Drug Recalls
Product Recalls and Withdrawals
Blood Component Transfusion
Substance Withdrawal Syndrome
Alcohol Withdrawal Delirium
Alcohol Withdrawal Seizures
Sticky decisions: peanut butter in a time of Salmonella. (1/12)
(+info)The rise and fall of Dimebon. (2/12)
(+info)Adverse events from cough and cold medications after a market withdrawal of products labeled for infants. (3/12)
(+info)Vaccines against Lyme disease: What happened and what lessons can we learn? (4/12)
(+info)Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk. (5/12)
(+info)Molecular traceability of beef from synthetic Mexican bovine breeds. (6/12)
(+info)A multistate outbreak of hepatitis A associated with semidried tomatoes in Australia, 2009. (7/12)
(+info)Marketed therapeutic antibodies compendium. (8/12)
(+info)A drug recall is the removal of a product from the market due to the discovery of safety issues or violations of manufacturing regulations. The decision to recall a drug can be made by the manufacturer, regulatory authorities such as the U.S. Food and Drug Administration (FDA), or both. There are different classes of recalls based on the level of risk involved, with Class I being the most serious and involving situations where there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. Recalled drugs must be properly handled, stored, and disposed of to minimize risks to patients and the public.
A product recall or withdrawal in the medical context refers to the removal or correction of a medical device, equipment, or medication from the market or from use due to the discovery of defects, safety issues, or violations of regulatory standards that could pose potential harm to patients or users. This action is typically initiated by manufacturers, distributors, or regulatory authorities such as the U.S. Food and Drug Administration (FDA) to protect public health and ensure patient safety.
A recall usually involves a situation where a product poses a significant risk to consumers, requiring immediate action to retrieve and correct the issue. In contrast, a withdrawal typically occurs when a product has a minor defect or violation that does not pose an immediate threat to consumer safety but still needs to be addressed. Both recalls and withdrawals can encompass various actions, such as repairing, replacing, or refunding the affected products.
A blood component transfusion is the process of transferring a specific component of donated blood into a recipient's bloodstream. Blood components include red blood cells, plasma, platelets, and cryoprecipitate (a fraction of plasma that contains clotting factors). These components can be separated from whole blood and stored separately to allow for targeted transfusions based on the individual needs of the patient.
For example, a patient who is anemic may only require a red blood cell transfusion, while a patient with severe bleeding may need both red blood cells and plasma to replace lost volume and clotting factors. Platelet transfusions are often used for patients with low platelet counts or platelet dysfunction, and cryoprecipitate is used for patients with factor VIII or fibrinogen deficiencies.
Blood component transfusions must be performed under strict medical supervision to ensure compatibility between the donor and recipient blood types and to monitor for any adverse reactions. Proper handling, storage, and administration of blood components are also critical to ensure their safety and efficacy.
"Mental recall," also known as "memory recall," refers to the ability to retrieve or bring information from your memory storage into your conscious mind, so you can think about, use, or apply it. This process involves accessing and retrieving stored memories in response to certain cues or prompts. It is a fundamental cognitive function that allows individuals to remember and recognize people, places, events, facts, and experiences.
In the context of medical terminology, mental recall may be used to assess an individual's cognitive abilities, particularly in relation to memory function. Impairments in memory recall can be indicative of various neurological or psychological conditions, such as dementia, Alzheimer's disease, or amnesia.
Substance Withdrawal Syndrome is a medically recognized condition that occurs when an individual who has been using certain substances, such as alcohol, opioids, or benzodiazepines, suddenly stops or significantly reduces their use. The syndrome is characterized by a specific set of symptoms that can be physical, cognitive, and emotional in nature. These symptoms can vary widely depending on the substance that was being used, the length and intensity of the addiction, and individual factors such as genetics, age, and overall health.
The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), published by the American Psychiatric Association, provides the following diagnostic criteria for Substance Withdrawal Syndrome:
A. The development of objective evidence of withdrawal, referring to the specific physiological changes associated with the particular substance, or subjective evidence of withdrawal, characterized by the individual's report of symptoms that correspond to the typical withdrawal syndrome for the substance.
B. The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.
C. The symptoms are not better explained by co-occurring mental, medical, or other substance use disorders.
D. The withdrawal syndrome is not attributable to another medical condition and is not better accounted for by another mental disorder.
The DSM-5 also specifies that the diagnosis of Substance Withdrawal Syndrome should be substance-specific, meaning that it should specify the particular class of substances (e.g., alcohol, opioids, benzodiazepines) responsible for the withdrawal symptoms. This is important because different substances have distinct withdrawal syndromes and require different approaches to management and treatment.
In general, Substance Withdrawal Syndrome can be a challenging and potentially dangerous condition that requires professional medical supervision and support during the detoxification process. The specific symptoms and their severity will vary depending on the substance involved, but they may include:
* For alcohol: tremors, seizures, hallucinations, agitation, anxiety, nausea, vomiting, and insomnia.
* For opioids: muscle aches, restlessness, lacrimation (tearing), rhinorrhea (runny nose), yawning, perspiration, chills, mydriasis (dilated pupils), piloerection (goosebumps), nausea or vomiting, diarrhea, and abdominal cramps.
* For benzodiazepines: anxiety, irritability, insomnia, restlessness, confusion, hallucinations, seizures, and increased heart rate and blood pressure.
It is essential to consult with a healthcare professional if you or someone you know is experiencing symptoms of Substance Withdrawal Syndrome. They can provide appropriate medical care, support, and referrals for further treatment as needed.
Alcohol withdrawal delirium, also known as delirium tremens (DTs), is a serious and potentially life-threatening complication that can occur in people who are dependent on alcohol and suddenly stop or significantly reduce their consumption. It is a form of alcohol withdrawal syndrome that is characterized by the sudden onset of severe confusion, agitation, hallucinations, tremors, and autonomic hyperactivity.
The diagnostic criteria for alcohol withdrawal delirium, as outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), include:
1. Disturbance in consciousness (i.e., reduced clarity of awareness of the environment) with reduced ability to focus, sustain, or shift attention.
2. A change in cognition (such as memory deficit, disorientation, or language disturbance) or the development of a perceptual disturbance that is not better explained by another medical condition or substance use disorder.
3. The disturbance develops over a short period of time (usually hours to a few days) and tends to fluctuate throughout the day.
4. There is evidence from the history, physical examination, or laboratory findings that the symptoms are caused by alcohol withdrawal.
5. The symptoms cannot be better explained by another medical condition, medication use, or substance intoxication or withdrawal.
Alcohol withdrawal delirium is a medical emergency and requires immediate treatment in a hospital setting. Treatment typically involves the use of medications to manage symptoms, such as benzodiazepines to reduce agitation and prevent seizures, and antipsychotic medications to treat hallucinations and delusions. Supportive care, such as fluid and electrolyte replacement, may also be necessary to prevent dehydration and other complications.
Alcohol withdrawal seizures are a type of seizure that can occur as a result of alcohol withdrawal in individuals who have developed physical dependence on alcohol. These seizures typically occur within 48 hours after the last drink, but they can sometimes happen up to five days later. They are often accompanied by other symptoms of alcohol withdrawal, such as tremors, anxiety, nausea, and increased heart rate.
Alcohol withdrawal seizures are caused by changes in the brain's chemistry that occur when a person who is dependent on alcohol suddenly stops or significantly reduces their alcohol intake. Alcohol affects the neurotransmitters in the brain, particularly gamma-aminobutyric acid (GABA) and glutamate. When a person drinks heavily and frequently, the brain adjusts to the presence of alcohol by reducing the number of GABA receptors and increasing the number of glutamate receptors.
When a person suddenly stops drinking, the brain is thrown out of balance, and the reduced number of GABA receptors and increased number of glutamate receptors can lead to seizures. Alcohol withdrawal seizures are a medical emergency and require immediate treatment to prevent complications such as status epilepticus (prolonged seizures) or brain damage. Treatment typically involves administering benzodiazepines, which help to calm the brain and reduce the risk of seizures.