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Avandia Side Effects Drug Toxic Chemicals

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Avandia Warning: Avandia Side Effects and Risks

Avandia, GlaxoSmithKline’s (GSK) top-selling diabetes drug, became the center of controversy on May 21, 2007 when an analysis of several studies appeared as a headline article in the online version of the New England Journal of Medicine (NEJM). The new meta-analysis revealed a significant increase in the risk of heart attack and other heart problems for patients taking Avandia, raising concerns that heart attacks may be an Avandia side effect.
On the day the new analysis was released the FDA (Food and Drug Administration) released an FDA Alert announcing the results of the analysis, but also claiming that the results of long-term clinical trials conducted by GSK contradict the results in the NEJM article. The FDA did not recommend that physicians take their patients off Avandia at that time, but promised a further investigation. Seven Galson, the physician director of the FDA’s Center for Drug Evaluation and Research, announced that the FDA would analyze the information it has on the Avandia risk as soon as possible and make the results available. The FDA would also present the issue of Avandia’s potential heart attack side effect and the need for an Avandia warning or other action to an advisory committee as soon as one can be convened.
The FDA eventually required a black box warning, its most serious level of warning, for the increased risk of coronary problems in patients taking Avandia.
Suffered harm from Avandia? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
The NEJM article raises concerns about the FDA’s approval of Avandia: These emerging findings raise an important question about the appropriateness of the current regulatory pathways for the development of drugs to treat diabetes. The FDA considers demonstration of a sustained reduction in blood glucose levels with an acceptable safety profile adequate for approval of antidiabetic agents. However, the ultimate value of antidiabetic therapy is the reduction of the complications of diabetes, not improvement in a laboratory measure of glycemic control.
Members of Congress have also expressed concern about the FDA handling of Avandia. Both houses of Congress are currently debating funding bills for the FDA that contain certain requirements for reform of the methods used by the FDA to monitor drug safety. Representatives John Dongell and Bart Stupac, both Democrats from Michigan, have vowed to investigate further whether GSK revealed the dangers of Avandia to the public. The House Oversight Committee has announced a hearing on the FDA’s handling of Avandia scheduled for June 6, 2007.
Another 2007 study raised additional concerns about Avandia side effects. The study found that Avandia increases the risks of fractures of the upper arm, hand, and foot of women taking it and two other drugs manufactured by GSK, Avandamet and Avandaryl. Since millions of people take this drug, bone deteriorization could have a major health impact.
The FDA required GSK to prepare and release a new medication guide for Avandia, which was released on February 26, 2008. The new medication guide contains warnings on bone fractures, as well as of coronary side effects.
Check out the following articles for more information about Avandia, filing a Avandia lawsuit and finding a Avandia attorney.
For more information about Avandia , see Drug Overview: Avandia Side Effects and Claims
For more information about Avandia side effects, see Avandia Side Effects – Heart Attack and Fractures
To find out more about the FDA warning, see Avandia Side Effects and Risks
For more information about Avandia updates, see Avandia Information and Warnings
If you would like to learn more about Avandia lawsuits, see Avandia Lawsuits, Litigation & Lawyers
To learn more about Avandia attorneys and how to find one, see Hiring a Avandia Attorney and Lawyer
Suffered harm from Avandia? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Suffered harm from Avandia? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Avandia Warning Drug Toxic Chemicals

Free Case Evaluation From An Experienced Drug Liability Attorney.

Avandia Information and Warning

A recent study raises concern about Avandia, GlaxoSmithKline’s (GSK) best-selling and widely prescribed oral diabetes drug. Avandia, generic resiglitazone maleate, is a PPAR agonist, a kind of drug that functions by activating and suppressing genes. Several other kinds of PPAR agonists have been denied approval by the FDA (Food and Drug Administration) because of serious side effects.
The new study is a meta-analysis of 42 predominantly short-term studies that appeared as a headline article in the May 21, 2007 online Journal of New England Medicine (JNEM). The article got extra attention because one of the authors, Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic, raised concerns several years before that Mereck’s painkiller Vioxx caused heart problems. Vioxx was later removed from the market and was the target of several lawsuits. Now Dr. Nissen is giving an Avandia warning that the drug is potentially deadly to type 2 diabetes patients.
Dr. Nissen and his fellow author, Kathy Wolski, M.P.H., did a meta-analysis of the results of 42 studies reported on the GlaxoSmithKline and FDA websites. Their analysis showed that Avandia significantly raised the risk of heart attack or other heart problems by 43%. Dr. Nissen admits that there are weaknesses in his study because he relied on public information and didn’t have access to the source data for patients in the various studies. As a result, he was unable to do some analysis. Nevertheless, Dr. Nissen thinks his results are cause for alarm.
Suffered harm from Avandia? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Heart disease is the leading cause of death for people with diabetes, with 65% of deaths caused by cardiovascular problems. In that population a drug that increases the risk of heart attacks and other cardiovascular problems could have devastating effects. For that reason Dr. Nissen is advocating more studies of Avandia’s side effects and stricter FDA requirements for approving such drugs. See Avandia Side Effects and Risks for more information about criticism of FDA monitoring of Avandia safety.
GlaxoSmithKline is denying that Avandia creates a significantly increased risk of heart attack or other cardiovascular problems. Glaxo claims that its long-term trials do not show a significant increase in risk.
On the other hand, Bruce M. Psaty of the University of Washington’s cardiovascular health research unit and Curt D. Furberg of the Wake Forest University division of public health wrote an editorial that accompanied the May 21, 2007 NEJM article, in which they questioned the wisdom of prescribing Avandia until the questions about its side effects have been resolved.
Another 2007 study revealed a less serious, but still significant Avandia side effect. The study found that women taking Avandia, and some other drugs manufactured by GSK, have an increased risk of bone fractures, particularly in the upper arm, hand, and foot. While this is not life threatening, the heath consequences on millions of women who take Avandia could be significant. Men don’t appear to suffer this side effect.
Check out the following articles for more information about Avandia, filing an Avandia lawsuit and finding an Avandia attorney.
For more information about Avandia , see Drug Overview: Avandia Side Effects and Claims
For more information about Avandia side effects, see Avandia Side Effects – Heart Attack and Fractures
To find out more about the FDA warning, see Avandia Side Effects and Risks
If you would like to learn more about Avandia lawsuits, see Avandia Lawsuits, Litigation & Lawyers
To learn more about Avandia attorneys and how to find one, see Hiring a Avandia Attorney and Lawyer
Suffered harm from Avandia? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Pain Pump Pagcl Attorneys Defective Products

Pain Pumps & PAGCL: How An Attorney Can Help

Shoulder surgery patients who used a pain pump during their recovery phase may be at an increased risk of developing Postarthroscopic Glenohumeral Chondrolysis (PAGCL), or shoulder arthroscopy, a very painful condition that may cause a permanent loss of mobility. So, how can a lawyer help?
Tapping into a product liability lawyer’s knowledge
If you’ve been injured due to a pain pump manufactured by Stryker, DJO Inc., I-Flow or BREG Inc., it’s important to find out as much as you can – as fast as you can. Experienced product liability lawyers who have been following the hundreds of pain pump lawsuits already filed across the county have the information you’re looking for. Tapping into that knowledge – even if you don’t end up pursuing a lawsuit – can be of great comfort. They’ll be able to assess whether you may have a lawsuit, discuss what damages might be available to you and, most importantly, explain why these manufacturers may be liable your injuries.
Why pain pump manufacturers may be liable for your injuries
Legal experts who have analyzed the pain pump litigation say that doctors who prescribe pain pumps may not realize the potential damage that these devices can cause. In fact, they say that doctors may actually know very little about the issue at all because manufacturers omitted warning labels about the dangers of inserting the pain pumps directly into the joint space of a patient’s shoulder – something that was never approved by the U.S. Food & Drug Administration (FDA), yet something that manufacturers know occurs every day.
What many patients don’t realize is that McKinley Medical (purchased by Stryker in 2000), asked the FDA whether it could promote the product by having doctors inject pain medication directly into the joint space of a patient’s shoulder. While the FDA requested that McKinley conduct studies about the effects of the process, the company doesn’t seem to have followed through.
To speak with an attorney involved in the pain pump litigation, click here.

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Pagcl What Is It Who Is Responsible Defective Products

A Closer Look At PAGCL: What Is It & Who’s Responsible?

What is it?
Postarthroscopic glenohumeral chondrolysis, or PAGCL, is a debilitating condition that occurs in the shoulder when cartilage between the ball and socket of your shoulder has broken down to such a degree that bone actually meets bone. While there are many possible causes of PAGCL, the one it is most commonly linked to is the use of a pain pump after someone has had shoulder surgery.
There are generally two ways to manage pain after shoulder surgery – oral pain killers or pain pumps. Both will do the job, but oral pain killers require administration by someone else. Pain pumps, on the other hand, are small devices which can be surgically implanted in the shoulder joint so that the painkiller medication can be delivered immediately – and don’t require someone else to act. While the latter would seem to be a better choice, medical experts have concluded that pain pumps may cause permanent damage to the shoulder by eating away at the patient’s cartilage.
Recent studies from the American Academy of Orthopedic Surgeons and the American Journal of Sports Medicine seem to corroborate that theory. In the first study, shoulder surgery patients who developed PAGCL had all used a pain pump after their surgery. In the second study, Dr. Charles Beck, an orthopedic surgeon and senior author of the study, stated that there is a, “.strong association between the intra-articular (inside the joint space) use of high volume pain pumps following arthroscopic shoulder surgery and an otherwise unexplainable loss of hyaline cartilage in the shoulder joint.” Beck went further and said that approximately 63 percent of patients that use pain pumps after surgery develop PAGCL.
Who’s responsible?
Companies that manufacturer pain pumps are alleged to have known about the risk of developing PAGCL years ago, but kept that information to themselves because this “new” way of administering pain medication became extremely popular. Manufacturers such as Stryker, DJO Inc., I-Flow or BREG Inc., all sold these devices, but only I-Flow warned about the risks of PAGCL.
Product liability lawyers say that while the FDA approved pain pumps for certain treatments, it never approved them for use directly into a patient’s synovial cavity – which is exactly what is happening. Manufacturers know this and most still haven’t warned about the risks of PAGCL. Hundreds of lawsuits have now been filed against these manufacturers and legal experts predict that many more will be filed in the future.
To speak with an attorney involved in the pain pump litigation, click here.

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