Tag Archives: Cathy Rosenbaum

Energy Drinks – Are Those Shots Really Safe?

Beverages like Red Bull, Rockstar, Monster Energy, 5-Hour Energy, Mountain Dew Kickstart, and Full Throttle are touted to increase energy, improve mental alertness, and enhance physical endurance. Some of these products are marketed as beverages while others are marketed as dietary supplements.

According to the Center for Disease Control and Prevention, between 2007 and 2011, the number of energy drink-associated emergency room visits doubled. In 2011, one in 10 of them resulted in a hospitalization. Some college students will unsafely consume energy drinks along with alcohol or other products/drugs (e.g., marijuana, OTC or prescription medications).

Ever looked at the nutrition label on the back of one of these products? They contain more than just caffeine and sugar, namely B vitamins, amino acids (taurine and carnitine), and other dietary supplements -> green tea extract, guarana, yohimbine, green coffee bean extract, bitter orange, glucuronolactone, ginkgo biloba, and ginseng. A single 16-oz bottle may contain up to 62 grams of added sugar, more than the maximum amount recommended in one day (15 teaspoonfuls – 250 calories).

In smaller quantities, caffeine may boost energy and alertness. In larger quantities, caffeine can negatively affect the cardiovascular system. Taurine may boost metabolism. In theory, extra carnitine may impact fat burn. The body is typically not deficient in endogenous carnitine, so it’s a waste of your money. Guarana contains caffeine. Green tea extract contains caffeine and the antioxidant EGCG. Green coffee bean extract contains caffeine. Yohimbine and bitter orange are central nervous system stimulants.

Ginseng does not impact energy and may lower blood sugar in diabetics – diabetics should be careful with its use. Ginkgo biloba has not been clinical proven to improve energy. Water soluble B vitamins protect nerves but may not improve energy. Thankfully, they will be eliminated by the kidney if taken in excess.

Glucuronolactone, a component of connective tissue, is metabolized into glucuronic acid and is touted to ‘detoxify’ (what?) in the body, a nebulous claim that is unproven in humans. It has no impact on energy.

Possible side effects from energy drinks include, but are not limited to, rapid heartbeat, heart palpitations, heart attack, and headaches. Caffeine and other stimulants may also be associated with anxiety, sleep problems, digestive problems, and dehydration.

If you feel you need to consume energy drinks, a good health rule is to consume them in moderation and remember that there may be negative outcomes. Talk it over with your primary care physician. Be healthy, eat whole foods, get ample restorative sleep, and stay safe.

REFERENCES:

Higgins. Energy beverages: content and safety. May Clin Proc 2010:85:1033-1941.
Sankararaman. Impact of energy drinks on health and well-being. Current Nutrition Reports 2018;7:121-130.
Uliah. Energy drinks and myocardial infarction. Cureus 2018;10;e2658

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Cathy Rosenbaum PharmD RPh MBA CHC 10/12/18©

 

 

Overview of Biofeedback

By Dr. Cathy Rosenbaum, Holistic Clinical Pharmacist, Founder & CEO, Rx Integrative Solutions, www.rxintegrativesolutions.com

By tapping into our mind body connection, we can learn how to heal! Biofeedback is a non-pharmacologic mind body technique taught by a trained practitioner that can help a person improve her/his physiological function (e.g., heart rate, blood pressure, breathing rate, skin temperature, muscle tone).  This practice can be used to help manage conditions such as headaches, anxiety, high blood pressure, and stress, among others.

Certified biofeedback practitioners follow a standard of care based on scientific evidence.  They can use different methods involving electrodes and sensors in their 30-minute to one-hour session (e.g., electrodermal test, thermal biofeedback, and electromyogram for muscles).  It may take several sessions before progress is seen.  One could learn how to relax using deep breathing, progressive muscle relaxation, guided imagery, and/or mindful meditation.

Computer graphics help visually guide relaxation so one can see progress made toward the health goal.  Wearable devices with sensors worn around the waist are also available. RESPeRATE is an FDA approved device for decreasing stress and lowering blood pressure that uses a downloadable app. Not all home use biofeedback devices are regulated by the FDA, so buyer be ware!

Consider adding biofeedback to your health tool kit.

Blessings for better health.

References:

McKee. Biofeedback: an overview in the context of heart-brain medicine. Cleve Clin J Med 2008;73(Suppl 2): S31-S34.

Gevirtz.  The promise of heart rate variability biofeedback: evidence-based applications. Biofeedback 2013;41(3):110-120.

Mayo Clinic. Biofeedback. www.mayoclinic.org/tests-procedures/biofeedback/about/pac-20384664.  Accessed September 1, 2018.

 

Lyme Disease

Background

Lyme disease is caused by a spirochete  called Borrelia burgdorferi  that is carried by blacklegged ticks (vector) found on deer (reservoir host).  The Center for Disease Control (CDC) tells us that more of these ticks are expected this summer due to reforestation and climate change across the country, including in Ohio.  While the majority of reported cases are from the Northeast and Upper Midwest, other cases have been reported as far south as Florida. Adult blacklegged ticks (Ixodes scapularis)  are the size of an apple seed so they are visible to the naked eye.

Symptoms

Symptoms can occur within 3 to 30 days after a bite. Ticks must be attached to the human for at least 36-48 hours to transmit disease.  If the human removes the tick within 48 hours, he/she probably won’t get the disease. Lyme disease is diagnosed by symptoms which can include chills, fever, headache, muscle and joint pain, and swollen lymph nodes. For many infected individuals, the classic red bull’s-eye round rash is one of the first symptoms.  Up to 30% of those bitten will not get a rash.

There are three stages to the disease:

  1. Early Localized – flu-like symptoms and rash
  2. Early Disseminated – flu-like symptoms with pain, numbness in arms/legs, Bell’s palsy
  3. Late Disseminated- arthritis, fatigue, dizziness, sleep disturbances, mental confusion

Treatment

Lyme disease is treated with antibiotics like doxycycline or others, depending on the patient and upon the physician’s preference, for a period of 2-3 weeks.

Prevention

Clothes treated with permethrin 0.5% make it hard for blacklegged ticks to bite you or stick to your clothes (Eisen. J Medical Entomology July 20, 2016).  In addition:

*Wear socks and pants when you walk in the woods

*Wear a tick repellent on skin and clothes that contains DEET, lemon oil, eucalyptus, or (better still) permethrin

*Take a shower within two hours of coming inside after possible exposure to blacklegged ticks

*Remove ticks from your skin with a pair of tweezers, then clean the area with 70% rubbing alcohol or soap and water

*Check your skin and hair, and wash ticks out of your hair ASAP after walking in the woods

*Place exposed clothing in a hot dryer to kill whatever ticks remain

 

Restless Leg Syndrome

Restless Leg Syndrome

By Cathy Rosenbaum PharmD MBA RPh CHC
Founder & CEO, Rx Integrative Solutions

Introduction
Restless leg syndrome (RLS) was first described over 70 years ago. Symptoms can show up as achy or crawling sensations in the resting leg that oftentimes go away with leg movement. RLS can be caused by iron or folate deficiency, kidney problems, pregnancy, rheumatoid arthritis, fibromyalgia, thyroid issues, Parkinson’s disease, and depression, among others. A family history of RLS is common in individuals with idiopathic RLS. Individuals with RLS can have trouble getting a refreshing REM sleep. RLS is often misdiagnosed as a vascular problem in the veins, and that’s why it’s important to get an accurate diagnosis from your PCP first before treating the condition.

Factors that may make RLS symptoms worse include cold, heat, fatigue, and stress. RLS prescription medication treatments can include, but are not limited to, benzodiazepines, gabapentin, clonidine, propranolol, and narcotics, each of which have significant side effects. The use of opioids and benzodiazepines together (e.g., Valium, Ativan, Xanax, clonazepam) is not safe. For perspective, benzodiazepines as a medication class are best avoided in seniors due to drowsiness and increased risk of falls and dementia. Depending on the type of RLS diagnosed, non-prescription medication and/or non-invasive alternatives can be considered to treat symptoms.

Iron Deficiency
Interestingly, there might be less iron in the brain of an RLS individual compared to non-RLS individuals. People with iron deficiency RLS respond well to iron supplementation. Improvement is most often seen in those with the lowest initial serum ferritin levels.

Pregnancy
Pregnant women are more likely to develop RLS than non-pregnant women due to reduced folate levels in the former population. In most instances, symptoms are mild and resolve after delivery. Treatment involves folate supplementation, reassurance, and appropriate food intake.

Medication-Induced RLS
Different medications can either cause or worsen RLS symptoms. Antidepressants like Prozac, Paxil, and Zoloft are three such culprits. One study showed that use of non-opioid analgesics is associated with an increased risk of RLS in individuals on long-term antidepressant therapy (Leutgeb. Eur J Med Res 2002;7:368-379).

Vitamin D and Magnesium Deficiency
Published literature (J Sleep Breath 2016) indicates that low vitamin D levels and/or low magnesium levels may be associated with RLS. Magnesium supplementation makes it easier for leg muscles to relax. Treatment with vitamin D or magnesium dietary supplements with the advice and consent of your PCP or pharmacist are two options to consider if you are suffering from these types of RLS.

Holistic Therapies
For individuals with mild RLS symptoms, other holistic options include relaxation/stress management therapy, acupuncture, and abstaining from caffeine and caffeinated products, nicotine, and alcohol to help improve sleep, help reduce stress, and indirectly lessen symptoms.

Summary
If you are experiencing RLS-like symptoms and are concerned about what to do, the first step is to schedule an office visit with your PCP to get an accurate diagnosis. It is unwise and unsafe to self-diagnose and try various remedies without your PCP’s knowledge.

Finding Gluten-Free Nutrition, Dietary Supplements, and Medications

Non-celiac gluten intolerance and celiac disease are becoming more common. Celiac disease is a chronic autoimmune disorder caused by a genetic intolerance to gluten. Non-celiac gluten intolerance is diagnosed in people who do not have celiac disease, but have intestinal or extra-intestinal symptoms related to ingestion of gluten-containing grains.

Both conditions are treated by avoiding gluten containing foods. Finding ‘gluten free’ nutrition is becoming easier to do, but eliminating gluten from one’s diet can be a complex and time-consuming process.

Gluten is the protein component of wheat (e.g., including spelt, kamut, semolina, and triticale), barley (e.g., including malt), and rye. When a person with celiac disease or non-celiac intolerance ingests gluten, specifically the antigenic gluten constituent called gliadin, it can cause intestinal inflammation, diarrhea, abdominal pain, bloating, weight loss, fatigue, and iron deficiency anemia. Food malabsorption and nutritional deficiencies result.

Over time, these conditions can cause liver disease, defective gallbladder emptying, and osteoporosis. Celiac disease may be a reversible cause of osteoporosis. Adherence to a gluten-free diet is one way to help suffers minimize overall symptoms and to maintain maximal bone mineral density.

For perspective, oats are considered a type of gluten grain, but do not have the antigen that other gluten grains above do. Thus, oats do not induce an immune reaction in the small intestine of people with celiac disease. However, many commercial oat products are contaminated with wheat, barley, or rye and it’s important to carefully read their labels. Look for products that are certified to contain less than 20 ppm of gluten (FDA’s ‘gluten free’ definition).

Consumption of as little as 10 mg-50 mg gluten daily can lead to a clinical relapse in people with these conditions. Celiac disease may increase the risk of developing some types of cancer (e.g., T cell lymphoma and intestinal adenocarcinoma) if gluten restrictions are not maintained or gluten intake is only partly restricted.

It is important to find out where gluten resides in foods. This means not only reading food labels on products you purchase for home but also on foods you consume from fast food establishments and restaurant dining. Soups, sausages, and ice cream may contain hidden amounts of gluten as fillers. Talk with your grocer and restaurant owners before you consume questionable food items.

Watch out for the gluten content in herbs, other dietary supplements, and medications.

Gluten-Free Foods
Consuming foods certified to be ‘gluten free’ will help keep the daily gluten total to under 50 mg and not cause symptoms for most people with celiac disease. Gluten-free grains include rice, millet, corn, quinoa, sorghum, and buckwheat. For more information, visit http://glutenfreecooking.about.com/od/gettingstarted/a/hiddengluten.htm
or http://www.glutenfreeliving.com/nutrition/ingredients.

Gluten-Free Herbs and Other Dietary Supplements
It would be impossible to find information about the gluten content in over 60,000 products on the worldwide market. One can contact dietary supplement manufacturers directly for more information on gluten content before taking any of these products, including vitamins.

Gluten-Free Medications
Over-the-counter and prescription medications may contain gluten in the list of inactive ingredients. For example, sweeteners used in medications may be hidden sources of gluten. Some manufacturers cannot guarantee their medications are gluten-free because the suppliers of raw materials can not do so, making it even more difficult for consumers to figure out what is safe to take and what is not.

A great resource for determining the overall ingredient content in medications, including whether or not gluten is present, can be found online at www.glutenfreedrugs.com .

Another online medication reference comes from the National Institutes of Health at www.dailymed.nlm.nih.gov. Go to the site, type in the generic name of the medication you want to review, then scroll down to the name of the manufacturer of that particular product, then click on ‘description.’ Scroll down to the inactive ingredients and look for gluten.

A third way to find more information about your medication’s gluten content is to call the medication manufacturer directly. Be sure to have the medication’s lot number available when you call.

Finally, click on https://www.ncbi.nlm.nih.gov/pubmed/?term=Gluten+content+of+the+top+200+medications+of+2009%3A+a+follow+up+to+the+influence+of+gluten+on+a+patient%E2%80%99s+medication+choices for “Gluten content of the top 200 medications: follow up to the influence of gluten on a patient’s medication choices” by AR King in Hosp Pharm 2013:48:736-43.

By Cathy Rosenbaum PharmD MBA RPh CHC

Grapefruit Interactions with Medication

Certain prescription and/or OTC medications and dietary supplements may negatively interact with grapefruit juice, grapefruit, Seville oranges, pomelos, and tangelos due to chemicals in the fruits.

Fruit chemicals are thought to block enzymes in the body that metabolize medication in the small intestine, thereby causing the medication to hang around longer than expected. Interestingly, these fruits may also interfere with transporters in the body, causing medication to be less well absorbed into the bloodstream, and may reduce medication or supplement effects. Sound confusing? It’s complicated.

Product classes involved in unwanted interactions include, but are not limited to:

-Antihistamines (e.g., Allegra)
-Antianxiety
-Antihypertensives
-Cholesterol-lowering ‘statins’
-Corticosteroids for Crohn’s disease and ulcerative colitis
Dietary supplements

Only some of the medications and supplements in each of the categories can be affected by the fruit/juices. Every person may react differently based on the amount of fruit they consume, the medication or supplement type/dose taken, and the individual’s natural ‘enzyme levels.’

Don’t worry, but do get educated about how and when to properly take your medications and supplements to be safe. Enjoy healthy nutrition. Talk with your pharmacist about what’s best for you!

Beyond Use Dates on Prescription/OTC Medications & Dietary Supplements

Expiration dates on OTC & prescription medications and dietary supplements typically fall between 12 – 60 months after product production. Pharmaceutical manufacturers are required by law to establish these dates but do not have to study product stability and potency beyond those dates.

A recent study published in JAMA Internal Medicine using eight medications containing 15 active ingredients demonstrated product potency for decades beyond the original expiration dates. Another study in the military concluded the same results for 100 medications after 15 years.

The U. S. government has a Shelf Life Extension Program to extend dates on federal stockpiles for the military. But this is the exception to the rule in a special population to save the government money in repurchasing.

The bottom line for consumers is this – > follow the product manufacturer’s established expiration date stamped on the OTC bottle or prescription vial. Follow these same guidelines for your dietary supplements as well.

Keep all of these products in a cool, dry, dark place in your home.

Turmeric (Curcuma Longa) & Osteoarthritis Pain

This yellow spice/dietary supplement from the ginger family has become popular in recent months. Its active ingredient is curcumin, one of the spices found in curry powder frequently used in Indian cuisine, and in yellow mustard. Curcumin is a potent anti-inflammatory and antioxidant.

Research studies have been conducted with turmeric for osteoarthritis pain management. Turmeric side effects include heartburn, as it is truly ‘spicy.’ So, if you already experience GERD (acid reflux disease) you will not be a candidate for this product.

A typical turmeric extract dose is 1 gram/day or less. One gram is ~ equal to 3 – 15 teaspoonsful of the ground spice, so there is wide variability between products and food. Some of the turmeric dietary supplement manufacturers add black pepper to their formulations to increase turmeric’s absorption and inhibit turmeric’s metabolism. I’m not sure that has been scientifically proven to work.

If you suffer from osteoarthritis pain and have been taking NSAIDs for years (e.g., Naproxen, Motrin, Celebrex, Feldene, Diclofenac), you may wish to consider talking with your physician about the appropriateness of taking the supplement turmeric in place of them to avoid significant long-term NSAID side effects on the stomach, heart, kidneys, and liver.

Please do not start taking turmeric without the advice and consent of your physician. Schedule an appointment for a prescription medication/dietary supplement/integrative health consultation with Dr. Cathy Rosenbaum today!

Happy New Year….Be healthy….Be Wise….Stay Safe

The Long and Short About Drug Shortages

Managing prescription drug shortages has become quite complex and requires a multidisciplinary team of creative healthcare professionals to keep up with the changing supply chain. Shortages include, but are not limited to, generic sterile injectables, anti-cancer drugs, anesthetics, pain medications, and nutritionals, creating an estimated annual impact on U.S. hospitals of $216 million from purchase of therapeutic substitutions.

Pharmacists are frequently asked, “Why does this happen?” There are multiple contributing factors in the supply chain that affect drug shortages.

• Raw Material Shortages. Nearly 80% of pharmaceutical grade raw materials are sourced outside of the USA. Drug availability is impacted when political instability interrupts U.S. trade in foreign countries, animal diseases contaminate tissue from which raw materials are harvested, or environmental issues affect plant growth from which raw materials are sourced. Remember the heparin recall a few years ago due to adulteration with oversulfated chondroitin in China?

• Quality Issues. Nearly 42% of sterile injectable drug shortages in 2010 were caused by product quality issues (e.g., particulates, microbial contamination, stability changes). Recently, Bedford Labs recalled injectable medroxyprogestrone due to silicone particles found in the product. A few years ago, Benvenue announced it was closing a plant that produced injectable methotrexate and Doxil, two chemotherapeutic agents, due to quality control issues. Only three other companies in the USA manufacture either methotrexate or Doxil, causing a supply issue for children with leukemia, as well as women with ovarian cancer, respectively.

• Manufacturing Difficulties or Production Decisions. Business decisions regarding branded drugs are made every day based on availability of generic drugs, the product’s market size, patent expirations, drug approval status, and anticipated clinical demand for the product. Manufacturers are not required to report product discontinuations to the FDA unless they are the sole source of a life supporting medication or a medication used to prevent a debilitating disease. Mature brand enthusiasm decays over time and there is a diminishing financial return to the manufacturer followed by a decision to sunset the brand. J&J stopped manufacturing branded IV Levaquin when it went generic.

• Change in Product Formulation. In 2006 there was a transition from albuterol and other metered dose inhalers with chlorofluorocarbons to metered dose inhalers containing hydrofluoroalkanes. Line extensions and formulation changes can evolve for marketing reasons or safety reasons or both.

• Regulatory Issues. FDA enforces standards like current Good Manufacturing Practice (cGMP). Yet, the FDA will help manufacturers out of cGMP compliance return to compliance when a significant corrective action involves a medically necessary product. FDA does not have the authority to require a manufacturer to produce any drug, even if the drug is a medical necessity. Bedford Labs’ oncology line was shut down by the FDA within the past year (i.e., carboplatin, cisplatin, leukovorin, Taxol). Bedford was told by the Feds that Bedford can not ship out any oncology product on hold in their warehouse until further FDA notice.

• Industry Consolidation and Company Mergers. Mergers frequently involve closing a manufacturing facility and result in a narrowed drug product portfolio for the post merger corporation. Baxter recently sold their entire generic injectable line to Westward resulting in a shortage of lidocaine, fentanyl, ketorolac, and midazolam. There are fewer generic drug manufacturers today than in the past even though there is a long line of applicants for new generic drug manufacturing processes at the FDA.

• Restricted Drug Distribution and Allocation. A drug manufacturer can place restrictions on limited drug supplies by requiring its drug is sourced through a specialty distributor. Clozapine and Tikosyn can only be supplied to a pharmacy registered in the manufacturers’ programs. Other prescription drugs are only supplied specific to each patient at the time the physician prescribes them.

• Just in Time Inventory (JIT). JIT is a strategy to minimize costs at various points along the supply chain. Some drug shortages may be wholesaler dependent, as drug shortages can occur when contracts with suppliers are delayed. Drug wholesalers oftentimes charge the drug manufacturers for stocking their drugs, and the drug manufacturers restrict the wholesalers from overstocking.

Wholesaler purchase differs from direct manufacturer purchase, or purchasing from med/surg suppliers.

• Changes in Product Demand and Shifts in Clinical Practice. When a new indication for a marketed drug is FDA approved, when new hospital programs start, or when a drug representative promotes new products and unanticipated demand increases for those products, it may be more difficult for the hospital or physician office based practice to keep up with supply. Direct-to-consumer advertising on television and in print ads also contributes to fluctuating product demand.

• Gray Market. The number of licensed non-traditional distributors who buy direct from the drug manufacturers to stockpile scarce drugs and resell at much higher prices are increasing as drug shortages go on. Purchasing from the gray market does not ensure drug pedigree, especially if sourced outside of the USA. Drug pedigree is a law in Florida and other states where most of the gray market wholesalers are located, but not law in Ohio. Gray market Epogen was available several years ago.

• Natural Disasters. About seven months ago a fire at a Hospira manufacturing plant in New York reduced inventory for emergency syringes (e.g., dextrose, sodium bicarbonate, epinephrine). This forced the manufacturer to decrease production of another medication in another facility to continue making the drug for a life threatening indication.

Managing Drug Shortages.

Government Interventions.
Participants of the Drug Shortage Summit on November 5, 2010, including the American Society of Health Systems Pharmacists, the Institute for Safe Medication Practices, the American Society of Anesthesiologists, and the American Society of Clinical Oncology, agreed that:

Congress should
• expand FDA authority to require manufacturers to notify FDA of supply interruptions/product discontinuations;
• allow FDA to require manufacturers to develop continuity of supply plans;
• require development of expedited approval pathways for pre-1938 drugs.

FDA should
• encourage confidential notification to FDA when there is a single source active pharmaceutical ingredient.
• explore incentives that encourage manufacturers to enter the market or stay in the market to minimize potential for shortages.
• collaborate with the DEA to alter quotas for controlled substances in short supply.

Senator Amy Klobuchar’s Bill 296 (H.R. 2245) requires drug manufacturers to notify the FDA at least six months in advance when experiencing a planned interruption in the production of a drug potentially resulting in a shortage situation or as soon as possible if an unexpected interruption or adjustment in supply transpires. The bill supports development of contingency plans for drugs vulnerable to shortage.

On October 31, 2011, President Obama issued an executive order directing the FDA to expand its reporting of prescription drugs and speed up regulatory reviews to respond to shortages.

Healthcare professionals around the country are actively working together in multidisciplinary teams to come up with alternate therapeutic options for these drug shortages which are not going away any time soon.

For more information, please visit the ASHP drug shortages web resource center @ www.ashp.org/drugshortages.