Recently in Pharmaceuticals Category

July 26, 2010

Avandia Clinical Trials Partially Stopped

Last week the Food and Drug Administration (FDA) advisory panel recommended that Avandia - a popular diabetes drug linked to higher risk of heart attack - contain either stronger warning labels or restrict its use.

Avandia is developed and manufactured by GlaxoSmithKline.

In addition to a well-documented increased risk of heart attack, Avandia has been shown to lead to other health complications such as:
• Stroke
• Congestive heart failure
• Liver damage
• Swelling of arms and legs

In the wake of last week's recommendation for stronger warning labels, the FDA has put a hold on the long-term TIDE study, which compared Avandia with a similar diabetes drug, Actos. Critics have long questioned the ethics of using diabetic patients as "human guinea pigs" to assess the level of risk associated with taking Avandia.

As New Mexico personal injury attorneys concerned about dangerous drugs, not only do we support stopping the clinical trials of Avandia which continue to put more consumers at risk, but believe this dangerous drug must be taken off the market before more people suffer deaths ad serious injuries as the result of Avandia.

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July 20, 2010

Manufacturers of dangerous drugs should not be immune from liability

The Sixth Circuit Court of Appeals has recently submitted a question to the Food and Drug Administration requesting a response to its position on immunity. At issue is the claim by manufacturers that because the FDA regulates prescription drugs, once the drugs they make have received FDA "approval," drug manufacturers cannot be held liable for the harm - sometimes life threatening - these products cause.

In the landmark case, Wyeth v. Levine, the U.S. Supreme Court determined that federal regulation of prescription drug labels does not grant manufacturers liability.

Makers of Reglan, a generic drug used to treat Gastroesohageal reflux (GER) and Gastroesophaegeal reflus disease (GERD) are now trying to use preemption arguments to avoid liability for harm caused by use of their dangerous products.

Reglan poses the threat of developing Tardive Dyskinesia (TD), a disabling and permanent movement disorder often characterized by shaking spells, blinking and slurred speech. Users have claimed that the generic drug's label failed to warn consumers of the risks of use.

Last year, the Eight Circuit determined that generic manufactures must provide warnings, even if the name-brand drug label doesn't contain the warning.

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June 29, 2010

DANGEROUS DRUG - Reglan

Reglan is a presciption drug pushed by pharmaceutical companies to patients to treat Gastroesophageal relfux (GER) Gastroesophaegeal reflux disease (GERD). Many studies dating back from the 1970s, have shown that Reglan is ineffective in resolving GER and GERD. A 2006 study published in Nature Clinical Practice: Gastroenterology & Hepatology concluded that "the evidence base for the use of [metoclopramide for GERD] is weak, with little or no sustained effect on acid exposure or healing of esophagitis." The studies also indicate patients suffer from irreversible side effect if used for longer than a 12 week period called Tardive Dyskinesia. TD is a tragic life-long medical condition that causes involuntary and abnormal body movement.

TAKE ACTION

If you or a loved one has taken Reglan and have experienced any of the harmful side effects listed below please seek the help of the Branch Law Firm. Fill out a contact form or call us today so that we can conduct a thorough evaluation of your Reglan use and any damaging or irreversible symptoms that you have experienced.

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June 29, 2010

AVANDIA RECENT NEWS

Please see our Avandia information page to learn about the most up to date news on the harmful diabetes drug. The attorneys and lawyers at the Branch Law Firm can help you take action against the pharmaceutical giant Glaxo Smith Kline, makers of the diabetes drug Avandia; also known as Rosiglitazone

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April 7, 2010

NEW MEXICO DANGEROUS DRUGS - AVANDIA RESEARCHERS TIED TO CONFLICTS OF INTERESTS

According to Bloomberg News, 94% of researchers who found positive results from using Avandia had financial ties to pharmaceutical companies. Avandia, is a controversial diabetes drug that has been linked to increased sharp increased risk of heart attack and death.

Despite the FDA's issuance of a formal safety alert concerning the risks associated with Avandia, GlaxoSmithKline continues to market and sell the drug.

The FDA has now also decided to hold public hearings in July to determine whether Avandia should be removed from the market after scores of lawsuits in New Mexico and across the country have been filed based on the increased risk of heart attack resulting from Avandia usage, along with several studies showing a substantial correlation.

While reviewing documents in preparation for the hearing, Mayo Clinic researchers noted that an astounding 45% of the researchers who had weighed in on the Avandia controversy had financial conflicts of interests and about a quarter of those failed to report those conflicts.

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March 28, 2010

New Mexico Dangerous Drugs - FDA Conflicts of Interest Compromise Our Safety

Recent allegations of research collaboration between the FDA's top drug official - Dr. Janet Woodcock - and a pharmaceutical company underscore the potential for conflicts of interests and the high stakes involved in drug marketing. In fact, over the years the FDA has been involved in many conflicts of interests involving dangerous drugs.

In August, 2009 Amphastar Pharmaceuticals, Inc. filed an ethics complaint against Woodcock alleging that she delayed approval of Amphastar's application for approval of a generic blood thinner because of her ties to it's competitor, Momenta Pharmaceuticals, Inc.. Woodstock co-authored medical articles with Momenta while both companies were competing to win FDA approval for their generic blood thinners.

Although ultimately Woodcock was cleared, this episode shows how closely FDA officials may work with those pharmaceutical companies who seek their approval. It is crucial these contacts be disclosed. The drugs that are eventually approved by those officials are the ones that end up in our bodies. Where the motives of officials at the FDA are compromised, it is those individuals who end up taking the potentially dangerous drugs that suffer the consequences.

This is not the first time Woodcock has come under fire. From the late 1990s through the early 2000s several dangerous drugs approved by the CDER on her watch were pulled from the market because they were sickening and killing people. She has also been criticized for her handling of Avandia, a diabetes drug linked to fatal heart attacks and heart failure.

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March 2, 2010

New Mexico Dangerous Drugs - GlaxoSmithKline Has Duty To Warn Of Avandia Risks

The U.S. Senate Finance Committee has recently issued a report on Avandia, a controversial drug produced by GlaxoSmithKline ("GSK") to control diabetes.

According to the report, GSK knew of possible heart attack risks tied to Avandia many years before the information became public.

The report unequivocally states "GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner."

However, according to the report, GSK failed to warn patients and states: "GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk."

This latest report reveals in great detail the length that pharmaceutical companies are willing to go to avoid revealing legitimate health risks associated with their drugs. It further exposes the widespread practice of pharmaceutical companies using supposedly "independent" scientific research to bolster their claims, when in actuality the company has sponsored the research.

Adding to the controversy, questions remain why the U.S. FDA continued to allow clinical trials of Avandia even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

In addition to heart attacks, Avandia has been linked to several significant health risks including:

• Congestive heart failure
• Liver damage
• Increased cholesterol levels
• Swelling of arms and legs
• Anemia
• Fluid retention

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January 13, 2010

New Mexico Dangerous Drugs - Wyeth v. Levine Should Apply To Generic Drugs

In a victory for consumers, last Friday the Fifth Circuit Court of Appeals agreed with the lower court that individuals may sue generic drug makers in state court for the "failure to warn" consumers of of potentially dangerous side effects from taking their drugs. This decision shadows last March's Supreme Court decision in Wyeth v. Levine, which held that federal law did not pre-empt state law failure to warn claims against pharmaceutical companies.

The U.S. Fifth Circuit of Appeals joins a handful of federal district courts that have extended Wyeth v. Levine to cover generic drugs. However, the issue has divided a "rapidly growing" number of district courts which may increase chances of Supreme Court review.

The Tenth Circuit Court of Appeals has not yet weighed in on whether Wyeth v. Levine extends to generic drug manufacturers.

However, as dedicated personal injury attorneys concerned about dangerous drugs, we believe that the right to sue in state court for the failure to warn must apply equally to generic drugs as it does to their name brand counterparts. Any other conclusion would lead to inconsistent results and unjustly deny recourse to those who suffer dangerous side effects as the result of taking generic drugs.

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