick Hits: Medical Treatment Adverse Event Death Drop and Antidepressant Tapering With Psychotherapy

Deaths related to the adverse events of medical treatments fell between 1990 and 2016. Researchers examined the causes of death listed on death certificates as well as data from the Global Burden of Diseases, Injuries and Risk Factor tool. Overall, the mortality rate due to adverse events declined by 21.4% from 1.46 per 100,000 people to 1.15 over the time period. However, researchers noted that age was a significant factor in mortality. The mortality rate for those aged 70 and over was nearly 20 times higher than for those between 15 and 49. Location also influenced the rate, with California having the lowest and Mississippi the highest. The most common reason for an adverse event from medical treatment was surgery and post-operative complications. Posted January 18, 2019. Via JAMA Network Open.

Tapering off antidepressants is more successful and a person has a lower risk for relapse if it is done along with psychotherapy. Researchers conducted a meta-analysis of 15 studies and found that after two years, the risk for relapse was between 15% and 25% for cognitive behavioral therapy and tapering compared to 35% to 80% with just regular clinical visits and tapering. The study’s authors note that in western countries, antidepressant prescriptions have doubled over the last decade. In addition, the average length of time on an antidepressant in the US is five years, and the medications are often prescribed by a primary care physician, not a psychiatrist. Posted January 22, 2019. Via Annals of Family Medicine.

Areas of the country where drugmakers spent more money marketing to doctors are linked to higher rates of opioid use, according to a new study. Researchers say that counties that had the most opioid marketing from pharmaceutical companies to healthcare providers subsequently had the highest rates of opioid prescribing and opioid overdose deaths. Between August 2013 and December 2015, drug companies spent about $40 million on opioid marketing to more than 67,000 physicians. The Northeast US had the highest marketing and the Midwest the lowest, the study found. Also, for every three additional payments made to doctors per 100,000 people in a county, opioid deaths increased 18%. Posted January 18, 2019. Via JAMA Network Open.

5 Non-Pharmacological Treatments for Depression

An estimated 17% of Americans will experience depression at some point in their lives. Antidepressant medications such as selective serotonin reuptake inhibitors (SSRIs), the most commonly used drugs for depression, are usually the first-line treatment, along with talk therapy. However, these drugs are only effective in 50–60% of people, and even when they do work well, there may still be side effects ranging from headache, nausea and sexual dysfunction to loss of motor control and suicidal thinking.

While antidepressants have certainly helped many people manage their symptoms, the poor response rate makes it clear that alternatives are needed. But first things first: Before trying to figure out what kind of treatment to opt for, make sure you’re covering your self-care basics, including regular exercise, adequate sleep, and proper nutrition as all three of these can have an influence on depression.

“For instance, it is well understood that sleep deprivation can adversely impact mood, yet 1 in 3 American adults are sleep deprived,” according to Fraser Smith, ND, assistant dean of the naturopathic medicine program at National University of Health Sciences. Naturopathic medicine is focused on using natural remedies and techniques such as herbs, acupuncture, exercise and nutrition to help the body heal. Also, the brain “needs adequate proteins and other nutrients to make the chemical compounds that we see as prerequisite for emotional balance. So, this is the start.”

If you’re doing well in those areas but still struggle with depression, there is a range of other options that have been found to be helpful.

1. Cognitive Behavioral Therapy (CBT). “From my biased perspective as a psychotherapist, I believe that all depressed patients should try a strong evidence-based psychotherapy like CBT as their first choice of treatment,” says Desmond Oathes, PhD, assistant professor of clinical psychology at the Perelman School of Medicine at the University of Pennsylvania.

Psychotherapy teaches patients new skills that can help them take control of their symptoms and manage stress better, and research suggests that it works as well as antidepressant medication and may benefit patients for a longer period of time after treatment ends.

A main goal of CBT is to help patients change negative behaviors and ways of thinking that are linked to depression. Tevin Blackwell often thought the worst when things didn’t go his way. If a friend didn’t return his call, for example, he would automatically focus on thoughts like, “No one likes me.” With CBT, he has learned to think more rationally and remind himself that there are lots of reasons someone might not return a call, and that it doesn’t mean people don’t like him.

2. Acupuncture. Acupuncture is a traditional Chinese medicine technique in which thin needles are inserted into the skin at specific points on the body with the aim of balancing the flow of energy in the body to reduce symptoms of various conditions, including pain, insomnia, and depression. Some acupuncturists suggest using the technique to complement psychotherapy.

A Cochrane review of studies suggested that this approach may reduce depressive symptoms more than usual treatment or no treatment. However, the review noted that comparing the effects of acupuncture to medication and psychotherapy is unclear because of low-quality evidence. But there appear to be fewer side effects with acupuncture than with antidepressant medications.

Two studies even showed that acupuncture was an effective treatment for pregnant women with major depression disorder – with the same rates of adverse events as those who received massage. In other words, this treatment appears to be quite safe. The most commonly reported side effects are soreness or slight bleeding or bruising in the areas of the body where the needles were inserted.

3. Supplements. Researchers have demonstrated the benefits of some dietary supplements on depressed mood. “There are herbs that boost the levels of chemicals in the brain that are linked with improvement in depression,” Dr. Smith explains. A 2016 review of 35 studies involving St. John’s wort found it to be as effective as antidepressants, but with fewer side effects, in those with mild to moderate depression. However, its effectiveness in those with severe depression is uncertain. Jennifer Keely turned to the herb after trying two different antidepressants and finding that they made her feel “emotionally numb,” and she has noticed a big difference in her mood.

There is one major downside to St. John’s wort: It can interact with many drugs, so the use of this herb in patients who take medications should be carefully planned and monitored by a healthcare professional. “Herbs sometimes get a bad rap for causing interactions, although there is far more documentation about drug-to-drug interactions,” Dr. Fraser points out. “All the same, consumers should take the risk of an herb-drug interaction seriously and tell their healthcare providers what they are using – including over-the-counter drugs and dietary supplements.”

While St. John’s wort has the strongest evidence so far for improving depression, other supplements, such as S-adenosyl-L-methionine (SAMe) and omega-3 fatty acids like those in fish oil pills, have also shown promise for this purpose.

4. Repetitive transcranial magnetic stimulation (rTMS). “For patients with severe depression that don’t respond to therapy or medications, there are a variety of options ranging from less to more invasive,” says Dr. Oathes. On the non-invasive side, rTMS is a technique provided on an outpatient basis that does not require anesthesia. This FDA-approved treatment delivers magnetic pulses to the brain to stimulate nerve cells that influence mood and depression.

Results of numerous studies indicate that rTMS is safe and effective for many patients who do not get better with other types of treatment. When side effects occur, they are usually mild and include headache and scalp discomfort where the stimulation took place. “Risks also include the possibility of inducing a seizure, but this risk is extremely small in people who have been medically screened and cleared for rTMS treatment,” notes Dr. Oathes. “Treatment with rTMS requires sessions five days a week for more than one month and possible booster sessions, which is not an option for everyone.”

5. Electroconvulsive therapy (ECT). ECT is a moderately invasive approach in which patients are given a shock (hence the term “shock therapy” that ECT was known as in the past), resulting in a seizure while under anesthesia. “Although this looks scary and has been given a negative stigma due to memory problems – usually temporary – that it can induce, this treatment is effective for severe cases,” says Dr. Oathes. “Benefits include possible dramatic symptom relief in six to 12 sessions.”

By some estimates, ECT is effective for 64–87% of patients with severe major depression. Since ECT was first invented in the 1930s, it has become much more refined and safer. For example, less electricity is now used during the procedure.

“Depression is common and treatable, but there are many patients for whom standard treatments do not work,” states Dr. Oathes. Fortunately, the approaches described above offer hope for individuals who do not respond to antidepressant medications or for whom side effects are too severe, as well as those who prefer or require a non-pharmacological option.

5 Things to Know About Ketamine for Depression

Two decades ago, ketamine was known as two things: an anesthetic used in pet surgery and a party drug nicknamed “special K” that was popular at raves. Now, it’s the hottest new treatment for depression that hasn’t responded despite psychotherapy or antidepressants.

How hot? Very. Dozens of ketamine “clinics” have popped up across the United States over the past few years, offering hope to people whose depression doesn’t respond to treatment. You’ll find them offering infusions everywhere from big cities like New York, Houston and Los Angeles to Boise, Idaho, and Charleston, S.C.

The clinics all offer a controversial medical treatment that’s approved by the FDA only as an anesthetic, not for depression. Ketamine is primarily used for starting and maintaining anesthesia. Your insurance company is unlikely to pay for ketamine infusions, the treatment’s long-term effects are unknown, and it may stop working over time.

So why is it so popular? There are claims that it alleviates depression rapidly – frequently in a matter of hours – though the effect can be temporary. And because those seeking care are often so desperate for relief, they’re willing to accept the risks, cost – a single infusion can cost hundreds of dollars – and the uncertainties.

Here are five things you should know about ketamine as a treatment for depression:

1. Ketamine is reserved for the worst cases

Depression is very common in the U.S. The CDC (Centers for Disease Control and Prevention) estimates that 8% of American adults aged 20 and up suffered from depression at any one time from 2013-2016 – 10% of women and 6% of men.

Ketamine isn’t a first-line treatment for depression. Instead, ketamine clinics focus on a smaller group: patients with so-called “refractory” or “treatment-resistant” depression that doesn’t respond to common treatments like talk therapy and antidepressants.

An estimated one-third of people with depression fall into this category, and their lives can be full of misery and suicidal thoughts. “Most of our patients have been severely disabled and impaired for many years,” said Dr. Cristina Cusin, a psychiatrist who studies ketamine at Massachusetts General Hospital. “A patient can get pretty desperate.”

2. Ketamine isn’t an easy or simple fix

At first glance, the news about the effects of ketamine sounds incredibly promising. Studies suggest treatment with ketamine can relieve depression symptoms in many patients in as few as two hours. It may go on to provide relief for as long as two weeks.

One patient with depression described the effects of ketamine this way in a 2015 National Public Radio report: “I remember I was in my bathroom, and I literally fell to my knees crying because I had no anxiety, I had no depression.”

As Dr. Cusin puts it: “There’s a lot of hope that this is a magic fix.” But ketamine isn’t easy to take, and it isn’t a simple solution even when patients respond.

For one thing, ketamine isn’t available as a pill. Patients must go to clinics and undergo intravenous — injected — treatments that require time and monitoring. A nasal spray form of ketamine known as esketamine is being studied as a fast-acting treatment for people at risk of suicide due to depression. Results from a small Phase 2 trial of the drug sponsored by Janssen, part of Johnson & Johnson, published in April 2018, showed those on esketamine demonstrated a significant reduction in depressive symptoms at four hours and 24 hours after administration, but not after that.

Intravenous ketamine treatments aren’t the same as a normal injection like a flu shot. Patients are hooked up to an IV for perhaps 40 minutes. The immediate effect is “like a light anesthetic,” said psychiatrist Mark S. George, MD, of the Medical University of South Carolina. “It makes you spacey and a little bit dreamy, but most people tolerate it.”

Most of the disorientation tends to lift within 15-30 minutes after a treatment, but patients aren’t allowed to drive home afterward, said Dr. Allison Wells, an anesthesiologist who runs a ketamine clinic in Houston. You may need to get someone to pick you up, although some clinics allow patients to ride home via Uber, she said.

There’s another complication: Ketamine isn’t a solo treatment. It must be used with complex regimens of other psychiatric medications that treat depression and anxiety, Dr. Cusin said. “If the expectation is to stop everything else and take ketamine,” she said, “it does not work this way.”

3. Other treatments may be better options

Ketamine is a good option for some patients, Dr. Cusin said, “but we consider many patients to not be appropriate because they haven’t failed other treatments that would be a good option.”

Alternative treatments include electroconvulsive therapy (formerly known as electroshock therapy), transcranial magnetic stimulation and older types of antidepressants. These are typically used before ketamine since there is more clinical evidence supporting their effectiveness.

Not all ketamine clinics have a psychiatrist or psychologist on staff to ask questions about the treatments you’ve tried. Many clinics are run by anesthesiologists who’ve pioneered the fledgling field of ketamine care, and some don’t have any mental health professionals on their staff. You may want to be wary of these clinics.

Critics don’t think this is a good idea. “It’s malpractice to not have a mental health professional involved if the disease being treated is depression,” Dr. George said.

4. Ketamine costs a lot, and your insurer probably won’t pay a dime

Insurers typically won’t pay for ketamine treatments. That’s because ketamine for depression is considered experimental since it hasn’t been approved for this purpose by the FDA. It’s legal for healthcare professionals to offer ketamine as an “off-label” treatment for depression. It’s not unusual for a doctor to prescribe drugs for a condition for which the FDA has not approved the drug.

Ketamine itself is cheap, but the equipment and monitoring needed to provide infusions are expensive. Patient costs can add up quickly. Intravenous ketamine treatments, which are known as infusions, can cost from $300-$800 each, and patients often start with six infusions over two weeks.

According to Dr. Wells, the Houston psychiatrist, “usually by four to six treatments, a patient can go four to six weeks between infusions.”

5. You might take ketamine forever…or not

How much ketamine should patients take and for how long? Research doesn’t provide much in the way of answers.

A 2017 report in the Journal of the American Medical Association noted that “most published data supporting the use of ketamine as a treatment for mood disorders are based on trials that have followed up patients for just 1 week after a single administration of the drug.”

Some patients have undergone ketamine infusions for years, while others have seen its effects fade over time. “The consequences of long-term use are not known,” Dr. Cusin said.

It’s also not clear if there’s a significant risk of addiction.

Dr. George, the Medical University of South Carolina physician, is so concerned about the various risks of ketamine that he only recommends its use in psychiatric emergencies, such as when a patient is suicidal and needs relief in order to make it to the next day.

Many physicians disagree with Dr. George about the appropriate use of ketamine. But one thing is clear: Even when ketamine works, patients aren’t instantly cured.

The psychological damage of depression — isolation, ruined relationships, loss of jobs — won’t get better on its own, with or without ketamine. “You need a good psychotherapist to work through the grief of everything you’ve lost,” Dr. Cusin said. “The medication isn’t going to fix that.”

Is Your Child on Multiple Meds? He May Be at Increased Risk for Adverse Events

When we think of drug interactions and adverse effects, we worry more about adults — and particularly seniors — who are often on a cocktail of drugs. But new research shows that children and teens are also at risk for adverse effects – some quite serious – from being on multiple drugs.

The study, published in September in the journal Pediatrics, found that one in five children is on regular prescription medication, and one in twelve is potentially at risk for serious side effects from two or more drugs interacting with each other. In particular, teen girls have a higher risk than boys.

In many cases, this happens when a child is on a chronic long-term medication, such as an antidepressant, birth control or an ADHD (attention-deficit/hyperactivity disorder) stimulant. He or she falls ill and is given an antibiotic, a short-term medication. At that point, there is the potential for those two drugs to interact and cause adverse effects.

The Risks of Using Multiple Drugs in Children

About 200,000 children (age 17 and younger) go to the ER each year as a result of an adverse drug event, according to the CDC. What wasn’t known before was how many children and teens were on prescription drugs, and how many were taking two or more at the same time — called concurrent use — and the risk from drug-to-drug interaction.

The researchers found that boys age six to 12 years old had the highest use of concurrent prescription drugs at 12%, followed by teen boys and girls at 10%.

Significantly, the risk of drug-to-drug interactions for teen girls on antidepressants was much higher at 18%, than for boys at almost 7%, because more teen girls were given antibiotics for infections.

The most common side effect seen with drug-drug interactions in the study was abnormal heart rhythm, with a risk of its leading to sudden death. It also found that the most commonly used combinations of drugs were associated with effects such as suicidal tendencies or depressive symptoms. These combinations include taking an antidepressant with at least one other psychotropic medication or a birth control pill.

What Parents Need to Know

Over-the-counter (OTC) pain and fever medicines and antacids can also potentially interact with antidepressants and other chronic drugs, the study authors pointed out.

“Parents need to be aware of these adverse effects, which are not typical but could happen for many reasons,” said Dima Qato, PharmD, MPH, PhD, associate professor of pharmacy at the University of Illinois, Chicago, and lead study author. “They need to be aware of the drugs that can cause it, which are not limited to prescription medicines, but can also be [OTC] analgesics and acid reflux drugs used to treat heartburn.”

If children see more than one doctor and they’re given different prescription drugs by different providers, parents need to inform their physicians and pharmacists about all drugs they’re on.

About 200,000 children (age 17 and younger) go to the ER each year as a result of an adverse drug event.

Sudden cardiac deaths are under-reported in children, but are more common among those who are athletes, have asthma or are on antidepressants.

“It’s a concern that children are taking medications that expose them to higher risk,” Qato cautioned. “We may not know, as physicians, pharmacists and school nurses, that this could happen.”

“We hope people will be more vigilant about giving children multiple medications, particularly teen girls,” she added.

Communication Key to Avoid Risk

“The study brings up some really good points,” said Siyi Yung, MD, a pediatrician and attending physician at the University of California, Los Angeles Mattel Children’s Hospital. “It shows how many kids are at risk for drug interactions. It’s definitely a problem, even if it’s not as prevalent as in elderly people. We need to be aware of it because of how often children go to the emergency room for adverse effects.”

But she cautioned that the study looked at potential interactions, not actual events that took place and were reported. These potential adverse effects are not common, but could happen.

“The potential is high, but in pediatrics, when we prescribe for a chronic period of time, we usually follow them very closely, especially if it’s an antidepressant, via phone or in-person,” Yung said. “When patients are already on chronic medication, and we are the ones prescribing an antibiotic, that is when it gets trickier.”

When an outside prescriber such as a psychiatrist writes up a prescription for an antidepressant, and communication between the doctor, the parents and the pediatrician is not clear, this can lead to gaps in knowledge which can complicate things, especially when the child is put on two or more drugs. Intake forms at clinics and hospitals always ask about current medications, but patients and caregivers can slip up and forget to list them all.

“Someone could come in for a urinary tract infection, forget to tell the doctor they’re also on antidepressants, and get antibiotics for their UTI, which could lead to a drug interaction,” Yung explained. “For many patients, their parents give us an oral report, but often can’t remember the name of the medicine, its potency, etc.”

System Improvements Needed

Part of the problem also lies with unnecessary prescriptions for antibiotics, which Yung said are often doled out when children are brought to the ER or urgent care, and seen by unfamiliar doctors. Antibiotics are only effective for bacteria-based infections. More than 60,000 children end up at the ER as a result of an adverse drug event from an antibiotic each year, according to the CDC.

“I think it drives home the need to improve our healthcare system so patients are not forced to go to the ER when they could be served by their normal clinic or primary care provider,” Yung said.

Similarly, for ADHD, when a parent raises concerns, there may be an explanation for a child’s behavior when physicians investigate, and maybe even contact the teachers, before prescribing drugs.

Parents also often start a child on OTC medicines without being aware of how they might interact with the chronic drugs the child is on, so it’s important to ask the doctor what medicines and supplements (including vitamins) should be avoided every time you meet with the doctor about the chronic drug, she said.

Quick Hits: Why Medication Errors Occur, Antidepressant No Help For Stroke Patients & More

Medication errors leading to death most commonly occur as a result of a patient not getting a medicine, in hospitals and in those over the age of 75. Researchers examined data from a medication error reporting system in England and Wales between 2007 and 2016. During that period, more than 517,000 medication administration errors were reported, of which 229 resulted in death. Among drug types, medication errors leading to death were most common with anticoagulants (blood thinners) and antibiotics. Other drug classes most commonly associated with medication errors include cardiovascular drugs and those impacting the central nervous system. Giving a wrong dose or the wrong strength of a drug were also top reasons for medication errors. Posted November 22, 2018. Via Research in Social and Administrative Pharmacy.

Taking a popular antidepressant does not help recovering stroke patients make physical recovery improvements compared to taking a placebo. About 3,100 stroke patients took part in the study. Half of them started taking Prozac (fluoxetine) within two weeks of their stroke, while the other group was given a placebo. Participants were followed for six months. Results indicated that those in the Prozac group did not see a significant improvement in their functional abilities at both six and 12 months. And while those on Prozac saw improvements in depression after six months, they also had more bone fractures. Posted December 5, 2018. Via The Lancet.

The FDA is alerting healthcare providers and patients that they need to be more aware of a potentially life-threatening side effect with a leukemia treatment. Patients receiving the acute myeloid leukemia treatment Idhifa (enasidenib) are at risk for differentiation syndrome. This is already reflected as a “boxed warning” – the most serious the FDA can require – on the drug’s labeling. Between May and July of this year, Idhifa’s manufacturer reported five deaths associated with differentiation syndrome in patients taking the drug. The FDA says that healthcare professionals should discuss the symptoms of differentiation syndrome when starting Idhifa and during follow-up visits. Some of those symptoms are fever, cough, shortness of breath, weight gain of more than 10 pounds in a week, bone pain and feeling lightheaded. Posted November 29, 2018. Via FDA.

Quick Hits: Meds, Falls and Dementia Patients; Avoid Male Enhancement Supplements & More

Seniors with dementia face a similar risk of falls or fractures whether they are prescribed trazodone, an antidepressant, or an antipsychotic. Antipsychotics are often given to seniors with dementia because they ease the agitation and aggression commonly seen with the disease. More doctors have been turning to trazodone, an old antidepressant, because of a perception it is safer than antipsychotics, according to a new study. Researchers examined data on seniors in long-term care facilities in Canada, some of whom were given antipsychotics and others trazodone. The rate of falls and fractures was similar in both groups. However, death risk was lower in the trazodone group. Posted November 26, 2018. Via Canadian Medical Association Journal.

Men should stop using Rhino-branded male enhancement supplements because of a rise in health problems related to their use, the FDA is warning. The agency said it has received reports of men taking the supplement and then experiencing chest pain, severe headaches and even prolonged erections that required surgery. The FDA also says that some Rhino products contain undeclared ingredients such as sildenafil and tadalafil, the active ingredients in the prescription erectile dysfunction drugs Viagra and Cialis. Posted November 27, 2018. Via FDA.

Multiple sclerosis patients taking the drug Gilenya (fingolimod) face a rare risk of the disease severely worsening should they stop taking the medicine, according to a new FDA alert. The agency said that, in rare cases, stopping Gilenya can lead to multiple sclerosis becoming much worse compared to while on the drug or even before treatment began. In severe cases, the worsening can result in permanent disability. If patients are stopping Gilenya and they experience weakness, trouble using arms or legs, or changes in thinking, eyesight or balance, they should contact their doctor immediately. The FDA recommends that healthcare providers tell patients about this new risk before starting Gilenya, and patients should be closely followed after stopping the drug for worsening of their multiple sclerosis. Posted November 20, 2018. Via FDA.

Many Medications Taken Longer Than Recommended

Many people continue to take prescription drugs months after clinical guidelines recommend, a practice that increases the risk of side effects from individual drugs as well as from drug interactions.

New research examines the issue of legacy prescribing, which is when drugs are taken for longer than needed to treat a condition. A new study, published in the Annals of Family Medicine, examined 50,000 patients in Canada who were prescribed drugs that are typically taken for more than three months but not indefinitely. The drug classes were antidepressants; proton-pump inhibitors (PPIs), which are used to treat heartburn and acid reflux; and bisphosphonates, which treat osteoporosis by stemming bone density loss.

Nearly half of patients on an antidepressant – 46% – were on it for more than 15 months, even though a current recommendation states they should be prescribed it for only six months after a mood episode is resolved. PPIs shouldn’t be taken for longer than three months. However, 45% of patients were prescribed them for longer than 15 months. The recommendation for bisphosphonate prescriptions is 5.5 years, yet 14% of people on those drugs took them for at least six months longer than that.

For example, long-term use of PPIs has been linked to several health issues. In one study, patients who had taken the drugs for at least five years had a higher risk of developing kidney disease than those on another type of acid-reducing medication. Another study found long-term PPI use may be associated with an increased risk for stomach cancer.

Moderate Aerobic Exercise Can Produce Antidepressant Effects

If you suffer from depression and anxiety, exercise that gets your heart pumping several times a week may help to ease symptoms, according to new research.

Researchers conducted a meta-analysis of 11 studies covering 455 patients. The participants engaged in moderate aerobic exercise an average of 45 minutes, three times per week, for nine weeks. Results, published in the journal Depression and Anxiety, found that those who engaged in aerobic exercise experienced a “significantly large antidepressant effect.”

Results also showed that it didn’t really matter how the exercise was done – whether with equipment or not, and inside or outside. The researchers concluded that aerobic exercise is an “effective antidepressant intervention.”

The reason exercise may help to alleviate depression is that it leads to the release of endorphins, the so-called “feel-good chemicals,” in the brain and central nervous system. There is also evidence that regular exercise helps to improve brain function.

Other types of exercise have been shown to alleviate depression. Resistance training, such as using free weights or weight machines, significantly reduces depressive symptoms, according to a study published in JAMA Psychiatry earlier this year.

Can a Test Take the Guesswork Out of Prescribing Meds?

Here’s the promise: A simple test, taken in a doctor’s office or even a drug store, will predict which medicine is the right one for you. No guessing, no false starts, no terrible side effects.

Here’s the reality: Not yet.

This is the growing area of pharmacogenomic testing, which for medications means predicting which drugs will work well inside of your body based on certain genes you possess. But at the moment, the testing has not demonstrated it is as good as its developers make it out to be.

The testing is of particular interest for those taking psychiatric drugs, where it can often take several tries before a medication that works for a given condition is found. For example, only 40 to 60% of those with depression find success with the first antidepressant prescribed.

Pharmacogenomic tests are becoming more widely available. As an example, back in May, grocery chain Albertsons, which also operates drug stores, began offering pharmacogenomic testing for psychiatric medications for customers at 28 of their pharmacy locations through a partnership with Genomind.

‘The Marketing Is Way Out Ahead of the Data’

A recent article in JAMA discussed psychiatric pharmacogenomic testing, interviewing doctors and other health care professionals. The bottom line: Pharmacogenomic testing for psychiatric meds may work, but the evidence so far is limited.

James Potash, MD, with the department of psychiatry and behavioral science at Johns Hopkins, said that the evidence for the tests has come mostly from small trials conducted by the manufacturers. Perhaps that’s why he told JAMA that for some tests, “the marketing is way out ahead of the data.”

A piece published in August in JAMA Psychiatry examined the trials behind 10 pharmacogenomic tests that are marketed to help determine the ideal medication choice for treating major depression. The authors found issues with the way all 10 trials were conducted.

A consensus is growing, according to the JAMA article, that pharmacogenomic testing may be more useful for predicting side effects than for a person’s response to a particular drug. So far, there is no test than can tell you, for example, what the “right” antidepressant is for a given patient, according to Potash.

An American Psychiatric Association task force this year also came to the conclusion that there is not enough evidence to support widespread use of pharmacogenomic testing, though “it may be informative, particularly in predicting side effects.”

There are other concerns. Just because an individual has a gene linked to a particular side effect doesn’t guarantee they will definitely experience that side effect. Along the same lines, lacking that gene doesn’t mean you won’t experience it or other effects. Many genes influence side effects you might experience, as do other health conditions and medications you are taking. In other words, pharmacogenomic tests can complement, not replace, existing clinical tools.

And then there is the cost — pharmacogenomic tests can easily cost hundreds of dollars.

To me, pharmacogenomic testing for drug side effects and efficacy holds great promise, but we are not there yet. If you decide to get a test, understand its limitations.

Mediterranean Diet’s Newest Benefit: Curbing Depression

The Mediterranean diet has been highly touted for helping to improve physical health, and a new study indicates that it may also help to curb the risk of developing depression.

Researchers conducted a review of 41 studies that examined the connection between diet and depression risk. Four of them, which included more than 36,000 people in the US and Europe, looked specifically at the Mediterranean diet and depression risk. The Mediterranean diet is one that is rich in in fish, olive oil, nuts, fruits and vegetables. It minimizes meat consumption and avoids processed foods and those that are high in saturated fats and sugars.

People that followed a Mediterranean-style diet had a 33% lower risk of developing depression, according to results presented in the journal Molecular Psychiatry.

As to why the Mediterranean diet may protect against depression, researchers say that anti-inflammatory and anti-oxidant elements found in the foods help protect the brain from oxidative stress and inflammation. Inflammation in the brain can also impact chemicals there known as neurotransmitters, which send messages between nerve cells that regulate mood.

A study published last year assigned people with depression to start either a Mediterranean-based diet or a social support group. While depression symptoms in both groups improved, those in the Mediterranean group saw bigger improvements.

Quick Hits: FDA Raids E-Cig Manufacturer, Asthma Drugs’ Side Effects & More

The FDA conducted a surprise inspection of JUUL Labs as part of the agency’s effort to gain more information on the e-cigarette company’s sales and marketing practices. The FDA reportedly seized more than 1,000 documents. The action comes just weeks after the FDA ordered JUUL and four other manufacturers to come up with plans to curb use of e-cigs by teens. JUUL has the largest share of the e-cig market, and its sales grew more than seven-fold from 2016 to 2017, according to newly released data from the CDC (Centers for Disease Control and Prevention). The CDC also noted that JUUL has among the highest nicotine content of e-cigs available. Posted October 2, 2018. Via CDC.

More than half of people with asthma that take oral steroids such as prednisolone experience significant side effects, according to a new survey. Asthma UK, a charitable organization, interviewed 1,200 patients with severe asthma, most of whom had at least two asthma attacks in the prior year and were on an oral steroid. Of those on a steroid, about 56% experienced weight gain, 55% had trouble falling asleep, 43% were more irritable and more easily upset. And 37% said they were more anxious and had less energy. Asthma UK said that healthcare providers should use newer biologic-based drugs known as monoclonal antibodies to treat asthma, as they have been shown to reduce asthma attacks by up to 50%. Some of these medications include Xolair (omalizumab), Cinqair (reslizumab) and Nucala (mepolizumab). However, they are more expensive than oral steroids. Posted October 2, 2018. Via The Times.

About 20% of people with Alzheimer’s disease use two or more psychotropic drugs that can raise the risk of experiencing adverse events. Researchers in Finland examined the medical records of more than 70,000 people diagnosed with the disease. Antipsychotics were eight times as likely to be prescribed in those with Alzheimer’s compared to those without the disease. The use of at least two psychotropics together was three times more common among people with Alzheimer’s. The most common combination was an antidepressant with either an antipsychotic or benzodiazepine, a class of medications used for anxiety and sleep. Use of acetylcholinesterase inhibitors, a first-line dementia treatment, such as Aricept (donepezil), was associated with less risk for psychotropic polypharmacy, while use of Namenda (memantine), another dementia drug, was associated with a higher risk. Posted October 1, 2018. Via European Neuropsychopharmacology.

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