Tag Archives: depression

Is Kratom Really As Dangerous As the FDA Makes It Out to Be?

America is in the midst of one of the worst epidemics in its history over opioids, which may be one of the reasons the FDA recently issued a warning that kratom, a plant-based supplement often used for pain, is potentially addictive since it has opioid-like qualities.

Kratom has also been used by some people to treat withdrawal from opioids. However, the agency stated that there is “no reliable evidence” to support this and “significant safety issues exist.” The FDA also said it has received reports of 44 deaths related to kratom use. However, as a recent Reason.com blog pointed out, in many of these cases, other substances were found along with kratom in the systems of the deceased, making it difficult to prove kratom was the cause of death.

In one of those deaths, a 22-year-old man had a cocktail of drugs in his system that included the antidepressant Prozac (fluoxetine), antipsychotics Seroquel (quetiapine) and Zyprexa (olanzapine), Lyrica (pregabalin), which is used for nerve pain, and several benzodiazepines (tranquilizers) – in addition to kratom. Also, as Jacob Sullum argued in another Reason.com blog, more people have died from prescription and over-the-counter pain relievers than kratom.

So is kratom really as dangerous as the FDA makes it out to be?

It’s hard to say. But it may be harder to get your hands on kratom. The FDA has already blocked importation of the substance. And in 2016, the Drug Enforcement Agency (DEA) ruled to classify kratom as a Schedule 1 drug, putting it in the same class as marijuana, LSD and heroin as substances with no currently accepted medical use and a high potential for abuse. The DEA backpedaled a bit later in the year following outcry from the public. However, the FDA’s warning could make it more likely for kratom’s Schedule 1 designation to go through.

To me, it seems the FDA is making a bit of a rash decision. Although the FDA says it conducted its own medical analysis of kratom, there is a lot of existing research supporting kratom as effective for conditions such as PTSD and depression. Did they consider this before issuing a warning?

Much like the FDA’s and DEA’s position on marijuana, it seems that decisions are being made based on incomplete examinations of the positives and negatives of herbal substances. The FDA and DEA owe it to patients who use kratom and find benefit from it to conduct a more thorough investigation before deeming it unsafe for public consumption.

Quick Hits: Antidepressants and Ovarian Cancer, Limiting Opioid Scripts & More

Antidepressants are not linked to ovarian cancer, according to a new study. Although there have been a few studies over the years showing a link between certain classes of antidepressants and the development of tumors, researchers from Shengjing Hospital of China Medical University are suggesting otherwise. The research team thoroughly analyzed data from observational studies that examined the connection between antidepressant use and cancer from 1984 to 2017. The results from this large-scale review indicated that there is not a significant association between antidepressant use and the risk of ovarian cancer, which is contrary to initial findings. Posted February 5, 2018. Via British Journal of Clinical Pharmacology.

Opioid prescriptions for Medicare enrollees would be limited to 7 days under a request from the Centers for Medicare & Medicaid Services. The agency has also proposed that patients who are considered “potentiators” of opioid misuse and opioid-related adverse events be closely monitored, especially those who take Neurontin (gabapentin) and Lyrica (pregabalin). According to the agency, there has been a significant increase in gabapentin use to treat pain. Via CMS. Posted February 2, 2018.

Senate Democrats want the FDA to reject a new alternative cigarette that will be marketed as less risky. Ten Democrats sent a signed letter requesting that the FDA to reject Philip Morris’ risk application for its new iQOS smoking device. The letter was sent after most of the FDA’s scientific advisory panel reported mixed findings on the new product. According to the advisory panel, the tobacco company did not prove whether its new “heat not burn” cigarette reduced harm compared to tobacco cigarettes. However, the advisory panel concluded that iQOS exposes users to lower levels of harmful chemicals. The senators also referenced the Family Smoking Prevention and Tobacco Control Act, noting that modified risk tobacco products must significantly reduce harm and benefit the health of the population. Posted February 7, 2018. Via The Hill.

Young People on Antidepressants at Increased Risk of Developing Type 2 Diabetes

Researchers from the University of Maryland examined the medical claims of nearly 120,000 patients between the ages of 5 and 20 years old who were using antidepressants. The team compared incident cases of diabetes among the young patients using antidepressants — patients who didn’t discontinue the medications for more than 90 days during the study period — with those in former patients.

Researchers found that the risk for type 2 diabetes was nearly twice as high among current users of certain types of antidepressants, they reported in JAMA. The antidepressants included selective serotonin reuptake inhibitors (SSRIs) such as Prozac (fluoxetine) and Zoloft (sertraline), and serotonin norepinephrine reuptake inhibitors (SNRIs) such as Effexor (venlafaxine) and Cymbalta (duloxetine). They added that the risk increased the longer one was on an antidepressant and the higher the daily dose.

Researchers also noted that for adolescents on older types of antidepressants for long periods of time, there was no increased diabetes risk.

Asthma Drug Singulair Causes Nightmares, Depression in Children and Adults

Dutch researchers have confirmed that the asthma drug Singulair (montelukast) has serious side effects, including depression, nightmares and even sleepwalking in some children and adults.

Their study, published in Pharmacology Research & Perspectives, is a meta-analysis of data from both the Netherlands Pharmacovigilance Center Lareb and the WHO Global database, VigiBase. The researchers found that while depression is the most reported side effect, nightmares and aggression were the most reported for children using the drug.

Interestingly, the researchers suggest that because asthma itself is known to cause depression among children, the use of Singulair may have lifted the depression. According to the authors, “a reason for the higher incidence of agitation in children can be that children have more energy because their symptoms of asthma and/or allergic rhinitis are being tempered by montelukast and parents may interpret this as abnormal behavior or aggression (de Vries and van Hunsel 2016).”

The study data reaffirms the 2009 decision by the FDA that depression, suicidal ideation and other neuropsychiatric symptoms must be listed among potential side effects included in the medication packaging. In addition, the Dutch researchers advise that doctors should talk to patients specifically about these potential side effects.

Overprescribing: Do You Really Need to Take That Med?

Do you take 4 pills a day? If so, you’re like most Americans. Yet what are we taking all these pills for, and are they improving our lives?

The overuse of prescription drugs has become a serious problem in the US. We hear about this most in the context of opioids — narcotic painkillers whose widespread use and abuse has become a national crisis.

The overuse of antibiotics has also become the focus of an intensive campaign to steer doctors and patients to more judicious use.

The soaring use of prescription drugs has been driven by several factors: A plethora of new drugs coming to the market; a culture that has come to expect a “pill for every ill”; aggressive marketing to both doctors and consumers by the pharmaceutical industry; and treating some “pre-”diseases with pills rather than with lifestyle changes.

Between 1997 and 2016, the number of prescriptions filled in the US increased 85% — from 2.4 billion to 4.5 billion — even though the population increased by just 21%. Nearly half (49%) of adults take at least 1 prescription drug, 23% take 3 or more and about 12% take 5 or more, according to the latest data from the CDC (Centers for Disease Control and Prevention). One in 10 adults takes 10 or more drugs, and the average adult takes 4 prescription medications, according to a Consumer Reports survey of 1,947 adults conducted in April.

What can you do to make sure you’re not getting a drug you don’t need and to avoid harm?

Ten “secret shoppers” were sent to 45 drugstores across the US in a recent Consumer Reports investigative study. The shoppers were testing how well pharmacists identified potential problems with drugs.

Of course, it’s your doctor who should be your main consultant on the medicines you take. But bring a big measure of skepticism to your doctor visits: The evidence is now clear that they can be a part of the problem.

Based on the secret shoppers’ findings and more than a decade of Consumer Reports’ grant-funded Best Buy Drugs program, we have compiled a list of drugs that you should use special caution with when prescribed by your healthcare provider.

(For more detailed information, check out Consumer Reports’ September 2017 cover story and the physician-led Choosing Wisely program.

Abilify and Seroquel for Dementia or ADHD

These powerful antipsychotics have potent sedative effects and can be downright dangerous. Studies over the last decade show they have been overprescribed in general and particularly for elderly people with dementia.

The FDA and other healthcare and physician organizations now advise against their use entirely in elderly people. Multiple studies over many years have found an increased risk of death in elderly people prescribed these drugs.

Abilify (aripiprazole) and Seroquel (quetiapine) are also overprescribed to treat children and adults with attention-deficit/hyperactivity disorder (ADHD). The two drugs are not even approved for this condition. Their use to treat ADHD is not advisable unless a person is diagnosed with other psychiatric conditions, such as bipolar disorder. And even then, caution is warranted. Behavioral therapy is a better initial treatment for ADHD.

Advil, Aleve, Celebrex and Any Opioid for Back and/or Joint Pain

The non-steroidal anti-inflammatory drugs (NSAIDs) Advil (ibuprofen), Aleve (naproxen) and Celebrex (celecoxib) are commonly prescribed to treat back and joint pain (and headaches, of course). Short-term use — up to 10 days — is fine at the lowest dose that helps.

But long-term use — which is all too common — is ill-advised because all these drugs can cause bleeding in the intestines and stomach, and increase the risk of heart attack and stroke (especially at higher doses).

Opioids should simply never be a first-line treatment for either chronic back pain or garden-variety periodic back pain (“I threw my back out” kind of pain). The risks are too high. The side effects include drowsiness, sedation, nausea, vomiting, constipation, addiction and overdose. Instead, try yoga, swimming, gentle stretches, tai chi, massage, physical therapy, acupuncture or heat.

For intense pain flare-ups (pain in the range of 8 to 10 on a 10-point scale), an opioid can be useful, but it should be prescribed at the lowest dose that’s effective and for the shortest time possible, like a day or 2. And never more than a week to 10 days.

Celexa, Cymbalta, Lexapro and Prozac for Mild Depression

Antidepressants are overprescribed for people who have mild or so-called “situational” depression — that is, depression triggered by a life event such as a death in the family, job loss, divorce or breakup, accident, trauma or diagnosis with a serious health condition.

You don’t need a pill if these life events befall you. Social support, time and psychotherapy or counseling almost always help. Also, be sure to exercise and perhaps try meditation and/or yoga. For the vast majority of people who have situational depression, the symptoms lift within a few weeks to a couple months.

Nexium, Prevacid and Prilosec for Heartburn

These drugs, called proton-pump inhibitors (PPIs), reduce stomach acid. They were designed to treat a condition called gastroesophageal reflux disease (GERD). But they are greatly overprescribed for common, uncomplicated heartburn, which most of the time can be just as effectively treated with over-the-counter (OTC) products such as Maalox, Pepcid AC, Tums or Zantac 75.

The problem with taking PPIs is that they carry serious risks — a few of which were not fully appreciated until a few years ago. These include a reduction in the body’s ability to absorb certain nutrients and medications, along with an increased risk of gastrointestinal and other infections.

Instead, as a first-line treatment, eat smaller meals, don’t lie down soon after eating, lose excess weight, and avoid acidic or greasy meals that trigger heartburn.

If heartburn occurs twice weekly or more for 4 weeks or longer despite the above diet and lifestyle changes, then you might have damaged your esophagus. Check with your doctor, and if GERD is diagnosed, it would be appropriate to take a PPI for a few months while your esophagus heals.

Ambien, Belsomra and Lunesta for Insomnia

These strong sleeping pills are way overprescribed for people who have insomnia triggered by a life event, as well as for people who have chronic insomnia.

If you find yourself in the first group, try an OTC sleep aid containing an antihistamine, but not for longer than a few days. People with chronic insomnia are not helped in the long term by taking these medicines, recent evidence shows. Instead, try cognitive behavioral therapy (CBT), where a provider teaches you good sleep habits and suggests ways to change your behavior and nighttime habits.

Prescription medicines have significant side effects and risks, including dizziness, next-day drowsiness, impaired driving, dependence, and worsened sleeplessness when you try to stop.

AndroGel, Axiron, Androderm and Aveed for Low Testosterone

Low testosterone (“low T”) is a controversial diagnosis. If you get such a diagnosis and your doctor advises you to take any of these medicines, get a second opinion.

A small percentage of men (usually in their 50s, 60s and 70s) have “low T,” but the manufacturers of these products have sought to create a condition that is not firmly established in medical literature — one marked by low energy and low sex drive due to “low testosterone.”

Don’t buy into it. The drugs can cause blood clots in the legs, sleep apnea, an enlarged prostate and possibly an increased risk of heart attack or stroke.

Instead, talk to your doctor about treating common underlying conditions that can decrease testosterone level, such as diabetes, obesity and aging. Also discuss non-drug ways to boost energy and vitality by exercising, getting enough sleep and couples therapy with your partner.

Actonel, Boniva and Fosamax to Treat Osteopenia (Low Bone Density)

These drugs, called bisphosphonates, are widely prescribed to treat a condition dubbed “pre-osteoporosis.” But there’s scientific controversy about the prevalence and impact of mildly or marginally low bone density, and whether it warrants treatment with these strong medicines.

All have side effects and carry risks, which include diarrhea, nausea, vomiting, heartburn, esophageal irritation and bone, joint or muscle pain. Long-term use has also been linked to an increased risk of fractures of the femur (thigh bone).

Before considering one of these medicines, walk more, quit smoking and try eating more foods high in calcium and vitamin D. If bone density tests show you have full-blown osteoporosis, you should consider one of these medicines. But use caution with long-term use.

Detrol and Oxytrol for “Overactive Bladder”

The sudden or frequent need to pee is frustrating and inconvenient. These medicines, called anticholinergics, are often prescribed even to people who have mild symptoms.

The drugs can cause constipation, blurred vision, dizziness and confusion. So before trying one, cut back on caffeine, soft drinks and alcohol, and watch your liquid intake overall. Also, try bladder training (slowly increasing the time between bathroom visits) and Kegel exercises — repeatedly tightening and relaxing the muscles that stop urine flow. These techniques have been proven effective.

If several weeks or months of non-drug strategies don’t provide enough relief, consider an anticholinergic.

Actos and Glucophage for “Pre-diabetes”

Pre-diabetes is a widely accepted condition (unlike “low T”), but there’s no consensus on how aggressively to treat it, or if people with it should take drugs. People with pre-diabetes have blood glucose (sugar) levels at the high end of normal.

Because these diabetes medicines have side effects and carry risks — including dizziness, fatigue, muscle pain and, in rare cases, the dangerous buildup of lactic acid and a vitamin B12 deficiency — talk to your doctor about non-drug options first, such as exercise, a diet rich in unprocessed and non-starchy foods, and weight loss.

If you develop type 2 diabetes, however, you should consider a diabetes drug.

Drugs to treat Pre-hypertension

Like pre-diabetes, pre-hypertension is an accepted condition that warrants monitoring. It’s defined as blood pressure at the high end of normal. But, also like pre-diabetes, there’s no consensus on when to treat it with drugs.

Many classes of medicines are used. They include ACE inhibitors, angiotensin receptor blockers (ARBs), calcium channel blockers and diuretics. All are effective at lowering blood pressure but have side effects. Diuretics can cause frequent urination, low potassium levels and erectile dysfunction. ACE inhibitors and ARBs can cause high potassium levels and reduced kidney function. Calcium channel blockers can cause dizziness, an abnormal heartbeat, flushing, headache, swollen gums and, less often, breathing problems.

Unless a patient has other conditions that make the case for starting a drug, non-drug options are a better initial treatment to bring blood pressure into the normal range. Most important among them: Quit smoking, cut back on sodium and alcohol, lose excess weight, and exercise.

Belviq, Contrave, Qsymia and Xenical for Obesity

These weight loss drgs have mixed effectiveness. They work for some people and not at all for others. For patients who are significantly overweight or have diabetes or heart disease, and have been unable to lose weight through exercise and diet, one of these medicines may be worth trying.

But the drugs should not be a first-line treatment for anyone who is just 10 to 20 pounds overweight and hasn’t yet really tried lifestyle and diet changes. All have side effects that are common and can be quite discomforting. Constipation, diarrhea, nausea and vomiting are common.

The drugs also carry rare but dangerous risks, including leaky heart valves with Belviq and liver damage with Xenical.

Americans are all too often pushed — or rushed — into taking drugs too soon. Sure, lifestyle changes can be hard. But they don’t have side effects and the risks are well defined and easily avoidable. And the payoff from adopting a much healthier diet or sticking to an exercise regimen often goes well beyond addressing the medical condition at hand and improves your overall physical and mental health.

Quick Hits: Antidepressant Use Soars, FDA Looks at Presenting Fewer Risks in Drug Ads and Marijuana Linked to Hypertension

Between 1999 and 2014, antidepressant use by Americans increased by 65%. By 2014, 1 in 8 Americans (12.7%) 12 and over reported using an antidepressant recently. In 1999, only 7.7% did, according to a new report published by the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS). Results also showed that women are twice as likely to take an antidepressant than men. Between 2011 and 2014, 24.4% of women had taken an antidepressant in the last month compared to 12.6% of men. Whites were more likely to use antidepressants than any other racial or ethnic group, with 16.5% of them admitting to doing so in the last month. That compares to 5.6% of blacks, 5% of Hispanics and 3.3% of Asians. Researchers also found that most people are using antidepressants over a long period of time. For example, 25% of people surveyed reported taking an antidepressant for 10 years or more, and 68% were taking one for 2 years or more. The findings are based on responses from a national health survey of more than 14,000 people conducted between 2011 and 2014, which were compared to responses from the same survey done in 1999. Posted August 16, 2017. Via NCHS.

The long list of risks mentioned in TV prescription drug ads may be whittled down to only covering the most severe risks and side effects. The FDA says research it has conducted found that “a more targeted presentation of risks” presented in direct-to-consumer (DTC) ads can lead consumers to remember more of the most relevant risks and side effects rather than overwhelming them with every single one. The agency noted that it wants to ensure consumers who are viewing these ads are walking away “properly informed” of the key benefits and risks associated with an advertised medication. The FDA is exploring the possibility that DTC ads will include only the most severe (life-threatening) side effects, along with a note that there are other risks not included in the advertisement. The FDA is also asking for comments from the public. “To inform our policies on how risks should be disclosed, we’re asking consumers, providers and other members of the public to help us better understand what risk information is most useful in TV and other broadcast ads,” FDA Commissioner Scott Gottlieb said in a statement. Posted August 18, 2017. Via FDA.

Regular marijuana use may more than triple the risk of dying from hypertension (high blood pressure). In addition, the risk increases with each year of smoking cannabis. Researchers from Georgia State University analyzed data from 1,213 people aged 20 and older who had been involved in an ongoing National Health and Nutrition Examination Survey. The information collected on marijuana use among the group was merged with mortality data from the U.S. National Center for Health Statistics in 2011. Researchers found that marijuana users had a 3.4 times higher risk of death from hypertension than non-users. Posted August 8, 2017. Via European Journal of Preventive Cardiology.

When Stopping Psychiatric Medication, Doctor Support Often Lacking

Around half of people on psychiatric medications for the long term who decide to stop taking at least one of them are successful, though they say their doctor could have provided more support to deal with withdrawal symptoms, according to a new study.

Researchers asked 250 long-term users (9 months or more) of psychiatric medications about their experiences trying to discontinue use. Overall, 54% did so for at least a year, with few reporting a relapse. Also, 54% experienced severe withdrawal symptoms such as crying, diarrhea and insomnia. The results were published in the journal Psychiatric Services.

More than 70% of those surveyed were on a drug for 10 years or more.

Many of the people that were successful were critical of the support they got from their prescriber: 55% said that individual was not helpful while they were discontinuing their medication.

When asked why they wanted to quit, a majority of respondents said it was over concerns about the health impacts of long-term use and side effects of the drugs.