Tag Archives: Cathy Rosenbaum

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.

Sweet Dreams, Melatonin

Having trouble falling asleep? Most prescription and OTC sleep medications are considered high risk for seniors as they can cause falls or impaired driving skills. Melatonin is a naturally produced chemical in the brain that helps regulate the sleep cycle. Our body produces around 0.1 mg melatonin per night, a very small amount indeed.

Melatonin as a dietary supplement might be an option to consider with the advice of your physician if other lifestyle changes don’t do the trick (e.g., cool bedroom, decluttering your mind, use of relaxing herbal teas like lavender, chamomile, or decaffeinated green tea before bedtime).

Melatonin may reduce the time it takes to fall asleep by only 10 minutes. Starting doses are 1 mg – 3 mg between 30 minutes to 60 minutes before bedtime, maximum 5 mg nightly only as needed. Melatonin does not work for everyone and if it does not, it’s best to stop taking it within a few weeks of trying. Finally, please don’t combine melatonin with other prescription or OTC sleep medications or you may experience drowsiness.

Stay safe and sweet dreams!

List of Excellent CAM Websites

Ask Dr. Weil (http://cgi.pathfinder.com/drweil/)
Alternative Health News Online (http://www.altmedicine.com/)
Colorado Health Site (http://www.coloradohealthnet.org/)
Dogwood Institute (http://www.people.virginia.edu/~pjb3s/Complementary_Practices.html)
NIH NCCAM (http://nccam.nih.gov/nccam/)
NOAH (http://ww.noah.cuny.edu/alternative/alternative.html)
UPitt (http://www.pitt/edu/~cbw/altm.html)

The Alpha and Omega of Omega 3 Fatty Acids

Growth in the dietary supplement category over the past few years has skyrocketed with over 60,000 products available to consumers worldwide. A dietary supplement is a product that contains an ingredient intended to add further nutritional value to (i.e., to supplement) the diet, and may be one or more of the following:
• a vitamin
• a mineral
• an herb or other botanical
• an amino acid
• a concentrate, tincture, or extract

In the U.S.A., the major regulatory driver within this product category has been the Dietary Supplement Health Education Act (DSHEA) of 1994. Under this Act, supplements are presumed to be safe and do not need FDA approval before they are marketed. Supplements are regulated by the FDA as food under the Center for Safe Food and Nutrition (CSFAN), and bear a nutrition label. However, supplements are used by many like medications to treat medical conditions, and as such may have side effects and interactions that need to be managed. With regard to prevention, supplements are not a replacement for good nutrition or a healthy lifestyle including restorative sleep, exercise, emotional, social, and spiritual wisdom (Proverbs 3:1-8).

According to a survey by Bailey, et al. (JAMA Intern Med 2013;173:355), polls showed people used supplements to improve their health, to improve bone density, to lower total cholesterol levels, boost immunity, or manage joint pain from osteoarthritis. Respondents reported they took multiple vitamins, calcium, and fish oil most often, without the recommendation of a health care professional. That practice may be unsafe!

Anti-Inflammatory Fish Oil Supplements
The USDA’s 2013 Dietary Guidelines for Americans recommend that adults keep daily fat intake to a maximum of 20%-35% of total calories. Most of this fat should come from mono- and polyunsaturated fats (i.e., fish, nuts, vegetable oils).

Omega 6 and omega 3 are two essential (polyunsaturated) fatty acids (EFAs) that we must obtain from our diet. At this time, clinical studies supporting any omega 3 health benefits are inconclusive, with the exception of prescription strength Lovaza (omega 3) which is FDA approved for lowering very high triglyceride levels.

The typical American diet is rich in omega 6 essential fatty acids and lacking in omega 3 essential fatty acids. However, many foods contain both. There are three main omega 3 constituents in nature, namely eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linolenic acid (ALA). ALA is a precursor to EPA and DHA. Our body does not metabolize ALA into EPA and DHA very well.

Foods rich in omega 6 essential fatty acids in order of decreasing content include sunflower oil, corn oil, wheat germ oil, safflower margarine, sesame oil, walnuts, avocado oil, almond oil, peanuts, peanut butter, and palm oil.

Foods rich in various types of omega 3 essential fatty acids in order of decreasing content include salmon oil, sardine oil, cod liver oil, canola oil, herring, shrimp, krill oil, flaxseed oil, and walnuts (ALA).

When purchasing fish oil-based products, make sure you check with the manufacturer to ensure they have been tested for mercury, polychlorinated biphenyls (PCBs), and other unwanted contaminants. This kind of information rarely appears on the label.

Check to see how much EPA and DHA are in that 1,000 mg dose of fish oil to assess product value before purchase. You should look for EPA and DHA as your active ingredients! If the amount of EPA plus DHA combined is 30% or less of the total dose (i.e. 300 mg in a 1,000 mg capsule) you are not getting the quality you desire for your money. Most of the rest of that dose is typically composed of omega 6 fatty acids or omega 3’s we cannot metabolize (i.e. ALA).

There are no established dietary reference intake (DRI) standards for DHA or EPA daily consumption. The Institute of Medicine suggests an intake of 160 milligrams of DHA and EPA combined each day. The American Heart Association recommends eating fatty fish at least two times each week, which is equal to about 1,250 mg DHA and EPA each day.

The European Food Safety Agency recommends 250 mg/day EPA and DHA combined for adults or 1-2 servings/week of oily fish. The World Health Organization recommends 1-2 servings of oily fish/week providing 200 mg – 500 mg/serving of EPA and DHA for the general population to prevent ischemic stroke and coronary heart disease.

Pregnant women require 200 mg of DHA daily to support fetal development. The Environmental Protection Agency advises women of childbearing age, nursing moms, and young children to consume only 2 servings per week of sardines or salmon and avoid tuna due to the methyl mercury content.

There are three grades of fish oil on the market, namely cod liver oil, health food grade fish oil, and pharmaceutical grade fish oil. Look for pharmaceutical grade omega 3 fatty acids as the highest quality of these three.

In general, please know that the dose of omega 3 that’s right for you may not be appropriate for others and could differ for diabetics and people with heart disease due to potential side effects. Talk with your physician and pharmacist about what’s best for your health needs before you purchase any dietary supplements.

By Cathy Rosenbaum PharmD MBA RPh, Rx Integrative Solutions