A couple of weeks ago the popular news program "60 Minutes" aired a story on Bayer's Trasylol. The broadcast told the tragic story of Joseph Randone and his experiences following heart surgery where Trasylol was used to reduce bleeding during the surgery. Physicians told the Randone family that the risk associated with the surgery was around five percent and that Joe would likely be able to return home in less than a week. Immediately following the surgery doctors made the family aware of complications during the surgery and alerted them that making it through the night would be the first challenge that he would face. The physician told the Joe's wife and daughter that he believed Trasylol was responsible for the complications. Ten days after Joe's surgery the New England Journal of Medicine published the results of the largest Trasylol study ever conducted at the time. The study, conducted by Dr. Dennis Mangano, "showed an important association between Trasylol use and kidney failure requiring dialysis." The study also showed an increased risk of death in patients who were given Trasylol. Researchers in Germany expressed concerns about Trasylol's effect on kidney function as far back as the early 1980's, long before the drug was ever introduced to the U.S. market. In 1992 a small study conducted by one this country's leading heart surgeons, Dr. Kouchoukos, Trasylol was administered to 20 patients. Of the 20 involved in the study 13 experienced kidney problems after the procedure. The FDA approved Trasylol for high-risk patients in 1993 and approval was expanded to cover all heart bypass patients in 1998. By 2005 Trasylol sales were at a one third of a billion per year with projections of three quarters of a billion in 2006, but then along came Mangano's study. After the study was published in the NEJM, Bayer hired Harvard professor Dr. Alexander Walker to review the records of almost 70,000 patients. This was an effort to determine the accuracy of Mangano's study before the FDA advisory panel meeting, scheduled to convene in eight month's time. The results of the Bayer sponsored study suggested the same risks that Mangano had seen to in his study. At the FDA advisory hearing Bayer representatives made no mention of the study that had been conducted on their behalf. Over this period Joe Randone had undergone 19 operations including the sewing shut of his eyelids, the removal of his gall bladder, and the amputation of his legs. In 2007 a Canadian study on Trasylol had to be stopped because the patients involved in the trail were dying. This prompted German authorities to ban Trasylol and Bayer temporarily suspended marketing for the drug in both the US and Canada. "Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market," [Mangano] says. Joseph Randone died in August of 2006. His family has filed a lawsuit against Bayer.
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A recent study found that patients that received Bayer's Trasylol during heart surgery were significantly more likely to die within the next decade. Another study of 78,000 patients, originally withheld by Bayer, found a 78 percent increased risk of death within a week following the surgery. In November Bayer suspended sales of Trasylol after a Canadian trial linked the drug to higher death rates. The FDA approved Trasylol in 1993 to help reduce bleeding during open-heart surgery and by 2005 had become "part of the fabric of cardiac surgery," but a 2006 study linked the drug to higher rates of heart attack, stroke, kidney failure and death sparking widespread concern. Indeed, the lives of 22,000 people could have been saved if the FDA removed Bayer's Trasylol two years ago, when the study revealed a growing number of deaths linked to the heart drug, according to the researcher who conducted the study. Bayer challenged the findings from the most recent studies claiming that the data analysis was flawed. Two panels of experts have advised the FDA to keep the drug on the market citing inconclusive evidence. Trasylol is still available through a restricted access program. "The data have to be reviewed and seen in the light of all the evidence. The bottom line is there are still more people dying using this drug. FDA is the agency that has all the evidence together at this point, and they need to make an informed decision." It is not clear when a decision will be made about the future of Trasylol, but the FDA is in the process of reviewing the data.
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Yesterday Johnson & Johnson announced a voluntary recall of a popular version of their Duragesic pain patch. About 32 million patches sold by PriCara, a unit of J & J, are being recalled due to concerns that a defect could expose patients to excess doses of the powerful opioid, fentanyl, leading to respiratory difficulties and even death. The company estimates that defects exist in two out of every one million patches, 64 in all. The recall involves the widely used 25-microgram per hour patch used to treat lower-weight and newer patients suffering from chronic pain. In 2004 the company issued a recall of some batches of the less popular 75-microgram per hour patch. Johnson & Johnson has been sued by 72 people alleging injury from the Duragesic patch. A case last summer delivered a $5.5 million verdict. Some plaintiffs' attorneys have argued that it may be time for the patches to be pulled from the US market, citing the prevalence of safer and more effective alternatives. "We're acting responsibly by recalling the defective lot," says the PriCara spokesman, Mr. Panico, adding that the company can't comment on pending lawsuits. "Despite the defect, there's much unaffected product on the market and we think overall the patients have been served by this therapeutic option." The company has said that no fatalities have been reported with the defective patches and hopes to avoid the bulk of legal issues associated with this recall by acting in a quick and preventative fashion.
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This week Chattem Inc., the makers of Icy Hot, announced a voluntary recall of its Icy Hot Heat Therapy patches after over 200 complaints of burns and skin irritations were reported in conjunction with the use of the patches. Some consumers experienced first, second, and third degree burns from the product. It is not yet clear whether injuries resulted from the improper or proper use of the product. Some people with sensitive skin or elderly patients may be more susceptible to adverse reactions. After receiving the first spate of injury reports in September, the company expanded the warning label to include specific instructions for people 55 and older, whose sensitive skin might be better protected by applying the patch to their clothing instead of directly to their skin. The recalled patches can be returned for a full refund by contacting the company's consumer affairs department during normal business hours.
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Today the FDA issued a Public Health Advisory for Pfizer's stop smoking drug Chantix to inform health care providers and consumers about concerns surrounding the drug. Last November the agency issued an Early Communication on Chantix in response to an abundance of adverse events reported to the agency following the tragic shooting death of Dallas musician Carter Albrecht. Reports of behavioral changes, depression, suicidal thought and even suicidal action have surfaced all too often over the past several months. The FDA now says that it is becoming increasingly likely that Chantix may be linked to serious nueropsychiatric symptoms.
The FDA has requested that Pfizer reevaluate the labeling of Chantix. The FDA has asked that patients with a history of psychiatric illness inform their physicians of this and to exercise caution when using Chantix. The drug may cause these illnesses to worsen or may cause old psychiatric problems to reoccur. Any patient experiencing changes in mood or behavior should report these changes to their physician immediately. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy. The FDA will continue to review Chantix and further explore the possibility of a link to neuropsychaitric symptoms. The agency may at a later time request further restrictions or labeling changes for Chantix if the results of further evaluation deem action to be necessary.
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Today I came across yet another story that appears to link Pfizer's blockbuster stop smoking aid Chantix, marketed as Champix in the UK, to an increased risk of suicidal thought and behavior. The horrifying story of a 38-year-old UK woman taking Chantix who tried to take her own life with no recollection of the event is one of the most disturbing accounts that I have come across. Karen McGhee woke up in the hospital with a bandaged arm and the left side of her mouth and neck feeling numb as if she had been to the dentist. When she asked what had happened and what she was doing in the hospital she was informed that she had tried to hang herself from the banister in her home. Her nine-year-old daughter found her hanging with the valance from the curtains around her neck. Karen listened intently as the events of her near death experience were revealed to her. She was told that she had turned blue due to lack of oxygen and that her heart had stopped five times on the way to the hospital in the ambulance. After three days on life support her family made the difficult decision to pull the plug, convinced by physicians that Karen would have severe brain damage if even if she were able to come out of the coma. She was expected to die within minutes, but Karen miraculously began to breathe on her own. Karen believes that the only explanation for her experience was Pfizer's Champix, which she had been taking to help her quit smoking. She had become irritable and depressed shortly after starting Champix, but had written it off to nicotine withdrawal. Others also noticed a change in the usually cheerful and energetic Karen to the lethargic and depressed woman she had become in a few short weeks after beginning a Champix regimen. Karen is thankful that she survived a very close brush with death and is trying to put the pieces back together after the traumatic events of the past. She began smoking again the week she left the hospital but says that she has not been criticized for it as everyone would rather have her alive than smoke free. Health Authorities around the world have responded to concerns about Chantix by adding additional warnings for possible increased risk of suicidal ideation and psychotic behavior. Last week the FDA made labeling changes to Chantix to warn patients and physicians about this possible link. As of thus far no causal relationship has been established, but according to both Pfizer and the FDA a link cannot be ruled out at this point.
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On Friday Pfizer announced that a labeling change for the popular stop smoking drug Chantix. The FDA is conducting an ongoing investigation of the drug and its possible link to suicidal thoughts and other psychological effects. The label has been altered to reflect the fact that some patients may experience "serious nueropsychiatric symptoms" including but not limited to suicidal behavior. Chantix was approved by the FDA in 2006 as a stop smoking aid and has seen tremendous success since its approval with continued growth in sales revenue combined with thousands of success stories. However, shortly following the September shooting death of musician Carter Albrecht, who was shot and killed after a series of bizarre psychotic events while taking Chantix, reports began to flood into the FDA's Adverse Event Reporting System with claims of psychological side effects. In November the FDA issued an early communication warning physicians and patients alike that the drug could be linked to suicidal thought and behavior. They encouraged doctors to closely monitor patients taking Chantix and report all side effects to the FDA. This new warning says that a possible link cannot be ruled out in some cases. This is not to say that a causal relationship has been established but this is a step in that direction. The drug company said this latest update was to ensure doctors and patients can better weigh up the benefits versus the risks of the various ways to quit smoking and the treatments available, including Chantix.
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Earlier this month the FDA issued a Class I Recall on defibrillator wires that connect implanted defibrillators to the heart. The wires, (leads) were manufactured by Medtronic Inc., one the leaders in this market. The Sprint Fidelis leads were linked to several reports of patients receiving unwarranted shocks from their defibrillators. Plaintiffs' attorneys have begun filing lawsuits against the manufacturer and with almost a quarter of a million of these leads implanted I expect more lawsuits to be pursued in the future. Leading heart device attorneys have filed suits in federal courts of Puerto Rico and Minneapolis. There have been allegations that that Medtronic was made aware of problems with the defective leads as early as January of this year, but failed to act until this month. Medtronic claims that implant method could greatly contribute to the likelihood of fracture. Before approving the Sprint Fidelis models, the FDA reviewed results from animal tests and extensive engineering "bench" studies, including 400 million repetitions of a bending motion designed to answer questions about the devices' strength, said Megan Moynahan, chief of the FDA branch that oversees defibrillator leads. Because the fracturing issue is "extraordinarily rare," a human clinical trial was unlikely to find it, she said.
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The FDA issue a warning to healthcare professionals on Monday about elevated risks of birth defects associated with the drug CellCept. The drug is used as anti-rejection aid for patients that have received transplants. The FDA warns of concerns of an increased likelihood of miscarriage in the first trimester of pregnancy and the risk of severe birth defects during fetal development. The FDA has also warned that CellCept may cause oral contraceptives to be less effective or ineffective in some situations. Women of childbearing potential should have a negative pregnancy test within a week of starting the immune-system suppressing drug, and must receive birth control counseling and use effective contraception, the FDA said. The new boxed is accompanied by a category change for the drug regarding its potential risk to the fetus. CellCept is no longer categorized under Category C meaning "risk of fetal harm cannot be ruled out," but rather the Category D reserved for drugs that have shown "positive evidence of fetal risk." The drug's maker, Roche estimates that almost 460,000 have been exposed to the drug since its approval in 1995. Switzerland's Roche Holding said it is difficult to estimate how often the problems have occurred, the company cited 25 miscarriages among 77 women exposed to the drug between 1995 and 2007. Fourteen of the women exposed to the drug had deformed babies or fetuses, according to a national registry that tracks women who undergo organ transplant.
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Over the past month since the Carter Albrecht story hit the press there has been plenty of attention paid to the stop smoking aid Chantix. I am sure that most of it is not the kind of publicity that manufacturer Pfizer was hoping for as they launched their new add campaign. Numerous people have contacted our law office over the past month with claims of serious adverse reactions to Chantix. We have had several claims of suicidal ideation and plethora of other ailments that are believed to be caused by Chantix. If you have not yet heard the about Chantix then I will give a little overview. It was approved last year by the FDA to assist people in the process of quitting smoking. The initial results were far more successful than those of any other smoking cessation aid in the past. The most common side effects associated with the drug are rather mild and do not pose any significant health threat; however, there have been some very bizarre side effects that seem to be somewhat rare but very dangerous, even life threatening. Many have claimed to experience intense suicidal ideation with no history of previous inclination and as in the case of Albrecht some seem to simply loose it, in violent and psychotic episodes. Hard hitting news stories have been surfacing on local news channels throughout the country, and Good Morning America even did a piece on Albrecht's death and the dangers associated with Chantix. If you have had an adverse reaction to Chantix we would like to help you. We are exploring the possibility of litigation against pharmaceutical giant Pfizer and we would like to hear about your experience with Chantix.
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Last Friday the FDA completed the decision made a few months back to add a "black box" warning to all FDA approved gadolinium containing contrast agents, by issuing a "Dear Healthcare Professional" letter. These contrast agents are commonly used in conjunction with magnetic resonance imaging (MRI) to greatly enhance the image produced by the procedure. These contrast agents however have been linked to a rare life threatening skin disease called nephrogenic systemic fibrosis (NSF). The letter sent out to healthcare professionals and posted to the FDA website on Friday tells of the dangers associated with certain patients and the use of these agents. Patients with moderate to severe kidney failure and certain liver conditions are at risk for developing the debilitating disease. NSF is characterized by the thickening of the skin, tissue, and internal organs and can lead to increased difficulty in movement and even death. A study claims that the risk of developing this disease after being injected with gadolinium-based agents is 4 percent in patients with severe renal failure. There have been no reports of this disease being linked to patients with normal or moderate kidney function. There has been little success treating the condition and there is no cure. Hopefully the new warning will shield potential patients from this dangerous disease.
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The shooting death of Dallas musician Carter Albrecht has gotten quite a bit of attention throughout the U.S. media. The Castle Doctrine has been the main focal point associate with Albrechts death, but concerns about the prescription stop smoking aid Chantix have also gotten nation wide attention. Albrechts girlfriend has alleged that Chantix had to play a significant role in the psychotic episode that eventually ended with him being shot and killed. Since the original story broke on Labor Day there have been numerous claims of serious adverse effects to the drug. Kenneth in Euless, TX said that he felt very aggressive and like he was loosing control when taking Chantix. He also claims to have suffered a mini stroke while on the medication at only 37 years of age. Karen from Washington alleges that her brother has now become a complete invalid after taking Chantix. She claims that he has suffered kidney failure in addition to neurological breakdown. She believes that this is a direct result of taking Chantix. There have been several allegations of suicidal thoughts and a few suicide attempts. There have even been a couple of claims of people who have taken their lives as a result of taking Chantix. Suicidal ideation is a listed under the rare side effects of this drug. Joseph of Terrell, TX says that he could not tell when he was awake and when he was dreaming. He tells a story of waking up to a doorbell ringing at two oclock in the morning. He heard his wife say she would get it and became concerned at the late hour. After grabbing his pistol he proceeded to the front door expecting to see his wife there. As it turns out she was not there and there was no one at the door either. Joseph says that he was dreaming up to the point of getting up and grabbing his gun and could not distinguish the dream from reality at all. This is exactly how Albrechts actions on the morning of his death. She says it was like he was in a dream, or better yet a nightmare. These allegations are very serious and should not be taken lightly. The FDA has said that they will be investigating the drug in detail. Some suspect that there could be serious interactions between Chantix and alcohol and other drugs. With more than 3 million people taking Chantix in the United States alone if this drug does turn out to have severe side effects associated with it the FDA and Pfizer could have their hands full. If you have been harmed by Chantix, we can help.
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The prescription medication Fentora has been implicated in four deaths this summer. The drug is intended for use in cancer patients suffering from intense pain and who are already tolerant of opioid drugs. Some doctors, however, are prescribing the drug for off-label uses, such as headaches and back pain. Fentora maker, Cephalon, responded to the deaths by issuing letters to doctors warning of the risks associated with off-label prescription of Fentora. The company has been accused of marketing Fentora to doctors for off-label uses. The active ingredient in the drug is fentanyl, an extremely addictive and powerful substance more than 80 times more powerful than morphine. The Schedule II drug has a high risk of fatal overdose and abuse, and is placed in the same category as cocaine and methamphetamines for this reason. Fentora is an oral lozenge designed to act as the successor to Actiq, Cephalon's pain lollipop, which has now been marketed in the generic market after its 1999 introduction. Fentora was approved only about 12 months ago and has been a very good performer for Cephalon, generating $68 million in sales over the first six months of this year, but the so called "Dear Doctor" letters may spell trouble for the future. If you or a loved one has been harmed by Fentora we can help.
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A rare disease has been linked to gadolinium based contrast agents used to enhance MRI images. Nephrogenic systemic fibrosis (NSF) is a debilitating disease characterized by widespread tissue fibrosis. While it has not been definitively proven that gadolinium agents cause NSF it is estimated that 90-95 percent of NSF cases have received gadolinium agents within a couple of months prior to developing the affliction. Gadolinium agents seem to only cause NSF in patients with renal failure. No cases have been reported of persons with normal kidney function. The FDA has cautioned that the use of these agents with even slight to moderate kidney problems could result in the development of NSF. Some doctors believe that this approach by the FDA will exclude a large group of people from getting the best test out there in many situations. "Studies investigating the relationship between NSF and gadolinium are currently underway at Yale, as well as the Centers for Disease Control, U.S. Food and Drug Administration (FDA) and the medical regulatory agencies of the European Union." If you or someone you love has been affected by gadolinium we can help.
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The stop smoking aid Chantix has been in the news recently after a popular Dallas musician was shot and killed last week while taking the drug. Friends of Jeffery Albrecht, the deceased, are convinced that Chantix is to blame for his actions. He apparently hit his girlfriend several times before she managed to lock him outside, when he then proceeded to beat and kick her neighbor's door in rage. The neighbor warned Albrecht to go away and attempted to fire a warning shot through the top of the door. The six foot five inch Albrecht was struck in the head and died almost instantly. His girlfriend and those who know him best say that this was compltly out of nowhere from him. She says he had never acted violently before and that he was completely out of touch with reality. Others claim have claimed that Chantix drove loved ones to suicide after having no previous suicidal ideation, which is one of the drugs listed rare side effects. This drug could be dangerous and should be taken with caution. If you or someone you love has been harmed by Chantix, we may be able to help.
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The FDA has requested that the makers of gadolinium-based contrast agents place a new risk warning on thier products. The warning pertains to the risk of a rare but life threatening skin disease associated with the agents. Kidney and liver patients are particularlly at risk for developing Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NDF). The new warning would apply to five gadolinium-based agents that have been approved for use in the U.S. If you have recently had a MRI and have kindney problems you could be at risk. If you or someone you love has been affected by gadolinium we can help.
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A rare skin disease has caught the attention of U.S. health officials who are now warning doctors of the grave health risk. The risk involves a common base for contract agents used to enhance MRI images. The gadolinium-based agents pose a risk of a particular skin disease to patients with poor kidney function. There are over 200 cases of the debilitating and life threatening disease, nephrogenic systemic fibrosis (NFS), reported thus far but many doctors believe the disease is under-recognized. There have been no cases reported of persons with normal kidney function. NFS causes thickening of the skin and possibly of organs and can lead directly to death. If you or someone you love has been affected by gadolinium we can help.
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In the cold late winter of last year a 20-year-old man was severely burned when a gas can he was using to pour fuel on a fire exploded. The burns were so severe the boy had to be life-flighted to Texarkana to the Arkansas Children's Hospital. After almost a month of excruciating treatment Jonathan Green eventually died. His mother, Rene Green, filed a wrongful death suit against the manufacturer of the gas container Blitz USA Inc. on Tuesday. The attorneys for the plaintiff claim that the gas can was unreasonably dangerous and therefore the company is liable. The gas can did not contain a flash arrester, a device designed to prevent flashback of flames into the container. The plaintiff's attorneys claim that the lack of this device contributed directly to Green's death. While there has been no official response from the defendant their website can provide some insight into the companys view of the situation. Blitz USA Inc.says that they are leader in gas cans and hold their product safety to a very high level. The company has been in business fro over 20 years and their website clearly illustrates safety awareness by stating: "Keep [gasoline] away from flames, pilot lights, stoves, heaters, electric sources and other sources of ignition. Gasoline vapors can explode and can be ignited by a spark of flame source many feet away."
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Today the Chicago Tribune reports that a three-year-old medical malpractice case has been settled for $1.6 million. Provena St. Joseph Medical and the pediatrician accused in the case will $600,000 and one million dollars respectively. Shequetta Wilson filed the case after her five-month-old son Noah died on September 26, 2002, from septic shock due to untreated constipation allegedly. The settlement was approved on Wednesday by a circuit judge was made public Thursday. If you or someone you love has been a victim of medical malpracice we can help.
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What (11-Jul-07)
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