Should I Stand Watch? A Review of New Medications and Herbal Products and the Possible Effects on Licensed Operators
Michael L. Zaruba, M.D. Auburn Family Health Center NPPD/Cooper Nuclear Station Objectives
• Provide an overview of newer FDA approved medications with regard to use in licensed operators. • Provide an overview over the counter (OTC) herbal products with regard to use in licensed operators. • Discussion of possible strategies and/or conditional restrictions with regard to each medication and herbal product. FDA Approved Medications FDA Approved Medications
• Weight Loss Medications: – BELVIQ/BELVIQ XR – CONTRAVE – Saxenda – Qysmia Weight Loss Medications
• BELVIQ (locaserin) – Mechanism of action: • Mechanism is not completely understood but is thought to increase serotonin in the brain. – Possible side effects/concerns: • This is a C(IV) drug. • Can cause Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions. Weight Loss Medications
• BELVIQ (locaserin) – Possible side effects/concerns: • Can cause changes in attention or memory: BELVIQ may slow your thinking. • Mental problems are reported especially with taking too much BELVIQ. It may cause hallucinations, a feeling of being high or in a very good mood, or feelings of standing outside your body. • Depression or thoughts of suicide have been reported with the use of BELVIQ. Weight Loss Medications
• CONTRAVE (naltrexone HCl and buproprion HCl) – Mechanism of Action • CONTRAVE is believed to work on 2 areas of the brain, the hypothalamus (hunger center) and the mesolimbic reward system. Although the exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood. • Buproprion is an anti-depressant. • Naltrexone is used for treatment of alcohol and opioid dependence. Weight Loss Medications
• CONTRAVE (naltrexone HCl and buproprion HCl) – Possible side effects/concerns: • Black Box Warning: Suicidal thoughts and behaviors; and neuropsychiatric reactions. • While taking CONTRAVE, you or your family members should: Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes. (Quoted from patient instruction sheet) Weight Loss Medications
• CONTRAVE (naltrexone HCl and buproprion HCl) – Possible side effects/concerns: • Contraindicated in patients with uncontrolled hypertension or seizure disorders. – May increase BP and HR even in people without known hypertension. – Lowers seizure threshold (this is dose related). Weight Loss Medications
• Saxenda (liraglutide) – Mechanism of action: • Saxenda is a glucagon-like-peptide (GLP-1). It works by activating areas of your brain that regulate appetite, Saxenda may make you feel less hungry, which can lead to lower calorie intake and weight loss. – Weight loss was seen in original diabetic studies with Victoza. Weight Loss Medications
• Saxenda (liraglutide) – Possible side effects/concerns: • Possible thyroid tumors, including cancer. • Inflammation of the pancreas (pancreatitis). • Gallbladder problems. • Low blood sugar (hypoglycemia) in people with type 2 diabetes who also take medicines to treat type 2 diabetes. • Increased heart rate. Weight Loss Medications
• Saxenda (liraglutide) – Possible side effects/concerns: • Kidney problems (kidney failure). • Serious allergic reactions. • Depression or thoughts of suicide. Weight Loss Medications
• Qsymia (phentermine and topiramate) – Mechanism of action: • Qsymia is a combination of phentermine and topiramate. It is thought that the medication helps you eat less by reducing your appetite (phentermine) and makes you feel more satisfied with what you have eaten (topiramate). • The precise mechanism of action of the 2 ingredients on chronic weight management is unknown. Weight Loss Medications
• Qsymia (phentermine and topiramate) – Possible side effects/concerns: • Mood changes and trouble sleeping. Qsymia may cause depression or mood problems, and trouble sleeping. • Concentration, memory, and speech difficulties. Qsymia may affect how you think and cause confusion, problems with concentration, attention, memory or speech. Weight Loss Medications
• Qsymia (phentermine and topiramate) – Possible side effects/concerns: • Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. • Central Nervous System (CNS) side effects. The use of prescription sleep aids, anxiety medicines, or drinking alcohol with Qsymia may cause an increase in CNS symptoms such as dizziness and light- headedness. Do not drink alcohol with Qsymia. Weight Loss Medications
• Qsymia (phentermine and topiramate) – Possible side effects/concerns: • Possible seizures if you stop taking Qsymia too fast. Seizures may happen in people who may or may not have had seizures in the past if you stop Qsymia too fast. • Kidney stones. Drink plenty of fluids when taking Qsymia to help decrease your chances of getting kidney stones. Weight Loss Medications
• Qsymia (phentermine and topiramate) – Possible side effects/concerns: • Decreased sweating and increased body temperature (fever). People should be watched for signs of decreased sweating and fever, especially in hot temperatures. Group Discussion FDA Approved Medications
• IBS/Constipation Medications: – Viberzi – Relistor – Movantik IBS/Constipation Medications
• Viberzi (eluxadoline) – Mechanism of action: • Viberzi is thought to target opioid receptors in the gut. – Possible side effects/concerns: • This is a C(IV) drug. • In clinical trials, the rate of euphoria was reported in 0.2% of patients receiving 100 mg, and "feeling drunk" was reported in 0.1%. IBS/Constipation Medications
• Viberzi (eluxadoline) – Possible side effects/concerns: • Increased exposure to eluxadoline when co- administered with strong CYP inhibitors (eg, ciprofloxacin, fluconazole). Patients need to be monitored for impaired mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. IBS/Constipation Medications
• Viberzi (eluxadoline) – Possible side effects/concerns: • Can cause severe pancreatitis. • Can cause sphincter of Oddi spasm. IBS/Constipation Medications
• Relistor (methylnaltrexone bromide) – Mechanism of action: • The targeted action of Relistor inhibits opioids from binding to mu-receptors in tissues such as the gastrointestinal (GI) tract, decreasing their constipating effects. IBS/Constipation Medications
• Relistor (methylnaltrexone bromide) – Possible side effects/concerns: • Dizziness, tremors, and feeling anxious has been reported as common side effects. • Excessive sweating is common. • Symptoms of narcotic withdrawal such as anxiety, sweating, chills, yawning, stomach pain, diarrhea. IBS/Constipation Medications
– Movantik (naloxegol) • The mechanism and side effect concerns are the same as Relistor. Group Discussion Sleep Medication
• Belsomra (suvorexant) – Mechanism of action: • Belsomra targets and inhibits the action of orexin. • Orexin is a central promoter of wakefulness. By inhibiting orexin, BELSOMRA is thought to help quiet the wake pathway. – Possible side effects/concerns: • This is a C(IV) drug. Sleep Medication
• Belsomra (suvorexant) – Possible side effects/concerns: • Sleepiness during the day • Not thinking clearly • “Sleep-walking” or doing other activities when you are asleep like eating, talking, or driving a car. Sleep Medication
• Belsomra (suvorexant) – Possible side effects/concerns: • Abnormal thoughts and behavior: Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions. • Memory loss. • Anxiety. Sleep Medication
• Belsomra (suvorexant) – Possible side effects/concerns: • Temporary inability to move or talk (sleep paralysis)for up to several minutes while you are going to sleep or waking up • Temporary weakness in your legs that can happen during the day or at night. Group Discussion OTC Herbal Products OTC Herbal Products
• Herbal Products – Aconite – Areca Nut – Bitter Orange – Ephedra – Guarana – Kava – St. John’s Wort OTC Herbal Products
• Herbal Products – Valeria – Yohimbe OTC Herbal Products
• Herbal Products – Aconite • Uses: – Despite serious concerns about safety, some people take aconite by mouth for facial paralysis, joint pain, gout, finger numbness, cold hands and feet. – Aconite is also used as a disinfectant, to treat wounds. – Some people apply aconite to the skin in liniment as a “counterirritant” for treating facial pain, joint pain, and leg pain (sciatica). OTC Herbal Products
• Herbal Products – Aconite • Side Effects/Concerns: – Aconite contains a strong, fast-acting poison that causes severe side effects such as nausea, vomiting, weakness or inability to move, sweating, breathing problems, heart problems, and death. OTC Herbal Products
• Herbal Products – Acrea Nut • Uses: – Areca nuts are chewed with betel leaf for their effects as a mild stimulant, causing a warming sensation in the body and slightly heightened alertness, although the effects vary from person to person. OTC Herbal Products
• Herbal Products – Acrea Nut • Side Effects/Concerns: – Habitual chewers of betel leaf and areca nut have a greatly increased risk of developing a range of serious diseases, including cancers of the mouth and esophagus. – Use of areca nut has been associated with deterioration of psychosis in people with preexisting psychiatric disorders. OTC Herbal Products
• Herbal Products – Bitter Orange • Uses: – Applying bitter orange oil seems to help treat fungal skin infections. Examples of these fungal skin infections include ringworm, athlete's foot, and jock itch. – Bitter orange is frequently used in “ephedra-free” products since the FDA banned ephedra in 2004. Bitter orange and caffeine, are a frequent combination in many weight loss and bodybuilding products OTC Herbal Products
• Herbal Products – Bitter Orange • Side Effects/Concerns: – It can cause high blood pressure and increased heart rate in healthy adults with otherwise normal blood pressure. – Using bitter orange, especially in combination with caffeine or other stimulants, might increase the risk of serious side effects in people with a particular heart problem called “long QT interval syndrome”. – May cause irregular heartbeat/heart arrhythmia. OTC Herbal Products
• Herbal Products – Bitter Orange • Side Effects/Concerns: – Some studies suggest that bitter orange, especially in combination with caffeine, can increase heart rate in healthy people. – There is no evidence to suggest that bitter orange is any safer than ephedra. – Bitter orange (synephrine) is considered a banned substance by the National Collegiate Athletic Association (NCAA). – OTC Herbal Products
• Herbal Products – Ephedra • Uses: – Available online in numerous dietary supplements and as “performance enhancers”. – Ephedra is starting to make a come back into a “positive spotlight” as one of the most efficient and effective ways to achieve weight loss and athletic enhanced performance. OTC Herbal Products
• Herbal Products – Ephedra • Side Effects/Concerns: – The FDA banned the U.S. sale of dietary supplements containing ephedrine alkaloids in 2004. It found that these supplements had an unreasonable risk of injury or illness and a significant risk of death. – Ephedrine is listed as a banned substance by the NCAA, NFL, NBA, International Olympic Committee and the World Anti-Doping Agency. OTC Herbal Products
• Herbal Products – Ephedra • Side Effects/Concerns: – Using ephedra may worsen many health conditions such as heart disease and kidney disease. Ephedra has been associated with stroke. It also may contribute to increased blood sugar levels. • There are numerous case reports of deaths in professional athletes linked to the use of ephedra. OTC Herbal Products
• Herbal Products – Ephedra • Side Effects/Concerns: – Ephedra may intensify or cause seizures in people with seizure disorders. – Taking ephedra may also cause anxiety, dizziness, difficulty urinating, dry mouth, headache, irritation of the stomach, nausea, psychosis, restlessness, sleep problems, and tremors. Some of these side effects may be associated with long-term use of ephedra. OTC Herbal Products
• Herbal Products – Ephedra • Side Effects/Concerns: – Ephedra use may lead to serious health problems when used with other dietary supplements or medicines. – Especially combining ephedra with caffeine increases the risk of potentially serious side effects. OTC Herbal Products
• Herbal Products – Guarana • Uses: – Guarana is used for weight loss, to enhance athletic performance, as a stimulant, and to reduce mental and physical fatigue. – It is a frequent addition to energy and weight loss products. – Some people also use guarana to treat low blood pressure and chronic fatigue syndrome. OTC Herbal Products
• Herbal Products – Guarana • Side Effects/Concerns: – At typical doses, the caffeine in guarana can cause insomnia, nervousness and restlessness, stomach irritation, nausea, vomiting, increased heart rate and blood pressure, rapid breathing, tremors, delirium, diuresis, and other side effects. OTC Herbal Products
• Herbal Products – Kava • Uses: – Some people take kava by mouth to calm anxiety, stress, and restlessness, and to treat insomnia. – Kava is also consumed as a beverage to promote relaxation. OTC Herbal Products
• Herbal Products – Kava • Side Effects/Concerns: – There are some BIG safety concerns about kava. Many cases of liver damage and even some deaths have been traced to kava use. As a result, kava has been banned from the market in Europe and Canada. This ban has hurt the economies of Pacific Island countries that export kava. Despite health concerns, kava has not been taken off the U.S. market. – Kava use might make depression worse. OTC Herbal Products
• Herbal Products – Kava • Side Effects/Concerns: – Using kava can make you unable to drive or operate machinery safely. Do not take kava before you plan on driving. – "Driving-under-the-influence" citations have been issued to people driving erratically after drinking large amounts of kava tea. OTC Herbal Products
• Herbal Products – St. John’s Wort • Uses: – St. John’s wort may help some types of depression but the evidence is not definitive. OTC Herbal Products
• Herbal Products – St. John’s Wort • Side Effects/Concerns: – Serotonin is a brain chemical targeted by antidepressants. Combining St. John’s wort and certain antidepressants can lead to a potentially life-threatening increase in serotonin levels—a condition called serotonin syndrome. – Symptoms range from tremor and diarrhea to very dangerous confusion, muscle stiffness, drop in body temperature, and even death. OTC Herbal Products
• Herbal Products – St. John’s Wort • Side Effects/Concerns: – Psychosis is a rare but possible side effect of taking St. John’s wort, particularly in people who have or are at risk for mental health disorders, including bipolar disorder. OTC Herbal Products
• Herbal Products – Valerian • Uses: – Valerian is most commonly used for sleep disorders, especially the inability to sleep. – Other uses for valerian include depression, mild tremors, epilepsy, attention deficit-hyperactivity disorder (ADHD), and chronic fatigue syndrome (CFS). OTC Herbal Products
• Herbal Products – Valerian • Side Effects/Concerns: – Valerian can cause some side effects such as headache, excitability, uneasiness, and even insomnia in some people. – Some people feel sluggish in the morning after taking valerian, especially at higher doses. It is best not to drive or operate dangerous machinery after taking valerian. – The long-term safety of valerian is unknown. OTC Herbal Products
• Herbal Products – Yohimbe • Uses: – It is used for athletic performance, weight loss, exhaustion, high blood pressure, chest pain, diabetic nerve pain, and for depression. – Yohimbe is taken by mouth arouse sexual excitement, for erectile dysfunction (ED), sexual problems caused by medications for depression called selective-serotonin reuptake inhibitors (SSRIs), and general sexual problems in both men and women. OTC Herbal Products
• Herbal Products – Yohimbe • Side Effects/Concerns: – When taken by mouth in typical doses, yohimbe and the ingredient yohimbine can cause stomach upset, excitation, tremor, sleep problems, anxiety or agitation, high blood pressure, a racing heartbeat, dizziness, stomach problems, drooling, sinus pain, irritability, headache, frequent urination, bloating, rash, nausea, and vomiting. – There are reports that individuals with PTSD suffered worse symptoms after using yohimbe.