Trial Lawyer Resource Center

Does Chelation Therapy Cause Heart Injuries? Chelation therapy is a recognized treatment for heavy metal (such as lead) poisoning. EDTA (Ethylenediamine tetraacetic acid) is injected into the blood and binds the metals, allowing them to be removed from the body in the urine.A potent chelator of cations, especially calcium, it is FDA-approved only for rapid, emergency treatments of hypercalcemia or digitalis toxicity,and for those indications it has long been obsolete. Source.

Na2EDTA is specifically contraindicated for “generalized arteriosclerosis.” Its labeling includes a “black box” warning: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy." You can find the warning here: http://www.circare.org/foia2/endrate_ppi19740716.pdf



Chelation therapy is not approved by the FDA to treat coronary artery disease, but some physicians and alternative medicine practitioners use it for this purpose.

In August 2002, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), which are both components of the National Institutes of Health (NIH), announced the launch of the Trial to Assess Chelation Therapy (TACT). This placebo-controlled, double-blind study involves participants age 50 years and older who’ve had a heart attack, and is expected to reach a total enrollment of 1,950. Participants are representative of the U.S. population.

Last August, the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected. Researchers then suspended enrollment.

The most common immediate side effects of oral chelation therapy include: skin rashes, redness and swelling, headaches, diarrhea, nausea, fainting, fatigue, joint pain, body aches, cramps and convulsions.

Kidney damage from chelation therapy has resulted in permanent damage requiring ongoing dialysis. Deaths have also occurred during chelation therapy from kidney failure and cardiac arrhythmia.

Death and permanent injury have resulted from chelation therapy, even in doctor-supervised clinical trials. The American Heart Association warns of severe and life-threatening side effects and does not endorse chelation as a treatment for heart disease.

Other observers have reported cases of hypocalcemia leading to cardiac arrhythmias and tetany;  decreased blood clotting ability with abnormal bleeding; thrombophlebitis and embolism; hypoglycemia and insulin shock; severe vasculitis and autoimmune related hemolytic anemia, dermatitis with pruritus and generalized eczema; and extensive clumping of platelets in the blood of some patients with atherosclerosis and other chronic diseases.

 

This post was written by Mark Zamora, and you can reach him at ageorgialawyer.com

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The US Food and Drug Administration has ordered the makers of a drug used to treat nausea and vomiting to put the strongest warning possible on the product due to its damaging side-effects.

It was found that tissue damage can be caused as a result of using the medication, in the worst cases leading to amputation.

Go to the FDA site for more information: fda.gov.

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At my offices, we are investigating claims of injury allegedly linked to this birth control pill, call  us at 877-573-4526, or email us at markzamora.com, or mark@mzlawyer.com

 

Yasmin and Yaz are two types of birth control pills manufactured by Bayer Healthcare, and the generic, Ocella, is marketed and distributed by Barr Laboratories, Inc. Yasmin and Yaz contain the same estrogenic compound, ethinyl estradiol, that has been used in “The Pill” since the 1970s, but the progestin in Yasmin and Yaz is new. Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin – no other birth control pills contain drospirenone, except for a recently approved generic version, Ocella.

 

 

Side Effects of Yaz/Yasmin Birth Control Pills

Yaz/Yasmin was approved by the Food and Drug Administration (FDA) in 2006 as an oral contraceptive, and was marketed by its manufacturer, Bayer. Once the drug hit the market, however, the FDA started to receive reports of side effects when taking Yaz/Yasmin, including:

• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Heart Arrhythmia
• Heart Attack/Myocardial Infarctions and
• Stroke and Transient Ischemic Attacks

What is in the pill:

Yaz/Yasmin contains a synthetic progestin called drospirenone, which some claim will raise blood potassium levels. Doing so may result in a dangerous condition known as hyperkalemia. Hyperkalemia can lead to life-threatening heart problems.

From the first quarter of 2004 through the third quarter of 2008, more than 40 reports of death among users of Yasmin and Yaz have been filed with FDA. These include numerous deaths with reported cardiac arrhythmia, cardiac arrest, intracardiac thrombus (blood clots in the heart), pulmonary embolism (blood clot in the lungs), and stroke in women under 50 years of age.

After ads were run on this pill, there were complaints. In an agreement with the FDA and attorneys general from 27 states, Bayer agreed to drop the misleading ads and run a new campaign to educate the public about Yaz/Yasmin’s health risks. Unfortunately, innocent women across the country have already been hurt by taking Yaz/Yasmin. To date, a number of lawsuits have been filed against Bayer, claiming that the drug company misled women and their doctors about the dangers of their birth control pill.

 

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This from Richard Shapiro, a lawyer in Bradenton, ,FL who is investigating the claims of people who may have been harmed by Reglan:

 

Reglan (r)

 

Our office is investigating injuries associated with Reglan, at 800-258-HELP.

 

If you were potentially seriously injured by Reglan®, or have a loved one who was injured or even died from taking Reglan®, please contact us immediately for a FREE potential case evaluation.

• Tardive Dyskinesia
• Death
• Coma
• Neuroleptic Malignant Syndrome

Death, Coma, and Kidney disease have allegedly been attributed to Reglan®. 

 

 What is Reglan? Reglan is used for the short-term treatment of heartburn in patients who have already tried other medications but had no relief of symptoms. The way that Reglan works is that it increases the muscle contractions in the upper digestive tract, which in turn speeds up the rate at which the stomach empties into the intestines. People that suffer from diabetes sometimes suffer from a slow gastric emptying, which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals, so they take Reglan as well.

 

From Web MD:

 

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bleeding/blockage/hole in the intestines/stomach, pheochromocytoma, seizures, porphyria.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, heart rhythm problems, Parkinson's disease, severe liver problems (e.g., cirrhosis), chronic heart failure, a certain blood enzyme problem (NADH-cytochrome b5 reductase deficiency), diabetes.

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness, confusion, mask-like facial expression, shuffling walk, drooling, uncontrolled shaking of the hands, twitching in the face, muscle spasm/weakness, trouble swallowing, and uncontrollable movements of the mouth/face/hands.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

http://www.webmd.com/drugs/drug-6177-Reglan+Oral.aspx?drugid=6177&drugname=Reglan+Oral

 

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Four generic drug makers named as defendants Federal Court in Vermont were not permitted to seek an interlocutory appeal on a Motion for Summary Judgment which was filed by them. Each claimed that because the warning label was not designed or written by any of them, there was no liability.  

Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders, and is only supposed to be used for under 12 weeks.

 

Specifically, the makers of generic Reglan argued that they should be dismissed from the litigation because the plaintiff’s failure to warn claims are preempted by FDA regulations that require the generic version of medications to contain the same warning label as the branded version.

Back at the end of 2008, the Court denied the motion to dismiss, and the drug makers filed a request for an interlocutory appeal to immediately challenge the Court’s decision and stay the proceedings.

In an order issued April 10, 2009, Judge Sessions denied the request, which will require the generic drug makers to participate in discovery and further litigation of the case.

Attorneys Mark Zamora and Joey James are investigating these claims.

http://www.markzamora.com/reg/index.html

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FDA Requires Boxed Warning and Risk Mitigation Strategy for Reglan and Metoclopramide-Containing Drugs

Alabama Attorney Joey James and Georgia and Florida licensed attorney Mark Zamora are investigating - Tel #888-422-2882, or email mark@mzlawyer.com.

 

 

From the FDA site:

The U.S. Food and Drug Administration announced that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines). It is recommended that treatment not exceed three months.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

What is Tardive Dyskinesia?

Tardive dyskinesias (TDs) are involuntary movements of the tongue, lips, face, trunk, and extremities that occur in patients treated with long-term dopaminergic antagonist medications. Although they are associated with the use of neuroleptics, TDs apparently existed before the development of neuroleptics. People with schizophrenia appear especially vulnerable to developing TDs after exposure to conventional neuroleptics, anticholinergics, toxins, substances of abuse, and other agents. TDs are most common in patients with schizophrenia, schizoaffective disorder, or bipolar disorder who have been treated with antipsychotic medication for long periods, but TDs occasionally occur in other patients as well. For example, people with fetal alcohol syndrome, other developmental disabilities, and other brain disorders are vulnerable to the development of tardive dyskinesias, even after receiving a single dose of the causative agent.

TDs may be differentiated from acute movement disorders that commonly occur in the same patient groups. The acute movement disorders that occur as manifestations of effects of neuroleptics and other dopamine antagonists include akathisia, acute dystonia, and other hyperkinetic dyskinesias. Acute effects of dopamine antagonists also include Parkinsonian syndromes manifested by bradykinesia, rigidity, and pill rolling tremor. The acute movement disorders resulting from exposure to dopamine antagonists are commonly termed extrapyramidal syndromes (EPS).

Reglan- associated with Dystonia?

Symptoms vary according to the kind of dystonia involved. In most cases, dystonia tends to lead to abnormal posturing, particularly on movement. Many sufferers have continuous pain, cramping and relentless muscle spasms due to involuntary muscle movements.

Early symptoms may include loss of precision muscle coordination (sometimes first manifested in declining penmanship, frequent small injuries to the hands, dropped items and a noticeable increase in dropped or chipped dishes), cramping pain with sustained use and trembling. Significant muscle pain and cramping may result from very minor exertions like holding a book and turning pages. It may become difficult to find a comfortable position for arms and legs with even the minor exertions associated with holding arms crossed causing significant pain similar to restless leg syndrome. 

Affected persons may notice trembling in the diaphragm while breathing, or the need to place hands in pockets, under legs while sitting or under pillows while sleeping to keep them still and to reduce pain. Trembling in the jaw may be felt and heard while lying down, and the constant movement to avoid pain may result in the grinding and wearing down of teeth, or symptoms similar to TMD. The voice may crack frequently or become harsh, triggering frequent throat clearing. Swallowing can become difficult and accompanied by painful cramping.

 

 

 

 

 

 

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For good hardworking people, it''s time to sound the alarm about proposed GA legislation:  

 

From the GTLA:

Governor Perdue wants to place the safety of Georgia’s citizens in the hands of a mismanaged federal bureaucracy

Georgia lawmakers introduced SB 101. Senate Bill 101 would grant new protections from product-liability suits to Georgia companies whose products have Food and Drug Administration approval.

In essence SB 101 seeks to rely on the federal Food and Drug Administration (FDA) amidst grave controversy while giving large pharmaceutical companies who harm Georgians a “Get out of Jail Free” card

Governor Perdue suggests that a federal bureaucracy embroiled in heavy controversy, the FDA, should have all the power in deciding the safety of pharmaceuticals and medical devices. SB 101 bars any Georgia citizen from bringing a products liability claim against a pharmaceutical corporation so long as it is headquartered or has 200 employees in Georgia and the product in question, either a drug or a medical device, is FDA approved.

“Vioxx was an FDA approved drug that harmed at least 139,000 people. If there were to be a drug or medical device made here in Georgia that injured or killed people like Vioxx did, Georgia residents would have absolutely no recourse. A person in Phoenix City, Alabama could pursue justice; a person in Columbus could not,” said Fred Orr, President of the Georgia Trial Lawyers Association. “The Governor believes SB 101 will bring corporations to Georgia. But I don’t think we want the kind of business this legislation would attract as this bill says, “Move to Georgia! You can harm or kill our citizens and you will not be held accountable!”

The Governor stated early in the session that FDA approval “should mean something” and that it should protect corporations from lawsuits.

“The FDA can’t protect us from peanut butter. How can we possibly rely on the FDA to protect us from dangerous drugs and medical devices?” said Orr. “If a pharmaceutical corporation manufactures a drug or medical device that seriously harms or kills an innocent person, that corporation should not, under any circumstance, be shielded from accountability. The Governor has simply gone too far with this proposal.”

On February 2, 2009 President Obama had harsh words for the FDA and he urged Congress to conduct a complete review of the FDA after the agency failed to protect the public from contaminated peanut butter. At this time the contaminated peanut butter has killed 8 people and sickened over 500 people.

In addition to the agency’s failure to protect the public from peanut butter, as recently as the last month, the FDA has been at the center of three other nationally publicized controversies concerning alleged corruption, mismanagement, and claims of serious financial conflicts of interest. First the federal Government Accountability Office (GAO) released a report revealing that the FDA has failed to comply with a congressional mandate set nineteen years ago that requires manufacturers of medical devices to provide proof of rigorous testing and safety analysis to the FDA for all Tier 3 medical devices (classified as those devices that are implanted or that a person relies on for life) prior to approval.

Second, a group of FDA scientists went public with their allegations of corruption, mismanagement and coercion within the FDA. The scientists stated that the scientific review process for medical devices “has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.” They allege that managers at the FDA lacked scientific knowledge and clinical expertise regarding medical devices and that they have ignored the experts and scientists within the FDA. The authors stated that they had been ordered to modify their findings and evaluations of medical devices—allowing for the approval of products that may not be safe.

And third, the Inspector General of the Department of Health and Human Services (HHS) issued a report uncovering a troublesome conflict of interest inherent in the FDA approval system. The FDA failed to collect information on financial ties between those that perform clinical tests and the pharmaceutical companies that manufacture the product being tested in an alarming 42% of the cases. HHS claims that such financial ties may compromise the safety of the people in the clinical trials and the authenticity and integrity of the final research data.

“The scientists working at the FDA think that Americans are in danger. Other governmental entities report that the FDA is inept at keeping the American public safe. Yet Governor Perdue inexplicably thinks we should trust a corrupt federal bureaucracy to keep Georgians safe,” said Andy Childers, an Atlanta attorney.

National leaders in medicine don’t think that FDA approval is enough to keep people safe either. In a friend-of-the-court brief filed in association with the case of Wyeth v Levine, multiple editors of the New England Journal of Medicine stated, “The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety." The doctors went on to say that without civil lawsuits and the discovery they produce, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."


NOTE: For more information on the FDA approval process and other Government reports, please contact Rebecca DeHart at GTLA.



The Georgia Trial Lawyers Association
Protecting the Constitutional Promise of Justice for all by
Guaranteeing the Right to Trial by Jury,
Preserving an Independent Judiciary, and
Providing Access to the Courts for all Georgian

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