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Adverse drug reaction



 
 
An adverse drug reaction (abbreviated ADR) or adverse drug event (abbreviated ADE) is an expression that describes the unwanted, negative consequences associated with the use of given medication
Medication

A pharmaceutical drug, also referred to as medicine or medicament, can be loosely defined as any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease....
s. An ADR is a particular type of adverse effect
Adverse effect (medicine)

In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as chemotherapy or surgery....
. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as pharmacovigilance
Pharmacovigilance

Headline text Pharmacovigilance is the pharmacology science relating to the detection, assessment, understanding and prevention of adverse effect , particularly long term and short term side effects of medicines....
.

may be classified by e.g.






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An adverse drug reaction (abbreviated ADR) or adverse drug event (abbreviated ADE) is an expression that describes the unwanted, negative consequences associated with the use of given medication
Medication

A pharmaceutical drug, also referred to as medicine or medicament, can be loosely defined as any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease....
s. An ADR is a particular type of adverse effect
Adverse effect (medicine)

In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as chemotherapy or surgery....
. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as pharmacovigilance
Pharmacovigilance

Headline text Pharmacovigilance is the pharmacology science relating to the detection, assessment, understanding and prevention of adverse effect , particularly long term and short term side effects of medicines....
.

Classification

ADRs may be classified by e.g. cause and severity.

Cause

  • Type A: Augmented pharmacologic effects
  • Type B: Bizarre effects (or idiosyncratic
    Idiosyncratic drug reaction

    Idiosyncratic drug reactions, also known as type B reactions, are Adverse drug reaction which occur rarely and unpredictably amongst the population....
    )
  • Type C: Chronic effects
  • Type D: Delayed effects
  • Type E: End-of-treatment effects
  • Type F: Failure of therapy


Types A and B were proposed in the 1970s, and the other types were proposed subsequently when the first two proved insufficient to classify ADRs.

Seriousness and Severity

The American Food and Drug Administration
Food and Drug Administration

The U.S. Food and Drug Administration is an Government agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, Medications, vaccines, Biopharmaceutical, blood transfusion, medical devices, Electromagnetic radiation-emitting devices, veteri...
 defines a serious adverse event as one when the patient outcome is

  • Death
  • Life-Threatening
  • Hospitalization (initial or prolonged)
  • Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
  • Congenital Anomaly
  • - or -
  • Requires Intervention to Prevent Permanent Impairment or Damage


Severity is a point on an arbitrary scale of intensity of the adverse event in question. The terms "severe" and "serious" when applied to adverse events are technically very different. They are easily confused but can not be used interchangeably, require care in usage.

A headache is severe, if it causes intense pain. There are scales like "visual analog scale" that help us assess the severity. A headache, on the other hand, can hardly ever be serious, unless it also satisfies the criteria for seriousness, listed above.

Overall Drug Risk

While no official scale exists yet to communicate overall drug risk, the iGuard
IGuard

The holding company for iguard.org is iGuard. The website's aim is to monitor the safety of prescription medicines, over-the-counter medicines and healthcare supplements in over 1,050,000 US patients....
 Drug Risk Rating System is a five color rating scale similar to the Homeland Security Advisory System
Homeland Security Advisory System

In the United States, the Homeland Security Advisory System is a color coded terrorism imminent threat advisory scale. The different levels trigger specific actions by federal agencies and state and local governments, and they affect the level of security at some airports and other public facilities....
:

  • Red (High Risk)
  • Orange (Elevated Risk)
  • Yellow (Guarded Risk)
  • Blue (General Risk)
  • Green (Low Risk)


Location

Adverse effects may be local, i.e. limited to a certain location, or systemic, where a medication has caused adverse effects throughout the systemic circulation
Systemic circulation

Systemic circulation is the portion of the cardiovascular system which carries oxygenated blood away from the heart, to the body, and returns deoxygenated blood back to the heart....
.

For instance, some ocular antihypertensives cause systemic effects, although they are administered locally as eye drop
Eye drop

Eye drops are saline -containing drops used as a Vector to administer medication in the eye. Depending on the condition being treated, they may contain steroids , antihistamines, sympathomimetics, Beta blockers, parasympathomimetics , parasympatholytics , prostaglandins, non-steroidal anti-inflammatory drugs or topical anesthetics....
s, since a fraction escapes to the systemic circulation.

Mechanisms

As research better explains the biochemistry of drug use, less ADRs are Type B and more are Type A. Common mechanisms are:
  • Abnormal pharmacokinetics due to
    • genetic
      Genetics

      Genetics , a discipline of biology, is the science of heredity and Genetic variation in living organisms. The fact that living things inherit traits from their parents has been used since prehistoric times to improve crop plants and animals through selective breeding....
       factors
    • comorbid disease states
  • Synergistic effects between either
    • a drug and a disease
    • two drugs


Abnormal pharmacokinetics


Comorbid disease states
Various diseases, especially those that cause renal
Renal failure

Renal failure or kidney failure is a situation in which the kidneys fail to function adequately. It is divided in acute and chronic forms; either form may be due to a large number of other medical problems....
 or hepatic
Liver failure

Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease , and indicates that the liver has sustained severe damage ....
 insufficiency, may alter drug metabolism. Resources are available that report changes in a drug's metabolism due to disease states.

Genetic factors
Abnormal drug metabolism may be due to inherited factors of either Phase I oxidation or Phase II conjugation. Pharmacogenomics
Pharmacogenomics

Pharmacogenomics is the branch of pharmacology which deals with the influence of genetics variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity....
 is the study of the inherited basis for abnormal drug reactions.

Phase I reactions
Inheriting abnormal allele
Allele

An allele is one member of a pair or series of different forms of a gene. Usually alleles are coding region, but sometimes the term is used to refer to a junk DNA....
s of cytochrome
Cytochrome

Cytochromes are, in general, membrane-bound hemoproteins that contain heme groups and carry out electron transport.They are found either as subunitss or as subunits of bigger enzymatic complexes that catalyze redox reactions....
 P450 can alter drug metabolism. Tables are available to check for drug interactions due to P450 interactions..

Inheriting abnormal butyrylcholinesterase
Cholinesterase enzyme

In biochemistry, cholinesterase is an enzyme that catalyst the hydrolysis of the neurotransmitter acetylcholine into choline and acetic acid, a reaction necessary to allow a cholinergic neuron to return to its resting state after activation....
 (pseudocholinesterase
Cholinesterase enzyme

In biochemistry, cholinesterase is an enzyme that catalyst the hydrolysis of the neurotransmitter acetylcholine into choline and acetic acid, a reaction necessary to allow a cholinergic neuron to return to its resting state after activation....
) may affect metabolism of drugs such as succinylcholine

Phase II reactions
Inheriting abnormal N-acetyltransferase
Acetyltransferase

Acetyltransferase is a type of transferase enzyme which transfers an acetyl group.Examples include:* Histone acetyltransferases including CBP histone acetyltransferase...
 which conjugated some drugs to facilitate excretion may affect the metabolism of drugs such as isoniazid
Isoniazid

Isoniazid is an organic compound that is the first-line antituberculosis medication in prevention and treatment. Isoniazid is never used on its own to treat active tuberculosis because resistance quickly develops....
, hydralazine
Hydralazine

Hydralazine hydrochloride is a direct-acting smooth muscle relaxant used to treat hypertension by acting as a vasodilator primarily in arteries and arterioles....
, and procainamide
Procainamide

Procainamide is a pharmaceutical antiarrhythmic agent used for the medicine Pharmacotherapy of cardiac arrhythmias, classified by the Vaughan Williams classification system as class Ia....
.

Inheriting abnormal thiopurine S-methyltransferase
Thiopurine methyltransferase

Thiopurine methyltransferase or thiopurine S-methyltransferase is an enzyme that methylation thiopurine compounds. The methyl donor is S-adenosyl-L-methionine, which is converted to S-adenosyl-L-homocysteine....
 may affect the metabolism of the thiopurine
Thiopurine

Sorry, no overview for this topic
 drugs mercaptopurine
Mercaptopurine

Mercaptopurine is an immunosuppressive drug.It is a thiopurine....
 and azathioprine
Azathioprine

Azathioprine is an immunosuppressant used in organ transplantation, autoimmune disease such as rheumatoid arthritis and pemphigus or inflammatory bowel disease such as Crohn's disease and ulcerative colitis as well as multiple sclerosis....
.

Interactions with other drugs
The risk of drug interaction
Drug interaction

A drug interaction is a situation in which a substance affects the activity of a medication, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own....
s is increased with polypharmacy
Polypharmacy

The term polypharmacy generally refers to the use of multiple medications by a patient. The term is used when too many forms of medication are used by a patient, when more medication are prescribed than is clinically warranted, or even when all prescribed medications are clinically indicated but there are too many pills to take ....
.

Protein binding
These interactions are usually transient and mild until a new steady state is achieved. These are mainly for drugs without much first-pass liver metabolism. The principal plasma proteins for drug binding are:
  1. albumin
    Albumin

    Albumin refers generally to any protein with water solubility, which is moderately soluble in concentrated salt solutions, and experiences heat Denaturation ....
  2. a1-acid glycoprotein
  3. lipoproteins
Some drug interactions with warfarin
Warfarin

Warfarin is an anticoagulant. It was initially marketed as a pesticide against rats and mice, and is still popular for this purpose, although more potent poisons such as brodifacoum have since been developed....
 are due to changes in protein binding.

Cytochrome P450
Patients have abnormal metabolism by cytochrome
Cytochrome

Cytochromes are, in general, membrane-bound hemoproteins that contain heme groups and carry out electron transport.They are found either as subunitss or as subunits of bigger enzymatic complexes that catalyze redox reactions....
 P450 due to either inheriting abnormal allele
Allele

An allele is one member of a pair or series of different forms of a gene. Usually alleles are coding region, but sometimes the term is used to refer to a junk DNA....
s or due to drug interactions. Tables are available to check for drug interactions due to P450 interactions..

Synergistic effects

An example of synergism is two drugs that both prolong the QT interval
QT interval

In medicine, specifically cardiology, the QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's Electrical conduction system of the heart....
.

Assessing causality

A simple scale is available at .

An ADR should not be labeled as 'certain' unless the ADR abates with a challenge-dechallenge-rechallenge
Challenge-dechallenge-rechallenge

Challenge-dechallenge-rechallenge is a medical testing Protocol in which a medicine or drug is administered, withdrawn, then re-administered, while being monitored for Adverse effect at each stage....
 protocol.

A more complicated scale is the Naranjo algorithm
Naranjo algorithm

The Naranjo algorithm or Naranjo Scale is a questionnaire designed by Naranjo et al for determining the likelihood of whether an ADR is actually due to the drug rather than the result of other factors....
.

Monitoring bodies

Many countries have official bodies that monitor drug safety and reactions. On an international level, the WHO
Who

*Who is an English language interrogative pronoun....
 runs the Uppsala Monitoring Centre
Uppsala Monitoring Centre

The Uppsala Monitoring Centre , located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring....
, and the European Union
European Union

The European Union is an economic and political union of 27 European Union member state, located primarily in Europe. It was established by the Treaty of Maastricht on 1 November 1993 upon the foundations of the pre-existing European Economic Community....
 runs the European Medicines Agency
European Medicines Agency

The European Medicines Agency is a European agency for the evaluation of medication. From 1995 to 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products....
 (EMEA). In the United States
United States

The United States of America is a Federal government constitutional republic comprising U.S. state and a federal district. The country is situated mostly in central North America, where its Contiguous United States and Washington, D.C., the Capital districts and territories, lie between the Pacific Ocean and Atlantic Oceans, Borders of the U...
, the Food and Drug Administration
Food and Drug Administration

The U.S. Food and Drug Administration is an Government agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, Medications, vaccines, Biopharmaceutical, blood transfusion, medical devices, Electromagnetic radiation-emitting devices, veteri...
 (FDA) is responsible for monitoring post-marketing studies.

Examples of adverse effects associated with specific medications


  • Abortion
    Abortion

    An abortion is the termination of a pregnancy by the removal or expulsion of an embryo or fetus from the uterus, resulting in or caused by its death....
    , miscarriage
    Miscarriage

    Miscarriage or spontaneous abortion is the spontaneous end of a pregnancy at a stage where the embryo or fetus is incapable of surviving, generally defined in humans at prior to 20 weeks of gestation....
     or uterine
    Uterine

    The word uterine can refer to different meanings:* relating to or near the uterus or womb* having the same mother, but different fathers, see matrilineality...
     hemorrhage associated with misoprostol
    Misoprostol

    Misoprostol is a Medication that is Food and Drug Administration-approved in the United States for the prevention of non-steroidal anti-inflammatory drug -induced peptic ulcers....
     (Cytotec), a labor-inducing drug (this is a case where the adverse effect has been used legally and illegally for performing abortions)
  • Addiction
    Addiction

    The term "addiction" is used in many contexts to describe an obsession, compulsion, or excessive physical dependence or psychological dependence, such as: drug addiction, video game addiction, crime, alcoholism, compulsive overeating, problem gambling, computer addiction, pornography addiction, etc....
     to many sedatives and analgesics such as diazepam
    Diazepam

    Diazepam , first marketed as Valium by Hoffmann-La Roche, is a benzodiazepine derivative drug. It possesses anxiolytic, anticonvulsant, hypnotic, sedative, skeletal muscle relaxant and amnestic properties....
    , morphine
    Morphine

    Morphine is a highly potent opiate analgesic Medication, is the principal active agent in opium, and is considered to be the prototypical opioid....
    , etc.
  • Birth defects associated with Thalidomide
    Thalidomide

    Thalidomide is a sedative-hypnotic, and multiple myeloma medication. The drug is a potent Teratology in rabbits and primates including humans: this means that severe birth defects may result if the drug is taken during pregnancy....
     and Accutane.
  • Bleeding
    Bleeding

    Bleeding, technically known as hemorrhaging or haemorrhaging is the loss of blood from the circulatory system. Bleeding can occur internally, where blood leaks from blood vessels inside the body or externally, either through a natural opening such as the vagina, Mouth , nose, or anus, or through a break in the skin....
     of the intestine
    Intestine

    In anatomy, the intestine is the segment of the Gastrointestinal tract extending from the stomach to the anus and, in humans and other mammals, consists of two segments, the small intestine and the large intestine....
     associated with aspirin
    Aspirin

    Aspirin , also known as acetylsalicylic acid , is a salicylate medication, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication....
     therapy
  • Cardiovascular disease associated with COX-2 inhibitors (i.e. Vioxx)
  • Deafness and kidney failure associated with gentamicin
    Gentamicin

    Gentamicin is an aminoglycoside antibiotic, used to treat many types of bacteriuml infections, particularly those caused by Gram-negative bacteria....
     (an antibiotic
    Antibiotic

    In common usage, an antibiotic is a substance or compound that kills or inhibits the growth of bacteria. Antibiotics belong to the group of antimicrobial compounds used to treat infections caused by microorganisms, including fungus and protozoa....
    )
  • Death
    Death

    Death is the permanent termination of the biological functions that define a life organism. It refers to both a particular event and to the condition that results thereby....
    , following sedation
    Sedation

    Sedation is a medical procedure involving the administration of sedative drugs, generally to facilitate a medical procedure with local anaesthesia....
     in children using propofol
    Propofol

    Propofol is a short-acting intravenous sedative agent used for the induction of general anesthesia for adults and children, maintenance of general anesthesia, and sedation in medical contexts, such as intensive care unit sedation for intubated, mechanically ventilated adults, and in procedures such as colonoscopies and endoscopies....
     (Diprivan)
  • Dementia
    Dementia

    Dementia is the progressive decline in cognition due to damage or disease in the body beyond what might be expected from normal aging. Although dementia is far more common in the geriatric population, it may occur in any stage of adulthood....
     associated with heart bypass surgery
  • Depression
    Depression (mood)

    In the fields of psychology and psychiatry, the terms depression or depressed refer to sadness and other related emotions and behaviours. It can be thought of as either a disease or a syndrome....
     or hepatic injury
    Cirrhosis

    Cirrhosis is a consequence of chronic liver disease characterized by replacement of liver Tissue by fibrous scar tissue as well as regenerative Nodule , leading to progressive loss of liver function....
     caused by interferon
    Interferon

    Interferons are natural proteins produced by the cells of the immune system of most vertebrates in response to challenges by foreign agents such as viruses, parasites and tumor cells....
  • Diabetes caused by atypical antipsychotic
    Atypical antipsychotic

    The atypical antipsychotics are a group of antipsychotic drugs used to treat psychiatric conditions. Some atypical antipsychotics are Food and Drug Administration approved for use in the treatment of schizophrenia....
     medications (neuroleptic psychiatric drugs)
  • Diarrhea
    Diarrhea

    In medicine, diarrhea, also spelled diarrhoea , is characterized by frequent loose or liquid bowel movements. The spelling of "diarrhea" is an appropriation of the Greek "diarrhoia" meaning "a flowing through." ....
     caused by the use of orlistat
    Orlistat

    Orlistat Orlistat is the saturated derivative of lipstatin?a potent natural product inhibitor of pancreatic lipases isolated from the bacteria Streptomyces toxytricini....
     (Xenical)
  • Erectile dysfunction
    Erectile dysfunction

    Erectile dysfunction is a sexual dysfunction characterized by the inability to develop or maintain an erection of the penis sufficient for satisfactory sexual performance....
     associated with many drugs, such as antidepressant
    Antidepressant

    An antidepressant is a psychiatric medication used for alleviating major depressive disorder or dysthymia. Drug groups known as MAOIs, tricyclics, and second-generation antidepressants such as SSRIs, and serotonin-norepinephrine reuptake inhibitors are particularly associated with the term....
    s
  • Fever
    Fever

    Fever is a frequent medical sign that describes an increase in internal body temperature to levels above normal. Fever is most accurately characterized as a temporary elevation in the body's thermoregulatory set-point, usually by about 1?2 ?C ....
     associated with vaccination
    Vaccination

    Vaccination is the administration of antigenic material to produce immunity to a disease. Vaccines can prevent or ameliorate the effects of infection by a pathogen....
     (in the past, imperfectly manufactured vaccines, such as BCG
    Bacillus Calmette-Guérin

    Bacillus Calmette-Gu?rin is a vaccination against tuberculosis that is prepared from a strain of the attenuated live bovine tuberculosis bacillus, Mycobacterium bovis, that has lost its virulence in humans by being specially cultured in an artificial medium for years....
     and poliomyelitis
    Poliomyelitis

    Poliomyelitis, often called polio or infantile paralysis, is an acute virus infectious disease spread from person to person, primarily via the fecal-oral route....
    , have caused the very disease they intended to fight).
  • Glaucoma
    Glaucoma

    Glaucoma is a group of diseases of the optic nerve involving loss of ganglion cell in a characteristic pattern of optic atrophy. Raised intraocular pressure is a significant risk factor for developing glaucoma ....
     associated with corticosteroid
    Corticosteroid

    Corticosteroids are a class of steroid hormones that are produced in the adrenal cortex. Corticosteroids are involved in a wide range of physiology systems such as stress , immune system and regulation of inflammation, carbohydrate metabolism, protein catabolism, blood electrolyte levels, and behavior....
    -based eye drops
    Eye Drops

    Eye Drops was a television program on TechTV that showcased short computer animation movies and clips made using Commercial off-the-shelf 3D computer graphics....
  • Hair loss and anemia
    Anemia

    Anemia or an?mia/anaemia is defined as a qualitative or quantitative deficiency of hemoglobin, a protein found inside red blood cells ....
     may be caused by chemotherapy
    Chemotherapy

    Chemotherapy, in its most general sense, refers to treatment of disease by chemicals that kill cells, specifically those of micro-organisms or cancer....
     against cancer
    Cancer

    Cancer is a class of diseases in which a group of cell display uncontrolled growth , invasion , and sometimes metastasis . These three malignant properties of cancers differentiate them from benign tumors, which are self-limited, do not invade or metastasize....
    , leukemia
    Leukemia

    Leukemia is a cancer of the blood or bone marrow and is characterized by an abnormal proliferation of blood Cell , usually white blood cells ....
    , etc.
  • Headache
    Headache

    In medicine a headache or wiktionary:cephalalgia is a symptom of a number of different conditions of the head and sometimes neck. Some of the causes are benign while others are medical emergencies....
     following spinal anesthesia
  • Hypertension
    Hypertension

    Hypertension, also referred to as high blood pressure, HTN or HPN, is a medical condition in which the blood pressure is chronically elevated....
     in ephedrine
    Ephedrine

    Ephedrine is a sympathomimetic amine commonly used as a stimulant, appetite suppressant, concentration aid, decongestant, and to treat hypotension associated with anaesthesia....
     users, which prompted FDA to remove the status of dietary supplement
    Dietary supplement

    A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to provide nutrients, such as vitamins, Dietary minerals, fatty acids or amino acids, that are missing or are not consumed in sufficient quantity in a person's diet ....
     of ephedra
    Ephedra

    Ephedra, from the plant Ephedra sinica, has been used as an herbal remedy in traditional Chinese medicine for 5,000 years for the treatment of asthma and hay fever, as well as for the common cold....
     extracts
  • Insomnia
    Insomnia

    Insomnia is a symptom of a sleep disorder characterized by persistent difficulty falling sleep or staying asleep despite the opportunity. Insomnia is a symptom, not a stand-alone diagnosis or a disease....
     caused by stimulants, Ritalin, Adderall
    Adderall

    Adderall is a brand-name pharmaceutical psychostimulant composed of mixed amphetamine Salt , which is thought to work by increasing the amount of norepinephrine and dopamine in the brain....
    , etc.
  • Lactic acidosis
    Lactic acidosis

    Lactic acidosis is a condition caused by the buildup of lactic acid in the body. It leads to acidification of the blood , and is considered a distinct form of metabolic acidosis....
     associated with the use of stavudine
    Stavudine

    Stavudine is a Reverse transcriptase inhibitor active against HIV....
     (Zerit, for anti-HIV
    HIV

    Human immunodeficiency virus is a lentivirus that can lead to AIDS , a condition in humans in which the immune system begins to fail, leading to life-threatening opportunistic infections....
     therapy) or metformin
    Metformin

    Metformin is an oral anti-diabetic drug from the biguanide class. It is the first-line treatment drug for the treatment of diabetes mellitus type 2, particularly in overweight and obesity people and those with normal kidney function, and evidence suggests it may be the best choice for people with heart failure....
     (for diabetes)
  • Liver
    Liver

    The liver is a vital organ present in vertebrates and some other animals; it has a wide range of functions, a few of which are detoxification, protein synthesis, and production of biochemicals necessary for digestion....
     damage from paracetamol
    Paracetamol

    Paracetamol or acetaminophen is a widely used over-the-counter drug analgesic and antipyretic . It is commonly used for the relief of fever, headaches, and other minor aches and pains, and is a major ingredient in numerous common cold and Influenza remedies....
  • Melasma
    Melasma

    Melasma is a tan or dark skin discoloration. Although it can affect anyone, melasma is particularly common in women, especially pregnant women and those who are taking oral or patch contraceptives or hormone replacement therapy medications....
     and thrombosis
    Thrombosis

    Thrombosis is the formation of a blood clot inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot, because the first step in repairing it is to prevent loss of blood....
     associated with use of estrogen-containing hormonal contraception
    Hormonal contraception

    Hormonal contraception refers to birth control methods that act on the hormone system.Currently, all hormonal contraceptives are designed for use by women rather than men, though research on a male oral contraceptive has been underway for some time....
     such as the combined oral contraceptive pill
  • Irreversible Peripheral neuropathy
    Peripheral neuropathy

    Peripheral neuropathy is the term for damage to nerves of the peripheral nervous system, which may be caused either by diseases of the nerve or from the Adverse effect of systemic illness....
     associated with the use of fluoroquinolone medications
  • Rhabdomyolysis
    Rhabdomyolysis

    Rhabdomyolysis is the rapid breakdown of skeletal muscle tissue due to injury to muscle tissue. The muscle damage may be caused by physical , chemical, or biological factors....
     associated with statin
    Statin

    The statins are a class of drugs that lower cholesterol levels in people with or at risk of cardiovascular disease.They lower cholesterol by inhibiting the enzyme HMG-CoA reductase, which is the rate-limiting step enzyme of the mevalonate pathway of cholesterol synthesis....
    s (anti-cholesterol
    Cholesterol

    Cholesterol is a lipidic, waxy alcohol found in the cell membranes and transported in the blood plasma of all animals. It is an essential component of mammalian cell membranes where it is required to establish proper membrane permeability and membrane fluidity....
     drugs)
  • Seizure
    Seizure

    An epileptic seizure is a transient symptom of abnormal, excessive or synchronous neuronal activity in the brain. It can manifest as an alteration in mental state, tonic or clonic movements, convulsions, and various other psychic symptoms ....
    s caused by withdrawal from benzodiazepine
    Benzodiazepine

    The benzodiazepines are a class of psychoactive drugs with varying hypnotic, sedative, anxiolytic , anticonvulsant, muscle relaxant and anterograde amnesia properties, which are mediated by slowing down the central nervous system....
  • Drowsiness or increase in appetite
    Appetite

    The appetite is the desire to eating food, felt as hunger. Appetite exists in all higher lifeforms, and serves to regulate adequate energy intake to maintain metabolism needs....
     due to antihistamine
    Antihistamine

    An H1 antagonist is a histamine antagonist of the histamine H1 receptor that serves to reduce or eliminate effects mediated by histamine, an endogenous chemical mediator released during allergy....
     use. Some antihistamines are used in sleep aids explicitly because they cause drowsiness.
  • Stroke
    Stroke

    A stroke is the rapidly developing loss of brain function due to a disturbance in the blood supply to the brain. According to the National Stroke Association, a "stroke" occurs when a blood clot blocks and artery or a blood vessel breaks, interrupting blood flow to an area of the brain....
     or heart attack
    Myocardial infarction

    Myocardial infarction , commonly known as a heart attack, occurs when the Blood flow to part of the heart is interrupted. This is most commonly due to occlusion of a coronary artery following the rupture of a Vulnerable plaque, which is an unstable collection of lipids and white blood cells in the wall of an artery....
     associated with sildenafil
    Sildenafil

    Sildenafil citrate, sold as Viagra, Revatio and under various other trade names, is a Medication used to treat erectile dysfunction and pulmonary hypertension ....
     (Viagra) when used with nitroglycerine
  • Suicide
    Suicide

    Suicide is the intentional taking of one's own life. Many dictionaries also note the metaphorical sense of "willful destruction of one's self-interest"....
    , increased tendency associated to the use of fluoxetine
    Fluoxetine

    Fluoxetine hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor class. Fluoxetine is approved for the treatment of major depressive disorder , obsessive-compulsive disorder , bulimia nervosa, anorexia nervosa, panic disorder and premenstrual dysphoric disorder....
     and other SSRI antidepressants
  • Tardive dyskinesia
    Tardive dyskinesia

    Tardive dyskinesia is a variety of Dyskinesia manifesting as a side effect of long-term or high-dose use of dopamine antagonists, usually antipsychotics....
     associated with long-term use of metoclopramide
    Metoclopramide

    Metoclopramide is a potent dopamine receptor antagonist used for its antiemetic and prokinetic properties. Thus it is primarily used to treat nausea and vomiting, and to facilitate gastric emptying in patients with gastroparesis....
     and many antipsychotic
    Antipsychotic

    Antipsychotics are a group of psychoactive drugs commonly but not exclusively used to treat psychosis, which is typified by schizophrenia. Over time a wide range of antipsychotics have been developed....
     medications
  • Spontaneous Tendon rupture associated with fluoroquinolone drugs even occuring as late as 6 months after treatment had been terminated.


See also

  • EudraVigilance
    EudraVigilance

    EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected Adverse event during the development of new Drug and for following the marketing authorisation of medicinal products in the European Economic Area ....
     (European Union
    European Union

    The European Union is an economic and political union of 27 European Union member state, located primarily in Europe. It was established by the Treaty of Maastricht on 1 November 1993 upon the foundations of the pre-existing European Economic Community....
    )
  • Iatrogenesis
    Iatrogenesis

    The terms iatrogenesis and iatrogenic artifact refer to adverse effect s or complication s caused by or resulting from medicine treatment or advice....
  • Paradoxical reaction
    Paradoxical reaction

    A paradoxical reaction is when medical treatment, usually a drug, has an opposite effect to an effect normally expected.An example of a paradoxical reaction is when a pain relief medication causes an increase in pain....
  • Polypharmacy
    Polypharmacy

    The term polypharmacy generally refers to the use of multiple medications by a patient. The term is used when too many forms of medication are used by a patient, when more medication are prescribed than is clinically warranted, or even when all prescribed medications are clinically indicated but there are too many pills to take ....
  • Toxicology
    Toxicology

    Toxicology is the study of the adverse effects of chemicals on living organisms. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people....
  • The Medical Letter on Drugs and Therapeutics
    The Medical Letter on Drugs and Therapeutics

    The Medical Letter on Drugs and Therapeutics, commonly referred to as The Medical Letter, provides independent, unbiased critical evaluations of new drugs and sometimes older drugs when important new information becomes available....
  • Yellow Card Scheme
    Yellow Card Scheme

    This article is about Human Medicines. For Veterinary Medicines, see the Suspected Adverse Reaction Surveillance Scheme.The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines....
     (UK)


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