PUBH 3003 1st Edition Lecture 15 Outline of Last Lecture I. Drugs and birth defectsa. Effects on pregnant motherII. Fetal Alcohol DisordersIII. Brain changes IV. Alcohol and PregnancyV. Prevention Outline of Current Lecture Societal Issue: Herbal Drugs and Steroids I. Herbal Drugsa. Natural does not always equal better b. St. John’s WortII. MelatoninIII. Anabolic Steroids a. Athletes and drug abuse b. Doping c. Patterns d. Abuse concerns Current LectureHerbal Drugs:- Herbal drugs (supplements)- drugs from ‘plant matter’o An herb (also called a botanical) is a plant or plant part used for its scent, flavor and or therapeutic propertieso Many herbs have a long history of use and claimed health benefitso However, some herbs have caused health problems for users Women who are pregnant or nursing should be especially cautious about using herbal supplements  This also applies to treating children with herbal supplementsNatural does not = betterThese notes represent a detailed interpretation of the professor’s lecture. GradeBuddy is best used as a supplement to your own notes, not as a substitute.- Important to know that just because an herbal supplement is labeled “nature” doesn’t mean it is safe or without harmful effects (many of most powerful drugs of abuse ar extracted from plants—cocaine, tobacco, etc)o Can cause medical problems if not used correctly or if taken in large amountso In some cases, people have experienced negative effects even though they followed the instructions on the supplement labelHerbal Drugs:- They are not regulated by the Food and Drug Administration (FDA) as drugso In the US, herbal and other dietary supplements are regulated by the US Food and drug Administration as foods- They are not scheduled by the Drug Enforcement Administration (DEA)- This means that they do not have to meet the same standards as drugs and over the counter medications for proof of safety, effectiveness, and what the FDA refers to as “Good Manufacturing Practices”- Dietary Supplement Health and Education Act (1994)o Dietary supplements with established ingredients – ingredients that were sold in the US before 1994 – may be marketed without any evidence of efficacy or safetyo For new ingredients manufacturers must provide FDA with evidence supporting areasonable expectation of safety”o However, this has not thus far been enforced o Since the dietary supplement health and education act of 1994 became law, the number of available dietary supplements has skyrocketed from an estimated 4,00to more than 55,000o It is not known how many of the estimated 51,000 new supplements now on the market include novel (post 1994) ingredients o However, FDA has received adequate notification for only 170 new supplement agreements since 1994o Recently the FDA proposed guidelines designed to help it assess new ingredients (and clarify what’s a new or old ingredient)  scientific evidence for purpose of improving safetyo Safety of supplements evaluated based on: documented history of use, formulation and proposed daily dose, and recommended duration of useo FDA would require in vitro, animal and tolerability testing for products that would be marketed for consumption at doses greater than those historically ingested o Any ingredient prepared or formulated in a novel manner, would be considered anew ingrediento Will create a database of evidence that scientists, physicians, regulators, and consumers can tap to make informed decisions about the use of supplementsSt. John’s Wort- Historically used to treat mental health disorders and nerve paino Also malaria, as a sedative, as a balm for wounds, burns and insect bites- Today used as traditional remedy for depression, anxiety and or sleep disorders- Although some studies of St. John’s Wort have reported benefits for depression, others have not- A large study sponsored by the National Study for complementary and alternative medicine found that the herb was no more effective than the placebo in treating major depression of moderate severity - A study co-funded by NCCAM and the National Institute of mental health found that neither St. John’s wort nor a standard antidepressant medication relived symptoms of minor depression better than placebo. - Research has shown that St. John’s Wort interacts with many medications in ways that can interfere with their intended effects including:o Antidepressants, birth controls, cyclosporine (prevents the body from rejecting transplanted organs) digoxin (a heart medication), indinavir (and possibly other drugs used to control HIV infection) Irinotecan (possibly other drugs used to treat cancer) Seizure control Drugs (phenytoin and phenobarbital) o St. john’s Wort May cause increased sensitivity to sunlight o Other side effects can include anxiety, dry mouth, dizziness, gastrointestinal symptoms, fatigue, headache, or sexual dysfunctiono Taking St. John’s Wort with certain antidepressants may lead to lead to increasedserotonin – related side effects, which may be potentially serious o St. Johns Wort is not a proven therapy for DepressionMelatonin- Melatonin is a hormone found naturally in the bodyo Melatonin’s main job in the body is to regulate night and day cycles or sleep-wake cycles o Darkness causes the body to produce more melatonin, which signals the body to prepare for sleepo Light decreases melatonin production and signals the body to prepare for being awake- Some people who have trouble sleeping have low levels of melatonin - Melatonin used as a medicine is usually made synthetically in a laboratory- Most commonly available in pill form, but also available in forms that can be placed in the cheek or under the tongue - Uses: adjusting body’s internal clock, jetlag, adjusting sleep- wake cycles in people with shift changes - Some people use melatonin for the followingo Alzheimer’s disease, ringing in the ears, depression, chronic fatigue syndrome, fibromyalgia, migraine and other headaches, irritable bowel syndrome, bone loss(osteoporosis), a movement disorder called tardive dyskinesia, as an anti agent, for menopause and for birth control- Should not be taken with sedative medication (CNS depressants)- Melatonin might cause sleepiness and drowsiness - Birth control pills seem to increase how much melatonin the body makes – taking melatonin with birth control pills might cause excessive melatonin in the body- Caffeine might decrease melatonin in the body-