FDA Alerts Physicians of Increased Fracture Risks from Fosamax
Earlier this week, the FDA announced that physicians need to watch for the possibility of femur fractures in patients taking Fosamax, a drug primarily used to treat osteoporosis and to. A femur fracture is an injury to the thigh bone, one of the strongest bones in the body, and usually occurs when a large amount of force is applied to the area. However, patients who have taken Fosamax for a couple of years have experienced femur fractures when very little force has been exerted on the area. Consider this patient’s case from a study published in Geriatrics in 2009:
A 59-year-old-woman took a step, her right leg gave out,and she fell to the ground as she heard her leg break. Her femur was fractured. The orthopedic surgeon on call told her, “We don’t usually see this type of fracture without trauma.” For the preceding year she’d experienced pain in her right thigh, which was severe enough to cause limping. An x-ray had been negative, and her primary care physician thought she had fibromyalgia. She had been on alendronate [Fosamax] for more than 5 years.
Two new studies have shown that Fosamax, and other similar osteoporosis drugs such as Actonel, Boniva and Reclast, are initially effective in slowing bone loss in post-menopausal women. However, after the patient has taken the drug for a period of time, the drug will no longer rejuvenate the bones, instead making the bones more brittle. The FDA is currently reviewing Fosamax and similar drugs to see if long-term use of the drugs can increase the risk of femur fractures.
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Nursing Homes Continue to Use Inappropriate Anti-Psychotic Drugs
According to the Boston Globe’s recent analysis, about 2,500 nursing home residents in Massachusetts were given powerful antipsychotic drugs last year that were not appropriate for their medical condition. In many cases, the medications were given due to the lack of behavior management techniques, experience or manpower in nursing homes to handle agitated patients.
This trend of increased antipsychotic drug use is very worrisome because a large number of nursing home residents suffer from dementia. Dementia patients taking antipsychotic drugs, also known as psychotropic drugs, have an increased risk of death. Psychotropic drugs are intended to treat patients with mental illnesses such as schizophrenia.
Officials in the Massachusetts Senior Care Association state that the state’s rank of frequency of use of psychotropic drugs, 12th in the nation, points to a need for more training in nursing homes. As Robert Stern, an Alzheimer’s specialist and brain research at Boston University School of Medicine states, “Way too many patients in nursing homes are treated with antipsychotics purely to sedate them or to control behaviors that are difficult for the staff.”
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Illinois Medical Malpractice Claims and Payouts Stable, Contrary to Insurance Company Claims
In 2005, Illinois enacted a law that was just struck down which placed a $500,000 cap on non-economic damages recoverable by patients against doctors and a $1,000,000 cap in cases against hospitals in medical malpractice cases. Although the caps were recently overturned by the Illinois Supreme Court, proponents of the caps argued that malpractice claims and verdicts have been rising rapidly, driving doctors out of Illinois and raising health care costs. However, insurance company data prove these assertions to be false.
Although an increased numbers of medical malpractice claims have been reported, this increase is not due to an increase in filing of cases but due to a change in how the claims are accounted. Before 2003, ISMIE, Illinois’ largest medical malpractice insurer, counted a claim involving an insured doctor and medical corporation as one claim. However, in 2003, the reporting system was altered and the doctor and corporation claim was counted as two separate claims. Consequently, this change greatly increased the number of total medical malpractice claims. Thus, in 2005, in hearings before the General Assembly regarding payout caps, ISMIE overstated its expectations of future payouts. Once the cap passed, the insurance company lowered their expected numbers again.
Court records have shown that the annual filings of malpractice lawsuits in Illinois have steadily decreased both before and after the damage caps laws were passed in 2005. The regulatory filings of the insurance companies show that since 2000, the frequency and severity of malpractice claims and payouts have been stable, or decreasing. Meanwhile, insurance companies have enjoyed record profits, with malpractice insurance rates dramatically rising. In addition, insurance companies admitted that business conditions and diminished returns due to the state of the market were responsible for the rise in insurance rates, not malpractice lawsuits.
Since the current caps have been overturned, families and individuals whose lives have been greatly impacted by medical malpractice can claim appropriate amounts for injuries sustained. While the caps may seem high, malpractice cases such as Lebron v Gottlieb Hospital, which prompted the Illinois Supreme Court’s action to overturn the caps, show that families are burdened with expenses stemming from medical malpractice for the rest of their lives.
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Confusion between Maalox Brand Products May Lead to Serious Medical Errors
Recently, the FDA notified consumers and healthcare professionals about reports of serious medical errors where patients had mistakenly used Maalox Total Relief, when they intended to use a Maalox liquid antacid. Both products are available without a prescription, but are not interchangeable. Consumers were confusing traditional Maalox with Maalox Total Relief, an anti-diarrhea medication that contains strong drug ingredients which may cause internal bleeding. Traditional Maalox uses a gentler formula which helps neutralize stomach acid. Due to the confusion, Novartis, the manufacturer of Maalox, has agreed to change the name and packaging of the potent medication Maalox Total Relief.
The FDA has announced that children and teenagers recovering from illness should not take the higher-strength Maalox. The higher-strength Maalox can also negatively interact with certain medications, such as oral antidiabetic drugs, anti-inflammatory drugs like aspirin, and the blood thinners warfarin and Plavix.
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Residents of Nursing Home Go Clubbing as Biker Gang
Nursing home residents at Bethesda Retirement Center in Chicago usually spend their time knitting or quilting. One day, they decided to try something different, and headed out to Evil Olive nightclub dressed as a biker gang. After recruiting hairstylists, make-up artists, professional costumers and tattoo artists, the seniors got transformed for their night of fun. The event at the Evil Olive was attended by over 100 people, including members of the Latino American Motorcycle Association and Chicago’s Chapter of A.B.A.T.E. The nursing home residents were even able to raise money to help purchase a touch screen computer for the retirement center for internet use.
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Newly Uncovered Reports Indicate FDA Debate over Avandia Heating Up
Avandia, a popular drug used to treat Type 2 diabetes, has been linked to a higher risk of heart attack and heart failure than any other diabetes drug. The drug has recently made headlines due to the uncovering of confidential government reports, in which doctors from the Food and Drug Administration concluded that “Rosiglitazone [Avandia] should be removed from the market.”
The uncovered reports are part of an intense debate over whether the federal agency should withdraw Avandia from the market. The debate has also been fueled by disagreements over a new clinical trial on the risks of Avandia and a Senate investigation which concluded that Avandia’s manufacturer, GlaxoSmithKline, should have warned patients about its risks years earlier. As Senator Baucus, a Montana Democrat who oversaw the Senate advisory committee on Avandia stated, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”
At one time, Avandia was one of the biggest-selling drugs in the world, until the risks associated with taking it emerged in 2007. Hundreds of thousands of diabetics still use Avandia, although top endocrinologists have stopped prescribing it. Avandia was ranked first among all prescribed drugs for the number of resulting serious or fatal problems, including 304 deaths in just the third quarter of 2009.
Contact an Experienced Pharmaceutical Litigation Attorney
If you or a loved one has suffered a heart attack or been diagnosed with congestive heart failure after taking Avandia, please contact the Pintas firm immediately. Our law firm will provide you with a free no-obligation consultation and explain your legal rights. However, do not discontinue taking your medication unless you have checked with your physician first.
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New Study Finds Overuse of Feeding Tubes in Advanced Dementia Patients
A new study in the Journal of the American Medical Association (JAMA) finds that the decision to give patients with advanced dementia feeding tubes depends more on cost concerns than the patient’s well-being. Hundreds of patients surveyed by Dr. Joan Teno of Brown University were given a feeding tube although they had specified in writing that they did not want one.
Feeding tubes do not increase survival for people with dementia who can no longer swallow. Rather, they can cause harm as demented patients often try to remove them, and are then consequently physically restrained or placed on heavy sedatives. Dementia is receiving more recognition as a terminal illness. Trouble eating indicates the arrival of the final stage of the illness, and careful hand feeding can provide the patient with a safer and more comfortable alternative than a feeding tube. However, feeding by hand requires a lot of time and effort.
Cost concerns are likely a significant factor in the large use of feeding tubes. Inserting a feeding tube allows hospitals to discharge patients faster and is less time-consuming for nursing homes. It is difficult to tell if hospitalizing demented patients is helpful, and ultimately financial incentive may be driving this tendency to feeding tube insertion. About a third of nursing home patients with advanced dementia have feeding tubes, and tubes were inserted into two-thirds of these patients while they were in the hospital. For-profit hospitals and larger hospitals are also more likely to use feeding tubes.
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Cognis and Teligen Defibrillators May Have Deadly Defect
According to a recent article in the journal HeartRhythm, Boston Scientific Corp’s Cognis and Teligen brand defibrillators have a dangerous design flaw. Defibrillators are portable electronic devices that automatically diagnose possibly life-threatening irregular heart rhythms in a patient, and help the heart re-establish effective rhythm with the application of electrical therapy. The defect in the Cognis and Teligen defibrillators by Boston Scientific may cause the devices to deliver unnecessary and life-threatening shocks to patients, and may affect the 90,000 patients who have the devices.
In December 2009, Boston Scientific reported the cases of two patients where the defibrillator that connects the device to the heart became loose. In January 2010, Boston Scientific stated the problem was fixed, and that the defect was limited to patients with defibrillators implanted under their chest muscles. However, HeartRhythm reported that Boston Scientific received at least three reports of problems from the defect in patients who had the device implanted above their chest muscles.
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Long Term Healthcare Hospitals: Lack of Scrutiny over Poor Standards of Care?
The New York Times recently published an article on the lack of scrutiny long-term healthcare hospitals face over their standards of care. According to the report, Medicare has never closely examined the care provided in these facilities, which are largely run by for-profit companies and have no doctors on staff. Many are “hospitals within hospitals”, as the company that runs them contracts space from a host hospital so the facility can be opened quickly and cheaply.
These facilities have been cited at a rate of up to four times higher than traditional hospitals for violation of Medicare rules. They also have a higher rate of patients developing bedsores and serious infections. Federal reports found that for-profit long-term hospitals spend less on patients and have a higher profit margin comparable to non-profit hospitals. These reports also detail preventable patient injuries and deaths as well as understaffed facilities.
The New York Times reported that many of these hospitals will manage how long patients stay to maximize profits, even if it goes against the doctor’s wishes for the patient. Maximum profit is gained when patients are discharged at or just after their 25th day. Interestingly, the average length of stay at Select Medical Corp’s hospitals, the company that runs the largest number of long-term hospitals in the U.S., is 24 days. Unfortunately, Medicare has few ways to discipline hospitals, and rarely takes action to decertify a facility.
Contact an Experienced Attorney
Our attorneys understand how difficult it is for victims or families of victims who have suffered from medical malpractice or negligence. We work to ensure that you receive the best representation and largest settlement possible. If you or a loved one has been injured as a result of medical malpractice or negligence in a long-term healthcare facility or another facility, contact us immediately. We will provide you with a free no-obligation consultation and explain your legal rights.
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FDA Warns Consumers about Counterfeit Version of Weight Loss Drug Alli
Recently, the FDA warned consumers that a counterfeit version of the over-the-counter weight loss product Alli could be harmful. The counterfeit Alli has been sold in 60mg capsules as part of a 120 count refill kit on online auction websites like Ebay. The manufacturer of Alli, GlaxoSmithKline, has stated that tests on the counterfeit version of the drug showed that it contained sibutramine. Sibutramine may interact adversely with other medications, and should not be ingested by patients with certain medical conditions.
Consumers can identify counterfeit versions of the drug through the following differences:
(1) There is no “LOT code” on the top of the outer cardboard packaging of the counterfeit version.
(2) The genuine version has an expiration date that only includes the month and the year.
(3) The counterfeit version does not have the statement “SEALED FOR YOUR PROTECTION” on the seal of the bottle.
(4) The counterfeit version has a slightly larger capsule size.
(5) The content of the capsules in the counterfeit version is powdery, which is not true in the genuine version.
Consumers who believe they have purchased the counterfeit version of the drug should contact the FDA at http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm.
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