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Pharmaceutical Class Action Lawsuit

An ABC report noted that a survey of clinical trials revealed that when a drug company funds a study, there is a 90 percent chance that the drug will be perceived as effective whereas a non-drug company-funded study will show favorable results 50 percent of the time. It appears that money can’t buy you love but it can buy you any "scientific" result you want.

This is not a complete list of medications

Accutane

Enbrel

OxyContin

Rezulin

Viagra

Adderall

Ephedra

Paxil

Risperdal

Videx

Arava

Herceptin

Permax

Seldane

Viga

Ativan

Hismanal

Posicor

Serentil

Vioxx

Avandia

Lamictal

PPA

Serevent

Zerit

Baycol

Lamisil

Prempro

Seroquel

Zicam

Cold-Eeze

Lariam

Propulsid

Serzone

Zoloft

Bextra

Lotronex

Protopic

Strattera

Zyprexa

Celebrex

Meridia

Raxar

Tasmar

 

Crestor

Naproxen

Redux

Thalidomide

 

Duract

Neurontin

Relenza

Thimerosal

 

Accutane- (active ingredient isotretinoin) - is used to treat a type of severe acne that has not been helped by other treatments, including antibiotics. Possible serious side effects of taking Accutane include birth defects and mental disorders. Accutane can cause birth defects (deformed babies) if taken by a pregnant woman. It can also cause miscarriage (losing the baby before birth), premature (early) birth, or the death of the baby. Some patients, while taking Accutane or soon after stopping Accutane have come depressed or developed other serious mental problems. Symptoms of these problems include sad, "anxious" or empty mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. The FDA continues to access reports of suicide or suicide attempts associated with the use of Accutane.

Adderall- (active ingredient amphetamine)- is a central nervous system stimulant used to treat attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older and in adults. The FDA alerts that Sudden Deaths in Children Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR. SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR. In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall. At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data. Amphetamines have a high potential for abuse. Taking amphetamines for long periods of time may lead to drug addiction. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. Adderall may make symptoms of existing mental illness worse. Adderall may decrease growth and cause weight loss. It may also worsen tics and Tourett's disorder.

Arava- (active ingredient leflunomide)- is used to treat active rheumatoid arthritis in adults to reduce signs and symptoms, slow down damage to joints, and improve physical function. Arava has been shown to cause birth defects to the fetus in pregnant women, and you should not take Arava if you are breast feeding or if you are a man whose sexual partner may become pregnant. Rare cases of severe liver injury, including death, have been reported by patients taking Arava. Also, interstitial lung disease (an inflammation of lung tissue) has been reported in patients taking Arava.

Ativan- (active ingredient lorazepam)- is a benzodiazepine medication used to treat panic and anxiety disorders. Side effects such as severe respiratory failure and death. Reactions to Ativan have included increased aggressiveness, exhibited by violent behavior in some instances, depression with or without suicidal thoughts or intentions, personality changes, hallucinations, depersonalization, derealization, as well as other psychotic symptoms. Dependence and possible withdrawal symptoms can occur when Ativan is discontinued that can cause social deterioration. Acute amnesia has been associated to Ativan, and benzodiazepines, like Ativan, have been known to impair memory, especially in acquired knowledge in long-term memory. Phobias, obsessive-compulsive disorder, chronic depression, personality changes, and tinnitus are associated with Ativan.

Avandia- (active ingredient rosiglitazone maleate)- a diabetes drug. The FDA sent a warning letter on July 17, 2001 saying that Avandia has falsely denied serious risk of congestive heart failure, hepatitis, and liver failure occurring in Avandia users. The FDA claimed Avandia was only believed to be safer than Rezulin on the liver but still had the risk of causing liver toxicity. Warnings of cardiac failure and other cardiac effects, in addition to hepatic risk information was added to the label in 2001.

 

Baycol- (active ingredient cerivastatin)- cholesterol-lowering drug. Baycol was withdrawn from the market in August 2001. Bayer AG, Baycol manufacturer, has had 8,800 Baycol lawsuits filed against them in U.S. courts after a high number of Baycol patients suffered rhabdomyolysis, a muscle-weakening disorder. Court documents showed that Baycol manufacturer executives continued to promote Baycol after the company was made aware of the fatal and severe Baycol side effects. Linked to more than 100 deaths, Baycol has found itself to be in the midst of legal troubles that have been thought to be responsible for setting off more drug litigation.

 

 

Bextra- (active ingredient valdecoxib)- FDA has requested that Pfizer voluntarily withdraw Bextra from the United States market. Pfizer has agreed to suspend sales and marketing of Bextra in the United States, pending further discussion with the Agency. At this time, the Agency has concluded that the overall risk versus benefit profile of Bextra is unfavorable. This conclusion is based on the potential increased risk for serious cardiovascular adverse events, which appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin), an increased risk of serious skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs.

 

Celebrex - (active ingredient celecoxib)- is used to relieve symptoms of osteoarthritis, rheumatoid arthritis in adults, manage acute pain in adults, treat painful menstrual cycles, reduce the number of colon and rectum growths in patients with a disease called Familial Adenomatous Polyposis (FAP). FDA alerts that Celebrex has been linked to an increased risk of serious cardiovascular events such as heart attack or stroke which appears to be a risk shared by all medicines called non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin). FDA has requested that the package insert (labeling) for all NSAIDs, including Celebrex, be revised to include a "boxed" or serious warning to highlight the potential increased risk of CV events, and the well known risk of serious, and potentially life-threatening, stomach bleeding. FDA has also requested that the package insert for all NSAIDs be revised to state that patients who have just had heart surgery should not take these medications.

Cold-Eeze- (active ingredient zinc gluconate)- Cold remedy products. When Quigley (Cold-Eeze manufacturer) announced it was offering a nasal zinc spray in 2003, the company was one of two major drug companies to offer the product. Just a year later, the company said it was discontinuing the product. Hundreds of consumers said they lost their ability to smell after using nasal spray containing zinc gluconate, but Quigley claimed it was not discontinuing the Cold-Eeze nasal spray because of the complaint reports but because the company claimed "the product has not developed into a viable entry in the nasal spray cold remedy category," saying it was solely a financial decision. According to the National Institutes of Health, about 2.5 million Americans are believed to suffer from a partial or complete loss of smell. There are no proven treatments to restore smell, and as a result, lawsuits have been filed against Cold-Eeze maker Quigley.

Crestor- (active ingredient rosuvastatin calcium)- is a medicine that lowers "bad" cholesterol and triglycerides and raises "good" cholesterol in the blood. FDA alerts Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. To date, it does not appear that the risk is greater with Crestor than with other marketed statins. However, the labeling for Crestor is being revised to highlight important information on the safe use of Crestor to reduce the risk for serious muscle damage, especially at the highest approved dose of 40 mg. In addition, a study has found that the amount of drug in the blood of a diverse group of Asian patients taking Crestor was two times higher than for Caucasians patients in the study. Therefore, the labeling for Crestor will now recommend a lower starting dose of 5 mg for Asian patients. Kidney failure of various types has also been reported in patients treated with Crestor as well as other statins. FDA has determined that there is not enough evidence to conclude that kidney damage is a direct result of Crestor therapy. If you are currently taking Crestor or any statin and develop signs and symptoms of muscle pain and weakness, fever, dark urine, nausea or vomiting, you should contact your healthcare professional right away.

Duract- (active ingredient bromfenac) a non-steroidal anti-inflammatory drug (NSAID) used for short term management of acute pain (use for 10 days or less). Wyeth-Ayerst Laboratories of St. Davids, Pennsylvania has announced that it is voluntarily withdrawing Duract from the market. The action follows post marketing reports of rare severe liver failure in patients in whom the drug was used for extended periods of time which was not in accordance with labeling instructions. No cases of serious liver injury were reported in the clinical trials; however, because there was a higher incidence of liver enzyme elevations in patients treated long term in clinical trials, the product was approved for use for 10 days or less. After Duract was marketed, FDA and the company received reports of several cases of rare severe hepatitis and liver failure (some requiring transplantation) in patients taking the drug for more than 10 days.

Enbrel- (active ingredient etanercept)- is indicated for reducing signs and symptoms and delaying structural damage in patients with moderately to severely active rheumatoid arthritis. In post marketing reports, serious infections and sepsis, including fatalities, have been reported with the use of Enbrel. Many of these serious events have occurred in patients with underlying diseases that in addition to their rheumatoid arthritis could predispose them to infections.

Ephedra- (active ingredient ephedra alkaloids) / Ephedrine - used in dietary supplements for weight loss. FDA announces rule prohibiting sale of dietary supplements containing ephedrine alkaloids effective April 12, 2004. The FDA declares dietary supplements containing Ephedra adulterated because such supplements present an unreasonable risk of illness or injury. The totality of the available data showed little evidence of ephedra's effectiveness except for short-term weight loss, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These reactions have been conclusively linked to significant adverse health outcomes, including heart ailments and strokes.

Herceptin- (active ingredient trastuzumab)- has been shown to inhibit the proliferation of human tumor cells that overexpress HER2 4-6. Herceptin administration can result in the development of ventricular dysfunction and congestive heart failure. Left ventricular function should be evaluated in all patients prior to and during treatment with Herceptin. The incidence and severity of cardiac dysfunction was particularly high in patients who received Herceptin in combination with anthracyclines and cyclophosphamide.

Hismanal- (active ingredient astemizole)- Rare cases of serious cardiovascular adverse events including death, cardiac arrest, QT prolongation, torsades de pointes, and other ventricular arrhythmias have been observed in patients exceeding recommended doses of Hismanal. While the majority of such events have occurred following substantial overdoses, torsades de pointes (arrhythmias) have very rarely occurred at reported doses as low as 20-30 mg daily (2-3 times the recommended daily dose.)

Lamictal- (active ingredient lamotrigine)- is used for treatment of Bipolar I Disorder and Epilepsy. Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal, as well as a rash-related death. In worldwide post marketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.

Lamisil- (active ingredient terbinafine hydrochloride)- indicated for the treatment of onychomycosis of the toenail of fingernail due to dermatophytes. Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of Lamisil Tablets for the treatment of onychomycosis in individuals with and without pre-existing liver disease. There have been isolated reports of serious skin reactions (e.g. Stevens-Johnson Syndrome and toxic epidermal necrolysis).

Lariam- (active ingredient mefloquine hydrochloride)- an anti-malarial drug widely used by military personnel, Peace Corps volunteers, and international travelers, and sold under the brand name Lariam now carries a warning about its possible link to suicidal behavior. During a two month investigation, United Press International (an international newswire service) uncovered a number of facts about Lariam that seem to prove that manufacturers had some idea that there was a link between the use of Lariam and psychological problems relating to suicide. The FDA's files include reports over the past four years of 11 suicides, 12 suicide attempts, 41 cases of thinking about suicide, and 144 cases of depression among Lariam users.

Lotronex- (active ingredient alosetron hydrochloride)- indicated for use by women with IBS whose main problem is diarrhea and IBS symptoms have not been helped enough by other treatments. Some patients have developed serious bowel side effects while taking Latronex. Serious bowel (intestine) side effects can happen suddenly, including the following two: 1) serious complications of constipation. These complications may lead to a hospital stay, and in rare cases, blood transfusions, surgery, and death. 2) Ischemic colitis (reduced blood flow to the bowel). Ischemic colitis may lead to a hospital stay, and in rare cases blood transfusions, surgery, and death.

Meridia- (active ingredient sibutramine hydrochloride monohydrate)- is an oral prescription medication used for the medical management of obesity, including weight loss and the maintenance of weight loss, and should be used in conjunction with a reduced-calorie diet. These serious side effects have been reported with Meridia: a large increase in blood pressure or heart rate, seizures, bleeding, a rare life-threatening problem called "serotonin syndrome". Cases of depression, suicidal ideation and suicide have been reported rarely in patients on Meridia.

Naproxen (Aleve)- is a part of the class of drugs known as non-steroidal anti-inflammatory drugs, or NSAIDs. The popular over-the-counter drug is used to treat a variety of ailments, including headaches, menstrual cramps, arthritis, and gout. U.S. health regulators warned that heart risks were connected to over-the-counter painkiller naproxen. A study trial showed a "fairly impressive signal of increased risk of heart attack and stroke" among naproxen users. FDA officials did urge patients taking naproxen to follow instructions carefully and avoid using the drug for more than 10 days.

Neurontin- (active ingredient gabapentin)- was approved by the U.S. Food and Drug Administration for the treatment of partial seizures with and without secondary generalization in adults with epilepsy. Pfizer Inc., the world's largest pharmaceutical company, on May 13, 2004 plead guilty and agreed to pay $430 million to resolve all criminal charges and civil liabilities related to the illegal and fraudulent marketing of its top selling epilepsy drug Neurontin by Warner-Lambert's Parke-David Division. Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved for such as: bipolar disorder, various pain disorders, Lou Gehrig's Disease, attention deficit disorder, migraines, drug and alcohol withdrawal seizures, restless leg syndrome, and first-line monotherapy treatment for epilepsy.

OxyContin- (active ingredient oxycodone HCI controlled-release)- FDA has strengthened the warnings and precautions sections in the labeling of OxyContin Tablets, a narcotic drug approved for the treatment of moderate to severe pain. There have been numerous reports of OxyContin diversion and abuse in several states. Some of these reported cases have been associated with serious consequences including death. In an effort to educate health care providers about these risk, Purdue Pharmaceuticals, manufacturer of the product, has issued a warning in the form of a "Dear Healthcare Professional" letter.

Paxil- (active ingredient paroxetine hci)- is an antidepressant drug that has been under a lot of critical target ever since an FDA warning was issued in December 2003. In the summer of 2003, British regulators issued a warning to doctors to avoid prescribing Paxil to children due to the new data linking the antidepressant to suicide attempts. Paxil has been linked to deadly side effects that some people claim was allowed to continue because the company manipulated data to diminish the appearance of suicide risk amongst patients and the FDA.

Permax- (active ingredient pergolide mesylate)- is indicated as adjunctive treatment to levodopa/carbidopa in the management of signs and symptoms of Parkinson's disease. Patients treated with Permax have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Adverse reactions include: headache, asthenia, accidental injury, pain, abdominal pain, chest pain, back pain, flu syndrome, neck pain, fever, facial edema, chills, enlarged abdomen, malaise, neoplasm, hernia, pelvic pain, sepsis, cellulitis, moniliasis, abscess, jaw pain, hypothermia, acute abdominal syndrome, LE syndrome, postural hypotension, syncope, hypertension, palpitations, vasodilatations, congestive heart failure, myocardial infarction, tachycardia, heart arrest, abnormal electrocardiogram, angina pectoris, thrombophlebitis, bradycardia, ventricular extrasystoles, cerebrovascular accident, ventricular tachycardia, cerebral ischemia, atrial fibrillation, varicose vein, pulmonary embolus, AV block, shock, vasculitis, pulmonary hypertension, pericarditis, migraine, heart block, cerebral hemorrhage, nausea, vomiting, dyspepsia, diarrhea, constipation, dry mouth, dysphagia, flatulence, abnormal liver function tests, increased appetite, salivary gland enlargement, thirst, gastroenteritis, gastritis, periodontal abscess, intestinal obstruction, gigivitis, esophagitis, cholelithiasis, tooth caries, hepatitis, stomach ulcer, melena, hepatomegaly, hematemesis, eructation, sialadenitis, peptic ulcer, pancreatitis, jaundice, glossitis, fecal incontinence, duodenitis, colitis, cholecystitis, aphthous stomatitis, esophageal ulcer, hypothyroidism, adenoma, diabetes mellitus, ADH inappropriate, endocrine disorder, thyroid adenoma, anemia, leukopenia, lymphadenopathy, leukocytosis, thrombocytopenia, petechia, megaloblastic anemia, cyanosis, purpura, lymphocytosis, eosinophilia, thrombocythemia, acute lymphoblastic leukemia, polycythemia, splenomegaly, peripheral edema, weight loss, weight gain, dehydration, hypokalemia, hypoglycemia, iron deficiency anemia, hyperglycemia, gout, hypercholesteremia, electrolyte imbalance, cachexia, acidosis, hyperuricemia, twitching, myalgia, arthralgia, bone pain, tenosynovitis, myositis, bone sarcoma, arthritis, osteoporosis, muscle atrophy, osteomyelitis, dyskinesia, dizziness, hallucinations, confusion, somnolence, insomnia, dystonia, paresthesia, depression, anxiety, tremor, akinesia, extrapyramidal syndrome, abnormal gait, abnormal dreams, incoordination, psychosis, personality disorder, nervousness, neuropathy, neuralgia, hypertonia, delusions, convulsion, libido increased, euphoria, emotional lability, libido decreased, vertigo, myoclonus, coma, apathy, paralysis, meurosis, hyperkinesia, agitation, hypotonia, stupor, neuritis, intracranial hypertension, hemiplegia, facial paralysis, brain edema, myelitis, rhinitis, dyspnea, pneumonia, pharyngitis, cough increased, epistaxis, hiccup, sinusitis, bronchitis, voice alteration, hemoptysis, asthma, lung edema, pleural effusion, laryngitis, emphysema, apnea, hyperventilation, pneumothorax, lung fibrosis, larynx edema, hypoxia, hypoventilation, hemothorax, carcinoma of lung, sweating, rash, skin discoloration, pruritus, acne, skin ulcer, alopecia, dry skin, skin carcinoma, seborrhea, hirsutism, herpes simplex, eczema, fungal dermatitis, herpes zoster, vesibulobullous rash, subcutaneous nodule, skin nodule, skin benign neoplasm, lichenoid dermatitis, abnormal vision, dipolpia, otitis media, conjunctivitis, tinnitus, deafness, taste perversion, ear pain, eye pain, glaucoma, eye hemorrhage, photophobia, visual field defect, blindness cataract, retinal detachment, retinal vascular disorder, urinary tract infection, urinary frequency, urinary incontinence, hematuria, dysmenorrhea, dysuria, breast pain, menorrhagia, impotence, cystitis, urinary retention, abortion, vaginal hemorrhage, vaginitis, priapism, kidney calculus, menopause, kidney failure, breast carcinoma, cervical carcinoma, amenorrhea, bladder carcinoma, breast engorgement, epididymitis, hypogonadism, leukorrhea, nephrosis, pyelonephritis, urethral pain, uricaciduria, withdrawal bleeding, neuroleptic malignant syndrome.

Posicor- (active ingredient mibefradil)- intended as a hypertension and chronic stable angina pectoris medication. Roche Laboratories withdrew Posicor from the market due to the drug's risk of serious interactions. When Posicor was combined with certain medications it increased the risk of serious side effects. There were are least 143 deaths as a result of individuals taking Posicor with the majority of deaths due to heart arrhythmias.

PPA- (active ingredient phenylpropanolamine)- The FDA is taking steps to remove PPA from all drug products and has requested that all drug companies discontinue marketing products containing PPA. In addition, FDA has issued a public health advisory concerning PPA. This drug is an ingredient that was used in many over-the-counter and prescription cough and cold medications as a decongestant and in over-the-counter weight loss products. A Yale University School of Medicine study reports that taking PPA increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk.

Prempro- (active ingredient conjugated estrogens/medroxygrogesterone acetate)- therapy relieves women from menopausal symptoms using lower doses of hormones. The Women's Health Initiative study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens combined with medroxyprogesterone acetate relative to placebo. Estrogens increase the chances of getting cancer of the uterus.

Propulsid- (active ingredient cisapride)- used as a treatment for severe nighttime heartburn experienced by adult patients with gastroesophageal reflux disease (GERD). On March 23, 2000, the FDA announced that Janssen Pharmaceutica (a wholly-owned subsidiary of Johnson & Johnson) would cease marketing of Propulsid in the United States as of July 14, 2000. In its announcement, the FDA stated that as of December 31, 1999, use of cisapride has been associated with 341 reports of heart rhythm abnormalities including 80 reports of deaths. A variety of lawsuits have been filed against Janssen Pharmaceutica and Johnson & Johnson over the effects of Propulsid.

Protopic- (active ingredient tacrolimus)- topical cream for treatment of eczema. The FDA has ordered a "black box" warning be placed on this popular skin cream because of possible cancer risk. Protopic is usually applied topically through a cream, but authorities warn if absorbed it can cause cancer. The drug agency issued a Protopic public health advisory based on information from animal studies. The FDA has received reports of lymphoma and skin cancer in children and adults treated with Protopic since its December 2000 approval. The FDA said the manufacturer has agreed to do more tests to determine the actual cancer risks in Protopic users, but until then, the FDA has recommended use of Protopic in children younger than two years of age be avoided and that it be used only as a second-line agent for short-term and intermittent treatment in adult patients that have been unresponsive or intolerant to other treatments.

Raxar- (active ingredient grepafloxacin hydrochloride)- Raxar oral fluoroquinolone antibiotic was prescribed to an estimated 2.65 million patients from when Raxar was first marketed in August 1997 until the October 1997 recall. Raxar was intended to treat a variety of infections, such as pneumonia, bronchitis, and some sexually transmitted infections. The antibiotic has been linked to serious side effects including Raxar prolonging the heart's QT interval that can lead to ventricular arrhythmia that can become fatal.

Redux- (active ingredient dexfenfluramine hydrochloride)- an anti-obesity drug, a serotonin reuptake inhibitor and releasing agent. On September 15, 1997 the FDA announced that they were withdrawing Redux from the market. This action was based on post marketing reports from the Mayo Clinic of 24 cases of heart valve disease in some patients that were treated. Additional adverse Redux heart valve findings were also found to occur. Cases of heart disease and heart damage are continuing to surface because of the delayed diagnoses that can often result because of the non-evident symptoms. The once popular Redux diet drug has resulted in a Nationwide Class Action Settlement Agreement that received Final Judicial Approval on January 3, 2002. Redux has been directly linked to instances of primary pulmonary hypertension and failed to properly warn patients that the deadly condition of PPH could occur.

Releza- (active ingredient zanamivir)- is used to treat uncomplicated illness due to influenza virus in people 7 years and older who have been symptomatic for no more than 2 days. Some patients have had bronchospasm (wheezing) or serious breathing problems when they used Relenza. Other side effects include: headache, diarrhea, nausea, vomiting, nasal irritation, bronchitis, cough, sinus inflammation, ear, nose, and throat infections, and dizziness.

Rezulin- (active ingredient troglitazone)- a drug used to treat type 2 diabetes mellitus. The FDA asked the drug's manufacturer Parke-Davis/Warner-Lambert to withdraw the drug from the market. The FDA took this action after its review of recent safety data on Rezulin that showed it is more toxic to the liver than other diabetes drugs. Severe liver toxicity has been known to occur with Rezulin since 1997.

Risperdal- (active ingredient risperidone)- used to treat symptoms of schizophrenia that may include hearing voices, seeing things, or sensing things that are not there, mistaken beliefs or unusual suspiciousness. FDA has found that older patients treated with Risperdal for dementia had a higher chance for death than patients who did not take the medication. A life-threatening nervous system problem called neuroleptic malignant syndrome is associated with Risperdal. Other serious side effects include tardive dyskinesia (a movement problem), high blood sugar and diabetes, strokes, low blood pressure, dizziness, increased heart beat and possibly fainting, seizures, persistent erection, thrombotic thrombocytompenic purpura, increase or decrease in body temperature, difficulty swallowing, anxiety, uncontrolled movements, constipation, nausea, upset stomach, runny nose, rash, vision change, saliva increase, abdominal pain, inability to control urination, and weight gain.

Seldane- (active ingredient terfenadine)- an antihistamine. The FDA, with the advice of Center officials of the Division of Pulmonary Drug Products, has determined that drugs containing terfenadine are no longer shown to be safe because Allegra (fexofenadine) is now available. The FDA received reports of serious and sometimes fatal cardiac arrhythmias associated with Seldane when it was taken with some other medications or by patients with liver disease.

Serentil- (active ingredient mesoridazine besylate)- used in the treatment of schizophrenia. Serentil has been shown to prolong the QTc interval in a dose related manner, and drugs with this potential, including Serentil, have been associated with torsade de pointes-type arrhythmias and sudden death.

Serevent- (active ingredient salmeterol xinafoate)- for the treatment of asthma. Serevent, manufactured by GlaxoSmithKline, later had its FDA-approved use extended to include treatment of chronic obstructive pulmonary heart disease. Used daily, Serevent controls the symptoms of asthma and is considered a long-acting bronchodilator. Users of Serevent are three times more likely to die asthma-related deaths as users of other asthma medications. 36 participants in a Serevent study experienced life-threatening asthma episodes, including several who died.

Seroquel- (active ingredient quetiapine fumarate)- used for the treatment of schizophrenia. Extensive clinical trials show that Seroquel is effective in the treatment of all manner of symptoms of schizophrenia, from delusions to apathy. Until recently, it appeared that Seroquel was a new miracle drug, effectively controlling symptoms of schizophrenia, while avoiding the side effects that many patients found irritating or embarrassing. However, warnings surfaced that Seroquel is linked to risk of elevated blood sugar and diabetes.

Serzone- (active ingredient nefazodone hydrochloride)- indicated for the treatment of depression. FDA has concluded that suicidal thinking or behavior may increase in pediatric patients treated with antidepressants, especially early in treatment. Increases in suicidal thinking or behavior due to drug can be expected in about 1 out of 50 treated pediatric patients. All patients being treated with antidepressants should be observed closely for clinical worsening and suicidality especially during the first few months of therapy and when the dose is modified. Note that nefazodone is not approved for use in pediatric patients. Serzone may cause serious liver problems, which may lead to death. Other risks include: low blood pressure and fainting, becoming hyperactive, excitable, or elated, seizures, an erection that will not go away, sleepiness, dry mouth, nausea, dizziness, constipation, weakness, lightheadedness, vision problems, and confusion.

Strattera- (active ingredient atomoxetine HCI)- non-stimulant medication used to treat Attention Deficit Hyperacitivity Disorder (ADHD). Allergic reactions, including angioneurotic edema, urticaria, and rash, have been reported in patients taking Strattera. Strattera can cause an increase in blood pressure and heart rate. Growth can also be affected and needs to be monitored while taking Strattera.

Tasmar- (active ingredient tolcapone)- used together with the Parkinson's medication carbidopa/levodopa to treat Parkinson's disease. In patients taking Tasmar serious side effects have been reported including non-traumatic rhabdomyolsis (unexplained muscle tenderness or pain), extremely high fever, confusion, and death. Due to the risk of serious liver injury and even death, Tasmar is reserved for use in patients who do not have severe movement abnormalities and who do not respond to or who cannot take other available treatments. Other side effects include: abnormal jerky movements, nausea, dizziness or fainting, sleep disorders, diarrhea, and hallucinations.

Thalidomide- (active ingredient thalidomide)- was first marketed in Europe in the late 1950's. It was used as a sleeping pill and to treat morning sickness during pregnancy. At that time no one knew thalidomide caused birth defects. Tragically, when thalidomide was used by pregnant women, it resulted in the birth of thousands of deformed babies. In 1961 scientists discovered that the medication stunted the growth of fetal arms and legs. Other side effects include: mood changes, dry mouth, headache, nausea, constipation, increased appetite, puffiness of the face and limbs (edema), dry skin, itching, irregular menstrual period, low white blood cell count, thyroid problems, blood sugar that is too high or low, slow heart beat.

Thimerosal- (active ingredient ethylmercury and thiosalicylate)- Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930's. No harmful effects have been reported from thimerosal at doses used in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999, the Public Health Service (PHS) agencies, the American Academy of Pediatrics (AAP), and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.

Viagra- (active ingredient sildenafil)- the first oral pill to treat impotence. In patients taking Viagra, several heart-related side effects have been reported, including heart attack, sudden death, irregular heart rhythm, stroke, chest pain, and increased blood pressure. It is not possible to determine whether these events are directly related to Viagra, to sexual activity, to the patient’s heart condition, to a combination of these factors, or to other factors.

Videx- (active ingredient didanosine)- Once-Daily Videx is used for the treatment of HIV-1 infection in adults whose management requires once-daily administration of didanosine or an alternative didanosine formulation. Fatal and nonfatal pancreatitis have occurred during therapy with Videx. Pancreatitis is a dangerous inflammation of the pancreas. Symptoms of pancreatitis may include abdominal pain, nausea, vomiting and weight loss. When the US Food and Drug Administration (FDA) first approved Videx in 1991, the drug's package insert (drug labeling) included a warning of a one percent to 10% risk of Videx-associated pancreatitis. A revised warning letter to physicians was issued as the result of four pancreatitis deaths in patients participating in a government-sponsored study in which patients took Videx plus Zerit with or without hydroxyurea.

Viga- is marketed as a dietary supplement and sold over the counter and on the Internet. Viga is distributed by Best Life International. U.S. Food and Drug Administration (FDA) investigators found that the tablets contained the unlabeled prescription drug ingredient, sildenafil (the prescription ingredient found in Viagra), which may pose possible serious health risks to some users. Sildenafil can interact with prescription nitrates that are used to treat chest pain and can cause a life-threatening drop in blood pressure. The use of nitrates is an absolute contraindication for sildenafil users. The potential for this product to be taken by unknowing nitrate users is real, since erectile dysfunction is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia, smokers, and patients with ischemic heart disease.

Vioxx- (active ingredient rofecoxib)- a medication given for relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, rheumatoid arthritis in adults and children, and for the treatment of menstrual symptoms. Vioxx was withdrawn from the market by Merck & Co., Inc. due to safety concerns of an increased risk of cardiovascular events including heart attack and stroke in patients of Vioxx.

Zerit- (active ingredient stavudine)- Zerit XR is the brand name for an extended-release formulation of stavudine, a synthetic thymidine nucleoside analogue, active against HIV. Fatal Lactic acidosis has been reported in pregnant women who received the combination of Zerit XR (stavudine) and didanosine with other antiretroviral agents. The combination of Zerit XR (stuvudine) and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk. Fatal and nonfatal pancreatitis have occurred during therapy when Zerit XR (stavudine) was part of a combination regiment that included dianosine, with or without hydroxyurea.

Zicam- (active ingredient soluble zinc)- is an over the counter homeopathic medication designed to reduce the duration of the common cold. Reports continue to surface that users of Zicam are suffering from a condition known as anosmia, or total loss of smell. According to the lawsuits filed by various users of Zicam, it has been known for decades that the use of intranasal zinc causes anosmia and hyposmia (partial loss of smell). Despite this seemingly obvious problem, Zicam and other cold remedies containing soluble zinc are not tested by the FDA for safety of efficacy. Despite the company's assurances that Zicam adheres to FDA guidelines and restrictions, lawsuits have been filed by Zicam users against both Matrixx Initiatives and Zicam LLC.

Zoloft- (active ingredient sertraline HCI)- an antidepressant. In 1998, a scientist at Pfizer, maker of Zoloft, found that "all SSRIs have the rare potential to cause akathisia." When referring to the most extreme cases, the scientist wrote that patients might feel "death is a welcome result." The Zoloft and other antidepressant drug controversy have escalated into a legal battle. Zoloft lawsuits and other SSRI related lawsuits have continued to be argued.

Zyprexa- (active ingredient olanzapine)- Zyprexa is a type of medicine called an atypical antipsychotic. FDA has found that older patients treated with atypical antipsychotics for dementia had a higher chance for death than patients who did not take the medicine. A life-threatening nervous system problem called neuroleptic malignant syndrome is associated with Zyprexa. NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. Other side effects include: a movement problem called tardive dyskinesia, high blood sugar and diabetes, strokes, low blood pressure (seen as dizziness, and possibly fainting, increased heart beat, seizures, liver problems, increased body temperature, and difficulty swallowing), sleepiness, dry mouth, dizziness, restlessness, constipation, upset stomach, weight gain, increased appetite, and tremor.