Consumer Drug Safety

UPDATE: SEPTEMBER 10, 2007: Study on Drug Safety shows Deaths related to Consumer Drugs on the Rise.

Study on Drug Safety shows Deaths related to Consumer Drugs on the Rise.

A recent study published September 10, 2007 by the Institute for Safe Medication Practices, in Huntingdon Valley, Pa. has illustrated that the number of serious adverse drug events more than doubled between 1998 and 2005 in the United States.

These study results are in the Sep 10, 2007 issue of the Archives of Internal Medicine.

Thomas Moore, the lead study author is quoted saying, "This is the first study to ask the question, 'Are we gaining ground or losing ground in drug safety and improving patient safety in prescription drugs?' And I think, inescapably, the conclusion is that we're losing ground,"

In the study the Institute for Safe Medication Practices analyzed all serious adverse drug events and medication errors reported to the FDA from 1998 to 2005.

The FDA defines a serious adverse drug event as an adverse event that results in death, a birth defect, disability, hospitalization or is life-threatening or requires intervention to prevent harm.

From the years 1998 to 2005, the number of reported serious adverse drug events increased 2.6-fold from 34,966 in 1998 to 89,842 in 2005. The number of fatal adverse drug events increased 2.7-fold during the same time period, from 5,519 in 1998 to 15,107 in 2005.

The number of adverse events increased four times faster than the total number of outpatient prescriptions, which rose from 2.7 billion to 3.8 billion during that time frame.

A total of 1,489 drugs were associated with adverse events, yet 51 drugs were accounting for a high percentage of the overall problem.

Pain medications and drugs that affect the immune system were disproportionately represented among those that caused death.

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Accutane:
The most severe side effects associated with Accutane include the increase of miscarriage and infant deaths, fetal malformations, mental retardation, heart defects, and facial abnormalities. Further, Accutane has been linked to depression. The FDA has received approximately 100 reports of suicides linked to the use of Accutane, and over 1,000 reports of various psychological problems among those who use the drug.

Advair:
The FDA issued a black-box safety warning that was added to Advair labels in 2003 for asthma "long-acting beta-agonist" or LABA treatments Serevent Diskus (salmeterol xinafoate) and Advair Diskus (fluticasone propionate; salmeterol xinafoate), based upon preliminary results of the Salmeterol Multicenter Asthma Research Trial. A Serevent study concluded that a small number of patients experienced severe exacerbations of their asthma after taking the drug. In a clinical trial, thirteen people died out of a group of 13,176 people taking salmeterol.

Ambien:
In some state toxicology laboratories, Ambien shows up in the top 10 list of drugs found in impaired drivers. In Wisconsin, Ambien was detected in the bloodstreams of 187 arrested drivers from 1999 to 2004. Often, these drivers later say they were sleep-driving and have no memory of any events that followed taking the drug.

Aranesp:
Together with the FDA, Aranesp’ maker, Amgen, has sent a letter to doctors advising them of a revision to the warning label for Aranesp. Two recent studies with other drugs in the same class of Aranesp, known as erythropoietic drugs, have shown that using the drugs at higher-than-recommended doses increases the risk of adverse effects including extreme high blood pressure, blood clots and death.

Aredia:
In September 2004, Novartis Pharmaceuticals and the FDA notified dental healthcare professionals of the occurrence of Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, such as Aredia. The revised prescribing information that followed recommended that cancer patients receive a dental examination prior to taking Aredia, and that they avoid invasive dental procedures while on this medication.

Baycol:
The FDA announced on August 8, 2001 that Bayer Pharmaceutical Division was voluntarily withdrawing Baycol from the U.S. market because of reports of fatal rhabdomyolysis, a severe muscle adverse reaction from taking the drug. Prior to this, the FDA had received reports that 31 people died as a result of complications from using Baycol. In every case, the drug caused rhabdomyolysis, where the content of muscle cells spill into the bloodstream and overload the kidneys until they shut down. Other serious side effects associated with Baycol use include liver damage and liver failure.

Bextra:
On April 7, 2005, Pfizer withdrew Bextra from the U.S. market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction. Pfizer first acknowledged cardiovascular risks associated with Bextra in October of 2004. The American Heart Association soon after was presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.

Celebrex:
COX-2 inhibitor painkillers, such as Celebrex, are suspected of causing fatal heart disease and may act to harden the arteries. Celebrex has been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes.

Cialis:
In May 2005, the FDA found that the use of Cialis could lead to blindness and the loss of vision in certain patient groups. Thus, the FDA approved new labels for Cialis to include information on possible eyesight loss, also known as non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow becomes blocked to the optic nerve. Cialis also has been reported to cause blood pressure to drop suddenly to an unsafe level if it is taken with any nitrate medication or with any alpha-blocker medication. Further complications can include hypotension, myocardial infarction, ventricular arrhythmias, sudden death, and stroke.

Cold-Eeze:
Recently, hundreds of consumers have claimed that taking Cold-Eeze has caused them anosmia, or a loss of smell and taste. Many Cold-Eeze users have also reported experiencing horrific, almost unbearable burning after using the nasal spray. Some scientists believe that zinc gluconate glycine, in certain quantities, can have an astringent effect that has been linked to olfactory nerve damage when applied through the nose. Furthermore, critics argue that zinc-based nasal sprays are ineffective against colds.

There are no proven treatments to restore smell, and as a result, lawsuits have been filed against Cold-Eeze maker Quigley, alleging that the company knew or should have known about the potential dangers associated with the use of nasal medications containing zinc, and that Quigley failed to provide sufficient warnings to the users of its product.

Crestor:
Crestor side effects could prove crippling or even deadly - rhabdomyolysis occurs when a large number of skeletal muscle cells die, resulting in the release of a massive amount of muscle protein into the bloodstream. The muscle protein becomes trapped in the kidneys, affecting the filtering process of the kidneys and leading to kidney failure. Related Crestor side effects include serious liver damage and liver death.

Duract:
In l998, in response to the reports of severe liver failure and transplants, the FDA and Wyeth-Ayerst strengthened the warnings in Duract’s labeling with a special black box warning. The revised label re-emphasized that patients should not take the drug for more than 10 days and alerted physicians and other health care professionals to the cases of severe hepatitis and liver failure in patients who had taken Duract. Despite these efforts, the FDA and Wyeth-Ayerst continued to receive reports of severe injuries and death with long-term use of the drug. Given the availability of other therapies, the FDA and Wyeth-Ayerst concluded that it would not be practical to implement the restrictions necessary to assure the safe use (less than 10 days) of Duract. Therefore, the company and the FDA agreed that it would be prudent to withdraw the drug from the market.

Duragesic Fentanyl Patch:
The FDA is investigating reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. The directions for using the Duragesic fentanyl patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl.

Ephedra:
The FDA has advised consumers to stop using dietary supplements containing ephedra due to serious heart complications associated with its use. After a careful review of the available evidence about the risks and benefits of ephedra in supplements, the FDA found that these supplements present an unreasonable risk of illness or injury to consumers. The data showed little evidence of ephedra's effectiveness, except for short-term weight loss, while confirming that the substance raises blood pressure and stresses the heart. The FDA concluded that the increased risk of heart problems and strokes negates any benefits of weight loss.

Epogen:
On December 1, 2005, Amgen, Ortho Biotech and the FDA notified healthcare professionals of revision to the ‘Warnings, Precautions, Adverse Reactions, and Dosage and Administration’ sections for Epogen, based upon a study that found a high risk of death, heart attack, hospitalizations for heart failure and stroke in patients with chronic kidney disease who were treated with Epogen. The study found that Epogen raised patient hemoglobin levels higher than what the labeling for the product recommends and about half of all kidney dialysis patients had their red blood cell counts boosted beyond what the FDA says is safe--about 20% experienced red blood cell counts in the potential danger zone for stroke and heart attack.

Femara:
Recent reports have found that Femara is being prescribed by fertility physicians to induce ovulation, especially in infertile females. The use of Femara as a fertility drug suppresses the development of estrogen that can cause ovulation to occur. However, it should not be taken by pregnant women, or women who are trying to become pregnant, as letrozole causes substantial damage to the fetus.

Fen-Phen:
Fen-Phen was withdrawn from the U.S. market in 1997 after reports of heart valve disease and pulmonary hypertension, including a condition known as cardiac fibrosis. In addition to heart valve disease, the use of fenfluramine has been found to increase the risk of developing Primary Pulmonary Hypertension or PPH. PPH is a rare disease that causes the progressive narrowing of the blood vessels of the lungs. Studies estimate that treatment with certain appetite suppressant drugs, such as Fen-Phen, tends to increase the chances of developing PPH by approximately 25 to 30 percent.

Fosamax:
Medical studies suggest that bisphosphonate compounds like Fosamax restrict blood flow to the bone and cause Osteonecrosis of the Jaw (ONJ); a progressively debilitating condition that results in actual bone death. Also known as “Dead Jaw Syndrome,” ONJ is associated with minor jaw trauma such as tooth extractions that do not heal properly, typically leading to exposure of the bone. Serious complications often follow this exposure including extreme pain, virulent infections, tooth loss and disfigurement.

In 2004, the FDA issued a written warning to Merck about false and misleading statements about Fosamax in some of its advertising and marketing materials, and demanded removal of all misleading statements. The FDA also urged Merck to make certain Fosamax labeling changes include a warning that ONJ has been reported in patients taking bisphosphonates.

Gandolinium:
The Danish Medicines Agency (DMA) issued a press release on May 29, 2006, that reported patients with renal failure developing a rare, potentially life-threatening condition called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) after being administered Gadolinium-containing contrast agents. The DMA was concerned because all patients received a Gadolinium enhanced MRI procedure a few weeks to a few months before developing NSF/NSD.

Hismanal:
In 1999, Janssen Pharmaceutica, the maker of Hismanal, notified health care providers that they were voluntarily discontinuing the manufacturing, distribution and marketing of the drug. In 1998, the FDA first warned consumers and healthcare providers of new safety information regarding Hismanal due to the risk of death, cardiovascular adverse events, anaphylaxis, and serious drug interactions that were occurring with its use. In addition, Hismanal labeling was changed to stress avoiding the use of Hismanal in combination with certain other medications and for liver disorder patients to completely avoid its use. After a series of labeling changes and warnings, Hismanal was recalled on June 21, 1999.

Ketek:
In May 2006, the FDA recommended that a black box warning be added to the Ketek label, stating that "severe, life-threatening, and in some cases fatal" liver toxicity has been reported in patients taking the drug. The recommendation came after FDA safety reviewers found that Ketek has been linked to 12 cases of liver failure, including four deaths, in the U.S. In some cases, liver damage worsened rapidly and happened after just a few doses of Ketek.

While this FDA advisory panel did not recommend a Ketek recall, according to a December 13, 2006 report by CBS News, there is a new Congressional probe underway to determine whether Ketek should remain on the market.

Lamisil:
In April 2001, the FDA issued a public health advisory on the safety of terbinafine hydrochloride (Lamisil) tablets, based upon a study finding 16 possible Lamisil associated cases of liver failure, including 11 deaths and two liver transplant patients.

Levitra:
In 2005, the FDA notified healthcare professionals of updated labeling for Levitra to reflect post-marketing reports of sudden vision loss attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. Levitra has also been reported to cause blood pressure to drop to an unsafe level if it is taken with any nitrate medication or with any alpha-blocker medication. Further complications can include hypotension, myocardial infarction, ventricular arrhythmias, sudden death, and stroke.

Lotronex:
In 2000, Glaxo Wellcome withdrew Lotronex tablets from the market, as the drug was reportedly causing serious, sometimes fatal intestinal side effects including constipation and ischemic colitis--a serious complication caused by reduced blood flow to the intestines. The FDA studied 70 cases of adverse reactions to Lotronex, including 5 deaths. The main concern was the potential for damage to the intestine from either ischemic colitis or severe constipation.

Meridia:
Meridia substantially increases blood pressure and heart rate in some patients and should not be given to patients with uncontrolled or poorly controlled hypertension, history of heart disease, stroke, severe liver or kidney disease, pregnant women or nursing mothers.

Important safety information about certain types of selective serotonin/norepinephrine re-uptake inhibitors (SNRIs), such as Meridia, has been posted due to the risk of heart failure, high blood pressure, blood clots, seizures, and neurological disorders associated with usage.

Metabolife:
There can be serious side effects when ephedra is used in combination with caffeine--two of the active ingredients in Metabolife. The FDA has collected reports of more than 100 deaths among Metabolife users, as well as over 800 reports of heart attacks, seizures, strokes, and other health problems since 1994. These health problems include hypertension, heart palpitation, nerve damage, muscle injury, psychosis and memory loss, heart rate irregularities, and tremors.

Mifeprex:
Since the approval of mifepristone in September 2000, the FDA has received reports of deaths in the United States following medical abortion with mifepristone (Mifeprex) and misoprostol. An FDA black box warning was issued on July 19, 2005, informing health care providers that infections have occurred after patients have used Mifeprex. This came after four women in the United States died from sepsis after medical abortion with Mifeprex and misoprostol. All four women were infected by the same type of bacteria, Clostridium sordelli.

Mirapex:
Mirapex is prescribed to treat moderate to severe primary restless legs syndrome, and can also be used in the treatment of Parkinson’s disease. Mirapex, a member of the class of drugs called "dopamine agonists" works by imitating the actions of dopamine in the brain, which also helps to control the tremors in smooth muscle that is associated with Parkinson's disease.

Mobic:
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. In 2005, the FDA issued a black box warning on the label of Mobic that highlights the increased risk of cardiovascular (CV) events while using the drug and the serious, potentially life-threatening gastrointestinal (GI) bleeding associated with its use. Mobic has also been linked to liver damage and may be associated with an increased risk of hypertension, congestive heart failure, and edema.

Ortho Evra:
In 2005, the FDA approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels (60% more) of estrogen than most birth control pills. High estrogen levels are linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks, pulmonary embolisms, and deep vein thromboses (DVTs).

Hormones from patches applied to the skin, such as Ortho Evra, get into the blood stream quicker and are removed from the body differently than hormones from birth control pills taken by mouth. According to the AP, about a dozen women, most of them in their late teens and early 20's, died from blood clots in 2004 from using the Ortho Evra patch.

Palladone:
In 2005, the FDA stopped the sale of Palladone, just five months after it made its entrance to the U.S. market. The FDA issued a public health advisory to notify health care professionals and consumers that the sponsor of Palladone, Purdue Pharma, has agreed to suspend sales and marketing of the drug because of the potential for severe side effects if Palladone is taken with alcohol. Drinking alcohol while taking Palladone may cause rapid release of hydromorphone, leading to high drug levels in the body. High drug levels of hydromorphone may depress or stop breathing, cause coma, and even cause death.

Paxil:
In March 2004, the FDA placed a black box warning on SSRI and other antidepressants, including Paxil, warning of the risk of potential suicidal thinking. It has been suggested that Paxil may cause depression to worsen and even lead to suicide in a small number of patients. These potential side effects are difficult to evaluate in depressed patients because depression can progress with or without treatment, and suicide is itself a consequence of depression. For pregnant women, there is also a potential risk to the fetus when taking Paxil (paroxetine). Some studies of paroxetine in pregnant women have suggested an increased risk of heart malformations.

Phenergan:
In 2006, the FDA issued an alert notifying healthcare professionals and the public that Phenergan should not be given to children less than two years of age because of possible breathing problems. This warning pertains to Phenergan (promethazine) in any form: syrups, suppositories, tablets, or injectables. In addition, excessive sedation may occur when Phenergan is combined with other medications that depress the central nervous system. Such drugs include ethanol, barbiturates, anti-anxiety medications, sedatives, other phenothiazines, and narcotic pain medications. Further, Phenergan should not be used with propylthiouracil (PTU) due to the potential dangerous drop in white blood cell count which can increase the risk of infections.

Pondimin:
Pondimin was withdrawn from the U.S. market in 1997 after reports of heart valve disease and pulmonary hypertension, including a condition known as cardiac fibrosis. In addition to heart valve disease, the use of Pondimin has been found to increase the risk of developing Primary Pulmonary Hypertension or (PPH). PPH is a rare disease that causes the progressive narrowing of the blood vessels of the lungs.

Medical reports have also linked Pondimin to the occurrence of serious regurgitant cardiac valvular disease, including disease of the mitral, aortic, and/or tricuspid valves. As of July 8, 1997, there have been 33 cases reported to the FDA of unusual valvular morphology and regurgitation involving the mitral, aortic, and/or tricuspid valves, usually being multivalvular.

Posicor:
In 1998, Roche Laboratories, the makers of Posicor, announced they were withdrawing the drug from the market. When Posicor is combined with certain medications, it increases the risk of serious side effects. There were at least 143 deaths reported as a result of individuals taking Posicor, with the majority of deaths due to heart arrhythmias.

Prempro:
In 2003, the FDA issued a black box warning to be included on the labeling of Prempro that states estrogens and estrogen plus progestin therapies should not be used for the prevention of cardiovascular disease. Specifically, it states that because the Women’s Health Initiative (WHI) study reported an increased risk of myocardial infarction, stroke, invasive breast cancer, and venous thromboembolism (VTE), estrogens and estrogens plus progestin therapies should be prescribed for the shortest duration consistent with treatment goals. Two-drug combination hormone replacement therapy can infrequently cause cancer of the breast, heart disease/heart attack, stroke, dementia, and blood clots in the lungs (pulmonary embolism) or legs. Estrogens may also increase the risk of ovarian cancer.

Procrit:
In 2006, the FDA notified healthcare professionals of a newly published clinical study showing that patients treated with Procrit are at a significantly increased risk for serious and life threatening cardiovascular complications. Procrit injections may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment.

Propulsid:
On December 31, 1999, the FDA announced that Propulsid had been associated with 341 reports of heart rhythm abnormalities, including 80 reports of deaths. Health professionals were notified that Janssen Pharmaceutica Inc. would stop marketing Propulsid in the United States as of July 14, 2000 due to serious, even fatal heart problems occurring when Propulsid was used alone or with other drugs such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), nefazodone, protease inhibitors (e.g., ritonavir), drugs used to treat irregular heartbeats such as quinidine or sotalol, antidepressants (e.g., tricyclic or certain tetracyclics), antipsychotics (e.g., certain phenothiazines, sertindole), astemizole, sparfloxacin, and terodiline.

Prozac:
In 2005, the FDA issued a black box warning to be included on the labeling of Prozac that recommends close observation of adult and pediatric patients treated with Prozac for worsening depression or the emergence of suicidality. The FDA announced that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior.

In 2006, the FDA announced the results of a study looking at the use of Prozac during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN). Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies.
Also in 2006, the FDA issued an alert stating that a life-threatening condition called Serotonin Syndrome can occur when medicines called Serotonin and Norepinephrine Reuptake Inhibitors (such as Prozac) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans) are taken together. Serotonin Syndrome is a condition caused by an excess of serotonin in the brain, and the effects may progress from headaches, dizziness and vomiting, to coma and death.

Raplon:
In March of 2001, Organon, Inc., the manufacturer of Raplon, voluntarily withdrew the product from the market because it may have been linked to 5 deaths and 90 other problems related to bronchospasm (an inability to breathe normally).

Raxar:
In 1999, the FDA notified the public and health care professionals that Glaxo Wellcome, the maker of Raxar, was voluntarily withdrawing the drug due to a small number of severe cardiovascular events. Raxar is linked to serious side effects including prolonging the heart's QT interval that can lead to fatal ventricular arrhythmia.

Redux:
Redux (dexfenfluramine) was withdrawn by the FDA from the U.S. market in 1997 after reports of heart valve disease and pulmonary hypertension, including a condition known as cardiac fibrosis, was connected with its use. In addition to heart valve disease, the use of Redux has been found to increase the risk of developing Primary Pulmonary Hypertension or PPH. PPH is a rare disease that causes the progressive narrowing of the blood vessels of the lungs.

ReNu with MoistureLoc Lens Solution:
On April 13, 2006, Bausch & Lomb announced that it is withdrawing all U.S.-manufactured ReNu with MoistureLoc products and is recommending that consumers stop using ReNu with MoistureLoc Lens Solution immediately because of a possible link between use of the product and the development of Fusarium keratitis, which may result in blindness if left untreated. The company, along with the FDA, has acknowledged 109 cases of suspected Fusarium keratitis in 17 different states linked to the use of ReNu with MoistureLoc.

Rezulin:
Rezulin was recalled on March 21, 2000 after a controversial FDA approval and stay on the U.S. market. There have been an estimated 430 Rezulin patients that suffered liver failure, including 391 deaths. It was found that a Rezulin patient's risk of liver failure was increased 1,200 times by taking the drug.

Risperdal:
Risperdal has been linked to type 2 diabetes, juvenile diabetes, hyperglycemia, other blood sugar disorders, diabetic coma, and pancreatitis—a dangerous inflammation of the pancreas. A 2003 study reported that there were 49% more cases of diabetes among patients taking Risperdal than among patients using older anti-psychotic drugs. After the study, the FDA required Risperdal to carry a new warning label that recommends its users be monitored for blood sugar abnormalities.

In addition, in April 2005, the FDA issued an alert stating that elderly patients treated with Risperdal for dementia had a higher chance for death by stroke and cardiac arrest than patients who did not take the drug. Other dangerous side effects of Risperdal include excessive weight gain, Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia. NMS is a potentially fatal condition that can cause severe muscle rigidity and spikes in blood pressure and pulse.

Ritalin:
It has been reported that there have been at least 19 cases of sudden death in children taking Ritalin, leading to calls to the Drug Safety and Risk Management Advisory Committee of the FDA to issue the most serious type of health warning (“black box”) on the label. Further reports have detailed 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia in patients taking Ritalin.

On February 9, 2006, the Drug Safety and Risk Management Advisory Committee of the FDA voted by a margin of eight to seven to recommend a "black-box" warning describing the cardiovascular risks of stimulant drugs used to treat attention-deficit hyperactivity disorder (ADHD), such as Ritalin. On March 22, 2006, the FDA Pediatric Advisory Committee decided that the medications do not need black box warnings about their risks. The FDA declined to include these black box warnings upon review.

Rituxan:
In 2004, Genentech notified healthcare professionals of revisions to the ‘Warnings’ section of the prescribing information due to reports of fulminant (lethal) Hepatitis B virus (HBV) contraction, hepatic failure, and death in some patients with hematologic malignancies from using Rituxan. The FDA also issued a public health advisory on Rituxan after two lupus patients taking the drug reportedly died of a viral brain infection. Both patients developed progressive multifocal leukoencephalopathy (PML), a brain infection caused by a common but usually harmless virus. However, in those who contract PML, the infection is usually fatal, as there are no effective treatments.

Other health complications reported with Rituxan use include hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, kidney failure, and severe mucous membranes/skin reactions.

Seldane:
After Seldane was approved, the FDA began receiving reports of fatal and serious instances of cardiac arrhythmias. These dangerous complications occurred when Seldane was taken in combination with erythromycin or ketoconozole, causing Seldane to build up in the blood and resulting in serious cardiac side effects.

Hoechst Marion Roussel and Baker Norton Pharmaceuticals, the manufacturer of the Seldane, have voluntarily discontinued the distribution and marketing of all terfenadine-containing antihistamine product lines in the United States. Due to the availability of alternative drug therapy, the FDA announced in January 1997 that Seldane would be withdrawn from the market.

Seroquel:
In 2004, the FDA and Seroquel manufacturer AstraZeneca notified healthcare professionals of revisions to the ‘Warnings’ section of the labeling, describing the increased risk of hyperglycemia, high blood pressure and diabetes in patients taking Seroquel. Further, elderly patients with dementia-related psychosis treated with this type of medicine are at an increased risk of death.

In addition, rare but potentially fatal disorders reported with Seroquel use include neuroleptic malignant syndrome (NMS) and tardive dyskinesia (TD). NMS is a serious condition that can cause severe muscle rigidity and spikes in blood pressure and pulse, while TD causes spastic movements of the face, tongue, or other parts of the body. TD may become permanent, and the risk of TD is believed to increase as the amount of and length of time on these medications increase. Other dangerous side effects reported with Seroquel include excessive weight gain, juvenile diabetes, pancreatitis, and diabetic coma.

Tequin:
In 2006, the FDA notified healthcare professionals about proposed changes being made to the prescribing label ‘Warnings’ section for Tequin, noting that hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) have been associated with use, and that the drug is contraindicated in diabetic patients. Other serious side effects include severe allergic reactions, seizures, dizziness, confusion, tremors, hallucinations, depression, suicidal thoughts, or pain, heart attack, stroke, and death. Public Citizen, the public interest group founded by Ralph Nader, filed a petition with the Food and Drug Administration demanding a Tequin recall. The petition made reference to 388 patients with blood-sugar irregularities associated with Tequin, including 20 deaths and 159 hospitalizations since January 2000.

Trasylol:
In 2006, the FDA issued a Public Health Advisory to warn doctors and patients about the serious risks of Trasylol side effects. An FDA report found the use of Trasylol doubled the risk of kidney failure and liver damage, increased the chance of heart attack or heart failure by 55%, and resulted in a 181% increase in the risk of stroke. Trasylol administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated.

Tysabri:
Tysabri’s maker, Biogen-Idec, took Tysabri off the market in February 2005 after three people out of about 3,000 patients taking Tysabri in clinical trials developed a rare, serious brain infection called progressive multifocal leukoencephalopathy (PML). Two of those patients died.

However, as of June 2006, the FDA is rolling out a risk-minimization plan along with Tysabri's return to the market. The plan is designed to inform patients, doctors, pharmacists, and infusion centers about Tysabri’s risks and to quickly flag PML cases in patients taking Tysabri. Under the new plan, patients must enroll in a risk-minimization program designed by Biogen-Idec before taking Tysabri. Potential patients also need to get a brain scan using magnetic resonance imaging (MRI). Doctors who prescribe Tysabri, pharmacies that dispense the drug, and infusion sites that administer the drug must also enroll in the risk-minimization program.

Viagra:
In 2005, the FDA notified healthcare professionals of updated labeling for Viagra to reflect post-marketing reports of sudden vision loss attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. Viagra has also been reported to cause blood pressure to drop to an unsafe level if it is taken with any nitrate medication or with any alpha-blocker medication. Further complications can include hypotension, myocardial infarction, ventricular arrhythmias, sudden death, and stroke.

Vioxx:
On September 30, 2004, the FDA acknowledged the voluntary withdrawal of Vioxx by Merck & Co. The FDA also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.
Merck chose to withdraw Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, blood clots, and pulmonary embolism among study patients taking Vioxx compared to patients receiving a placebo. The study was being done in patients at risk of developing recurrent colon polyps.

Zicam:
Despite the manufacturer's assurances that Zicam adheres to FDA guidelines and restrictions, lawsuits have been filed by Zicam users against both Matrixx Initiatives and Zicam LLC, claiming that taking Zicam has caused anosmia, or a loss of smell and taste. Many Zicam users have also reported experiencing horrific, almost unbearable burning after using the nasal spray.

Zoloft:
In July 2006, the FDA issued two alerts related to Zoloft. The first FDA alert announced the results of a study concerning the use of antidepressant medicines during pregnancy by mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN). The second FDA alert states that a life-threatening condition called Serotonin Syndrome can occur when SSRIs, such as Zoloft, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans) are taken together.

Further, over the last few years, the FDA has worked closely with the manufacturers of Zoloft to fully evaluate the risk of suicidality in children, adolescents, and adults treated with these medications. Zoloft maker Pfizer Pharmaceuticals added a black box warning to Zoloft's prescribing information describing the increased risk of suicidal thoughts and behavior in children and adolescents taking antidepressants.

Zometa:
In September 2004, Novartis Pharmaceuticals and the FDA notified dental healthcare professionals of revisions to prescribing information to describe the occurrence of Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates such as Zometa. The revised prescribing information recommends that cancer patients receive a dental examination prior to starting bisphosphonate treatment, and that they avoid invasive dental procedures while on these medications.

Zyprexa:
In 2005, the FDA issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning the use of certain drugs called “atypical antipsychotic drugs,” such as Zyprexa. These drugs are approved for the treatment of schizophrenia and mania, but clinical studies of these drugs to treat behavioral disorders in elderly patients with dementia have shown a higher death rate associated with their use compared to patients receiving a placebo (sugar pill).

Further, rare but potentially fatal disorders reported with Zyprexa use include neuroleptic malignant syndrome (NMS) and tardive dyskinesia (TD). NMS is a severe condition that can cause severe muscle rigidity and spikes in blood pressure and pulse, while TD causes spastic movements of the face, tongue, or other parts of the body. TD may become permanent, and the risk of TD is believed to increase as the amount of and length of time on these medications increase. Other dangerous side effects reported with Zyprexa include excessive weight gain, juvenile diabetes, pancreatitis, and diabetic coma.

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