Public Citizen, the national, non-profit organization founded in 1971 by Ralph Nader, publishes a long list of drugs which it advises people “Do Not Use” because of questions over their effectiveness and/or safety.
- Awareness Female Balance
- Black Cohosh
- Erythromycin Estolate
- Forteo Injection
The organization’s Health Research Group, noting that adverse drug reactions result in an estimated 100,000 deaths each year and millions of injuries and illnesses, has published a book titled Worst Pills, Best Pills delineating the drugs and reasons they should be avoided. The list is updated on the Public Citizen website and so far includes 189 drugs, both prescription and over-the-counter.
Public Citizen makes numerous recommendations in its listing, including that patients consult with their physicians before discontinuing the use of medications.
The following is a partial list of the “Do Not Use” drugs along with a summary of the concerns and potential safety hazards they present, according to Public Citizen’s Health Research Group, whose staff and outside specialists reviewed the medications.
The list contained on this page includes information from the latest, January 2005, edition of Worst Pills, Best Bills about some of those drugs that pose among the most severe potential health risks according to Public Citizen.
Among categories covered are (click on one to forward):▪Heart Drugs ▪Mind Drugs ▪Pain and Arthritis ▪Cold, Cough, Allergy and Asthma ▪Diabetes ▪Diet Drugs ▪Oral Contraceptives ▪Attention Deficit Hyperactivity Disorder (ADHD) ▪Osteoporosis ▪Urinary Disorders ▪Neurological Disorders ▪Infections ▪Hormones ▪Dietary and Herbal Supplements
The following does not include drugs listed as “Do Not Use” simply because they were considered ineffective or less effective than other treatments, addictive, dangerous when used for “off-label” purposes, or when the adverse side effects were seemingly relatively minor. For a more complete list and additional information about the drugs listed by Public Citizen you may want to visit www.worstpills.org or www.citizen.org.
The following partial listing is presented by Kline & Specter, PC, to help inform the general public about the potential dangers of certain medications. Other drugs not listed on this page that have been cited as problematic – including some that have been the targets of lawsuits, from Adderall to Viagra and Vioxx – can be found on our Mass Tort and Drug Cases page or on the list at the bottom of this page.
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From Public Citizen’s “Do Not Use” List …
(listed by condition -- with brand name, manufacturer and generic name)
Catapres (Boehringer Ingelheim), clonidine Combipres (Boehringer Ingelheim), clonidine and chlorthalidone
A high blood pressure medication, Public Citizen warns that clonidine “has severe adverse effects and should not be used.” It noted that the main problem is that missing only one or two doses of the drug can cause side effects that include sweating, tremors, flushing and severe high blood pressure, while clonidine can also cause severe depression and is especially dangerous for patients with histories of depression. (Patients should, however, not suddenly stop using these drugs but rather consult a physician for a schedule to gradually reduce usage.)
Dyrenium (Wellspring Pharm), triamterene
The drug is a water pill, or diuretic, that removes less potassium from the body than other types of diuretics. Public Citizen cautions that Dyrenium should not be used by older adults because it can cause serious and sometimes fatal adverse effects such as kidney stones, kidney failure, retention of too much potassium and a drop in the body’s production of blood cells, known as bone marrow depression.
Lopid (Pfizer), gemfibrozil
Lopid is a fibrate used to lower cholesterol. Not only does Lopid have no demonstrable health benefits such as reducing the chances of suffering a heart attack, according to Public Citizen, it quotes one study in which patients using gemfibrozil suffered injury compared to those given a placebo. One U.S. Food and Drug Administration (FDA) physician was quoted as noting “adverse trends with higher total mortality, higher coronary deaths and higher coronary heart disease events in the gemfibrozil (Lopid) group.”
Additional adverse effects were noted when Lopid was used in combination with statin drugs such as Mevacor and Zocor, including reports of severe muscle damage sometimes accompanied by life-threatening destruction of muscle and subsequent kidney damage.
Moduretic (Merck), amiloride and hydrochlorothiazide
Used to treat high blood pressure, Moduretic contains an FDA “black box warning” – the most stern used by the federal agency – noting that it may cause hyperkalemia in patients, particularly among those with renal impairment or diabetes mellitus. It noted that hyperkalemia, if uncorrected, is potentially fatal.
Pletal (Otsuka American Pharmaceutical), cilostazol
Prescribed to improve blood flow, Pletal carries an FDA “black box warning” noting that drugs that work by inhibiting the enzyme phosphodiesterase III, a clumping agent, to treat conditions such as congestive heart failure have caused “decreased survival.” Public Citizen noted that a similar drug, Manoplax, was removed from the market in 1993 for just that reason. It cited clinical trials that showed a higher mortality rate at 30 days after treatment compared to patients given a placebo.
Ticlid (Roche) ticlopidine
A blood-clotting inhibitor prescribed to prevent stroke, Public Citizen advised that Ticlid not be taken by people who can take aspirin. While somewhat more effective than aspirin, it said that ticlopidine has more significant side effects, including life-threatening blood disorders. It lowers the white blood cell count, which increasing the risk of infection. Hundreds of cases of serious blood disorders were cited, with severe cases reported most often in women older than 75.
Trental (Aventis) pentoxifylline
Another blood flow improver, Public Citizen cited a report of two cases in which pentoxifylline caused fatal damage to patients’ bone marrow, where blood cells are produced.
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Elavil (AstraZeneca) amitriptyline
An antidepressant, Public Citizen cited Elavil as having “more harmful adverse effects than any other drug in its family.” It cited FDA-approved product labeling for antidepressant drugs warning of the possibility of suicide and recommended other antidepressant drugs as a better choice.
Mellaril (Novartis), thioridazine
The antipsychotic drug bears an FDA “black box warning” that it has been associated with life-threatening heart rhythm disturbances and death. Thioridazine causes a prolongation in the time it takes the large chambers of the heart to discharge and recharge, which can lead to an ailment known as torsades de pointes, a type of cardiac arrhythmia. The FDA warning noted that the drug should be used only by schizophrenic patients who failed to respond to treatment using other antipsychotic drugs. Public Citizen cited additional side effects, including confusion, delirium, blurred vision, sexual dysfunction and worsening of glaucoma.
Serentil (Novartis) mesoridazine
This antipsychotic medication carries an FDA “black box warning” that it has been associated with life-threatening heart rhythm disturbances and death. Mesoridazine causes a prolongation in the time it takes the large chambers of the heart to discharge and recharge, which can lead to an ailment known as torsades de pointes, a type of cardiac arrhythmia. The FDA warning noted that the drug should be used only by schizophrenic patients who failed to respond to treatment using other antipsychotic drugs. Public Citizen noted additional side effects, including confusion, delirium, blurred vision, sexual dysfunction and worsening of glaucoma.
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Arava (Aventis), leflunomide
This medication for arthritis and gout was approved in 1998 and has been associated with reports of severe liver reactions, including 22 deaths in its first three years on the market. Public Citizen noted that some of the deaths were among patients in their 20s.
It said evidence of leflunomide’s liver toxicity appeared in clinical trials.
Feldene (Pfizer), piroxicam
Feldene is in the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), which can cause serious injury or death from bleeding in the stomach or intestines. Public Citizen’s Health Research Group petitioned the FDA in 1994, unsuccessfully, to remove piroxicam from the market. While piroxicam relieves pain and inflammation caused by rheumatoid arthritis and osteoarthritis, Worst Pills, Best Pills said piroxicam “has caused serious adverse effects and numerous deaths, especially in older adults” and even when taken only recommend dosages. It also noted instances of serious skin reactions, some of them fatal, in people of all ages who took piroxicam.
Indocin (Merck), indomethacin
Indocin also is in the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) often used to treat arthritis in older patients. This drug can cause serious injury or death from bleeding in the stomach or intestines. Noted Public Citizen’s Worst Pills, Best Pills: “Bleeding can occur at any time and without warning and older people are more likely to experience adverse effects from bleeding.” It noted that older patients also were more likely to experience reduced liver and kidney function with the use of Indocin.
Toradol (Roche), ketorolac
Toradol is in the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), which can cause serious injury or death from bleeding in the stomach or intestines. It has also been associated with reduced liver and kidney function in older patients.
The FDA has issued a lengthy “black box warning” for Toradol noting the drug “can cause peptic ulcers, gastrointestinal bleeding and/or perforation.” It also noted that hypersensitivity reactions, including anaphylactic shock, have occurred in patients using Toradol. (In labor and delivery, the warning further noted, the medication may negatively affect fetal circulation and inhibit uterine contractions.)
Ultram (Ortho-McNeil), tramadol
Ultracet, (Ortho-McNeil), tramadol with acetaminophen
An old German-made painkiller first sold in the United States in 1995, tramadol was on the market only a year when the FDA began receiving reports of serious adverse side effects, including seizures and allergic reactions. Public Citizen said the FDA received roughly 300 reports of seizures in the first two years of use.
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Accolate (Astra Zeneca), zafirlukast
This leukotriene inhibitor has been associated with an adverse reaction called Churg-Strauss Syndrome in which some blood vessels become inflamed, according to Public Citizen. Zafirlukast also has been linked to drug-induced lupus and a recurrence of ulcerative colitis, or inflammation of the colon. In addition, cases of liver toxicity have been noted with zafirlukast and the drug’s professional product labeling was strengthened in 2004 to note that some patients using the drug were reported to have suffered life-threatening liver failure.
Singulair (Merck), montelukast
The leukotriene inhibitor has been linked to Churg-Strauss Syndrome in which some blood vessels become inflamed, according to Public Citizen. It noted that while some researchers believe that such events occur because of changes in steroid dosage following the use of montelukast, Churg-Strauss has been documented in cases in which patients were not using steroids at all.
Sudafed (Warner Lambert), pseudoephedrine
Public Citizen noted that pseudoephedrine is related to the group of “speed-like” drugs that include amphetamines, the dangerous dietary supplement ephedra and phenylpropanolamine, or PPA. It warned: “All of these drugs can raise heart rate and blood pressure that can lead to serious cardiovascular consequences.” In addition, Public Citizen noted reports in medical literature of ischemic colitis, a serious gastrointestinal ailment.
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Actos (Takeda Chemical Industries), pioglitazone
Avandia (GlaxoSmithKline), rosiglitazone
These thiazolidinediones, or glitazones, are in the same class of diabetes drugs as Rezulin, which was banned in the United States in 2000. Public Citizen noted that in trials patients using pioglitazone and rosiglitazone experienced elevations in liver enzymes, an early sign of possible liver damage. It noted that cases of liver failure associate with the use of the drugs have also been reported. Glitazones have also been associated with anemia, and FDA product labeling also warns that the drugs can also cause or worsen heart failure.
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Meridia (Abbott), sibutramine
Public Citizen concluded that “the risks of this drug outweighed its benefits,” noting that and FDA advisory committee had expressed concern about sibutramine’s potential to increase blood pressure and heart rate. It said that from the time of the drug’s introduction in 1998 through September 2001 there were nearly 400 adverse reactions, including 19 cardiac deaths, three of whom were women younger than 30. In a later 18-month period, through March 2003, there were an additional 30 reports of cardiovascular deaths among people using sibutramine – or a total of 49 reported deaths.
In addition, sibutramine can inhibit the reuptake of the brain transmitter serotonin, according to Worst Pills, Best Pills. This condition is called serotonin syndrome and can cause, among other things, loss of consciousness, anxiety, weakness, tremors and rapid heartbeat.
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Desogen (Organon), Mircette (Organon) Ortho-Cept (Ortho-McNeil)
Public Citizen cited studies showing that the risk of blood clots with this contraceptive was double that of older birth control pills. These newer, so-called third-generation birth control pills contain the progestins desogestrel and gestodene which were linked in a worldwide study with a greater incidence of blood clots, or deep venous thrombosis.
Yasmin (Berlex), drospirenone/ethinyl/estradiol
Yasmin is a close cousin of a diuretic that causes potassium retention. It was included on the Public Citizen “Do Not Use” list because, it said, drospirenone causes elevated blood levels of potassium than can cause serious heart conditions, a change in the blood’s acid balance and muscle weakness.
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Focalin (Novartis), dexmethylphenidate
Public Citizen noted that among studies Novartis submitted to the FDA to support approval of this ADHD medication there were several safety risks noted. Among them were headaches, abdominal pain, nausea, vomiting, appetite and loss of weight, fluctuations of blood pressure and heart rate. It said one study showed a significant increase in systolic blood pressure among children administered the drug.
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Forteo injection (Lilly) teriparatide
This osteoporosis medication bears an FDA “black box warning” that teriparatide caused an increase in the incidence of osteosarcoma – a type of bone cancer – in male and female rats. The warning notes that the drug should be given only to patients for whom the potential benefits outweigh the potential risk.
At the same time the warning was issued, the manufacturer agreed to restricted initial marketing of the drug with no direct-to-consumer advertising and restrictions on free samples. Public Citizen’s Health Research Group testified before an FDA advisory committee about teriparatide. It said the ability of the drug to cause cancer in lab rats was “some of the most striking animal carcinogenicity date we had ever seen. Tumors developed in the animals at even the lowest dose level of teriparatide administered, which was only three times the drug levels in humans.”
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Pyridium (Warner-Chilcott), phenazopyridine
This drug is available over the counter despite what Public Citizen termed “its propensity to cause cancer.” It noted that phenazopyridine can remain in older patients’ systems longer than it should and can build up to dangerously high levels in the blood stream, which can lead to anemia and liver damage. The World Health Organization’s International Agency for Research also was quoted as saying the drug can cause cancer. (Public Citizen noted that the FDA recommended not using phenazopyridine for more than two days.)
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Tasmar (Roche) tolcapone
Approved in 1998 to treat Parkinson’s disease, tolcapone was on the market less than a year when the FDA required new warning labels noting that the drug was associated with cases of liver failure, some fatal. The “black box warning” states that “because of the risk of potentially fatal, acute fulminant liver failure,” TASMAR should ordinarily be used in patients with Parkinson’s disease who were not responding or not appropriate candidates for other medications. It noted that the incidence of liver failure may be 10 to 100 times greater than the background incidence in the general population. Public Citizen estimated that through 2001 there had been 21 cases of severe liver toxicity reported with tolcapone, with eight cases resulting in death.
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This antibiotic is listed on the “Do Not Use” list because it has an effect on the electrical conduction in the heart – known as QT prolongation _ which in turn can cause potentially fatal heart rhythm disturbances, or cardiac arrhythmia, known as torsades de pointes. Public Citizen also cited other serious side effects, including convulsions, dizziness, tremors, depression and sometimes suicidal thoughts or acts.
Chloromycetin (Parke-Davis) chloramphenicol
Though an effective medication for a variety of conditions, Public Citizen cautions that it should be used only in a very limited number of situations “because it is so dangerous.” It noted that chloramphenicol can cause an irreversible depression of the bone marrow (where blood cells are produced) which “usually results in death.”
Public Citizen noted that erythromycin is one of the safest antibiotics but that people taking a particular type called erythromycin estolate, or Ilosone, were about 20 times more likely to suffer liver damage from the drug as opposed to patients who used other forms.
Sporanox (Janssen), itraconazole
Used to treat nail fungal infections, this medication has been associated with the development of congestive heart failure and liver toxicity. Public Citizen pointed out that the medication was first approved to treat serious fungal infections in people with compromised immune systems, such as AIDS patients, yet it was later heavily promoted directly to consumers to treat toenail fungus. The FDA reviewed a number of cases through April 2001 and concluded that itraconazole contributed to or caused 58 cases (of 94 reviewed) of congestive heart failure, with 13 of those fatal. The agency also reviewed 24 cases of liver failure possibly associated with the medication, with 11 of those resulting in death.
Macrodantin and Macrobid (Procter & Gamble); Furadantin (First Horizon)
Used to treat certain urinary tract infections, Public Citizen said nitrofurantoin is a “dangerous drug and should not be used in older adults.” Because older people’s kidneys do not work as effectively to eliminate this drug from their bodies, nitrofurantoin can accumulate to dangerously high levels in the blood stream. Adverse effects can result, including a nerve disease called peripheral neuropathy and scarring of the lungs. This injury may be irreversible and deaths have been reported as result. Said Worst Pills, Best Pills: “If you are taking this drug, ask your doctor to change your prescription.”
Trovan (Pfizer) trovafloxacin
This antibiotic has been linked to severe and unpredictable liver injuries. In June 1999, the FDA issued a public health advisory about trovafloxacin and said it had received more than 100 reports of liver toxicity in patients using the drug. Some of those patients developed liver injury that resulted in the necessity of liver transplants or death, according to Public Citizen.
Lamisil (Novartis), terbinafine
Terbinafine – promoted directly to consumers as a treatment for toenail fungus -- has been associated with liver toxicity. The following warning was added to the product’s label: “Rare cases of liver failure, some leading to death or liver transplant, have occurred with use of Lamisil …” Public Citizen said other side effects were reported, among them liver and bone marrow toxicity and changes in the lens and retina of the eye. It cautioned that using the drug for a condition that is basically cosmetic in nature “is risky.”
Lindane, gamma benzene hexachloride
Lindane shampoo is used to treat head lice, while a cream variety and lotion are available to treat scabies. Public Citizen noted that Lindane is a pesticide in the same family as DDT and is classified as a carcinogen. The shampoo Lindane bears an FDA “black box warning” that states: “Seizures and death have been reported following Lindane Lotion (shampoo) use with repeat or prolonged application, but also in rare cases following a single application used according to directions.” It recommended the shampoo be used “with caution” for infants, children and the elderly. Public Citizen said that rashes, dizziness, convulsions, vomiting, muscle cramps and fast heart beat, among other symptoms, have been reported with the use of Lindane, which is readily absorbed through the skin.
Estratest, Estratest H.S. (Solvay), esterified estrogens with methyltestosterone
The FDA has mandated a “black box warning” for this product noting that: “Three independent case control studies have reported an increased risk of endometrial cancer in postmenopausal women exposed to exogenous estrogens for prolonged periods.” The studies found that the risk of endometrial cancer in estrogen users was 4.5 to 13.9 times greater than in non-users of the treatment.
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Awareness Female Balance (Amerfit), Estroven (Amerfit); Remfemin (GlaxoSmithKline)
This supplement is derived from black cohosh, a plant in the buttercup family that goes by a number of popular names, including snakeroot, rattleroot and bugbane. Public Citizen listed its adverse effects as stomach upset, weight gain and headache but noted that there were also two reports in medical literature of liver transplants associated with the use of black cohosh. It also noted that black cohosh was possibly linked to the ability of cancer to spread. It said that in cancer tests on laboratory animals, the supplement did not cause an increase in the rate of breast tumors but if tumors did occur, they were more likely to have spread to the lungs of animals given black cohosh.
OTHER PROBLEM DRUGS
Other potentially dangerous drugs, some also included in Worst Pills, Best Pills, are posted separately on the Kline & Specter website. Click on any of the drugs below for more information:
- Asthma Drugs
- Atypical antipsychotics
- Diet Drugs
- Ortho Evra Patch
- PPA (Phenylpropanolamine)
- Viagra / Cialis / Levitra