Recently in Pharmaceuticals Category

December 9, 2011

Yaz Required To Provide New Information On Warning Labels

The Food and Drug Administration (FDA) has recently issued documents recommending that birth control pills such as Yaz should contain additional warnings concerning the risk of blood clots. The FDA noted that patients and doctors should be informed about the risks. A statement from FDA scientists provides, "We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility."

A predecessor to Yaz, Yasmin, was the first birth control pill using drospirenone, a new form of progestin. In 2006 Yasmin was reformulated and sold as Yaz. Although it was originally thought to have fewer side effects than older contraceptives, Yaz has now been shown to have a higher risk of blood clots than earlier types of birth control pills.

If you or a loved one has taken Yaz or other birth control pill containing drospirenone it is important to speak to a New Mexico Yaz attorney to determine your next steps. Birth control pills such as Yaz, Yasmin or Ocella have been associated with several side effects in addition to blood clots including:

• stroke
• heart attack
• gallbladder disease

The FDA will also ask a panel of experts to provide advice whether the drug is too dangerous for some women to take.

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June 1, 2011

Yaz Investigated For Increased Risk Of Blood Clots

Many types of birth control pills create risks of blood clots. However, new birth control research suggests that certain types of pills create an even higher risk of blood clots than others. Birth control pills that contain drospirenone - such as Yaz, Yasmin and Beyaz contain a two to three time higher risk for developing blot clots than other types of pills.

Yaz and Yasmin have been under fire for several years as a result of their potentially dangerous side effects including increased risk of death and stroke. With the added increased risk of blood clots, as well as gall bladder disease, women are urged to speak to a physician about alternatives to this dangerous drug.

Two recent studies released in the British Medical Journal determine that the risk from taking drospirenone is significantly higher than taking pills containing levonorgestrel. The FDA responded in an alert "the FDA ...will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills."

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March 18, 2011

FDA Removes 500 Unapproved Prescription Drugs From The Market

The FDA has announced that it will be seeking to remove nearly 500 unapproved prescription drugs from the market. In a statement, the director of compliance at the Center for Drug Evaluation and Research notes that they "don't know what's in them, whether they work properly, or how they are made."

If believe you may have suffered a seriously or harmful side effect after taking a prescription drug, contact a New Mexico pharmaceutical malpractice lawyer for more information.

Often, a drug's potential for injury is unknown until patients begin reporting harmful side effects. It was only after years of studies and lawsuits that dangerous drugs such as Avandia and Vioxx received adequate warnings. Recent cases involving dangerous drugs such as Baycol, Bextra and Reglan have all brought to light the potential for debilitating side-effects and in some cases an increased chance of life-threatening effects from taking these harmful prescription drugs.

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December 6, 2010

American Dangerous Drug Trials Being Conducted Overseas

A recent investigative article has disclosed some scary statistics. Even with FDA approval, prescription drugs kill nearly 200,000 Americans each year. As a result of consumer backlash and the raised awareness of the potential risks of dangerous drugs such as Avandia, Reglan and Darvon/Darvocet, many U.S. drug companies have now moved their clinical trials overseas to Russian, Poland and China where regulation is virtually non-existent and the F.D.A. has no authority. In fact, the 20 largest U.S.-based pharmaceutical companies now conduct one-third of their clinical trials at foreign sites.

According to reports, pharmaceutical representatives are now scouring the world to find people willing undergo clinical trials for new drugs in order to help persuade the F.D.A. to declare drugs safe and effective for Americans. Additionally, if a U.S. study finds a drug has no benefit, a foreign study can be used to secure F.D.A. approval.

One drug being tested in foreign cities is Celebrex, an anti-inflammatory drug that has been heavily promoted in the U.S. for more than a decade. Although Pfizer, the manufacturer of Celebrex has reported 290 trials for the drug, with 107 in other countries, an informal polling revealed at least 207 trials in other countries.

Recently, it has been disclosed that Celebrex patients were more likely to suffer heart attacks and strokes than those consumers who took older and cheaper painkillers. Further, reports indicate that Pfizer knew of these problems.

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November 29, 2010

Darvon/Darvocet Pulled From The Market

Last week, the FDA finally pulled propoxyphene - sold as Darvon and Darvocet - from the U.S. market. For nearly 50 years concerns have been raised over the side effects of Darvon/Darvocet usage, including its toxicity even at low levels and its highly addictive properties. Additionally, it has not been shown to be very effective as a painkiller - its intended use.

According to reports, its toxicity and risk of causing abnormal heart rhythms have caused thousands of deaths in patients who took these medications.

As recently reported, the FDA now concludes, even the recommended dose caused "significant changes to the electrical activity of the heart" which can "increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death."

Although last week's FDA actions in removing the drug, as well as its generic equivalents, is a positive step, it comes several decades too late, after thousands of consumers may have died as a result.

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October 24, 2010

Doctors With Questionable Records Hired By Drug Companies

ProPublica, an independent news organization, has been investigating the connection between physicians and pharmaceutical companies, and how pharmaceutical company payments influence physician prescription practices, including the prescription of dangerous drugs such as Avandia, Levaquin and Meridia.

This in-depth report reveals that hundreds of doctors received payments from drug companies who had been accused of professional misconduct, disciplined by state boards or lacked credentials as researchers or specialists. As stated by a researcher "Without question, the public should care...Why would you want your doctor learning from a bad doctor, someone who hasn't displayed good judgment in the past?"

Based on their research ProPublica published a database of doctors who have taken money from seven different drug companies in the past two years. The database features over 17,000 doctors - many of whom are paid substantial sums of money to act as speakers for drug companies. However, only seven drug companies have publicly reported payments and as such, represent only a small fraction of doctors who speak for pharmaceutical companies in the United States. In fact, this number could be as large as 100,000.

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October 18, 2010

Can Parents Sue For A Vaccine's Design Defect?

Last week the United States Supreme Court heard argument concerning whether parents of a girl who became sick shortly after being vaccinated against diphtheria, tetanus and pertussis can sue the vaccine's manufacturer. The parents allege a design defect. Nearly 5,000 potential lawsuits may result if the court allows the parents to sue, asserting a link between autism and the vaccine.

At issue - whether Congress intended to preempt state lawsuits when it enacted the National Childhood Vaccine Injury Act of 1986, which created a separate court and compensation scheme for those injured by vaccines.

Side effects from taking prescribed medications and vaccines can be serious.

Here, the family's six-month-old daughter developed a seizure disorder and mental disabilities shortly after receiving a dose of Wyeth's (now part of Pfizer) vaccine. The vaccine court denied their claim, citing a lack of evidence proving the vaccine caused the seizures. However, the vaccine court process does not allow discovery so whether the link existed was not fully explored. In state court, the family sued on the grounds that the vaccine was defectively designed, and that safer alternatives exists, but that Wyeth failed to market those alternatives.

Several key issues are raised, including the extent injuries caused by vaccines are "unavoidable." The outcome of this case may have a significant impact. Some fear that pharmaceutical firms will stop making vaccines due to the cost of defending design defect cases. However, without the threat of design-defect cases, manufacturers may lack the incentive to produce safer alternatives, placing profits over safety.

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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.

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

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

Continue reading "New Mexico Dangerous Drugs - GlaxoSmithKline Has Duty To Warn Of Avandia Risks " »

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.