Research: The Adverse Effects of Pharmaceuticals
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1. Studies have found pharmaceutical use to be a leading cause of hospitalisations and the third leading cause of death. In 1998 an extensive study published in the Journal of the American Medical Association (JAMA) showed that 106,000 people die each year in American hospitals from medication side effects. But studies also show that less than 5% of hospitalisations and deaths due to pharmaceuticals are identified as such so the actual total is much higher.
From 1998 through 2005, reported serious adverse drug events to the FDA increased 2.6-fold from 34,966 to 89,842, and fatal adverse drug events increased 2.7-fold from 5,519 to 15,107. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period. Only a small percentage of such cases are reported to the FDA.
2. Tylenol/acetaminophen can cause serious or chronic liver damage. Tylenol/acetaminophen reduces glutathione levels, especially in elderly; glutathione levels have been documented to be a marker for ageing and health, as well as chronic health conditions including degenerative eye conditions (Dr. David Williams, Alternatives, 1). Last year an FDA review estimated that there are more than 14,000 unintentional overdoses of acetaminophen every year, with about 100 of those cases resulting in death. In a large clinical trial taking acetaminophen every six hours for one week, over 1/3 experienced serious liver damage [more than tripled liver enzyme levels]. Studies have shown that N-acetyl cysteine (NAC) is an effective antidote for acetaminophen poisoning and is especially effective within 8 hours of ingestion of the overdose.
3. NSAID use has been linked to “leaky gut” and intestinal damage by a large number of studies. Of a group of arthritis patients with a history of NSAID use, 70% were found to have intestinal erosion, and 25% had severe, large lesions. "NSAIDs are among the world's most frequently prescribed drugs for arthritis and inflammatory conditions, but their use can quadruple the risk of upper gastrointestinal problems". Ibuprofen (Advil, Midol, Motrin, Nuprin, Pamprin), naproxen (Aleve, Naprosyn, Anaprox), and indomethacin had the worst adverse effects.
4. Newcastle University researchers found that NSAIDs are major contributors to heart problems. There was evidence that NSAIDs are a major factor in over 20% of first hospital admissions for congestive heart failure. NSAIDs decrease the ability of the body to excrete excess salt and water, resulting in fluid retention and buildup, the beginning of congestive heart failure.
In those with a history of heart problems, NSAID use increased the risk of hospital admission over 10 fold. NSAIDs have been found to sometimes cause adverse health effects including gastrointestinal, cardiovascular, and skin relations – some of which have been fatal.
5. NSAIDs taken by pregnant women dramatically increase the risk of miscarriage. In a large study those who took NSAIDs during pregnancy had an 80% increase in miscarriages and even those taking baby aspirin had an increased risk of 60%. NSAIDs interfere with the attachment of a fertilised egg to the uterus. The Royal College of Obstetrics and Gynaecology in Britain has issued an advisory telling women to avoid NSAID use during pregnancy.
6. NSAID use has been found to induce hypersensitive reactions including asthma, respiratory problems, and urinary problems. Between 8 - 20% of adult asthmatics experience bronchospasm following ingestion of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). Termed aspirin-induced asthma, this reaction is potentially fatal. "The prevalence of aspirin and NSAID-sensitive asthma in Australia is probably as low as 5-10 per cent in all adults with asthma,"
7. Studies have documented an increased risk of renal failure in some groups of elderly who use NSAIDs.
8. Long term aspirin use commonly causes gastrointestinal bleeding, and can increase your risk of heart attacks and stroke. Long term aspirin use also increases the risk of macular degeneration and the risk of cataracts by up to 44% (8).
9. Antibiotic use in the first 6 months of life has been found to be a major cause of asthma and allergies, with an increased incidence of over 250%. For those taking broad spectrum antibiotics, the risk increased by from 8.9 to 11.5 times that of those not taking antibiotics. In addition to the potential of leading to emergence of ABx-resistant bacterial strains, Antibiotic treatment is also responsible for 10 - 30% of all medication-induced adverse events.
10. Gray syndrome may be especially likely to occur in children, who are usually more sensitive than adults to the effects of chloramphenicol which is commonly used in the treatment of ear infections in children. Effects include: blue tone to the skin, changes in blood pressure or heart rate, eating problems, irregular breathing, passage of loose green stools, or stomach bloating with or without vomiting.
11. The statin class of cholesterol-lowering drugs (Lipitor, Zocor, etc.) interrupt the body’s natural production of CoQ10 reducing blood and cellular levels
11a. CoQ10 is a necessary enzyme for heart function and other body processes. Cholestyramin (Questran, Prevalite) causes various gastrointestinal problems including constipation, bloating, inhibition of fat soluble vitamins which can lead to night blindness, bruising, increased triglyerides, osteoporosis. Numerous adverse side effect reports have implicated Lipitor and other statin drugs as a probable cause for severe neuromuscular degeneration. Some people who have been using Lipitor for as little as two months report serious muscle weakness and pain. Some who have taken it longer report much more serious symptoms, similar to Muscular Dystrophy, Parkinson's Disease, Multiple Sclerosis or ALS – Lou Gehrig's Disease – in which they are losing neuromuscular control of their bodies or losing significant muscle mass. Others have reported serious liver and kidney damage; many report significant cognitive impairment and memory loss problems. Still others have been told that they have nvCJD, the human equivalent of mad cow disease.
11b. According to Dr. Orli Etingin, vice chairman of medicine at New York-Presbyterian Hospital, “Statin drugs make women stupid,” There are similar effects on men.
11c. For healthy men, for women with or without heart disease and for people over 70, there is little evidence, if any, that taking a statin will make a meaningful difference in how long they live.
11d. A partial listing of the potential side effects of statins: muscle pain; liver disease; digestive trouble; kidney failure; rhabdomyolysis (the breakdown of muscle fibres that can result in death); neuropathy (numbness, tingling, burning pain); memory loss, cognitive impairment, tinnitus, etc.
12. The FDA has notified Bristol-Myers Squibb Co. that it must include a so-called black-box warning on its label for the antidepressant Serzone advising patients that life-threatening liver failure can occur with use of the drug. Serzone has been taken off the market in all European countries because it has been linked to 26 deaths from liver damage.
13. Fluoroquinolone antibiotics have been found to cause peripheral neuropathy. This study found that many cases are severe and long term, with some cases affecting many organs. Of the cases followed in this study, 70% lasted more than 3 months and 58% more than one year. Examples of fluoroquinolones causing PN are levofloxacin, ciprofloacin, afloxacin.
14. Most cases of acute generalised exanthematic pustulosis (AGEP) are drug induced, and get better after cessation of drug use. Drugs implicated include: amoxicillin, pristinamycin, hydroxychloroquine, ampicillin, diltiazem, co-trimoxazole, terbinafine, carbamazepine and spiramycin.
15. Merck deliberately misled doctors and public about the safety of Vioxx. After a company study in March 2000, known as VIGOR, reported increased heart attack risks, Merck directed its sales force to show physicians a "cardiovascular card" that made it appear Vioxx could be eight to 11 times safer than other anti-inflammatory drugs. The card omitted any reference to VIGOR and was based on data the FDA considered to be inappropriate for a safety analysis.
After an FDA advisory committee agreed in a 2001 vote that physicians should be informed of the risks found in the VIGOR study, Merck sent a bulletin to its sales force that advised: "Do not initiate discussions of the FDA Arthritis Committee ... or the results of the ... VIGOR study." If physicians asked about the study, Merck representatives were told to respond, "I cannot discuss the study with you."
After the New York Times reported on the cardiovascular danger of Vioxx in May 2001, Merck instructed its field staff to tell physicians that patients on other anti- inflammatory medications were eight times more likely to die from cardiovascular causes than patients on Vioxx.
After extensive negotiations with the FDA, Merck agreed to a label change for Vioxx in April 2002 that mentioned the cardiovascular risks found in the VIGOR study, but it included a statement that the significance of the findings was "unknown." The committee said Merck then instructed its sales force to emphasise the uncertainty of the VIGOR study to counter physician's concerns.
For Vioxx®, the risk of blood clots was approximately 34 per cent higher than the risk in comparable patients not treated with Vioxx®. On average, blood clots appeared in 0.3 per cent of Vioxx® users.
16. Data from the ADAPT trial indicated an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen (Aleve) when compared with those on placebo.
17. Inositol supplementation was found to be more effective than the SSRI fluvoxamine for panic disorder, while also having less adverse health effects. Poor nutrition and lack of exercise have been found to be major factors in neurological conditions such as depression. Regular exercise, meditation, and nutritional supplements including 5-HTP, SAMe, Tryptophan, vitamin B12, multi B vitamins, magnesium, St. John’s Wort, DHEA, Rodelia rosea, DMAE, choline, etc. and testosterone in older men with low testosterone have been found to be effective in preventing and treating depression. Double blind studies have found 5-HTP to be as effective as prescription antidepressives including SSRIs at treating conditions such as depression. Mercury from dental amalgam fillings and toxic metals have also been found to be common causes of depression and mood disorders, with recover or significant improvement common after amalgam replacement and detoxification.
18. Bruxism (tooth grinding) and headaches have been found to be associated with the use of certain medications, such as L-dopa (used in Parkinson's Disease) and with some of the so-called "SSRI" antidepressants. These include Prozac, Paxil, Zoloft, Celexa, and Luvox.
19. SSRIs cause hyperprolactinaemia which results in erectile dysfunction, increased breast cancer, autoimmune conditions such as lupus, etc. Proscar (finasteride) has been found to increase significantly the risk of breast cancer in men as well as breast enlargement (gynaecomastia).
20. Children and young people treated with SSRI or SNRI more frequently exhibit suicidal thoughts and suicidal behavior as well as hostile behaviour than comparable patients treated with a placebo.
21. Preliminary results of a Danish register study show an increased occurrence of malformation in children born by mothers who had used an antidepressant of the type SSRI during the early pregnancy (first trimester).
22. Moms' Antidepressants Affect Newborns. A study, headed by Dr. Rachel Levinson-Castiel of the Children's Medical Center in Petah Tiqwa, found that nearly one in three infants born to women taking anti-depressants showed signs of withdrawal. Symptoms such as high-pitched crying, tremors, gastrointestinal problems and disturbed sleep showed up in the first 48 hours after birth and were more pronounced in babies whose mothers had been taking higher doses. The risk was highest among those exposed to 27 mg or more. Thirty percent of the 60 newborns exposed before birth to selective serotonin reuptake inhibitors had withdrawal symptoms and the symptoms were classified as severe in 13 percent. Symptoms usually did not peak until after the first day of life but the long-term effects are not known, the researchers said.
23. The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found. When all data is considered the drugs outperform placebos, but by a modest margin, concludes the new report.
24. It has been detected that there is an increased risk of blood clots by use of the selective COX-2 inhibitors (celecoxib, etoricoxib, lumiracoxib, paracoxib).
25. Two osteoporosis drugs, Reclast, a drug made by Novartis AG and Fosamax by Merck & Co, were found to sometimes cause irregular heart rhythms.
26. Antibiotics are the leading cause of drug related adverse effects and deaths.
27. Certain antibiotics, such as the fluoroquinolones, the class of antibiotics that includes the name-brands and generic brands of Levaquin™, Cipro™, Tequin™, and Avelox™, actually are known to trigger a type of virus called bacteriophages (viruses that can infect bacteria), to change the genetic sequencing of the bacteria, causing the bacterium they have infected to start producing toxins. These viruses can act as genetic delivery vans, invading bacteria, such as spirochetes, and often lying dormant until activated by a change in the host (your body) environment. Once activated, these viruses insert their toxin-generating genes into the bacterial chromosomes. These viruses can turn basically harmless bacterium into killers through this genetic sequencing of toxins.
28. Based on five years of data on 3,876 heart bypass patients from around the world, the death rate among the 1,072 patients given Bayer AG's anti-bleeding drug aprotinin (Trasylol) was nearly 21 percent, two-thirds higher than the mortality rate among surgery patients not given anti-bleeding drugs.
Bayer failed to reveal to U.S. regulators the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the U.S. Food and Drug Administration has announced.
29. In clinical trials by Merck, the cholesterol lowering drugs Zetia and Vytorin were found to not be effective at preventing heart attacks, and in fact caused fatty plaques to grow almost twice as fast as in the control. Fatty plaques are a known risk factor for heart attacks and strokes.
30. Liberty Link (Bayer) genetically modified corn has been found to cause adverse health effects to test animals and people.
31. A new study gave 28 of the men a one-year course of finasteride (Proscar), the standard drug for benign prostate problems. The other 25 were given nothing. When the year was up, researchers gave each man a second biopsy. Nearly 30% of the men taking Proscar developed prostate tumours. Yet tumors were found in only one of the 25 men taking nothing.
32. Although studies have shown a connection between Singulair use to suicidal thoughts, Merck does not widely publicise this, as they are supposed to.
33. Two creams used to treat eczema, Elidel and Protopic, will also soon carry the FDA's strongest "black box" warning on their packaging to alert doctors and patients to healh risks including cancer. The warning advises doctors to prescribe short-term use of Elidel and Protopic only after other available eczema treatments have failed in adults and children over the age of 2. The FDA's Pediatric Advisory Committee reviewed research in animals that linked Elidel and Protopic to an increased of skin cancer and non-Hodgkin's lymphoma. In those studies, the risk of cancer increased as the dose of the drugs increased. Research presented at the meeting also linked Elidel and Protopic to about 25 cases of cancer in adults and children who used the drugs. The FDA has also received reports of serious adverse events in children under the age of 2 who were prescribed the drugs.
34. An independent analysis of thousands of older people with diabetes found that those treated with the widely used drug Avandia had significantly elevated risks of heart attack and death. “Our study suggests that at least in this high-risk population, the harms of the drug may outweigh the benefits,” Confidential government reports say that about 500 heart attacks and 300 cases of heart failure would be averted every month if patients switched away from Avandia. One report, by Dr. David Graham and Dr. Kate Gelperin of the FDA, argued that Avandia should be withdrawn from the market. A study was published in the New England Journal of Medicine (NEJM) that linked Avandia to a 43 percent increased risk of heart attack and a 64 percent higher risk of cardiovascular death than patients treated with other methods. A bipartisan multiyear Senate investigation found the sharply criticises GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly. The study concluded that rosiglitazone causes increased weight gain and edema, and has a hazard ratio greater than unity.
35. Computed tomography scans, or CT, are a health risk for radiation. Each scan gives the patient a far higher dose of radiation than a conventional X-ray would. Unfortunately, even many doctors have no idea how much radiation a CT scan delivers. The researchers suggest, as many as 2 percent of all cancers in the United States may be because of radiation from CT scans performed today.
36. An experimental anti-clotting drug from Eli Lilly, Prasugrel, quadrupled the risk of fatal bleeding though other benefits were found compared to Plavix.
37. The Rx painkillers oxycodone and fentanyl caused at least 9,000 deaths between 1998 and 2005. The antipsychotic Clozapine caused at least 3,277 deaths between 1998 and 2005.
The antipsychotic medication risperidone (Risperdal) was responsible for at least 1093 deaths between 1998 and 2005. interferon-beta, a drug that helps regulate the immune system; and two immune-affecting drugs, Infliximab and Etanercept, were each responsible for over 1,000 deaths between 1998 and 2005.
38. Sodium benzoate with vitamin C produces benzene, which is toxic and carcinogenic. Found in most soft drinks, juices, pickles, salad dressings, jams, etc. FDA tests have found levels of benzene in some soft drinks 16 times the health standard for drinking water.
39. Seroquel, a drug used for schizophrenia, caused weight gain, hyperglycaemia (increased blood sugar), and diabetes in thousands of patients. A Washington Post analysis found that 4 out of 5 patients quit taking Seroquel in less than a year. A large study found that Seroquel was no more effective than other options.
40. Drug-coated stents may hinder the heart's natural ability to form tiny collateral blood vessels that can salvage heart muscle by rerouting the blood supply, according to at least 3 studies. Because drug-eluting stents reduce arterial tissue growth, they can increase the risks of blood clots. Nearly a third of patients who had drug-coated stents implanted in vein grafts to improve coronary blood flow died within 32 months, Dutch cardiologists report. According to the American Heart Association, invasive heart treatments supply 45% of large hospital revenues.
41. Patients getting angioplasty after heart attacks had more repeat attacks than otherwise. Angioplasty works no better than standard heart medication (drugs to control blood pressure, lower cholesterol, and prevent blood clots) in preventing heart attack, stroke, and hospitalisation in patients with stable coronary artery disease.
42. People who drink two or more sweetened soft drinks a week have a much higher (87%) risk of pancreatic cancer. The high levels of sugar in soft drinks may be increasing the level of insulin in the body, which the authors think contributes to pancreatic cancer cell growth.
43. Excess zinc exposure from sources such as GSK Superpolygrip found to cause many neurological conditions including pareasthesias, disaesthesias, and conditions related to copper deficiency such as anaemia, neuropathy, etc. Some of the effects are similar to those of MS, Demyelinating Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
44. Depakene/Depakote (valproate acid) is a deadly drug that robs many nutrients and damages the liver. Carbamazepine (Tegretol) is even more dangerous. It also drains biotin, folic acid, vitamins D and E, carnitine, sodium, and may contribute to allergies by decreasing IgG2. Ammonia is increased while alpha-ketoglutarate is reduced. GI upset is common. While one should normally drink lots of water, this drug may make you water intoxicated! Thyroid testing on this drug is unreliable.
45. The ADHD drugs Ritalin and Adderall have been found to cause cardiovascular problems in some, with hundreds of deaths reported. Health Canada has ordered ADDERALL XR to be taken off the market in that country, primarily because of deaths that occurred in the U.S. In psychotic children Ritalin may worsen symptoms of behaviour disturbance and thought disorder. Abuse of this drug can lead to tolerance and psychic dependence with varying degrees of abnormal behaviour, severe depression can occur with withdrawal. Growth retardation (suppression of height and/or weight gain) has been reported in children using this drug. Long-term therapy (greater than 24 months) is especially dangerous.
Further resources
The fully referenced PDF version of this research article is available by clicking: The Adverse Effects of Pharmaceuticals. Many other research papers are also available on the Research page.
The problems inherent in the pharmaceutical approach to disease are discussed along with an alternative paradigm in The Natural Recovery Plan book.
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