The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Methadone, sold under the brand names Dolophine and Methadose among others, is a synthetic opioid agonist used for opioid maintenance therapy in opioid dependence and for chronic pain management. It is most commonly used to treat addiction to heroin or other opioids, and to reduce risk of fatal overdose from street drugs. Prescribed daily, the medicine relieves craving and removes withdrawal symptoms. Detoxification using methadone can be accomplished in less than a month, or it may be done gradually over as long as six months. While a single dose has a rapid effect, maximum effect can take up to five days of use. The pain-relieving effects last about six hours after a single dose. After long-term use, in people with normal liver function, effects last 8 to 36 hours. Methadone is usually taken by mouth and rarely by injection into a muscle or vein.
Oxycodone, sold under the brand names Roxicodone and OxyContin among others, is an opioid medication used for treatment of moderate to severe pain. It is highly addictive and a common drug of abuse. It is usually taken by mouth, and is available in immediate-release and controlled-release formulations. Onset of pain relief typically begins within fifteen minutes and lasts for up to six hours with the immediate-release formulation. In the United Kingdom, it is available by injection. Combination products are also available with paracetamol (acetaminophen), ibuprofen, naloxone, naltrexone, and aspirin.
Recreational drug use is the use of a psychoactive drug to induce an altered state of consciousness either for pleasure or for some other casual purpose or pastime by modifying the perceptions, feelings, and emotions of the user. When a psychoactive drug enters the user's body, it induces an intoxicating effect. Generally, recreational drugs are divided into three categories: depressants ; stimulants ; and hallucinogens.
Naloxone, sold under the brand name Narcan among others, is a medication used to reverse the effects of opioids. It is commonly used to counter decreased breathing in opioid overdose. Naloxone may also be combined with an opioid, to decrease the risk of misuse through injection. Effects begin within two minutes when given intravenously, and within five minutes when injected into a muscle. The medicine can also be administered is by spraying it into a person's nose. Naloxone commonly blocks the effects of opioids from 30 to 90 minutes. Multiple doses may be required, as the duration of action of some opioids is greater than that of naloxone.
Loperamide, sold under the brand name Imodium, among others, is a medication used to decrease the frequency of diarrhea. It is often used for this purpose in inflammatory bowel disease and short bowel syndrome. It is not recommended for those with blood in the stool, mucus in the stool, or fevers. The medication is taken by mouth.
A drug overdose is the ingestion or application of a drug or other substance in quantities greater than are recommended. Typically it is used for cases when a risk to health will potentially result. An overdose may result in a toxic state or death.
A prescription drug is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
Pethidine, also known as meperidine and sold under the brand name Demerol among others, is a synthetic opioid pain medication of the phenylpiperidine class. Synthesized in 1938 as a potential anticholinergic agent by the German chemist Otto Eisleb, its analgesic properties were first recognized by Otto Schaumann while working for IG Farben, Germany. Pethidine is the prototype of a large family of analgesics including the pethidine 4-phenylpiperidines, the prodines, bemidones and others more distant, including diphenoxylate and analogues.
Opioid use disorder (OUD) is a substance use disorder relating to the use of an opioid. Any such disorder causes significant impairment or distress. Signs of the disorder include a strong desire to use opioids, increased tolerance to opioids, difficulty fulfilling obligations, trouble reducing use, and withdrawal symptoms with discontinuation. Opioid withdrawal symptoms may include nausea, muscle aches, diarrhea, trouble sleeping, agitation, and a low mood. Addiction and dependence are components of a substance use disorder. Complications may include opioid overdose, suicide, HIV/AIDS, hepatitis C, and problems at school, work, or home.
Buprenorphine is an opioid used to treat opioid use disorder, acute pain, and chronic pain. It can be used under the tongue (sublingual), in the cheek (buccal), by injection, as a skin patch (transdermal), or as an implant. For opioid use disorder, it is typically started when withdrawal symptoms have begun and for the first two days of treatment under direct observation of a health-care provider. In the United States, the combination formulation of buprenorphine/naloxone (Suboxone) is usually prescribed to discourage misuse by injection. Maximum pain relief is generally within an hour with effects up to 24 hours. Buprenorphine affects different types of opioid receptors in different ways. Depending on the type of receptor, it may be an agonist, partial agonist, or antagonist. In the treatment of opioid use disorder buprenorphine is an agonist/antagonist, meaning that it relieves withdrawal symptoms from other opioids and induces some euphoria, but also blocks the ability for many other opioids, including heroin, to cause an effect. Unlike full agonists like heroin or methadone, buprenorphine has a ceiling effect, such that taking more medicine will not increase the effects of the drug.
Mitragyna speciosa is a tropical evergreen tree in the coffee family native to Southeast Asia. It is indigenous to Thailand, Indonesia, Malaysia, Myanmar, and Papua New Guinea, where it has been used in herbal medicine since at least the nineteenth century. Kratom has opioid properties and some stimulant-like effects.
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Tianeptine, sold under the brand names Stablon and Coaxil among others, is an atypical antidepressant which is used mainly in the treatment of major depressive disorder, although it may also be used to treat anxiety, asthma, and irritable bowel syndrome.
George F. Koob is a Professor and former Chair of the Committee on the Neurobiology of Addictive Disorders at The Scripps Research Institute and Adjunct Professor of Psychology, Psychiatry, and Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego. In 2014 he became the director of the National Institute on Alcohol Abuse and Alcoholism.
This article is about the history of the United States Food and Drug Administration.
The opioid epidemic is the extensive ongoing overuse of opioid medications, both from medical prescriptions and from illegal sources. The epidemic began in the United States in the late 1990s, according to the Centers for Disease Control and Prevention (CDC), when opioids were increasingly prescribed for pain management and resulted in a rise in overall opioid use throughout subsequent years. Use of opioids constitutes a public health emergency. The great majority of Americans who use prescription opioids do not believe that they are misusing them.
Drug disposal is the discarding of drugs. Individuals commonly dispose of unused drugs that remain after the end of medical treatment. Health care organizations dispose of drugs on a larger scale for a range of reasons, including having leftover drugs after treating patients and discarding of expired drugs. Failure to properly dispose of drugs creates opportunities for others to take them inappropriately. Inappropriate disposal of drugs can also cause drug pollution.
The opioid epidemic, also referred to as the opioid crisis, is the phrase used to describe the overuse, misuse/abuse, and overdose deaths attributed either in part or in whole to the class of drugs opiates/opioids, and the significant medical, social, psychological, and economic consequences of the medical, non-medical, and recreational use of these medications.
Barry H. Rumack is an American medical toxicologist and pediatrician. His primary clinical and research interest has been in clinical toxicology with a special interest in acetaminophen poisoning. Since 2014 he is Emeritus Professor of Emergency Medicine and Pediatrics at the University of Colorado School of Medicine.
