Recently in Drug Defects Category

April 21, 2011

Plavix Allegedly Causes Abdominal Bleeding

Combining the perscription drug Plavix and aspirin may be dangerous to your health and may increase the likelihood of internal bleeding, according to reports.

As reported by CNN.com, a 2006 study revealed that combining Plavix and aspirin may be more dangerous than beneficial in people with no history of cardiovascular disease. The study also found that the combination does not lower the risk of heart attack or stroke for people with high risk factors for cardiovascular problems. According to research, Plavix and aspirin together may be beneficial for people with a history of heart attack or other cardiovascular issues, but combining the two drugs raises the risk of internal bleeding and death for those who only have risk factors for cardiovascular disease.

According to a 2006 CBS News report, the combination of the two drugs "is not significantly more effective than aspirin alone in reducing the rate of heart attacks, strokes, or death from cardiovascular disease in this broad population of high-risk patients," quoting Cleveland Clinic's Dr. Deepak Bhatt. Additionally, the combination could be more harmful than effective in people with high cholesterol and high blood pressure.

Plavix (clopidogrel) is a blood thinner used in the prevention of blood clots in people who have recently suffered a heart attack or stroke, and in people with cardiovascular disorders. Plavix is marketed by Sanofi-Aventis and Bristol-Myers. Plavix has been linked to several personal injury lawsuits alleging that the makers of Plavix did not properly warn doctors and patients about potential side effects. The suits also claim that Plavix may raise the risk of heart attacks, strokes, severe ulcers, gastrointestinal bleeding, and the blood disease TTP (thrombotic thrombocytopenic purpora).

Aspirin has long been known as a miracle drug to prevent heart disease. However, as with any other drug, seek your doctor's approval before starting a daily aspirin regimen. According to the Mayo Clinic, only people with a history of heart attack or stroke, or those at a high risk, should think about taking an aspirin daily. People with a history of bleeding, stomach ulcers and heart failure, for example, are advised against taking a daily aspirin, according to the Mayo Clinic. Talk to your doctor about whether taking an aspirin a day is right for you.

If you are taking both Plavix and aspirin, or have a family member who is taking both, get a second opinion from another doctor as to whether both are needed, particularly if you have no prior history of heart attack or stroke.

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January 31, 2011

Merck Vaccine Gardasil Linked to 56 Deaths in the U.S.

Gardasil, the popular HPV vaccine, has been linked to 56 deaths in the United States as of September 30, 2010. Over 17,000 adverse side effects have also been reported, some of the more serious side effects including blood clots, epilepsy, miscarriages, and Guillain-Barre Syndrome, a nerve disorder that can cause muscle weakness and paralysis.

Gardasil, manufactured by Merck, got FDA approval in 2006 to help protect against certain strains of HPV (Human Papillomavirus), which can lead to cervical cancer in females and genital warts in males. According to the Centers for Disease Control and Prevention, about 32 million doses have been given in the U.S. Gardasil is commonly used for females ages 9-26, but as of October 2009 when the FDA approved use of the vaccine in males, it has also been used by males ages 9-26. Merck also manufactured Vioxx, the painkiller that was recalled because it allegedly caused thousands of deaths from heart problems and strokes.

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October 13, 2010

FDA Recalls Diet Drug Meridia

Drawing similarities to the now infamous drug, Fen Phen, the FDA recently recommended the recall of another weight loss drug, Meridia. Abbott Labs, the manufacturer of Meridia, followed through, withdrawing it on October 8, 2010. This decision comes after last month's split vote of an FDA panel over whether to withdraw the drug or add a black box warning to its label.

A medical study which showed an increased risk of strokes and heart attacks in people with heart disease prompted the FDA's recommendation to recall Meridia. The study, called the Sibutramine Cardiovascular Outcomes Trial (SCOUT), revealed that patients who took Meridia, also known as Sibutramine, had a 16% higher chance of heart attack and stroke than patients who took a placebo.

Meridia was approved by the FDA in 1997 and before the recall, was being used by about 100,000 people in the United States. Some of its side effects include chest pain, lightheadedness, irregular heartbeat and nausea. On January 21, 2010, the FDA alerted doctors and patients about Meridia's updated label information, in which Abbott agreed to include a new contraindication that it should not be taken by people with a history of cardiovascular problems including congestive heart failure, arrhythmias, and coronary artery disease. Other warnings included Meridia's link to cardiac valve dysfunction and primary pulmonary hypertension (PPH). The FDA advises that doctors stop prescribing Meridia, and patients cease taking this drug and ask their doctors for a different weight loss plan.

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June 1, 2010

Recent Warning & Recalls on Potentially Dangerous Drugs

Xenical & Alli May Cause Severe Liver Damage

The orlistat-based weight loss pills, Xenical and Alli, will now come with warnings of potential liver damage. The revised warnings come after the U.S. Food and Drug Administration (FDA) received and studied 13 cases of severe liver damage, including two deaths and three liver transplants, in patients taking the drugs. Although only one case involved a patient in the United States, the FDA felt the danger was serious enough to require warnings on all future Xenical and Alli packages sold in the U.S. Although a direct causal relationship has not yet been established between severe liver damage and taking orlistat, the FDA is warning the nearly 40 million people taking Xenical or Alli to discontinue use if they notice signs of liver damage. These signs may include yellow eyes and skin, itching, dark urine, light-colored stool, or loss of appetite.

Proton Pump Inhibitors May Increase Fracture Risk

The FDA is also reporting that recent epidemiological studies have shown that use of proton pump inhibitors, such as Nexium and Prilosec, at high doses or for more than one year may increase the risk of bone fractures. Proton pump inhibitors are used to treat acid reflux, GERD, and other conditions by stopping acid secretion. The increased fracture risk is associated with the hip, wrist, and spine. While the potentially dangerous drugs are not being recalled, they will receive a revised warning label which includes this fracture risk.

Adverse Incidents Related to Children's Tylenol Continue to Surface

The FDA continues to investigate nearly 800 reports of adverse medical incidents following the recall of over-the-counter children's medication, according to reports. The recall was prompted by an inspection of Johnson & Johnson's McNeil manufacturing plant which uncovered bacterial contamination of ingredients, dirty equipment, and the potential of drugs being more potent than indicated. Although the FDA has not linked any of the adverse events, including seven reported deaths, directly to the recalled products, the FDA continues to investigate whether the adverse incidents are related to the poor manufacturing conditions. The recalled products include children's Tylenol, Motrin, Zyrtec and Benadryl.

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May 10, 2010

Drug Alert: Patients Using Certain Anticonvulsant Drugs may be at Risk of Suicide

Users of some well-known anticonvulsant drugs may be at risk of committing or attempting suicide, according to researchers at Brigham and Women's Hospital in Boston in a study published in the Journal of the American Medical Association last month.

The study researched records of over 297,000 patients who took anticonvulsants between 2001 and 2006 and were 15 years of age or older. The analysis revealed 801 attempted suicides, 26 suicides and 41 violent deaths in the first 60 days of patients taking anticonvulsant drugs. This research comes after a 2008 FDA drug warning on anticonvulsants in which the FDA made it mandatory for anticonvulsant drug manufacturers to have a warning about suicidal risks on product labels. The FDA took action after nearly 200 studies were conducted on 11 different medications. The studies revealed that patients who took anticonvulsants doubled their risk of suicide.

Neurontin, manufactured by Pfizer and Novartis's Trileptal were among the drugs researchers found to increase suicide risk by as much as double in people taking these drugs for the first time.

GlaxoSmithKline's Lamictal, and Gabitril, made by Cephalon were also found to increase suicide risk. It is uncertain as to why some anticonvulsant drugs raise the risk of suicide, but it is known that these drugs cause behavior and mood changes.

Anticonvulsant drugs are commonly used by patients with epilepsy; however, drugs such as Lamictal have also been marketed to treat conditions including bipolar disorder and migraine headaches.

The FDA allows doctors to prescribe any medicine they consider suitable for any condition, which means doctors may prescribe drugs off-label (meaning prescribing it for uses unapproved by the FDA) if they think it's necessary. Drug manufacturers, on the other hand, are only allowed to market the drugs for uses that are FDA-approved. However, drug manufacturers don't always follow FDA guidelines for marketing drugs. Earlier this year, in January, Novartis paid a 185 million dollar fine for off-label marketing of the epilepsy drug Trileptal.

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March 26, 2010

Chantix and Zyban, Used to Quit Smoking, Linked to Over 100 Suicides

Last summer the FDA issued a warning on the drugs Chantix and Zyban, used by people trying to quit smoking, for their link to suicides. Zyban is also sold as Wellbutrin and is also used to treat depression. A July 2009 New York Times article states that Chantix has been linked to 98 suicides and 188 attempted suicides; Zyban is linked to 14 suicides and 17 attempted suicides.

According to FDA reports as well as information gathered from clinical trials, many people started experiencing mental health side effects a short time after taking the drugs, which ended after they stopped taking the medication. In addition to suicidal thoughts, some people also reported depression and behavioral changes such as irritability. Although some of these changes may be linked to patients experiencing withdrawal symptoms, some patients experienced side effects while they continued to smoke.

The FDA has made it mandatory for the manufacturers of Chantix and Zyban to alert the public about their risks. Pfizer, the maker of Chantix, will add a black box warning to the drug. GlaxoSmithKline already has a black box warning on Wellbutrin, which includes suicidal thoughts as a danger of taking the drug, and plans to add a warning to Zyban. The FDA is also requiring Pfizer and Glaxo to do clinical trials to determine the psychiatric effects on patients taking these drugs.

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February 24, 2010

FDA Urges Avandia Recall, Diabetes Drug Linked to Heart Problems

The popular diabetes drug Avandia has been reported to cause hundreds of heart attacks each month and has also been linked to heart failure. According to a Senate report and as reported by The New York Times, the U.S. Food and Drug Administration (FDA) is urging a recall on Avandia because of the health risk associated with the drug. The reports state that heart failure and heart attacks suffered as a result of Avandia would be prevented if diabetes patients were instead given the drug Actos.

The Senate report says GlaxoSmithKline, the manufacturer of Avandia, was aware of Avandia's health risks for years but did not tell the public. In 2007, The Journal of the American Medical Association challenged Avandia's safety. The same year, a scientific study published in the New England Journal of Medicine showed a 43% higher risk of a heart attack from using Avandia. The pharmaceutical giant stood by its product, saying it was safe. Not too long after the study, the FDA added a black box warning of Avandia's heart attack risks.

Avandia (Rosiglitazone) has been on the market since 1999 for the treatment of Type 2 diabetes. GlaxoSmithKline continues to stand by its product, claiming there is no link between Avandia and heart attacks. However, the drug is estimated to have induced nearly 100,000 heart attacks in the 11 years it has been on the market.

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January 19, 2010

Contaminated Heparin Injury Lawsuits Continue to Mount for Manufacturers

Heparin manufacturers, including Baxter International, Inc., are facing mounting lawsuits alleging that a known 2008 contamination of the anticoagulant caused severe injuries and deaths. Lawsuits addressing the defective drug are being filed in state and federal courts. The federal court cases are being transferred to multi-district litigation in the Northern District of Ohio.

Heparin is a blood thinner (anticoagulant) used to prevent blood clots in veins, arteries, and lungs, which is often used prior to surgery or as a coating for medical devices. In 2008, the U.S. Food and Drug Administration (FDA) identified an increase in the number of deaths and adverse events, such as anaphylactic-type reactions (allergic reactions) and acute hypotension (extremely low blood pressure), associated with Heparin use. Scientists identified a contaminate in the Heparin described as oversulfated chondroiton sulfate which mimicked heparin activity and eluded routine testing. Because of the contamination, the FDA adopted a new standard for testing Heparin in 2009.

Baxter and other manufacturers began recalling suspected contaminated Heparin in 2008. Investigations have shown that the problem may stem from Chinese producers of crude heparin. A key ingredient in Heparin is made from pig intestines in China because of the large number of available animals. Although the source of the contamination has not yet been determined according to reports, some lawsuits are alleging that the China production facilities did not meet U.S. regulation and were not inspected or approved by the FDA.

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January 12, 2010

Humira, Other TNF Blockers Linked to Cancer in Children

The U.S. Food and Drug Administration (FDA) recently announced that it would require Humira and other tumor necrosis factor (TNF) blocker prescription medications to include its strictest warning on both the packaging and prescribing information for the potentially dangerous drugs. The 'boxed warning' or 'black box warning' is now required after analysis of adverse medical incident reports submitted to the FDA showed an increased risk of lymphoma and other cancers with the use of TNF blockers such as Humira, Enbrel, Remicade and Cimzia in children and young adults. The FDA is requiring that manufacturers warn doctors and patients of the increased risk of leukemia, as well as new-onset psoriasis, on the TNF blocker packaging.



TNF blockers such as Humira, Enbrel, Remicade and Cimzia are used to treat children and young adults with Juvenile Idiopathic Arthritis (also known as Juvenile Rheumatoid Arthritis), Crohn's disease and other diseases. The drugs work by suppressing the immune system to block the tumor necrosis factor which causes inflammation and immune system related diseases.

The black box warning for TNF blockers comes after approximately 30 reports of cancer in children and young adults under the age of 18 taking TNF blockers were reported to the FDA between 1998 and April 2008. The concern included the development of lymphoma (cancer of the cells in the immune system) and other cancers such as leukemia, melanoma and solid organ cancers in children taking TNF blockers such as Humira, Enbrel, Remicade and Cimzia. In August 2009, the FDA announced that it had tracked 48 malignancies from 2001 through 2008 associated with the use of TNF blockers in children after an average of 30 months of treatment. The FDA will continue to investigate and analyze data from long-term studies of the potentially dangerous drugs.

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December 29, 2009

Paxil Lawsuits Costing Manufacturer Approx. $1 Billion

Paxil is an antidepressant manufactured by GlaxoSmithKline which is used to treat a variety of psychological disorders including depression, obsessive compulsive disorder, anxiety, and other mental issues.  Paxil is a member of a group of drugs known as selective serotonin reuptake inhibitors (SSRI) and is used to balance serotonin levels in the brain.  However, since Paxil's introduction on the market in 1993, the potentially dangerous drug has been plagued with complaints of serious adverse medical events including an increase in suicide rates and attempts, addiction, and birth defects.

According to reports, Glaxo has paid nearly $390 million for suicide death and attempts attributed to Paxil.  The family of a Valparaiso, Indiana, boy who killed himself shortly after he started taking Paxil recently settled their suit against Glaxo for an undisclosed amount.  In that case and other suicide cases, Glaxo has attempted to blame the suicides on the underlying depression and not the drug itself.  However, Glaxo has reportedly settled 150 Paxil-related suicide cases and 300 Paxil-related suicide attempt cases.

Paxil has also been linked to severe birth-defects in children whose mothers took the antidepressant while pregnant.  In October, a Philadelphia jury found that Glaxo negligently failed to warn doctors of Paxil's risk to pregnant women and found that Paxil caused the heart defect in the three-year-old boy involved in the case.  The jury awarded the family $2.5 million in compensatory damages including future medical care.  According to reports, this case was the first of some 600 lawsuits against Glaxo for failing to warn of Paxil's dangers to pregnant women.  Glaxo has reportedly settled 10 other birth-defect cases to date.

Paxil has also been accused of causing addiction and severe withdrawal effects for those attempting to quit the drug.   According to reports, Glaxo has settled nearly 3,200 cases involving addiction-related complaints and complications.

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October 27, 2009

FDA Sticks to Zicam Cold Remedy Warning Letter on Loss of Smell

The U.S. Food and Drug Administration (FDA) has refused to back down from a warning letter sent to Zicam manufacturers, Matrixx Initiatives, Inc., regarding the potential dangers of its over-the-counter cold medication.  In June 2009, the FDA warned consumers that three Zicam products -- Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kids Size (discontinued product) -- were associated with 130 reports of the loss of sense of smell (also known as anosmia).  According to the FDA, the loss of sense of smell reportedly occurred after the first dose of the drug, but is also known to occur after multiple doses.

The potentially dangerous Zicam products contain zinc gluconate (labeled "zincum gluconicum") as the active ingredient.  The FDA warns on its website that although these products are marketed to reduce the duration and severity of the common cold, the products have not been shown to be effective in doing so.  Consumers are advised not to use the potentially dangerous drugs for any reason and to throw away any remaining product.  Matrixx Initiatives has since pulled the products in question from the market, but the FDA fears that unknowing consumers will use products still stored in their medicine cabinets.

In the June 2009 warning letter, the FDA accused Matrixx Initiatives of failing to provide any data to establish that Zicam Cold Remedy intranasal products are safe and effective for the uses identified in their labeling.  On the contrary, the FDA said that there is published scientific literature that evidences various salts of zinc can damage olfactory function in humans.

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October 5, 2009

Florida Woman First Fosamax Multidistrict Litigation Plaintiff

Ironically, 71-year-old Shirley Boles took Fosamax (the brand name for alendronate) to increase her bone density, but instead the Walton Beach, Florida woman found her jawbone deteriorating, her teeth loosening, and her gums turning black. This condition resulting in jawbone death is known as osteonecrosis of the jaw (ONJ).

Boles took Fosamax from 1997 to 2006 and asserts that Merck, the manufacturer, failed to warn doctors about the relationship between the drug and ONJ. There are now approximately 900 plaintiffs participating in the class action against Merck. This first lawsuit is being heard this month in the US District Court in Manhattan.

A study performed at the University of Southern California School of Dentistry and reported in the Journal of the American Dental Association (Jan. 1, 2009) found that 1 in 23 of the 208 patients studied taking alendronate had active ONJ. Researchers noted that even short-term use of alendronate was correlated with ONJ in some patients after certain dental procedures.

According to an article in USA Today (March 13, 2005) the chairman of the division of oral and maxillofacial surgery at the University of Miami, Robert Marx, stated that he knew of 40-50 cases of ONJ nationwide in patients who had taken Fosamax.

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September 29, 2009

FDA Orders Black Box Warning for Generics of Wyeth's Phenergan

The U.S. Food and Drug Administration (FDA) has ordered manufacturers of the promethazine hydrochloride injection to include a black box warning regarding potential dangers associated with the administration of the drug.  Promethazine hydrochloride was formally manufactured by pharmaceutical giant Wyeth under the name Phenergan.  Promethazine is used to treat nausea, vomiting, and pain after surgery and anesthesia, as well as allergy symptoms, motion sickness, and other ailments.

According to the FDA, the warning only applies to the injectable form of the drug which presents a serious risk of tissue damage if improperly administered.  The FDA warns that gangrene and other tissue injuries can be caused by administering promethazine in an artery or under the skin.  Because Phenergan, or promethazine, can potentially leach out of a vein and damage surrounding tissue during intravenous administration, the drug should be injected deep into muscle according to the FDA.

The black box warning label ordered for promethazine follows a March 4, 2009, U.S. Supreme Court decision in the landmark case Wyeth v. Levine.  In Levine, Diana Levine, a musician, had her arm amputated after Phenergan was injected into her vein using the "IV-push" method, entered her artery, and caused gangrene.  A state jury found that Wyeth failed to provide adequate warning of the dangers of such administration and awarded Ms. Levine $6.7 million in compensatory damages.  Wyeth appealed claiming that federal law pre-empted Levine's claim because the warning label had been approved by the FDA and it would be impossible to comply with both state and federal law.  The Supreme Court found against Wyeth and upheld the state court decisions in favor of Ms. Levine.


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September 22, 2009

Trasylol Increases Death Rate Among Heart Surgery Patients

Bayer's drug trasylol, also known under the generic name aprotinin, was widely administered during heart surgery to control bleeding, but research indicates that it may be responsible for a multitude of deaths.

A 2006 study in the New England Journal of Medicine reported that trasylol increased patients' risks of kidney failure, heart attack, and stroke. The researchers concluded that the drug accounted for $1 billion in annual dialysis costs as a result of the 10,000 to 11,000 cases of kidney failure attributed to its use.

Additional studies in the United States and Canada revealed that patients receiving trasylol incurred a much higher death rate than those who had received other drugs

According to a report on CBS News' 60 Minutes, trasylol was given to 52-year-old Joseph Randone in January 2008 to decrease the bleeding risk during what should have been routine heart valve replacement surgery. Shortly after the surgery, he suffered two heart attacks and kidney failure. Eventually, his legs had to be amputated, his eyes sewn shut, and a pacemaker implanted in his heart before his eventual death. His surgeon indicated that he believed trasylol caused the complications.

Bayer allegedly concealed information from one of its own studies about the dangers of using trasylol during an FDA advisory hearing in September 2006. In the face of mounting evidence of the drug's adverse effects, the FDA requested in November 2007 that Bayer stop sales. However, it was not until May 2008 that Bayer recalled any remaining supply of the drug from the market.

On April 25, 2008, Bayer announced that 78 trasylol lawsuits were filed. The first trasylol trial consolidated in a multidistrict litigation is now scheduled to begin on January 18, 2010 in the U.S. District Court for the Southern District of Florida.

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August 27, 2009

Diet Pills, Alli & Xenical, May Cause Liver Damage

The U.S. Food and Drug Administration (FDA) recently alerted consumers to instances of liver damage associated with the prescription diet pill Xenical and the over-the-counter diet pill Alli.  Both Alli and Xenical contain the chemical orlistat which is used to block the absorption of fat in the intestines.  According to the FDA, there have been 32 reports of serious liver damage, including six cases of liver failure, from people taking orlistat.

The FDA advises people taking prescription drugs containing orlistat to contact their physicians immediately if they experience any signs associated with liver damage.  Symptoms of possible liver injury include:
  • weakness or fatigue
  • fever
  • jaundice (yellowing of the skin or the whites of the eyes)
  • brown urine
  • abdominal pain
  • nausea
  • vomiting
  • itching
  • light-colored stool
  • loss of appetite
Although the FDA has stated there is no definite association between liver injury and orlistat, they continue to investigate the relationship between the reported cases of liver injury and the drug.

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