Tag Archives: Lyrica

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.

Quick Hits: Some Drs Swapping Anti-Seizure Drugs for Opioids, a Corticosteroid Study Stopped & More

In an effort to combat the opioid epidemic, doctors may be overprescribing anti-seizure drugs as an alternative, according to a letter from researchers published in of the New England Journal of Medicine. Physicians are frequently prescribing the epilepsy drugs Neurontin (gabapentin) and Lyrica (pregabalin) to treat chronic pain.

However, these medications are only FDA-approved to treat certain types of pain, and may cause serious side effects if prescribed for the wrong type of pain symptoms. Some of the side effects patients have experienced include allergic reaction, fatigue, balance problems, impotence, change in bowel movements, sluggishness, confusion and dizziness. Researchers have suggested that doctors direct patients toward non-drug methods of pain management instead, such as physical therapy and cognitive behavioral therapy. Posted August 2, 2017. Via US News.

Researchers concluded a clinical trial early when they found that patients who were using a corticosteroid called methylprednisolone experienced severe side effects, including such serious infections as pneumonia and meningitis. The research team randomly administered either methylprednisolone pills or an inactive placebo to 262 patients with a kidney disease that causes inflammation (immunoglobulin A [IgA] nephropathy). The study’s results, which are published in the Journal of the American Medical Association, showed that nearly 15% of patients experienced a serious “adverse event” –- mainly infections –- over a 2-year period. Posted August 1, 2017. Via Health Day.

Pregnant women who take opioid painkillers together with psychiatric drugs for depression or anxiety during pregnancy have a greater risk of giving birth to an infant in withdrawal, according to a Harvard Medical School study. The study found that the risk and severity of drug withdrawal symptoms in newborns significantly increased when opioids were taken with psychiatric drugs, particularly antidepressants, benzodiazepines such as Valium (diazepam) and the seizure drug Neurontin (gabapentin). After examining more than 200,000 pregnant women, researchers found that mothers who took narcotic painkillers — such as OxyContin or morphine — with psychiatric drugs have a 30% to 60% greater risk of giving birth to an infant in withdrawal than those taking opioids alone. The highest risk of withdrawal — more than 11% — occurred with a mother’s use of gabapentin along with a narcotic painkiller. Posted August 2, 2017. Via Health Day.

Treating Neuropathy: Why Medications Are a Pain, and Some Alternatives for Relief

Patricia Braden liked hiking for hours in the woods and walking her Corgi-mix dog near her home in Greensboro, NC. The retired clinical psychologist also enjoyed long conversations with friends, family, and her clients.

But those days are over because of peripheral neuropathy and the side effects — such as problems with balance and concentration — of drugs used to treat it.

She is not alone. An estimated 20 million people in the US have some form of peripheral neuropathy, according to the National Institute of Neurological Disorders. The condition results from damage to the peripheral nervous system, the nerves running from the brain and spinal cord to the rest of the body.

Symptoms are numbness and a prickling or tingling sensation in your feet or hands, which can spread to the legs and arms. Other signs include sharp, throbbing, freezing or burning pain, extreme sensitivity to touch, and a lack of coordination that can lead to falls.

Drugs Used to Treat Neuropathy

The drugs to treat neuropathy fall into 2 classifications: antidepressants and anti-seizure medications, though it is not totally clear why they work for nerve pain. Many patients also experience a host of sometimes debilitating side effects from the drugs. The good news is that there are several alternative treatments and therapies that many patients have used to find relief that can minimize the use of medications.

David Cornblath, MD, professor of neurology at Johns Hopkins Hospital in Baltimore and a specialist in peripheral neuropathy, said the 3 main drugs approved for treating diabetic neuropathy — the most common type of neuropathy — “all have positives and negatives.”

He said the anti-seizure medication Neurontin (gabapentin) has the fewest side effects. Lyrica (pregabalin, another anti-seizure medication) comes next, and the antidepressant Cymbalta (duloxetine, a serotonin and norepinephrine reuptake inhibitor) has the most.

Doctors prescribe those same drugs for other kinds of neuropathy, such as the category of idiopathic neuropathy (meaning no known cause) into which Braden and many others fall. They are also used for fibromyalgia, another nervous system disorder with some of the same symptoms as neuropathy.

According to Cornblath, “Many start with gabapentin. It’s well-tolerated. But relief rarely occurs until people get to 1,800 milligrams a day,” he said. “Many are underdosed.”

However, “many patients find the side effects of increased dosages intolerable,” said Marlene Dodinval, executive director of The Foundation for Peripheral Neuropathy, a nonprofit in Buffalo Grove, IL.

Common side effects of the 3 drugs include fatigue, nausea, drowsiness and confusion, and weight gain or loss, in addition to side effects specific to each drug and the possibility of drug interactions. But they can be more extreme: The FDA requires manufacturers of antiepileptic drugs to carry warnings about increased risks of suicidal thoughts and behaviors. Antidepressants may also increase suicidality, especially for children, young adults and teenagers. In trials, patients who took an antiepileptic drug had almost twice the risk of suicidality as those who did not.

Falls, Forgetfulness and Other Side Effects

The 83-year-old Braden has not been immune from side effects. “I’ve fallen 3 dozen times in the last 10 years.” To help alleviate the sharp pain and the sensation that she likened to wearing iron shoes, her doctor put her on a high dose of Neurontin, which made her forget words in the middle of a thought, as did the Cymbalta that she takes.

“The thing I struggle with is, I don’t know if the benefit is worth the side effects,” she said.

Others have a similar dilemma. Valerie Lloyd, a retired government employee, could take more Neurontin for her painful chemotherapy-induced peripheral neuropathy, but is deterred by the side effects. “It’s in my feet, hands, and sometimes lips,” she said. “I feel OK in the morning, and that’s when I shop and garden. By about 6 in the evening, I get a burning, electrical feeling, the pins and needles.”

Lloyd started on three 300mg capsules of Neurontin a day, working up to 4 and 5 capsules daily.

“My doctor said I could take 6, but the thought of taking more turns me off. I didn’t like the way it made my feet feel swollen and fat,” she said. “I stopped taking it and it was a different kind of pain, so I went back” on Neurontin.

Alternatives to Medication for Nerve Pain

However, medications aren’t the only way to treat nerve pain. Lloyd, a 65-year-old Alexandria, VA, resident, said she has found some relief in a foot cream whose main ingredient is capsaicin, a substance found in hot peppers, and thought to reduce chronic neuropathic pain by making nerves less sensitive to pain messages.

Water aerobics also help her “feel a little better about my strength and definitely helps my state of mind.”

This approach is consistent with a slew of mind and body therapies and other complementary and integrative therapies, according to The Foundation for Peripheral Neuropathy.

Carolyn Hicks, a psychologist and landscape painter in Northampton, MA, found relief in one such therapy — acupuncture — when the 70-year-old got peripheral neuropathy after chemotherapy for breast cancer. “I found that it was very helpful having more energy and balance and also in mitigating symptoms associated with neuropathy such as numbness and tingling, aches and sensitivity to the cold, and burning in fingers and toes,” she wrote in an email.

Elayne Goldstein, a 68-year-old retired teacher from Philadelphia, developed numbness and pain “like a knife was slicing my foot” after a knee replacement 2 years ago. She was on a high dose of Neurontin but weaned herself down to 300mg at night “because I didn’t want to be on medication.”

At night she wears a magnetic wrap “because something compressing it seems to help.” She also teaches yoga dance to seniors. “When I’m moving, I don’t feel any pain.”

Jennifer Buttaccio, an occupational therapist in Chicago, advises patients on better managing daily activities, strengthening exercises, and pain management strategies to find relief.

“I can recommend a patient talk to their doctor about having their vitamin B12 and magnesium levels checked,” she said. “I can also tell them to see if the doctor will provide them with a script for physical therapy to see if there are more specific modalities, strengthening, and pain management strategies that can be implemented.”

Effective Natural Alternatives for Fibromyalgia Sufferers

From the outside, a person with fibromyalgia looks perfectly normal. But on the inside, it can feel like the pain volume dial has been cranked up to high and can’t be turned down. On top of this, the high level of fatigue can interfere with life on every single level.

“Fibromyalgia is a very interesting illness,” says Dr. Jordan Tishler, a Harvard-trained physician who focuses on holistic care. “Twenty years ago we felt that it was largely a psychological illness, partly because we couldn’t find much else wrong, and partly because it responds, at least for some, to antidepressants like SSRIs.

“We’re now coming to learn that fibromyalgia is a complex illness with multiple things going on,” he adds. “There is clearly a psychological component, but this exists on top of a vague immune condition that we’re still working to define.”

The symptoms of fibromyalgia are widespread diffuse pain; psychological symptoms such as depression and anxiety; and somatic symptoms such as fatigue, memory difficulties and poor sleep quality. Due to these wide-ranging symptoms, there are an equally wide number of medications commonly prescribed for fibromyalgia — everything from strong pain medicines and sleeping pills to antidepressants.

While medications may provide benefits, all pharmaceutical drugs come with side effects that may contribute to more negative outcomes, rather than the positive improvements you might hope for. That’s why we’re here to inform you about the possible side effects of commonly prescribed medications and to provide more information about natural treatment options that are known to be effective.

MEDICATIONS

Lyrica (pregabalin)

You may have heard of the heavily advertised fibromyalgia drug, Lyrica (pregabalin). It’s an antiepileptic, anticonvulsant medication that slows down seizure-related impulses in the brain, and also influences nervous system pain-signalling chemicals in the brain, which is why it’s commonly prescribed for fibromyalgia.

According to a recent review of studies on Lyrica, using the drug daily does reduce pain by 30 to 50%. But 70 to 90% of people also experience side effects, the most common being dizziness (38%), drowsiness (23%), weight gain (9%) and peripheral edema (8%).

Common side effects of Lyrica are:

  • dizziness
  • drowsiness
  • loss of balance or coordination
  • problems with memory or concentration
  • breast swelling
  • tremors
  • dry mouth
  • constipation

There are more serious side effects that can also occur:

  • mood or behavior changes
  • depression and anxiety
  • panic attacks
  • trouble sleeping
  • feeling impulsive
  • irritable, agitated, hostile, aggressive behavior
  • suicidal tendencies, or having thoughts about suicide or hurting yourself

If you experience any of these more serious symptoms, consult with your doctor immediately.

Antidepressants

Antidepressants such as tricyclics (amitriptyline and cyclobenzaprine), selective norepinephrine reuptake inhibitors (SNRIs) such at Cymbalta (duloxetine), Savella (milnacipran) and the SSRI Prozac (fluoxetine) are often prescribed. Though they can be effective, nearly all antidepressants are associated with side effects and can sometimes result in serious adverse events, too.

‘We’re now coming to learn that fibromyalgia is a complex illness with multiple things going on.’
— Jordan Tishler, MD

Opioids

For more severe pain, opioid receptor agonists may be prescribed, the side effects of which are sedation, dizziness, nausea, constipation (very high rate), tolerance (requiring higher doses) and psychological addiction/physical dependence on the drug. Chronic opioid use leads to changes in brain neuroplasticity, which is what causes this.

As you can see, it’s important to read up on the possible side effects because if you find your fibromyalgia symptoms are getting worse, not better, it could be the type of medication you’ve been prescribed. Don’t be afraid to ask your doctor to review your options.

Alternatively, you could try some natural treatments that have demonstrated efficacy.

NATURAL TREATMENTS

Regular Exercise

“Even though it seems counteractive due to the high levels of fatigue experienced by fibromyalgia sufferers, exercise (both aerobic and strength-based approaches) actually works to decrease symptoms and fatigue,” says Dr. Tishler. “The message here, though, is to ‘start low and go slow.’”

Eliminate Inflammatory Foods

Registered dietitian Ryan Whitcomb recommends identifying inflammatory and allergenic foods through a food sensitivity test known as an MRT (mediator release test.)

“This is my first go-to line of defense because it eliminates all the guesswork when it comes to problematic foods,” says Whitcomb. “Once these foods are identified, they are removed from the diet and we slowly add in safe, non-reactive foods.”

One such inflammatory food identified as a problem is gluten. Studies have shown that people with fibromyalgia commonly have non-celiac gluten sensitivity — not an allergy, but an intolerance to gluten. In one small study with fibromyalgia patients, 75% of them experienced a dramatic reduction in widespread pain after eliminating gluten. Some even no longer had pain at all. And in a few of the patients taking opioid medications, the drugs were discontinued, simply by following a gluten-free diet.

Address Nutrient Deficiencies

Once inflammatory foods are removed from the diet, it may be that people have nutrient deficiencies that also need to be addressed.

“Magnesium and vitamin D are common deficiencies,” says Whitcomb. “But rather than assuming that’s the patient’s issue, I run a comprehensive micronutrient panel that looks at 33 nutrients to get a broad overview of what’s really going on in their body.

“Once we know their deficiencies, we can talk about repleting through food and supplements. Food is preferable, but some nutrients, like vitamin D, need to be supplemented since there aren’t many foods that contain it.”

Examine Sleep Quality

“Poor sleep seems to be a major contributor to this illness, so good sleep habits, such as reducing stimulants like coffee, and the occasional use of prescription sleep aids are important approaches,” says Dr. Tishler.

Try Medical Cannabis Therapy

“I have many fibromyalgia patients in my practice and have found cannabis can be a very effective treatment,” says Dr. Tishler, who is also a medical marijuana specialist. “Cannabis is great for pain control and equally good for promoting sleep. In fact, it’s considerably better for sleep than any conventional medication. It’s also considerably safer for pain control than opioid options.

“And on top of this, cannabis is effective for mild depression and anxiety, both of which are associated with fibromyalgia as well. I have certainly found cannabis to be truly effective for fibromyalgia patients because it addresses the illness on so many levels,” he adds.

Lyrica No More Effective for Sciatica Than Placebo

Lyrica (pregabalin) is no better for treating sciatica than a placebo, and has far more side effects.

A new study examined 209 patients with sciatica, which is pain that radiates down the sciatic nerve, resulting in back and leg pain. They were randomized to receive either Lyrica or a placebo for up to 8 weeks. Those on Lyrica started on a low dose that was adjusted over time to a higher dose.

Participants were asked to rate their leg pain at the outset and then at the end of the study. The average pain score at 8 weeks was 3.1 in the placebo group compared to 3.7 in the Lyrica group, researchers reported in the New England Journal of Medicine. Ten was considered severe pain.

However, those on Lyrica reported many more side effects. For example, 40% of those on the active drug experienced dizziness.

Use of neuropathic pain medicines, such as Lyrica for back pain and sciatica, has increased by 535% over the past 10 years, according to Christine Lin, PhD, a senior research fellow at Australia’s George Institute of Global Health, and one of the study’s authors.

Lyrica is approved for nerve pain related to diabetes or shingles, fibromyalgia, and spinal cord injury nerve pain. It is actually not indicated for sciatica, but is widely prescribed off-label for that purpose.

Think Twice Before Taking Drugs for Fibromyalgia

Fibromyalgia is one of those conditions that frustrates doctors and patients. Some question it’s even a real thing, although the American College of Rheumatology, other medical groups and the FDA recognize it. An estimated 2% to 4% of Americans suffer from it.

The research is very mushy and inconclusive as to fibromyalgia’s causes, symptoms, biological manifestations and treatment. For example, people with fibromyalgia can experience pain and tenderness almost anywhere — neck, shoulders, back, hips, arms, legs, all their joints, etc.

The symptoms are wide-ranging. They include: fatigue, difficulty sleeping, morning stiffness, headaches, painful menstrual periods, tingling or numbness of hands or feet, difficulty thinking and remembering, irritable bowel syndrome, pelvic pain, restless leg syndrome and depression.

There’s no diagnostic test yet so the American College of Rheumatology has set the following criteria for the formal diagnosis: Pain in numerous parts of the body for at least 3 months and the presence of at least 11 of 18 specified “tender points” on examination.

There are as many potential treatments for fibromyalgia as there are symptoms. Because drug interventions have been shown to be either not effective or effective only with some people and only sometimes, it’s best to start with yoga, exercise, meditation, mindfulness, guided relaxation and stress reduction

The list of medications used for fibromyalgia are troublesome. It’s a kitchen sink of different kinds of drugs, many of which can cause significant adverse events and side effects, especially when used in combination. Both studies and online sites indicate that it’s not uncommon for people with a diagnosis of fibromyalgia to take several kinds of drugs. (For example, see drugs.com’s patient/consumer review page for drugs to treat fibromyalgia.)

Among the drugs prescribed are over-the-counter pain relievers (not effective), opioid painkillers (no evidence of effectiveness), antidepressants, muscle relaxants, antiepileptics and insomnia drugs. The only medicines that have been tested to be somewhat effective with fibromyalgia are Lyrica (pregabalin, an antiepileptic), Cymbalta (duloxetine, an antidepressant), and Savella (milnacipran, another antidepressant). Be aware that all other medicines that might be prescribed to you are off-label uses, they have not been tested for safety or effectiveness for fibromyalgia.

The table below lists some of the risks and potential side effects of the classes and individual medicines most widely prescribed to treat fibromyalgia. But the real problem is when the drugs are used in combination. For example, many of these medicines cause drowsiness, sedation, dizziness, unsteadiness and mental confusion. An overwhelming body of research indicates that such effects are additive and exacerbated when multiple drugs are taken.

Possible Side Effects of the Fibromyalgia Drugs

Name Common Side Effects Serious Rare Side Effects
Amitriptyline
(antidepressant, generic)
Blurred vision, constipation, dizziness, dry mouth, gait disturbances, sedation Increased risk of suicide, especially in those 25 years old or younger, heart arrhythmias, lowering of blood counts
Paroxetine
(Paxil)
Drowsiness, dry mouth, sexual dysfunction Increased risk of suicide, especially in those 25 years old or younger, serotonin syndrome
Duloxetine (Cymbalta)
Milnacipran (Savella)
Constipation or diarrhea, dizziness, dry mouth, headache, stomach upset, sweating Increased risk of suicide, especially in those 25 years old or younger, serotonin syndrome
Milnacipran: rapid heart beat
Gabapentin (generic)
Pregabalin (Lyrica)
Blurred vision, confusion, dizziness, liver and kidney function impairment, problems with concentration, swelling Pregabalin: Heart failure

A 2014 report on fibromyalgia from Consumer Reports Best Buy Drugs concludes: (a) the evidence for the effectiveness of treatment with any of the above-mentioned classes of drugs is “weak;” (b) the benefits patients get from drugs is generally small or not long-lasting; (c) there are no studies showing one class of drug — or individual drug — is better than another, and (d) there are too few studies examining combination treatments to render a judgment about the effectiveness of combination therapy.

Consumer Reports offers the following advice:

✔ Try non-drug therapies either first or in combination with medication.

✔ OTC pain relievers such as Advil (ibuprofen), Aleve (naproxen) and Tylenol (acetaminophen) don’t appear to do much, if any, good.

✔ Since the effectiveness of one drug may wane over time, you may have to switch to another medication.

✔ Don’t take opioids/narcotic painkillers since there’s no good evidence they offer long-term relief from the pain associated with fibromyalgia.

✔ Avoid expensive brand-name medicines since, if you and your doctor concur that drug treatment is warranted, many of the drugs available to treat fibromyalgia are generic.