Nursing Homes Abuse Blog - By Jonathan Rosenfeld

When Robert Bettorf started taking Actos in 2007, he thought it might help control his Type II diabetes.

Instead, he got cancer.

Bettorf is one of several people to recently come forward with allegations that Takeda Pharmaceuticals’ Actos drug directly causes bladder cancer. He joins Nancy Rios, 54, of Reading, Pennsylvania, who says she now faces the possibility of losing her bladder. And Tommy Thompson, of New Orleans, Louisiana, who filed suit in federal court on September 9.

Like many around the country, Bettorf says his cancer was caused by long-term exposure to Actos. Recent FDA studies have indicated that those who take Actos for 12 months or longer are at a 40 percent higher risk for developing bladder cancer.

“An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative does of Actos,” a Sept. 17 study said.

Despite early links to heart failure, Actos became the No. 1. diabetes drug in the United States, posting sales of $2.9 billion in 2006, and more than $4.3 billion in 2010. More than 2.3 million people were prescribed Actos, or similar drugs, in 2010.

As evidence mounts against Takeda, I wouldn’t be surprised if the pharmaceutical giant will face lawsuits numbering in the thousands.

If you or your loved is affected by adverse side effects of Actos, I would encourage you to seek legal action without delay. Rosenfeld Injury Lawyers remains committed to to helping you understand your legal rights, and to moving your case forward as quickly as possible.

Related:

What We Know and Don’t Know Huffington Post October 24, 2011

Lawsuit Accuses Diabetic Drug Manufacturer Takeda of Not Warning of Risks of Bladder Cancer The Louisiana Record September 16, 2011

Diabetes Drug Clouded in Lawsuits CBC - Canada August 5, 2011

FDA Safety Announcement Regarding Actos June 15, 2011

If you ever needed proof that there's no such thing as a 'safe' drug, check out a new study published in the Archives of Internal Medicine conducted by Daniel Solomon.  

The results of the study were discussed in a New York Times article, "Narcotic Painkillers May Pose Danger to Elderly Patient, Study Says," and the overwhelming conclusion was that narcotic painkillers put seniors at an increased risk for: bone fractures, heart attack and death compared to milder, over-the-counter pain relief medications such as Advil and Motrin.

In reaching its conclusions, the study analyzed the records from a group of women who were diagnosed with different types of arthritis, using varying types of pain medication, over a six-year period.  

Based on data in the patients medical records, patients who took narcotic-based pain medications were at a significantly higher risk for medical complications compared with their peers using other types of medications.  

While, researchers look closer at the underlying reasons for the increased rates of patient injury, I think this study should give patients reason to pause and re-consider the medications they are taking with their physicians to assure all medications are necessary and in the proper dosage.

In a previous post, I talked about Reglan (Metoclopramide), a drug commonly used to relieve heartburn in patients with GERD (gastroesophageal reflux disease) or to relieve symptoms of slow stomach emptying for people with diabetes. Well, it turns out that this drug can also cause tardive dyskinesia (TD). Tardive dyskinesia is abnormal muscle movements, mostly in the face muscles, that you have no control over. TD has no treatment, and the symptoms might not go away even you stop taking raglan. 

Clearly, TD is not a minor side effect. The FDA took action requiring manufacturers of the drug to add a “black box” warning about the drug’s risks. The U.S. National Library of Medicine – National Institute of Health Website now includes an IMPORTANT WARNING in its information for metoclopramide (better known as Reglan) –

“Taking metoclopramide may cause you to develop a muscle problem called tardive dyskinesia. If you develop tardive dyskinesia, you will move your muscles, especially the muscles in your face in unusual ways. You will not be able to control or stop these movements. Tardive dyskinesia may not go away even after you stop taking metoclopramide. The longer you take metoclopramide, the greater the risk that you will develop tardive dyskinesia. Therefore, your doctor will probably tell you not to take metoclopramide for longer than 12 weeks. The risk that you will develop tardive dyskinesia is also greater if you are taking medications for mental illness, if you have diabetes, or if you are elderly, especially if you are a woman. Call your doctor immediately if you develop any uncontrollable body movements, especially lip smacking, mouth puckering, chewing, frowning, scowling, sticking out your tongue, blinking, eye movements, or shaking arms or legs.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with metoclopramide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website(http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide. Talk to your doctor about the risks of taking metoclopramide.”

The FDA’s medication guide also includes warnings about how Reglan can cause tardive dyskinesia. TD (as a result of Reglan) is most common in the elderly, especially elderly women.  

Reglan Drug Timeline

• June 1985 – FDA approved metoclopramide – FDA approved metoclopramide for short-term use (less than 12 weeks). 
• February 26, 2009 – FDA Press Release – “FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs – Agency warns against chronic use of these products to treat gastrointestinal disorders”
• March 2009 – FDA’s MedWatch Safety Alerts, March 2009 – FDA alert discussing boxed warning. Also, manufacturers must ensure that patients receive a medication guide with the drug risks each time they receive the medication from a pharmacy.

Prescribing Reglan

At the time of the FDA’s decision to require a black box warning, more than 2 million Americans were taking metoclopramide drugs. Reglan was commonly prescribed for patients suffering from acid reflux, GERD (gastroesophageal disorders), and nausea. According to the FDA, metoclopramide is only recommended for short-term treatment (≤ 3 months) of gastrointestinal disorders. 

However, many patients have taken Reglan for longer periods of time, increasing their risk of TD. In many cases, Reglan was a treatment option that offered positive results in treating gastroesophageal problems, but it came with a serious risk. Reglan now carries a warning against frequent and long-term use, but this warning came too late for many people who now suffer from lasting side effects such as tardive dyskinesia. Older people, especially older women, and people who have been taking Reglan for a long time are most at risk for tardive dyskinesia. 

Metoclopramide was even prescribed to women suffering from morning sickness. In a June 2009 article, MSNBC reported about a study in the New England Journal of Medicine that showed that metoclopramide could be prescribed to pregnant women suffering from morning sickness in the first trimester without causing harm to their babies. The drug was prescribed to pregnant women for short-term use and most women in the study only took the drug for 7 days. 

Morning sickness is most common in the first trimester, but it can last throughout pregnancy for some women. Because morning sickness can last longer than the 12-week maximum that the FDA recommends in order to reduce the risk of TD, it seems misleading and inappropriate that the reports would not at least mention the FDA black box warning. The risks associated with long-term use of a drug should be discussed, or at least mentioned, when discussing a new use of a drug, especially to inform potential users of all possible risks. 

Status of Reglan Litigation

Reglan has been prescribed to numerous patients since it was approved in 1985. And, according to the FDA, over 2 million Americans use metoclopramide. According to the drug makers, there have been over 20 years of Reglan litigation. 

On June 3, 2009, the U.S. Judicial Panel on Multidistrict Litigation denied the plaintiffs request to consolidate the Reglan litigation during pretrial proceedings in a Multidistrict Litigation (MDL). This motion was filed by plaintiffs in 15 different Reglan lawsuits in 11 different district courts. The drug makers opposed the consolidation, citing that since the first Reglan case was filed in 1988, there have been more than 20 years of Reglan litigation, and 80% of those cases were resolved. 

The Panel determined that there was no single common defendant and most questions that remained were too complex or numerous to support consolidation, despite the cases involving the common factual issue about whether Reglan causes tardive dyskinesia. 

In one of the Reglan cases, a woman from Arkansas alleges that she developed TD after taking Reglan for over a year. Her case alleges that she did not have access to the FDA’s warnings. The lawsuit states that almost one-third of all patients taking Reglan took the drug for at least a year, increasing their risk for TD. These patients trusted their doctors to make informed and safe decisions about their medical treatment, and they also trusted the drug companies to test the drugs and provide information to patients so they could make informed decisions. Some of the lawsuits claim that the drug makers knew about the risk of tardive dyskinesia for decades. Unfortunately in the case of Reglan, the system seems to have let people down. 

If you believe that you or a loved one suffered an injury after taking Reglan, we would honor the opportunity to speak with you.  In certain situations, a lawsuit may be pursued against the drug manufacturer and the physician who was prescribing it at the time.  As will all of our cases, we prosecute drug-related claims on a contingency basis-- clients never pay any expenses out of their pocket.  (888) 424-5757.

Thank you to Heather Keil, J.D. for her assistance with this Nursing Homes Abuse Blog entry.

Sources:

Nursing Homes Abuse Blog: Use of Reglan Has Been Linked to Development of Tardive Dyskinesia or Abnormal Muscle Spasms

Medicine Net: Metoclopramide

FDA’s MedWatch Safety Alerts, March 2009: Reglan and Nervous System Disorder

About Lawsuits: Reglan Litigation Will Not Be Consolidated in MDL

eMedicine: Tardive Dyskinesia

National Institute of Neurological Disorders and Stroke: NINDS Tardive Dyskinesia Information Page

The Public Record: More Warnings Needed on Reglan Side Effects

Recognition of Movement Disorders: Extrapyramidal Side Effects and Tardive Dyskinesia

The New England Journal of Medicine: The Safety of Metoclopramide Use in the First Trimester of Pregnancy

The New York Times: Drug Appears Safe for Morning Sickness

In the wake yesterday's announcement from GlaxoSmithKline that they will stop the manufacture, distribution and advertising of their well-known denture adhesive product Super PoliGrip, we have been inundated with calls from concerned clients and their families who are concerned about the health risks and their legal rights.

At the heart of the matter is zinc, a metallic chemical element, that is commonly used in everyday products from sunscreens to vitamins.  With respect to denture adhesives, like Super Poligrip and Fixodent, some recent studies have demonstrated that the zinc found in denture adhesives may leach out into the body resulting in elevated zinc levels.

Elevated zinc levels in the body are believed to be responsible for neurological problems and neuropathy.  A blood test can confirm if the zinc levels have reached toxic levels.  Unfortunately, research has also demonstrated that the effects of zinc poisoning may be permanent and irreversible.

Common physical symptoms of zinc poisoning may include:

• Numbness in hands, feet, arms or legs
• Tingling in the hands, feet, arms or legs
• Inability to move arms or legs
• Pain in arms or legs
• Frequent falls

PoliGrip and Proctor & Gamble's Fixodent compose a large portion of the denture adhesion cream market composed of more than 30 million denture users.  However, never in the long-term history or these products, has GlaxoSmithKline or Proctor & Gamble given any warning to the consumer that the use of their products could be dangerous.

What remains clear at this point, is that a generation has been betrayed by drug companies that they had put their trust in--- to provide a safe and fairly labeled product. 

If you believe you or your loved one sustained an injury or death related to zinc poisoning from a PoliGrip product (Super PoliGrip Original, Super PoliGrip Ultra Fresh or Super PoliGrip Extra Care) or Fixodent,  we would be honored to speak with you regarding your legal rights.  At this time, there may be several legal avenues to recover damages for injuries including: an individual lawsuit or joining a 'class action' involving the Denture Cream Products Liability Multidistrict Litigation.  

As with every case we have handled for more than 30 years, all legal consultations are free and confidential. (888) 424-5757

Resources:

Study Finds a Possible Link Between Denture Cream and Imbalance, ABC News, May 5, 2009

Study cites danger of zinc poisoning from denture creams, Times-Standard, July 12, 2009

Glaxo to remove zinc from denture cream, ABC News, February 18, 2010

GSK Consumer Healthcare warns consumers of potential health risks associated with long-term excessive use of zinc-containing denture adhesives

Two suits claim zinc in P&G’s Fixodent causes harm, BusinessCourier, March 20, 2009

My office frequently gets contacted by concerned family members who may be unable to specify the exact type of error and facility made, but nonetheless they have a clear belief that their loved one's condition has changed for the worse due to improper care or taking an dangerous drug.  

Recently we were contacted by the family of a lady who within several months of taking Reglan Tablets, began to develop severe muscle spasms in her face.  We soon found out that the staff physician had prescribed Reglan several months before the spasms started.

Reglan (generic name – metoclopramide) speeds up the movement of the stomach muscles, which increases the rate at which the stomach empties into the intestines. This prescription drug is used to treat gastrointestinal disorders including heartburn caused by gastroesophageal reflux disorder (GERD), diabetic gastroparesis (stomach does not contract), and to prevent nausea and vomiting caused by cancer chemotherapy and surgery.

Reglan can cause serious side effects including:

• Tardive Dyskinesia - abnormal muscle movements (see “Black Box Warning” below)
• Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia)
• Depression, thoughts about suicide, and suicide
• Neuroleptic Malignant Syndrome (NMS) –
• Parkinsonism – condition similar to Parkinson’s, symptoms include slight shaking, body stiffness, trouble moving or keeping your balance

The FDA's Black Box Warning On Reglan

The FDA has recently required that manufacturers of metoclopramide add a “black box” warning about the risk of its long-term or high-dose use. The black box warning is the FDA’s strongest warning for drugs.

According to the FDA, more than 2 million Americans use drugs that contain metoclopramide (including Reglan tablets, Reglan oral disintegrating tablets, metoclopramide oral solution, and Reglan injection). Following this new warning, the FDA advises that chronic metoclopramide therapy should be avoided in all but rare cases where the benefits outweigh the risks.

Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary, repetitive, and purposeless movements of the body (including grimacing, lip smacking, tongue protrusion, eye blinking, or rapid leg and arm movements). These symptoms are rarely reversible and there is no known treatment; although, in some patients, symptoms may lessen once metoclopramide treatment is stopped.

The risk of development of tardive dyskinesia is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Elderly patients are among the greatest at risk, especially older women and patients who have been on the drug for a long time. Therefore, extreme caution should be taken in prescribing Reglan to elderly nursing home residents. Your chances for getting tardive dyskinesia go up:

• The longer you take Reglan and the more Reglan you take (you should not take raglan for more than 12 weeks)
• If you are older, especially if you are a woman
• If you have diabetes

Nursing homes should immediately evaluate all residents who are currently taking Reglan in order to determine whether continued Reglan treatment is necessary and beneficial in light of the FDA warning.

If you believe that your loved one, suffered an injury after taking Reglan, we would honor the opportunity to speak with you.  In certain situations, a lawsuit may be pursued against the drug manufacturer and the physician who was prescribing it at the time.  As will all of our cases, we prosecute drug-related claims on a contingency basis-- clients never pay any expenses out of their pocket.  (888) 424-5757

Resources:

FDA: FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs

National Institute of Neurological Disorders and Stroke: Tardive Dyskinesia

FDA: Reglan Medication Guide

Stevens-Johnson Syndrome (“SJS”) is a systemic disorder that affects the skin and mucous membranes, usually caused by a severe drug reaction.  SJS often begins with flu-like symptoms (fever, sore throat, cough, burning eyes), then progresses to red or purple rashes and blisters (photos), especially around the mouth, nose, eyes.  These symptoms eventually lead to skin sloughing (the shedding of the top layer of skin) because of cell death.  Some patients with extreme cases of SJS appear as though they were severely burned due to the extensive skin loss.

Stevens-Johnson syndrome is a hypersensitivity disorder usually caused by a reaction to a newly prescribed medication.  Although any drug can cause SJS, several drugs are often associated with SJS including: anti-gout medications, non-steroidal anti-inflammatory drugs, sulfonamides and penicillins, and anticonvulsants.

Some drugs which have been associated with SJS that are frequently prescribed to nursing home patients include:

• Advil
• Motrin
• Vioxx
• Celebrex
• Bextra

Although Stevens-Johnson Syndrome is difficult to predict, there are several risk factors.  These include existing medical conditions (pre-existing infections) and genetics (carrying the HLA-B12 gene).  Still, there are no tests to help determine who is at risk for SJS.  To diagnose SJS, doctors conduct a physical exam and possibly a biopsy of the skin for further examination. 

Elderly patients in nursing homes are particularly susceptible to Stevens-Johnson syndrome because nursing home facilities fail to properly screen residents prior to administering potentially reactive drugs.  This is especially when a medication is prescribed by a physician who does not have ongoing contact with the patient.  Also, many nursing homes do not adequately train their staff to look for adverse reactions to drugs.

Treatment of Stevens-Johnson syndrome often requires hospitalization, especially because of possible complications.  These complications include a secondary skin infection, sepsis (bacteria entering the bloodstream, which can cause shock and even organ failure), eye problems (resulting from inflammation caused by any rash and blisters around the eyes), damaging lesions on internal organs, and permanent skin damage including abnormal coloring and scars.  The rash and blisters can take several weeks to heal, depending on the severity of the attack.  In more severe cases, where lesions cover about a third of the body, it is referred to as Toxic Epidermal Necrolysis (TEN). If SJS is left untreated, it can result in death.

The main treatment of SJS includes stopping the use of any medications that could be causing the Stevens-Johnson syndrome.  Further treatment includes fluid replacement and application of cool, wet compresses, accompanied by medication to ease itching and discomfort.  These supportive treatments are often performed in burn units. 

It is difficult to prevent Stevens-Johnson syndrome the first time because of how difficult it is to predict what will cause it; however, once a trigger is identified, that medication should be avoided in order to prevent further reactions.  Because recurrences of SJS are often more severe, it is important to properly identify SJS triggers. 

In the case of nursing home patients, we frequently see that staff physicians fail to alert staff to the fact that a new (and potentially dangerous drug) was introduced to patients.  This failure to communicate can lead nurses and other staff misinterpreting an allergic reaction to the medication as an general illness.  In some cases, the delay in diagnosis has resulted in irreversible injury or death.

Resources:

MayoClinic.com - Stevens-Johnson Syndrome

The Stevens-Johnson Syndrome Foundation

Photo Of Individual With Stevens Johnson Syndrome

 What is Avandia?

Avandia is the most commonly prescribed diabetes drug in the United States.  Avandia (rosiglitazone) is used to treat type 2, non-insulin dependent diabetes by increasing the bodies sensitivity to insulin. Avandia is manufactured by pharmaceutical giant GlaxoSmithKline and has been on the market since 1999.  If you have type 2, diabetes there is a strong likelihood you may have taken Avandia at some time.

What Type Of Adverse Side Effects Have Been Associated With Avandia?

Avandia has been linked to two types of edema (swelling or accumulation of fluid). Peripheral edema is swelling of the extremities due to fluid buildup.  Macular is the swelling and protein buildup in the eye area.  People who have taken Avandia have reported one or both types of edemas.  The edemas have been linked to congestive heart failure.  Studies suggest that there is a 43% increase in having a heart attack in people who have taken Avandia than the general population.

In addition to heart problems, Avandia has been linked to the following adverse medical conditions:

• Blurred vision
• Decreased visual acuity
• Liver problems
• Weight gain
• Jaundice
• Hypoglycemia

What Are My Rights If I Have Taken Avandia And Suffered Side Effects?

Given the fact that GlaxoSmithKline was aware of many of Avandia's side effects and did not act to immediately recall Avandia from the market, there appears to be significant culpability on the part of the manufacturer.  Depending on when you were prescribed, Avandia, you may also have a potential cause of action against the individual doctor or clinic.  

If you you a loved one has suffered from an injury since taking Avandia, you may contact our office for a free consultation and to learn your rights.  All consultations are kept confidential and there is no obligation on your part.  Please use the contact form or call, toll-free (888) 424-5757 to speak with our Avandia lawyers day or night.

Here is the May 21, 2007 FDA Safety Alert on Avandia.

Heparin is a commonly used blood thinner that has come under scrutiny for possible contamination.  The FDA has recommended restricting the use of high doses of Heparin, or generally known as Bolus dosing in an attempt to limit the severity of adverse reactions to the drug. Bolus dosing is used to quickly thin blood in some patients. 

The following people should be particularly aware of the Heparin contamination: hemodialysis patients, cardiovascular patients who have had surgery, photopheresis patients, plasapheresis patients and people who have had blood clots in their arteries.

There have been more than 350 complaints of adverse reactions to Heparin.  The adverse  reactions have been reported with the Heparin Sodium Injection multiple dose vials, 10 ml and 30 ml vials, 5000 units/ml, 10 ml vials and 10,000 units/ml, 4 ml vials.  The following reactions have been reported shortly following the administration of Heparin:

• Severe allergic reactions
• Death
• Severe nausea
• Vomiting
• Disphoresis
• Difficulty breathing
• Low blood pressure

If you were administered Heparin and experienced any of the above conditions, contact an attorney to learn your rights both individually and as part of a class action lawsuit today.

See the FDA recall of Heparin here.