Dangerous Drugs
Medication trials on animals can be a deceptive guidepost to human health
These drugs harbour hidden dangers that only surface when these drugs are administered to humans. The perils of this process are illuminated by numerous instances of drugs, proven safe in animal tests, yet later withdrawn due to harmful human effects. Adverse drug reactions (ADRs) – excluding those caused by prescribing errors- are estimated to kill more than 100,000 people in the US every year (1). Whilst these reactions may be caused by interactions with other medicines and cannot be attributed solely to the unreliability of animal data, a study of ninety-three serious ADRs concluded that only eighteen of them could have been detected on the basis of preceeding animals data (2).
Examples where animal tests have misled clinical development (3)
- Immunosuppressant drugs cyclosporine & tacrolimus were almost abandoned because animal tests failed to predict efficacy and safety
- Alzheimer’s vaccine caused severe brain swelling in early human trials despite appearing safe in animal tests
- Immunomodulatory drug Tegenero left healthy human volunteers with catastrophic organ failure despite prior unremarkable animal testing using 4 species
- Hepatitis B drug was abandoned because it caused severe liver injury and multiple deaths in human trials despite encouraging animal data
Misleading animal experiments not only cost lives but also obstruct scientific progress, leaving us questioning our advancements had we focused more on human-specific studies. The tale of these trials serves as a stark reminder:Â what works for animals doesn’t always work for us.
The list of drugs below were successfully tested on animals. These are stark examples where animal research findings were not translatable to humans and posed great risks to human health. These are not isolated examples but illustrative of the inability of animal tests to safeguard humans, as clear by broader research confirming the lack of specificity of animal tests to determine toxicity in human patients (4).
| Drug | Use | Side effects |
|---|---|---|
| Alatrofloxacin | Antibiotic | Liver damage |
| Amrinone | Heart failure | Thrombocytopenia (a lack of blood cells needed for clotting) in 20% of patients taking the drug on a long term basis |
| Ariprazole | Psychosis | Neuroleptic malignant syndrome (fever, confusion, disorientation, muscle rigidity, profuse sweating and autonomic instability) |
| Atenolol | High blood pressure | Associated with 26% higher risk of stroke compared to newer drugs |
| Avandia | Type 2 diabetes | Weight gain, bone fractures, heart disease |
| Benoxaprofen | Pain and inflammation | Phototoxic in elderly (sunburn-like symptoms) |
| Benzarone | Gout | Liver injury and death |
| Benziodarone | Coronary vasodilator | Acute uric acid build up in the kidneys |
| BIA 10- 2474 | Pain relief and anxiety | Volunteers in a Phase I clinical trial were hospitalised with brain damage; one person died (January 2016) |
| Bromfenac | Post-operative pain | Liver damage |
| Celebrex | Arthritis painkiller | Heart attack, weight gain, abdominal pain, headache, dyspepsia, diarrhoea, nausea, kidney failure, fainting, blurred vision, allergic reactions, chest pain, ringing in ears, intestinal bleeding |
| Cerivastatin | High cholesterol | Muscle toxicity |
| Cisapride | Gastrointestinal stimulant | Disorders of heart rhythm, headaches, diarhhoea, constipation, nausea, abdominal pain |
| Clioquinol | Ingredient in anti-diarrhoea drugs | At least 10,000 people, and possibly up to 30,000, fell victim to SMON (subacute myelo-optic neuropathy), a disease that causes nerve damage, resulting in numbness, weakness in the legs, paralysis, eye problems including blindness |
| Clomacron | Psychotropic drug | Liver damage |
| Clozapine | Antipsychotic | Seizures, shaking hands, fainting, loss of bladder control, confusion, changes in vision, fever, severe muscle stiffness, sweating, changes in behaviour, sore throat, unusual bleeding or bruising, loss of appetite, upset stomach, yellowing of skin or eyes, flu like symptoms, lack of energy |
| Cyclofenil | Antiestrogen | Liver damage |
| Dexfenfluramine | Weight loss | Cardiac risks |
| Diethylstillbestrol (DES) | A synthetic estrogen prescribed to pregnant women to prevent miscarriage | Increased spontaneous abortions, premature births and neonatal deaths, increased risk of vaginal cancer in daughters and granddaughters of users |
| Domperidone | Relieve nausea/vomiting, improve gastric mobility | Headaches, dizziness, dry mouth, nervousness, flushing, irritability, hot flushes, trouble sleeping, leg cramps, chest pain, slow/fast heart beat, discharge from breasts, swelling of feet and ankles, difficulty urinating, menstrual changes, sexual difficulties. |
| Droperidol | Antiemetic & anti psychotic | Spasms of the face, disorders of heart rhythm. |
| Enbrel | Treat rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis. | Hypersensitivity reaction, sepsis, tuberculosis, reactivation of hepatitis B, malignancy, haematological reactions, autoimmunity, seizures and heart failure |
| Enzyme-inducing antiepileptic medicines | Epilepsy | Reduced bone mineral density and subsequent increased risk of fractures. |
| Eraldin | Treatment for heart conditions | Found to cause serious eye damage, including blindness. 23 deaths. Over a 1000 patients received compensation for the damage it caused. |
| Exanta | Blood thinner to treat thrombosis | Causes long term liver damage. |
| Ezetimibe | Reduces the amount of cholesterol and fatty substances in the blood. | Rapid onset of depression, hives, rashes, difficulty breathing or swallowing, hoarseness, swelling of the face, lips, ankles, throat, legs, hands eyes and tongue, upset stomach, tiredness, unusual bleeding and bruising, lack of energy, loss of appetite, chills, chest pain. |
| Fenfluramine | Anti obesity medication | Heart valve disease, pulmonary hypertension. |
| Fialuridine | Hepatitis B | Successful in mice, rats, dogs, woodchucks and primates, but in human trials caused seven people to develop liver failure – killing five and others requiring liver transplants. |
| Grepafloxacin | Antibiotic | Caused disorders of heart rhythm |
| Humira | Rheumatoid arthritis treatment | Hypersensitivity reaction, sepsis, severe reactions occurred with patients who had tuberculosis or hep B or lupus, can cause swelling, shortness of breath, chills, flu symptoms, weight loss, fever, patchy skin, chest pain, coughing up blood, easy bruising, pale skin, unusual weakness. |
| Ibufenac | Non steroidal Anti inflammatory (Ibuprofen) | Caused severe liver damage. |
| Kava kava | Herbal remedy for stress and anxiety | Liver toxicity |
| Leflunomide | Anti inflammatory disease modifying anti rheumatic | Hepatotoxicity, nausea, diarrhea, hair loss, flu like symptoms, mild dizziness, chest pain, back pain, sore mouth, muscle cramping, numbness / tingling sensations. |
| Levacetylmethadol | Treatment for opium addiction | Withdrawn, caused severe cardiac disorders. |
| Methandrostenolone | Anabolic Steroid | Enlargement of male breasts, water retention, oily skin, acne, unwanted body hair, aggression, male pattern baldness, liver damage. |
| Metipranolol | Treatment of Glaucoma | Severe eye irritation or inflammation, slow heart beat or chest pain. |
| Mibefradil | Treatment of high blood pressure | Abdominal pain, belching, heartburn, stomach discomfort, flushing, headache, nausea, vomiting, pounding heart, stuffy nose, dizziness, lightheadedness, swelling legs, unusual tiredness. |
| Mumps vaccine | Prevention of mumps | Allergic reactions – difficulty in breathing or swallowing, hives, itching, reddening of skin, swelling of eyes, face or inside of nose, unusual tiredness or weakness. Other side effects include bruising or purple spots on skin, confusion, fever, headache, irritability, pain, tenderness, swelling of testicles, stiffneck and vomiting. |
| Naftidrofuryl oxalate injection | Treatment for disorder of blood flow to the brain | Cardio toxicity, rash, inflammation of liver, nausea, stomach pain. |
| Nefazodone | – | – |
| Nomifensine | Anti depressant | Linked to kidney failure, anemia and death |
| Odanacatib | Treatment for osteoporosis | Withdrawn from development in September 2016 due to high risk of atrial fibrillation and stroke. |
| Olanzapine | Anti psychotic | Confusion, sluggishness, fever, disorientation, muscle rigidity, spasms, profuse sweating, autonomic instability, swelling of face, breathing problems, uncontrollable chewing and arm and leg movements, loss of memory, nervousness. |
| Opren | Arthritis drug. | Found to be highly toxic in humans, with 3,500 reports of harmful effects including 61 British deaths, mainly through liver damage in the elderly. |
| Osmosin | Non steroidal anti inflammatory | Stomach ulceration and death |
| Pacritinib | Treatment for rare blood cancer called myelofibrosis | Trials halted in February 2016 as a number of volunteers taking part died from brain haemorrhages or heart failure. |
| Paroxetine | Anti depressant and anxiety treatment | Suicidal ideation, serotonin syndrome, bipolar mania or hypomania, schizophrenia, jaw / neck and back muscle spasms, fever, chills, sore throat and flu like symptoms, jaundice, GI bleeding, fetal defects, withdrawal syndrome, headache, weight loss, nausea, dry mouth, sweating, drowsiness, insomnia, constipation or diarrhea, erectile dysfunction, tremor, vertigo, dizziness. |
| Pemoline | ADHD, and narcolepsy | Liver toxicity |
| phenylbutazone and oxyphenbutazone | Non steroidal anti inflammatory | Gastrointestinal ulcers, kidney damage, oral lesions, internal heamorrhage, decreased appetite, excessive thirst, suppression of white blood cell production, aplastic aenemia. |
| Prenylamine | Angina pectoris | Depletes myocardial catecholamine stores |
| Propanidid | Short acting general anaesthetic | Withdrawn due to causing anaphylactic reactions |
| Pulmonary surfactant | To increase pulmonary compliance | Increased mortality. |
| Risperdal | Antipsychotic medication used to treat schizophrenia and symptoms of bipolar disorder (manic depression). Also used in autistic children to treat symptoms of irritability. | Increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar. |
| Ritalin and Dexamphetamine | Treatment of ADHD, especially in children. | Children as young as 5 suffered strokes, heart attacks, hallucinations and convulsions, shortness of breath, heart palpitations, hair loss, muscle spasms, severe abdominal pain, tremors, insomnia, severe weight loss, depression and paranoia. |
| Sertindole | Anti psychotic | Cardiac arrhythmias, also caused some deaths |
| Simvastatin | Control hypercholesterolemia & prevent cardio vascular disease | 17 % patients died between December 2005 and February 2006. Common side effects include, diarrhea, abdominal pain, indigestion, weakness. Less common – joint pain, memory loss and muscle cramps |
| Sitaxentan | Antihypertensive drug | Mitochondrial dysfunction and liver damage |
| Suprofen | Pain relief and inflammation | Caused kidney toxicity, withdrawn from the market. |
| Temafloxacin | Antibiotic | Death, low blood sugar, hemolytic anemia, other blood cell abnormalities, kidney dysfunction resulting in renal dialysis, liver dysfunction, allergic reactions causing life threatening respiratory distress. |
| Terbinafine (Lamisil) | Fungal skin infections, thrush | As of January 2008 there were 722 reports of adverse effects, including 3 deaths from liver failure and 70 liver reactions. |
| Terodiline | Urinary incontinence | Cardiac arrhythmias |
| Thalidomide | Sedative, morning sickness | Found to cause damage to the human foetus, resulting in 10,000 children born crippled and deformed with missing limbs. |
| Tienilic acid | High blood pressure | Liver damage |
| TGN1412 | Â Rheumatism, leukemia | Volunteers in a clinical trial suffered poor breathing, heavy swelling of neck and head, organ failure |
| Tolcapone | Parkinsons disease | Life threatening liver disease |
| Torcetrapib | High cholesterol | Up to 82 known deaths reported worldwide. |
| Trasylol | Prevent blood loss during surgery | Kidney problems, heart attack and stroke |
| Trovafloxacin | Antibiotic | Liver damage |
| Triazolam | Sedative | Neuropsychiatric |
| Troglitazone | Diabetes | Liver damage, resulted in 28 deaths and 7 liver transplants |
| Trovan | Antibiotic | Acute liver failure and death |
| Viagra | Erectile dysfunction | Given to pregnant women in a clinical trial to help boost growth of unborn babies; growth was severely limited in the womb and 11 babies died |
| Vioxx | Pain relief for rheumatoid and osteoarthritis | Heart and circulation problems |
| Voltaren | Pain relief | Heart and circulation problems, including heart attack and stroke |
| Ximelagatran | Blood thinner | Liver damage |
| Zelmac | Irritable bowel syndrome | Link to heart attack and stroke |
| Zelmid | Antidepressant | Linked to Guillain Barre syndrome, liver damage |
| Zolpidem | Short term treatment of insomnia | Possible death or coma from overdose, anterograde amnesia, hallucinations, delusions, ataxia and poor motor coordination, increased appetite, decreased libido, altered thought patterns, extroversion |
| Zomax | Arthritis, post-operative pain | Death and severe allergic reactions |
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