Tag Archives: Neurontin

Quick Hits: Medical Marijuana and Chronic Pain, Are Rx Pain Creams Effective? & More

The vast majority of people who use medical marijuana do so to treat chronic pain. Researchers examined data on patients who were legally registered in their state to access medical marijuana. Their analysis found that 62.2% of those medical marijuana license holders reported using cannabis to ease chronic pain. And 85%% of them said they were using marijuana for an evidence-based condition. The number of medical marijuana licensees soared from 641,176 in 2016 to 813,917 in 2017, though this number is likely a lot higher as it is based on data from only 20 states. At the present time, 33 states have legalized marijuana for recreational purposes and 10 have legalized cannabis for recreational use. Posted February 4, 2019. Via Health Affairs.

Prescription pain creams aren’t better for treating chronic pain compared to a placebo. Researchers enrolled about 400 people with either neuropathic pain (e.g., fibromyalgia, pain after shingles, carpal tunnel syndrome), nociceptive pain (arthritis, sprains, fractures, burns) or a combination of the two. Patients were then divided to receive treatment with either a cream compounded to contain ingredients such as gabapentin, diclofenac, baclofen, cyclobenzaprine and lidocaine or a placebo. There was no significant difference in reduction in average pain score between those who used a cream and those who received the placebo. After one month, 36% in the treatment group and 28% in the control group reported a positive outcome. Posted February 5, 2019. Via Annals of Internal Medicine.

Many literature reviews of studies involving drugs and other healthcare interventions, such as surgery, do not fully report the side effects associated with them. An analysis of adverse events in 187 systematic reviews found that in 35% of them, the reviewers didn’t appropriately report the side effects associated with the medical intervention being examined. Part of the problem, the researchers found, is that in about 60% of the reviews, adverse events weren’t even a factor to be examined. As to why review authors might not fully report adverse events, the researchers of the new study say it could be because of how the original studies defined or recorded adverse events or because the review authors didn’t have enough space to include those details in their review. Posted February 6, 2019. Via Journal of Clinical Epidemiology.

5 Things to Know About CBD Oil

Given the number of states now legalizing marijuana, many people are less hesitant to try cannabis and other cannabis-related products like CBD (cannabidiol) oil. In many places, you can walk into your local health food store and buy CBD oil drops and lozenges — even shampoos and hand lotions. Before you start using CBD oil, take a few moments to review information about it.

1. What Is CBD Oil?

CBD oil is created when cannabidiol, one of 104 chemical compounds found in the cannabis sativa plant, is combined with a carrier such as hemp oil or coconut oil. Both hemp and marijuana are derived from the same plant. CBD oil does not, however, have intoxicating properties. Getting high from the cannabis plant requires the presence of another chemical compound, tetrahydrocannabinol, or THC. Eric Poehner, general manager of Mana Supply Inc., a medical marijuana dispensary in Annapolis, Maryland, confirms that CBD oil is not psychoactive.

2. Is CBD Oil Legal?

As more and more states legalize medicinal and even recreational marijuana, the market for CBD oil and CBD oil products in those states has exploded. Although there are rules and regulations in many states, for the most part CBD oil is considered legal. There is not, however, any federal law legalizing CBD oil, so be aware that each state has differing laws. In California, for example, by law CBD oil is not to be added to food products. However, that law is largely being ignored, and products containing CBD are widely available in the state. If you live in a state where you can walk into your neighborhood health food store and purchase CBD oil, it is either legal or laws are not being enforced, while if you live in one of the 14 states with CBD restrictions, you may not be able to do so.

3. Why Are People Taking CBD Oil?

The human body has an endocannabinoid system (ECS) in addition to its other systems. The ECS was discovered in the past 25 years and is believed to help regulate sleep, appetite, pain and the immune system.

People who take CBD oil often do so to address sleep issues. Madeline Ulivieri decided to try CBD oil instead of sleep medications. “I’m not really a pill person,” she says. “So I tried CBD oil after some friends told me it worked for them.” Ulivieri says each night she takes a drop of the oil about 30 minutes before her bedtime, and if she isn’t asleep in an hour, she takes an additional half a drop. “It’s been amazing for me,” she says.

Mary Hallgren vapes CBD oil several times a day in order to manage her fibromyalgia pain. “It has helped me so much more than the gabapentin [Neurontin] prescription,” she says. Hallgren learned of the oil’s use on a fibromyalgia support site and says it relieves her muscle pain.

4. What Does the FDA Say About CBD Oil?

The FDA does not consider CBD oil as a supplement, even though it is often sold that way. In fact, CBD oil products are very lightly regulated. When companies make claims about the effectiveness of CBD oil as a medical treatment, the agency can intervene. In June, however, the FDA approved Epidiolex, making it the first FDA-approved drug derived from marijuana.

Epidiolex, which contains CBD, is an anti-seizure medication that is currently approved only to treat two rare forms of epilepsy. The FDA has said that Epidiolex’s approval will lead to more drug trials and the development of more therapies involving CBD and other cannabinoids. The FDA warns, however, that they “…. are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.”

5. Are There Any Precautions?

According to the prescription insert for Epidiolex, side effects may include insomnia, diarrhea, sleepiness, rash and decreased appetite. Ulivieri says that CBD oil makes her sleepy, which in her case is the desired effect versus an adverse one. But she does report that when using CBD oil, she always makes sure to take it with food, since she has a sensitive stomach. On the occasions where she has neglected to eat a little something along with her CBD oil, Ulivieri reports waking up with a sour stomach. Pasqua Osso was prescribed a CBD oil vapor pen, but she has requested a different form of the medication because it burned her throat and left a bitter aftertaste in her mouth.

There are concerns that CBD may negatively interact with some medications, potentially causing side effects. There are also indications that CBD may harm the liver, as it has been shown to increase liver enzymes in patients in some studies.

A 2017 research letter published in JAMA found that 70% of CBD products purchased were mislabeled, as they either had a higher or lower concentration of CBD than listed on the label. Some of the products also contained THC, even though they weren’t supposed to.

Whether you are seeking better sleep, relief from anxiety or pain management, discuss CBD oil with your physician.

MedShadow’s Top 10 Stories of 2018

What were the most popular stories we published in 2018? Our Top 10 includes two stories on drugs that have become popular among opioid abusers, as well as articles dealing with drug interactions, a controversial class of antibiotics and a first-person story on an herbal supplement that has come under attack from the FDA, among others. Here are excerpts of the stories with the highest readership.

1. Gabapentin’s Secret: The Drug Opioid Abuser’s Crave

By Ronni Gordon

For many people who take gabapentin – a drug prescribed to treat seizures and pain caused by shingles – side effects such as sedation can be a challenge, as those who take it off-label for neuropathic pain told MedShadow in the past.

But an increasing number of opioid abusers crave that side effect, reporting a calm feeling when combining gabapentin – developed by Pfizer under the brand name Neurontin – with opioids, muscle relaxants and anxiety medications. Some also get a marijuana-like high and an enhanced euphoria. But when overused or abused, it can cause significant organ or brain damage. Read more →

2. Managing Eczema: Are New Treatments Like Eucrisa Worth It?

By Madeline Vann

Eczema (atopic dermatitis) can feel like a moving target for people who live with it. They get control over one flare, only to have eczema redden and irritate another patch of skin. For some patients, changing their bathing and beauty habits along with a thick moisturizer and topical corticosteroid ointments are enough.

“Steroids are the mainstay of treating atopic dermatitis. They’ve been around for decades. They are generally inexpensive, and for the vast majority of patients, that’s how we start treatment,” explains dermatologist Amy Paller, MD, director of the Northwestern University Skin Disease Research Center in Chicago. American Academy of Dermatology (AAD) guidelines recommend using emollient moisturizers, lifestyle changes to avoid triggers, and corticosteroids at first. Read more →

3. How Imodium Became Appealing to Opioid Addicts

By Padma Nagappan

A sports injury from playing squash in high school lead to a herniated disc for Bob Johnson (name changed to protect his privacy), who was initially given codeine for his pain, and then bumped up to hydrocodone, which is more powerful and used to treat severe pain.

He stopped taking the drugs once he began recovering. All was well until he left for college in Philadelphia and started playing on the squash team — and his back began hurting again. He found it was easy to get access to drugs and began buying OxyContin (oxycodone) from a dealer. Read more → 

4. What is the Best Way to Treat Heat Rash?

By Dave Walker, RPh

Question: It’s summer and I’m going to be spending a lot of times outdoors. I’m susceptible to heat rash. What is the best treatment for it?

I remember anticipating summer vacation as a kid. We were always busy planning and participating in neighborhood sporting activities, biking, hiking, fishing and camping trips. The neighborhood moms always had a ready supply of Band-Aids, Bactine and antiseptic cream to take care of those expected and inevitable scratches, scrapes, cuts and insect bites along the way. Read more →

5. 4 Drugs That Interact with Anxiety Meds

By Christy Huff, MD

If you suffer from anxiety, panic disorder or insomnia, your doctor may have prescribed you a tranquilizer belonging to a class of drugs known as benzodiazepines.

Drugs such as Xanax (alprazolam), Valium (diazepam), Ativan (lorazepam), and Klonopin (clonazepam) are some of the most-prescribed medicines – more than 133.4 million such prescriptions were filled in the US in 2014. As with any medication, drug interactions can occur if you take a benzo with another medication, and in certain cases, may be life-threatening. Read more → 

6. Why Aren’t Seniors Getting the Shingles Vaccine?

By Rita Colorito

Nearly 12 years after the FDA approved Zostavax, the first vaccine to prevent shingles in adults 60 and older, the vast majority of seniors still haven’t received it. Only 30.6% of adults age 60 and older reported getting the shingles vaccine, according to the latest CDC (Centers for Disease Control and Prevention) assessment of vaccine coverage.

Since it became available, Zostavax has faced numerous barriers in terms of getting seniors vaccinated, the assessment found. In October, the FDA approved a new shingles vaccine, Shingrix, for people age 50 and older. Less than a week later, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended Shingrix as the CDC’s preferred shingles vaccine for adults age 50 plus due to Shingrix’s better efficacy and fewer side effects compared to Zostavax. Read more → 

7. Floxed! The Painful, Life-Lasting Effects of Some Antibiotics

By Suzanne B. Robotti

Last week, we ran a news story on antibiotics causing “rare” damages to people. We had a very passionate response from more than 75 people who all claimed to be harmed by a particular type of antibiotics. More than 60,000 people have complained to the FDA about them. It begs the question, how unusual are these “rare” harms.

The side effects and adverse events associated with Cipro, Levaquin and other fluoroquinolones (FQs) can be significant and life altering. Yet many people who have been damaged by fluoroquinolones complain that there are too few warnings. Many claim that doctors don’t believe that their new illnesses have come from the FQs. Worse, sometimes FQs are prescribed when other, less risky — and just as effective — antibiotics are available. Read more →

8. The FDA Has It Wrong on Kratom: How the Herb is Helping People Like Me

By Andrew Turner

Some may ask who are the consumers of kratom, an herb used to treat pain, depression and anxiety that has been the subject of controversy lately in the news. It’s complicated.

We can be anyone. We are your neighbor, the veteran in the supermarket, your college professor and even your best friend. There’s a lot of misconceptions about kratom, how it’s used to treat certain ailments and its potential for addiction. Read more →

9. Can An Opioid Addiction Drug Treat Autoimmune Disorders

By Deborah Lynn Blumberg

A slew of drugs, both new and old, are used to treat autoimmune disorders like multiple sclerosis (MS), lupus and Crohn’s disease. Most of them come with side effects, some of them serious. But research and experience from patients and doctors are mounting that a drug used to treat substance abuse, when used in lower doses, can effectively treat autoimmune conditions with few side effects.

The drug is naltrexone, which was first approved in the 1980s to treat heroin addiction. In recent years, it has been prescribed more and more at a low dose for patients with autoimmune disorders. But is this off-label use (yet to be approved by the FDA) safe and effective? Read more →

10. Pros and Cons: Prednisone

By Tori Rodriguez

If you visit the doctor from time to time for anything other than a routine checkup, it’s likely that at some point you’ve received a prescription for a type of drug called corticosteroids. These are among the most commonly prescribed medications in the US, and they are used in almost every medical specialty.

In a study published last year, researchers at the University of Michigan found that 1 in 5 American adults with commercial health insurance had been prescribed a corticosteroid at least once over a 3-year period. Read more →

Gabapentin’s Secret: The Drug Opioid Abusers Crave

For many people who take gabapentin – a drug prescribed to treat seizures and pain caused by shingles – side effects such as sedation can be a challenge, as those who take it off-label for neuropathic pain told MedShadow in the past.

But an increasing number of opioid abusers crave that side effect, reporting a calm feeling when combining gabapentin – developed by Pfizer under the brand name Neurontin – with opioids, muscle relaxants and anxiety medications. Some also get a marijuana-like high and an enhanced euphoria. But when overused or abused, it can cause significant organ or brain damage.

“Gabapentin was prescribed off-label for pain because it was thought to be a safer alternative to opioids,” said Steven Evans, MD, medical director of American Addiction Centers/Nevada. “But now people who don’t need it are starting to use it,” he said.

According to American Addiction Centers, rates of gabapentin misuse are 1.1% in the general population and 22% among those who abuse opioids. The most serious problems resulting from abuse are rash, itching, swelling of the face or mouth, hoarseness, difficulty swallowing or breathing and seizures.

The pills are known as “gabbies” or “johnnies” on the street, where a 300 mg tablet goes for 75 cents.

At Solutions Recovery Treatment Center in Las Vegas, where gabapentin is used in addiction treatment, “In the last two years we’ve noticed a spike in clients losing medications and needing more refills,” said David Marlon, an addiction specialist and CEO of the center.

“It also happens in sober living communities and outpatient addiction treatment,” he said.

Given off-label in addiction treatment and for migraine, hot flashes, fibromyalgia, neuropathy and more, it is the 7th-most prescribed drug in the United States. Pharmacy Times reported that 57 million prescriptions for gabapentin were written in the United States in 2015, a 42% increase since 2011.

“My radar was not on in terms of gabapentin being abused,” said Michele Matthews, associate professor of pharmacy practice at the Massachusetts College of Pharmacy and Health Sciences in Boston.

“With the shift from prescription opioids, there was an increase in non-opioid alternatives, and gabapentin was at the top of the list,” she said. “For the most part it wasn’t something we had to worry about. We’re seeing something different now.”

Matthews works with high-risk patients in the pain management clinic at Brigham and Women’s Hospital.

She said that a typical dose for pain is between 1,800 and 3,600 mg a day.

“Instead of taking it throughout the day, they might take it all at once, and that would cause a mood-altering effect,” she said. “Or they are taking it as part of a cocktail [of drugs].”

“We’re starting to see requests for early refills,” Matthews said. “It’s similar to patients maybe misusing opioids. You can also tell if patients are difficult, [such as] yelling.”

“It reminds prescribers that medications need to be monitored closely,” she said.

Gabapentin is not scheduled as a controlled substance because when given alone it has not been considered addictive. When the drug is taken with other medications, gabapentin’s potential for abuse and addiction increases.

“Gabapentin has been linked with impaired driving and opioid use, highlighting the need to understand more fully its risk profile,” the authors of a 2017 study wrote in
the Journal of Addictive Behaviors.

They questioned 33 drug users in Appalachian Kentucky reporting nonmedical use of gabapentin after first being prescribed it for not unusual off-label uses such as pain, anxiety and opioid detoxification.

“Focus group responses highlighted the low cost of gabapentin for the purpose of getting high and noted increasing popularity in community, particularly over the last two years,” researchers wrote.

It doesn’t have the same risk of deadly overdose as opioids, but overdose can happen, and it carries the risk for significant organ or brain damage.

However, unlike opiates, there is no antidote for an overdose. Because of the drug’s long half-life — the amount of time in the body before it is half gone — immediate medical attention is necessary to manage the complications associated with a toxic amount of this drug,

The Charlestown Gazette-Mail reported that the number of fatal overdoses related to gabapentin in West Virginia jumped from 3 in 2010 to 109 in 2015.

Between 2008 and 2011 the number of emergency room visits in metropolitan areas for misuse or abuse of gabapentin increased by nearly 5 times, according to the Drug Abuse Warning Network.

Andrew Kolodny, MD, co-director of Opioid Policy Research at the Heller School for Social Policy and Management at Brandeis University, said that because of the abuse potential, it should probably be scheduled as a controlled drug.

“Then people can’t doctor-shop for it. That’s where drugs with abuse potential belong,” he said.

He noted that Lyrica (pregabalin) is closely related, but is classified as schedule 5.

“It doesn’t make sense for Lyrica to get scheduled as controlled and for gabapentin not to be,” he said.

According to GoodRx, in July 2017, Kentucky became the first state to make gabapentin a schedule 5 controlled substance, even though the FDA is the authority that schedules drugs.

Ohio, Minnesota, Virginia, Illinois, Wyoming and Massachusetts have started to track gabapentin through prescription drug monitoring and reporting programs, seen as a precursor to making it a schedule 4 or 5 substance.

Gabapentin’s Secret: The Drug Opioid Abusers Crave

For many people who take gabapentin – a drug prescribed to treat seizures and pain caused by shingles – side effects such as sedation can be a challenge, as those who take it off-label for neuropathic pain told MedShadow in the past.

But an increasing number of opioid abusers crave that side effect, reporting a calm feeling when combining gabapentin – developed by Pfizer under the brand name Neurontin – with opioids, muscle relaxants and anxiety medications. Some also get a marijuana-like high and an enhanced euphoria. But when overused or abused, it can cause significant organ or brain damage.

“Gabapentin was prescribed off-label for pain because it was thought to be a safer alternative to opioids,” said Steven Evans, MD, medical director of American Addiction Centers/Nevada. “But now people who don’t need it are starting to use it,” he said.

According to American Addiction Centers, rates of gabapentin misuse are 1.1% in the general population and 22% among those who abuse opioids. The most serious problems resulting from abuse are rash, itching, swelling of the face or mouth, hoarseness, difficulty swallowing or breathing and seizures.

The pills are known as “gabbies” or “johnnies” on the street, where a 300 mg tablet goes for 75 cents.

At Solutions Recovery Treatment Center in Las Vegas, where gabapentin is used in addiction treatment, “In the last two years we’ve noticed a spike in clients losing medications and needing more refills,” said David Marlon, an addiction specialist and CEO of the center.

“It also happens in sober living communities and outpatient addiction treatment,” he said.

Given off-label in addiction treatment and for migraine, hot flashes, fibromyalgia, neuropathy and more, it is the 7th-most prescribed drug in the United States. Pharmacy Times reported that 57 million prescriptions for gabapentin were written in the United States in 2015, a 42% increase since 2011.

“My radar was not on in terms of gabapentin being abused,” said Michele Matthews, associate professor of pharmacy practice at the Massachusetts College of Pharmacy and Health Sciences in Boston.

“With the shift from prescription opioids, there was an increase in non-opioid alternatives, and gabapentin was at the top of the list,” she said. “For the most part it wasn’t something we had to worry about. We’re seeing something different now.”

Matthews works with high-risk patients in the pain management clinic at Brigham and Women’s Hospital.

She said that a typical dose for pain is between 1,800 and 3,600 mg a day.

“Instead of taking it throughout the day, they might take it all at once, and that would cause a mood-altering effect,” she said. “Or they are taking it as part of a cocktail [of drugs].”

“We’re starting to see requests for early refills,” Matthews said. “It’s similar to patients maybe misusing opioids. You can also tell if patients are difficult, [such as] yelling.”

“It reminds prescribers that medications need to be monitored closely,” she said.

Gabapentin is not scheduled as a controlled substance because when given alone it has not been considered addictive. When the drug is taken with other medications, gabapentin’s potential for abuse and addiction increases.

“Gabapentin has been linked with impaired driving and opioid use, highlighting the need to understand more fully its risk profile,” the authors of a 2017 study wrote in
the Journal of Addictive Behaviors.

They questioned 33 drug users in Appalachian Kentucky reporting nonmedical use of gabapentin after first being prescribed it for not unusual off-label uses such as pain, anxiety and opioid detoxification.

“Focus group responses highlighted the low cost of gabapentin for the purpose of getting high and noted increasing popularity in community, particularly over the last two years,” researchers wrote.

It doesn’t have the same risk of deadly overdose as opioids, but overdose can happen, and it carries the risk for significant organ or brain damage.

However, unlike opiates, there is no antidote for an overdose. Because of the drug’s long half-life — the amount of time in the body before it is half gone — immediate medical attention is necessary to manage the complications associated with a toxic amount of this drug,

The Charlestown Gazette-Mail reported that the number of fatal overdoses related to gabapentin in West Virginia jumped from 3 in 2010 to 109 in 2015.

Between 2008 and 2011 the number of emergency room visits in metropolitan areas for misuse or abuse of gabapentin increased by nearly 5 times, according to the Drug Abuse Warning Network.

Andrew Kolodny, MD, co-director of Opioid Policy Research at the Heller School for Social Policy and Management at Brandeis University, said that because of the abuse potential, it should probably be scheduled as a controlled drug.

“Then people can’t doctor-shop for it. That’s where drugs with abuse potential belong,” he said.

He noted that Lyrica (pregabalin) is closely related, but is classified as schedule 5.

“It doesn’t make sense for Lyrica to get scheduled as controlled and for gabapentin not to be,” he said.

According to GoodRx, in July 2017, Kentucky became the first state to make gabapentin a schedule 5 controlled substance, even though the FDA is the authority that schedules drugs.

Ohio, Minnesota, Virginia, Illinois, Wyoming and Massachusetts have started to track gabapentin through prescription drug monitoring and reporting programs, seen as a precursor to making it a schedule 4 or 5 substance.

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

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

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

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

Quick Hits: 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.

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

NameCommon Side EffectsSerious Rare Side Effects
Amitriptyline
(antidepressant, generic)
Blurred vision, constipation, dizziness, dry mouth, gait disturbances, sedationIncreased risk of suicide, especially in those 25 years old or younger, heart arrhythmias, lowering of blood counts
Paroxetine
(Paxil)
Drowsiness, dry mouth, sexual dysfunctionIncreased 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, sweatingIncreased 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, swellingPregabalin: 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.

FDA Warns Against Tablet Splitting to Save Money

While many consumers split pills in half in order to save money, even if the tablets are not scored down the middle, the FDA is warning against the practice as the dose in each half can vary significantly, potentially leading to taking too much medicine.

FDA researchers tested whether a score on a tablet impacted the uniformity of the dose in drugs, Norvasc (amlodipine), which is used to treat high blood pressure, and Neurontin (gabapentin), an anticonvulsant used to treat seizures.

Tablets were purchased from 5 amlodipine and 6 gabapentin drug manufacturers, Monthly Prescribing Reference reported. Both drugs are available as a generic.

When unscored amlodipine tablets were split, the variability in the dose of the two halves were significant. In addition, none of the split tablets met established criteria for “content uniformity.”

With gabapentin, the fully scored tablets met criteria for acceptable weight and dose of the active ingredient.

Overall, splitting tablets produced more variability in doses in both of the drugs, though the change in amolodipine was more significant.

The FDA warns against splitting tablets to save money, and in its own guidance, says that splitting “can affect how much drug is present in the split tablet and available for absorption.”

Quick Hits: Opioids Tied to Heart Problems, Diabetes Meds Linked to Kidney Injury, & More

People who take an opioid medication for pain are at a higher risk for heart problems. Patients prescribed an opioid painkiller had a 64% higher risk of early death compared to patients given an another type of pain med, researchers reported in JAMA. Much of the increased risk was connected to difficulty breathing during sleep, as well as abnormal heartbeat and other cardiovascular complications. Some of the alternatives meds examined in the study were Neurontin (gabapentin), Lyrica (pregabalin) and Tegretol (carbamazepine), and some low doses of antidepressants. The authors concluded that long-acting opioids should be in favor of other meds, especially in people with existing cardiovascular issues or diabetes. Posted June 14, 2016. Via Healthday.

The FDA is strengthening existing warnings about kidney injury risk for a popular class of type 2 diabetes drugs. The medications, Invokana and Invokamet (canagliflozin), as well as Farxiga and Xigduo XR (dapagliflozin), belong to a relatively new class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Between March 2013 and October 2015, the agency said it received word of 101 cases of acute kidney injury associated with the meds. The FDA is advising doctors to monitor a patient’s kidney function prior starting and while on therapy, and avoid prescribing the drugs to patients who may be predisposed to kidney injury. Posted June 14, 2016. Via FDA.

The FDA is calling on drugmakers to conduct long-term bone quality studies for the development of new osteoporosis treatments. The agency says in its guidance that the nonclinical studies are needed to investigate whether long-term use of osteoporosis drugs results in poorer bone quality. Because the studies are not to be conducted in humans, the FDA says companies should conduct studies in 2 animal species. In addition, the FDA is advising drugmakers that are developing anabolic drugs for osteoporosis study whether they have the potential to cause cancer. The agency says previous studies have shown potential for bone tumor growth in mice and rats when given parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP) drugs. Posted June 13, 2016. Via Regulatory Affairs Professionals Society.

5 Common Medications That Can Cause Erectile Dysfunction

Erectile dysfunction. We’ve all heard of it. And Pfizer’s advertising campaign when it introduced its blockbuster ED drug Viagra (sildenafil) made it a household phrase. Up to 30 million men in the US have trouble getting or maintaining an erection sufficient for sexual intercourse, according to recent estimates. It can affect men of all races and ages, though rates are moderately higher among men aged 70 and older, compared to men in younger age groups.

Contrary to popular belief, however, aging does not cause ED. A wide range of physical and psychological conditions can lead to ED, including high blood pressure, heart disease, diabetes, anxiety, depression and lifestyle factors such as alcohol and illicit drug use and smoking.

Another common cause of ED is prescription medication, and 5 drugs in particular have the biggest effect on libido.

1. Beta-blockers

“No question these impact erectile function,” says Landon Trost, MD, head of andrology and male infertility at the Mayo Clinic in Rochester, Minn. It is not clear why these blood pressure lowering medications can cause ED, but it reverses if a patient quits taking the drug. Unfortunately, however, “people usually can’t get off of these, but if the medication can be switched for another blood pressure drug, angiotensin receptor blockers or ACE nhibitors are preferred,” adds Trost.

2. Androgen blockers

Often prescribed to treat prostate cancer, these medications can cause ED and decreased libido along with many other side effects. “It typically takes several months to years to see the full impact of these medicines, and often they cannot be discontinued,” says Trost, unless they were prescribed for recurrent long-lasting erections — a condition called priapism — in the first place. In that case, your doctor may be able to prescribe an alternative medication.

3. Finasteride

This medication is sold under the brand names Propecia and Proscar and is used to treat male hair loss. It “diminishes dihydrotestosterone levels and suppresses libido in about 10 percent of men but is much more profound in younger guys,” according to Jesse N. Mills, MD, an associate professor of urology at the David Geffen School of Medicine at the University of California, Los Angeles, and director of The Men’s Clinic at UCLA. “Try stopping and using minoxidil instead for hair preservation,” if you have ED that is caused by this drug, he advises.

4. Sedatives and anxiolytics

“Anything that depresses nerves, such as Xanax, Ativan, Valium, alcohol, Neurontin (gabapentin), Lyrica (pregabalin), and any of the sleep aids often impact erectile function,” says Trost. The effect is reversible and is most likely caused by direct suppression of nerve signals or possibly by changes in hormonal signaling. Mills adds that “narcotic use causes suppression of testosterone which can alter blood flow to the penis.”

5. Antidepressants

These commonly prescribed medications affect sexual function in different ways depending on the specific type of drug and how it works. “Central regulation of erections relies on dopamine and serotonin, so any impact on these processes can worsen erectile function,” says Trost. He notes that Wellbutrin (buproprion) and Remeron (mirtazipine) are the antidepressants that likely have the least impact on erectile function.

While each of these medications alone can affect erectile function, “the greater the number of medications a patient is taking, the greater the impact on sexual function,” says Trost. “In addition to eliminating as many of these as possible, changing to an alternative where possible, and optimizing health through lifestyle choices, we can typically treat the ED directly through other therapies.”

While you shouldn’t stop taking prescribed medications without consulting your healthcare provider, you can have a discussion about whether a particular drug is necessary in the first place, suggests Mills. “For blood pressure medications and antidepressants, there are alternatives that most physicians know to prescribe if the man is having ED,” he says.