Tag Archives: multiple sclerosis

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 →

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

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

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

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

Medical Marijuana Has ‘Limited’ Effectiveness in Multiple Sclerosis

Drugs containing compounds found in marijuana may have a modest benefit in treating the symptoms associated with multiple sclerosis (MS).

Researchers analyzed 17 clinical trials involving more than 3,100 patients with MS to determine the safety and effectiveness of cannabinoids, chemical compounds found in marijuana. Use of medications containing cannabinoids led to “limited and mild reduction” in contracted muscles, pain and bladder dysfunction in patients, according to results published in JAMA Network Open.

The analysis also found that there were few serious side effects. Some side effects patients did report, however, included memory problems, dizziness, dry mouth, fatigue, drowsiness and poor balance. And the rate of side effects was higher in those that took a marijuana product compared to placebo.

The trials examined in the meta-analysis did not involve smoked marijuana. The versions used in the trials were administered orally (such as Namisol) or nasally (such as Sativex) cannabis extract, or Marinol (dronabinol) and Cesamet (nabilone). The latter two are drugs that are synthetic versions of THC, a cannabinoid, and are used to prevent nausea and vomiting associated with chemotherapy.

Researchers also noted that most of the studies examined were conducted by the manufacturers of the cannabinoid drugs. A new cannabinoid-based medication, Epidiolex, will become available later this year in the US for the treatment of seizures associated with two types of epilepsy. The liquid contains extracts of the cannabinoid cannabidiol.

Can an Opioid Addiction Drug Treat Autoimmune Disorders?

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?

Proponents say low-dose naltrexone (LDN) is a treatment with few side effects that, for autoimmune patients, can regulate the immune system (keeping it from behaving abnormally), provide pain relief and stop the body from attacking itself further.

How It Works

Naltrexone is an opioid antagonist, meaning it blocks the brain’s opioid receptors. Opioid receptors interact with endorphins, the body’s “feel good” chemicals, and give us a sense of calm. Drugs like heroin or opioid painkillers can also attach to these receptors, and they produce that same calming effect.

Naltrexone keeps a substance like heroin from attaching to the brain’s opioid receptors, preventing users from getting high. That’s why it’s used to keep drug users in recovery from relapsing, and even to save the life of a patient who’s overdosed. LDN is thought to treat autoimmune diseases because it helps to trigger the body’s production of endorphins, and a lack of these chemicals is thought to contribute to the diseases.

It’s also been prescribed for alcohol addiction. The typical addiction treatment dose is 50 mg a day, a dose that’s been associated with nausea and vomiting, headache, fatigue and joint pain.

Patient Experience

While some autoimmune patients who’ve taken LDN report no change at all in their health, and others note side effects like insomnia, vivid dreams or night sweats, others, like Darlene Nichols from St. Louis, report successes. Nichols was diagnosed with lupus in 1989, and later, myasthenia gravis.

She tried prednisone and other drugs typically prescribed for autoimmune conditions, “but they didn’t really work for me,” she said. “I had days where my legs would be so weak I couldn’t walk.” In 2009, she started taking 3.5 mg a day of LDN and then 4.5 mg.

“After two weeks, I was feeling great,” she said. “I had energy and strength, my fatigue disappeared. It’s like a miracle for me.” As for side effects, Nichols said initially her quality of sleep declined slightly, but soon returned to normal.

Other autoimmune patients who’ve taken LDN point to decreased autoantibodies — the cause of many autoimmune conditions — and an improvement in their pain.

No Significant Side Effects For Most

Physicians prescribing LDN for autoimmune conditions typically give between 1.5 to 4.5 mg to be taken before bed for peak effectiveness. Patients having vivid dreams, insomnia or night sweats, however, can take their dose in the morning instead.

The medication is popular with functional medicine doctors. Functional medicine aims to restore health by getting to the root cause of patients’ symptoms.

Ann Shippy, an Austin, Texas, doctor board certified in internal medicine and functional medicine, has prescribed LDN for patients with a variety of autoimmune conditions for the last 10 years. “It can be so helpful for a person’s general sense of well-being while we’re working on the root cause of getting the body repaired,” she said.

Some of her patients have found the medication to be “a game changer,” she said, while some report no change in symptoms. Others have been very sensitive to it, she said, reporting vivid dreams. Intense dreams typically subside though, Shippy added, or improve on a lower dose. “I haven’t seen any significant side effects,” she said.

Since LDN is not approved by the FDA for autoimmune diseases, it’s not commercially available. Patients must obtain the medication from a compounding pharmacy. Doctors advise finding a pharmacy familiar with making LDN to ensure they don’t compound a slow-release formula or add calcium carbonate as a filler, which can slow absorption.

An Immune System Regulator

In the mid-1980s — when naltrexone was approved for addiction treatment — New York City physician Bernard Bihari found it could help patients with autoimmunity, cancer, HIV and AIDS when taken at low doses of around 4 mg.

Low doses only partly block opioid receptors at times when our endorphin levels are high, at around 3 or 4 am. That tells the brain our endorphin levels are low, prompting our brain to make more. It’s a mechanism that can theoretically help autoimmune patients, who typically have lower levels of endorphins, which play a key role in regulating the immune system.

In treating HIV patients in the 1980s, “it wasn’t a home run,” said Ronald Hoffman, a physician and medical nutritionist in private practice in Manhattan.

However, decades later, Hoffman has seen his patients with ulcerative colitis, Crohn’s disease and itchy skin conditions improve on LDN. He uses it in conjunction with lifestyle changes, including diet modifications and adding supplements. He now also prescribes LDN routinely for cancer patients.

Seemingly Safe, But More Research Needed on Efficacy

Research has shown LDN can reduce symptom severity in autoimmune conditions marked by chronic pain, especially Crohn’s.

A study in Digestive Diseases and Sciences found more than 80% of participants with Crohn’s taking LDN saw an improvement in symptoms. Another study, however, in the Multiple Sclerosis Journal, showed no difference between MS participants taking LDN and those taking a placebo in terms of quality of life.

Researchers from the MS study concluded that LDN is a “relatively safe therapeutic option” for MS patients. However, “its efficacy is under question and probably a long duration trial is needed in the future.”

Research supports LDN for other major autoimmune conditions. A March study in the Journal of Translational Medicine showed that 74.5% of patients with inflammatory bowel disease treated with LDN showed an improvement in symptoms, and 25.5% went into remission.

Meanwhile, pharmaceutical company Immune Therapeutics is in talks with the FDA about a clinical trial for its LDN-based drug Lodonal, which is currently being used abroad for various indications.

New York-based internist David Gluck, MD, writes about LDN at www.lowdosenaltrexone.org, where physicians and patients report they’ve seen success in autoimmune conditions including Hashimoto’s disease, rheumatoid arthritis, ulcerative colitis, celiac, Sjogren’s syndrome and scleroderma.

LDN “provides a new, safe and inexpensive… medical treatment by mobilizing the natural defenses of one’s own immune system,” he writes.

Quick Hits: Are Smokeless Tobacco Devices Safer, Another Muscular Dystrophy Drug & More

Smokeless tobacco devices that are marketed as a safer alternative to traditional cigarettes may not be as harmless as claimed, according to new research. IQOS – which stands for “I quit original smoking” – is a new “heat not burn” smokeless tobacco product manufactured by Philip Morris International (PMI), the biggest tobacco company in the world. PMI has conducted and published several extensive studies evaluating the effects of their new IQOS device. However, researchers from the University of California note that “these studies appeared in a journal that may have a deficient review process, emphasizing the need for independent evaluation of the iQOS.” Researchers conducted an independent review. Results indicated that people who use the iQOS heat stick tend to speed up their puff rate to breathe in more nicotine because the device only lasts for 6 minutes, after which it automatically shuts off and requires recharging. Published March 13, 2018. Via Tobacco Control.

Sarepta Therpeutics plans to submit an application for another Duchenne muscular dystrophy drug (DMD). In 2016, the FDA approved Sarepta’s currently marketed DMD drug, which went against the recommendation of a panel of independent advisors who said eteplirsen did not demonstrate clear efficacy in treating the rare muscle-wasting disease. Now, the company has submitted an application for the approval of golodirsen, which is a drug used to treat patients with DMD. This drug is said to help produce a smaller but functional form of dystrophin protein. A review conducted by Sarepta indicated that golodirsen significantly increased dystrophin protein production in 25 boys with confirmed deletions of the DMD gene amenable to exon 53 skipping. Published March 12, 2018. Via Sarepta.

The FDA is continuing to work with Abbvie and Biogen on the withdrawal of their multiple sclerosis drug from the market. Earlier this month, MedShadow reported that Zinbryta (daclizumab) would be voluntarily pulled from the market worldwide after reports of brain inflammation and severe liver damage. The FDA stepped in to assist with the process in order to “ensure a well-organized withdrawal from the market in the United States.” Furthermore, the agency wants to make sure that doctors are equipped with the necessary information to carefully transition their patients using Zinbryta to another treatment. Zinbryta will not be administered to new patients nor will new patients participate in clinical studies.The company has started notifying doctors and patients and Zinbryta will only be available for patients as needed until April 30, 2018. The FDA says that patients should not stop taking the medication without consulting their doctor. Published March 14, 2018. Via FDA.

6 Uses for Botox You May Not Know

While Botox (botulinum toxin) is most well known as a wrinkle-reducing treatment, you might be surprised at what other conditions the drug is used to treat. For one of the ailments below, Botox is not approved for that purpose.

1 Excessive Sweating (Hyperhidrosis)

The FDA approved Botox for treatment of severe primary axillary hyperhidrosis (excessive underarm sweating) in 2005. It is approved for this treatment in 20 countries. According to the International Hyperhidrosis Society, research shows that Botox use results in an 82 to 87% decrease in excessive underarm sweating. Results become apparent after 2 to 4 days and can last up to 12 months, at which time the injection will need to be repeated. In the case of excessive hand sweating, research indicates that Botox is 80 to 90% effective and lasts about 6 months. Botox can be used on the head and face to prevent excessive sweating. However, there is a risk that Botox can affect other facial muscles, resulting in asymmetry. Lastly, Botox can be used for excessive sweating of the feet, but it only results in about 50% satisfaction and the injection is more painful when given in the foot.

2 Overactive Bladder (Urinary Incontinence)

Botox was approved by the FDA for overactive bladder in January 2013. The condition causes the bladder to contract too often without warning, which leads to a constant urge to urinate and/or causes leakage. A study, funded by Botox maker Allergan (so consider that Allergan financially benefits from more uses of Botox), found that 9 out of 10 patients saw a 50% or greater drop in daily urinary incontinence. Incontinence completely stopped in between 44% and 52% of patients. Another study showed a consistent drop in daily incontinence with 1 injection producing stable results for a year among one-third of patients. A third study, however, found that 1 in 5 incontinence patients needed catheterization despite Botox injections.

3 Voice Tremors (Spasmodic Dysphonia)

Studies indicate that Botox injections can successfully treat voice tremors. In a 2004 study, Botox treatment was successful in 50 to 65% of patients. Thirty to 50% of patients showed improvement on an objective basis, and 65 to 80% subjectively reported improvements based on their own assessment. Botox is not approved by the FDA for this purpose.

4 Spasticity

Many conditions cause spasticity — a muscle control disorder characterized by tight or stiff muscles and sustained muscle contraction — including multiple sclerosis, cerebral palsy, stroke and spinal injuries. The brain sends signals to muscles through nerves to contract or move. These messages are sent from the nerves to the muscles by a chemical called acetylcholine. Botox works by blocking the release of acetylcholine to the nerves so muscles relax, according to the Cleveland Clinic.

5 Cervical Dystonia

This condition causes muscles in the neck and shoulder to involuntarily pull, leading to head tilting and turning. Botulinum neurotoxin injections have been used since the late 1980s to treat cervical dystonia, according to the Dystonia Medical Research Foundation. A 2006 review of trials found that the injections led to an improvement in abnormal posture and movements, as well as reduced pain. Also, long-term follow-up of patients treated for up to 20 years with botulinum therapy found that the benefits of the medication were consistent and a risk of immunoresistance very small.

6 Crooked or Crossed Eyes

Botox is injected into the eye’s in-pulling muscle to weaken it. The Botox wears off, but in the meantime the outward-pulling muscle strengthens itself and gives the brain a chance to regain control of binocular vision and eye alignment, according to information from Boston Children’s Hospital.

Quick Hits: Long-Term Opioid Use in Neuropathy, Risk of Health Issues Seen with MS Drug & More

Patients with polyneuropathy – a type of nerve damage characterized by numbness and burning pain in parts of the body – who take opioids for 90 days or more have a higher risk for depression, dependency and overdose compared to those taking opioids for a shorter period. Researchers compared the results of 2,892 patients with polyneuropathy who had been treated with opioids for at least 90 days with the results of 14,435 patients who received opioids for a shorter time. Researchers, writing in JAMA Neurology, found that long-term opioid chronic therapy was associated with negative outcomes and failed to improve functional status. Via JAMA Neurology. Posted May 22, 2017.

People with multiple sclerosis (MS) that take Avonex or Rebif (interferon beta) are at a higher risk for several serious health issues, according to a new study. The new finding, published in Neurology, highlights the need for further investigation of the drug. The health records of more than 2,000 patients with relapsing-remitting MS were examined. Researchers identified an increased risk of stroke, migraine and depression among patients with MS treated with interferon beta compared to those not on the medication. Additionally, they found that patients had blood abnormalities. However, researchers also found that those taking interferon beta for at least 2 years had a reduced risk of bronchitis and upper respiratory infections. The study authors noted they hope the research will spur the development of biomarkers that can identify patients most likely to experience these adverse events. Via Neurology. Posted May 12, 2017.

A 100-year-old drug called suramin – initially developed to treat parasitic infections found mostly in Africa – displayed significant, but temporary, improvement in core symptoms of autism. A total of 10 boys with autism who received a suramin infusion displayed improvements in language and social behavior. However, suramin’s effectiveness was short-lived because the improvements peaked and then gradually faded after several weeks as the single dose of suramin wore off. Posted May 26, 2017. Via UC San Diego Health.

Drug Side Effects Reported to FDA Skyrocket

Since 2004, the number of side effects reported to the FDA has increased nearly fivefold, according to a new analysis.

In 2004, 205,727 drug-related side effects were reported to the FDA. In 2015, the number skyrocketed to 1.19 million, an increase of 477.2%, according to data compiled by the Milwaukee Journal Sentinel and MedPage Today.

Figures for 2016 are not yet available, but they are expected to at least match the number of reports seen in 2015.

Drugs used to treat conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, a type of cancer and diabetes garnered the greatest number of reports.

The actual number of side effects is likely much higher, as reporting of side effects is voluntary.

One reason for the surge is that in 2015, the FDA began requiring drugmakers to report side effects electronically, rather than on paper. That led to an increase in reports of not so serious events, and 300,000 additional reports, the largest year-over-year jump since the agency began compiling side effect reports.

Also, reporting of side effects is increasingly coming from patients rather than doctors. In 2004, 20% of reports came from patients. By 2013, patient reports of side effects outnumbered those reported by medical professionals. In 2015, patients accounted for 55% of side effect reports.

Benefits of Vitamin D Not Backed by Scientific Evidence

Many people swear by the benefits of vitamin D supplements, including that it can treat multiple sclerosis (MS) or depression. However, a new study is throwing water on those supposed benefits, arguing that scientific evidence simply doesn’t back them up.

Michael Allan, MD, a professor of family medicine and director of evidence-based medicine at University of Alberta’s Faculty of Medicine & Dentistry, examined evidence regarding 10 common beliefs about the benefits of vitamin D. Among them: Improving depression and mental well-being, preventing rheumatoid arthritis, treating MS and cutting cancer risk.

However, as he reported in the Journal of General Internal Medicine, vitamin D supplementation doesn’t have much of an impact at all.

“Even areas that we really thought there was good evidence for benefit early on, don’t seem to be bearing out,” Allan said in a statement. “The one that we probably have the most evidence for is fractures. If you were to take a group of people who were at higher risk of breaking a bone — so had about a 15% chance of breaking a bone over the next 10 years — and treated all of them with a reasonable dose of vitamin D for a decade, you’d prevent a fracture in around one in 50 of them over that time.”

Allan notes that most people would agree that taking a drug for a decade or more that would only impact 1 in 50 fractures is “probably not meaningful.”

Even though there is a lack of concrete evidence on the benefits of vitamin D, millions of Americans turn to the vitamin daily. Allan argues that the reason for the high utilization is because of prior research that claimed that low vitamin D levels were associated with poorer health outcomes, even though that doesn’t prove causation.

It is also important to keep in mind that taking high levels of vitamin D can potentially be harmful. There are relatively few studies of the effect of taking more than 2,000 IU daily of vitamin D.

In addition, other drugs can influence the absorption of vitamin D. For example, steroid drugs like prednisone, weight loss drugs like Alli (orlistat) and the cholesterol-lowering drug Questran (cholestyramine) can reduce the absorption of vitamin D.

Quick Hits: FDA Approves New Drug for MS, Diabetes & More

Zinbryta (daclizumab), a monthly self-administered injection that aids in the treatment of relapsing forms of multiple sclerosis, has been approved by the FDA. Due to Zinbryta’s serious side effects including liver injury and immune conditions, it is recommended that the drug only be used in patients who have had a poor response to two or more MS drugs. The medication also has a boxed warning, which tells prescribers that the drug can cause severe liver injury, including life-threatening and fatal events. Daclizumab was previously marketed as Zenapax to prevent rejection of kidney implants, but was discontinued in 2009 due to a lack of market demand. Posted May 27, 2016. Via FDA.

The FDA has approved a new drug, Ocaliva (obeticholic acid), to treat an uncommon, slow-progressing liver disease known primary biliary cirrhosis. The medication was approved under the agency’s accelerated approval process. Ocaliva is Intercept Pharmaceuticals Inc. first product to reach the U.S. market. The FDA cleared the drug under the condition that Intercept conduct further research to show that the drug reduces patients’ risk of liver transplant and death. Posted May 28, 2016. Via Bloomberg.

Although many patients experience side effects associated with medical marijuana use, they also experience significant improvement in pain relief and functioning. The use of medical marijuana in Israel has significantly increasing as it’s approved for non-cancer and cancer pain, nausea and lack of appetite in cancer patients, multiple sclerosis, epilepsy, inflammatory bowel disease and more. A study that ran over the course of two years (starting in 2013) examined whether patients experienced after-effects from medical marijuana use. While most users saw benefits from marijuana use, more than 77% reported side effects. The most frequent side effects were following: dry mouth, hunger, high moods, sleepiness, fatigue, red eyes and blurred vision. Posted May 29, 2016. Via Medical Jane.

The FDA approved Jentadueto XR, to treat adults with type 2 diabetes. Jentadueto XR is a once-daily oral combination of Tradjenta (linagliptin) and metformin. When paired with proper diet and exercise, Jentadueto XR can help improve glycemic control. A boxed warning will be placed on the Jentadueto label due to the risk for lactic acidosis, which is associated with major metabolic dysregulation. Posted May 31, 2016. Via Medscape.

A new study has found that many parents do not fully understand their children’s asthma medications. The parents of 740 children with asthma were surveyed on their knowledge about their offspring’s asthma meds. Results showed that only 49% were knowledgeable about what kind of medication their child was prescribed and how often they should use it. According to the study’s primary author, Ann Chen Wu, MD, of the Harvard Pilgrim Health Care Institute in Boston, “we need to improve provider-patient communication in the medical office, especially for controller medications for children with asthma, but providers may be unaware of their patient’s lack of adherence.” Published May 31, 2016. Via HealthDay.

The Problem with Weed

For many years I stood in favor of legalizing pot. The primary reason for my opinion was that it is not healthy for a society to consider a common behavior criminal. You can’t put 20% of our kids in jail.

I advocated on this blog to regulate pot (What We Don’t Know About Marijuana) and put guidelines into place for when and how much. Then I learned that guidelines are not straightforward with weed: The same amount ingested by the same person can have 4x the effect one day and very little effect the next day (Weed Is Not Like Wine).

At present, 23 US states and Washington D.C. have legalized medical marijuana and 4 states have legalized pot for recreational use. The continued decriminalization of pot seems unstoppable. But do we know what we are doing?

I started digging into what we do know, and it’s not much. There are many people who are thrilled with marijuana’s apparent ability to slow or stop seizures in some cases. Others claim it’s wonderful for chronic pain and more. See our story, Medical Marijuana Can Ease Pain and Lessen Side Effects to see how it’s being used and which groups are endorsing it.

Do We Know Enough? (The Correct Answer Is No)

But that doesn’t change the fact that we don’t know enough about pot’s medical properties and we don’t know enough about how it affects cognitive abilities. I wonder: In the rush to decriminalize marijuana, are we at risk of damaging our children and ourselves?

I ask this question for 3 reasons:

  1. We are legalizing pot before we have reasonable safeguards in place. Can someone smoke weed at lunch and then go back on the job at a daycare center? Response to pot is highly variable each time it’s ingested or smoked. How do you gauge if you’ve had too much to drive?
  2. How does anyone know what quantities of THC (the chemical that creates euphoria) and CBD (the chemical connected with most of the medically beneficial aspects) are in pot whether grown or purchased? What about pot in foods — what kind of pot, how much and how to identify them once they are out of their wrappers?
  3. There is a growing body of research that indicates regular use of marijuana will impair your cognitive functions — particularly if you use it before the age of 21. These effects may possibly be permanent ones. But we already suspected that, didn’t we? Look at the stoner movie genre.

Why are we changing laws based on guesses and anecdotal information? Why don’t we have research? Because the FDA still has marijuana listed as a Schedule 1 drug, which means it has “No redeeming medical use.” It’s in the same category as heroin. To conduct legal research in the US one needs a permit and can only use the marijuana supplied by the government from a controlled planting area. With the legalization of marijuana in some states, more research is being initiated. But for now the research we need about if and why cannabis has the ability to calm seizures, or if heavy recreational use can lead to permanent damage to one’s intelligence doesn’t exist in the US.

Looking Abroad for Answers

Internationally there’s much more research. Medscape published a comprehensive review of international research literature, Medical Marijuana: The State of the Science in February 2015 which examined all the relevant research on marijuana focusing on the 2 derivative cannabinoids: THC and CBD. We have the ability to measure and manipulate the THC and the CBD levels in marijuana plants.

The Medscape report is packed with worrisome indications from international research (follow the link above for research citations and much more information):
Chronic bronchitis: “The relationship between the long-term smoking of marijuana and lung cancer is unclear, they also concluded that marijuana smoking is associated with the inflammation of large airways, increased airway resistance, and lung hyperinflation, all of which are consistent with the development of chronic bronchitis.”

Reproductive impact: “Long-term use of cannabis has an adverse impact on reproductive potential, as it disrupts the menstrual cycle, suppresses oogenesis (creation of an egg cell), and impairs embryo implantation and development. Cannabis use may also have a detrimental effect on male reproductive health.”

Death rate: It’s highly unlikely for marijuana to cause death directly, but those who use pot have a markedly higher rate of death from other causes: “We cannot ignore the association between cannabis use and mortality. A systematic review found that people who had used marijuana had higher rates of mortality from fatal motor vehicle accidents, AIDS, and lung cancer.”

Cognitive function: Parts of your brain start to shrink: “In addition, they described published case reports that identify a safety signal between cannabis use and stroke. Of considerable concern are data indicating diminution of the volumes of the hippocampus, amygdala, and cerebellum in adult and adolescent heavy users compared with healthy controls.”

Time Magazine interviewed many research doctors in the US whose experiments and studies are underway but incomplete in the May 25, 2105 issue (subscriber access only). An interesting study of the offspring of rats who had been exposed to pot — but who were clean when the offspring were conceived — found changes in the 2nd and perhaps 3rd generation that made them more susceptible to addiction. The writers summarized:

Your Brain on Pot

Positive Effects

  • Chronic Pain — Cannabinoids interact with specific receptors on cells in the brain and immune system which may allow them to reduce pain and inflammation.
  • Multiple Sclerosis — a mouth spray made from a mix of 2 marijuana compounds, THC and CBD, can be an effective treatment of neuropathic pain, disturbed sleep and spasticity.
  • Epilepsy — Animal experiments and a recent survey of parents with children who suffer epileptic seizures suggests that CBD may work as an antiepileptic agent. Clinical studies are ongoing.

Negative Effects

  • Developing Brain – Prenatal or adolescent exposure can lead to altered brain development, including changes in the connections between the neurons, or circuits, in certain brain regions.
  • Mental illness – youthful exposure can lead to earlier onset and more severe psychoses, including schizophrenia, for that part of the population with a genetic predisposition to certain mental illnesses.
  • Addiction – Approximately 9% of those who experiment with marijuana become dependent, a proportion that increases to 1 in 6 (16.67%) if use starts during one’s teenage years.

Source: The Great Pot Experiment, Time magazine, May 26, 2015 (subscription needed).

I’m not saying pot’s more dangerous or more addictive or more anything than alcohol or cigarettes. But is that the bar? Should we point to 2 legal products that are often abused and use them as the standard? Every drug should be evaluated on its own benefits and burdens with clear and independent research.

Multiple Sclerosis – oral drugs

MS – Oral Drugs and the side effects

The measurement of efficacy for an MS drug is slowing the amount of relapses than a placebo. MS is commonly treated with drug injections or infusions. Oral treatments are a new option.

Tecfidera

Generic name: dymethyl fumarate. Newly approved by the FDA (March 2013).  European regulators recommended approval in March also. Tecfidera cut the relapse rate 44% and 53% in two different trials. Must be taken 2x per day. Patients have to have their blood cell levels tested before using the drug and then annually. Tecfidera can lower white blood cell levels (which fight infection). Also, animal studies suggest Tecfidera might cause fetal harm. There is a warning for pregnant women on the label.

Common side effects: flushing (in 40% of patients), nausea, vomiting and diarrhea (especially when starting the treatment).

Long-term side effects (not common): lowered white blood cell levels, possible danger to fetus for pregnant women.

Gilenya

Generic name: fingolimod. Approved by the FDA in 2010 as the first oral “disease-modifying” therapy for relapsing MS. Cut the relapse rate by 54% and only needs to be taken once daily. More effective than interferon treatments. Patients must have an ECG and be monitored in a medical facilty for six hours the first time Gilenya is taken because it could slow the heart to dangerous levels. It requires ongoing testing for heart, liver and eye problems.

Common side effects: headache, flu, diarrhea, back pain, cough, shortness of breath (call your doctor if ever short of breath). Slowed heart rate should return to normal levels within 1 month. (from the website)

Long-term effects: elevated liver enzymes, liver and eye problems. Increases in blood pressure.

Aubagio

Generic name: teriflunomide. Approved for use in MS by the FDA in September 2012. The relapse rate for Aubagio was about 30% lower than placebo. It is taken 1x day. Before you start Aubagio, your doctor will check your white blood cell count and perform a tuberculosis skin test. Your liver should be checked before you start Aubagio and every month while you take it.

Aubagio can stay in your blood stream for as long as 2 years after you stop taking it. This is important when considering the side effects but also if you are planning on becoming pregnant. Aubagio may cause harm to an unborn baby. There is a pregnancy registry that you should enroll in if you become pregnant while on Aubagio or while Aubagio is still in your blood stream.

Common side effects:  abnormal liver test results, hair thinning or loss, diarrhea, flu, upset stomach, burning or prickling feeling in skin.

Long-term/serious side effects: Reduced white blood cell count which can lead to more infections, numbness or tingling in your hands or feet (different from the numbness that MS can cause), kidney problems, high potassium levels in your blood, serious skin problems, breathing problems (new or worsening), high blood pressure.