Recently in Dangerous drugs 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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September 21, 2011

Study Reveals Propecia May Cause Persistent Sexual Dysfunction

Recent reports have linked finasteride - marketed as Propecia - with persistent and possibly irreversible sexual dysfunction. Propecia, which treats hair loss, works by decreasing the conversion of testosterone to dihydrotestosterone, a hormone that causes hair loss.

In fact, doctors have known for years that Propecia has been linked to sexual problems including impotence, but a recent Propecia study performed by George Washington University found that as much as 38% of all users have adverse sexual events based on dosage and duration.

These side effects include low sexual desire, problems with orgasms and erectile dysfunction. In addition to the sexual side effects, additional life threatening ailments may arise including an increased risk of developing an aggressive form of prostate cancer and breast cancer.

The study also determined that sexual dysfunction associated with taking the drug is persistent, and not reversible as was previously thought. The Propecia study found that the side effects from taking the drug lasted an average of 40 months, with 20% of the men having side effects lasting more than six years.

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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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May 8, 2011

Topamax May Alter Effectiveness Of Birth Control Pills

Recent reports indicate that in addition to problems such as cleft palates and cleft lip from taking Topamax, Topamax may cause oral contraceptives to loose their effectiveness.

Topamax (topiramate) is a popular migraine and seizure medication that has been recently revised by the FDA as a "Class D" pregnancy drug - i.e. one where significant evidence exists that the drug may cause harm to a fetus during pregnancy. Now, combined with evidence that Topamax may render certain birth control ineffective, physicians are urged to inform patients of the danger of Topamax and oral contraceptive interactions.

In addition to the potential for birth defects, patients taking Topamax have developed eye disorders such as glaucoma and acute myopia.

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April 19, 2011

Topamax Recall After Reports Of Unusual Odors

Johnson & Johnson has issued a Topamax recall after receiving complaints about an unusual odor linked to a byproduct from a chemical used in treating wood. Sources believe the contamination may have occurred as a result of the way medication is shipped and stored.

Topamax has recently come under fire after the FDA issued warnings of an increased risk of cleft lips and cleft palates in infants of mothers who take Topamax (topiramate) during pregnancy.

The FDA has given the Topamax a pregnancy risk rating of D, indicating positive evidence of human fetal risk and birth defects.

Topamax has also been linked to eye disorders such as blurred vision, acute myopia and secondary angle closure glaucoma.

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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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March 8, 2011

Topamax Linked To Birth Defects

The New York Times reports that Topamax, manufactured by Johnson & Johnson, has been linked to birth defects, such as a higher risk of developing cleft lips and palates, genital malformations and cranial malformations.

Topamax is an anti-seizure and migraine drug used in the treatment of migraines and epilepsy. It is also used in the weight-loss drug Qnexa.

Infants exposed to the dangerous drug during their mother's first trimester of pregnancy had a 3 times higher rate of mouth defects than those whose mothers took other seizure medications.

If you or a loved one has been harmed by taking Topamax, contact an experienced New Mexico Topamax attorney to discuss your options.

The FDA notes "doctors should think carefully before prescribing the drug to women of childbearing age and 'alternative medications that have a lower risk of birth defects should be considered.'"

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February 23, 2011

Medical Malpractice Reform Should Focus On Patient Safety

Medical Malpractice reform has been receiving much attention recently with the introduction of H.R. 5, which seeks to impose national tort reforms measures, including the imposition of caps on non-economic damages as well as potentially taking away the right to trial by jury in some medical malpractice cases.

As New Mexico medical malpractice lawyers, we believe such measures often fail to address the real issue - patients safety. Study after study show that patients suffer significant harm and costs in hospitals due to adverse reactions from dangerous drugs, infections, surgical errors and unnecessary procedures. Rather than limiting victims' access to justice, more focus must be placed on improving patient safety and ensuring that those responsible for causing harm be held accountable.

Recent examples include the DePuy Hip, now shown to leak dangerous chemicals into the bodies of recipients. Often, the only way to get companies to remove dangerous products from the marketplace and be compensated for the harm caused is through litigation. Capping our damages or limiting access to the court room will remove an important incentive to improving the safety of our health care.

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December 13, 2010

Supreme Court Agrees To Hear Generic Reglan Drug Label Suit

The U.S. Supreme Court has agreed to hear argument over whether generic drug makers can be sued for the failure to warn about dangerous side effects on their drug label even when they follow federal rules.

In PLIVA, Inc. v. Mensing a woman took metoclopramide - the generic equivalent of Reglan - for four years to fight diabetic gastroparesis. She claims that the drug caused a severe neurological movement disorder - tardive dyskinesia - not warned about by the drug's manufacturers and distributors.

The 8th U.S. Circuit Court of Appeals found in favor of the woman, noting that more should have been done to warn consumers about possible risks. The court reasoned, "If they realized their label was insufficient but did not believe they could propose a label change, they could have simply stopped selling the product. Instead they ...placed a drug with inadequate labeling on the market and profited from its sale."

The FDA has now required Reglan to add warnings about tardive dyskinesia in February 2009.

The Supreme Court will hear argument in the spring.

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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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September 27, 2010

FDA's Avandia Restrictions - A "Victory" For Consumer Safety

In a victory for consumers, the FDA finally restricted sales of Avandia in the United States (as well as suspending all use in Europe.)

However, as noted in the New York Times, the dangers associated with Avandia only came to light after a cardiologist analyzed data from clinical trials that GlaxoSmithKline, the maker of the drug, had been forced to post on its website as a result of the legal settlement. "Such public postings are increasingly the norm which means that drug makers can no longer easily hide or control scientific information about their medicines." (Emphasis added.)

After engaging in an 11-year cover up of these health risks, "the decision brought an end to one of the worst drug safety tragedies in our lifetime." One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure, or died."

Despite the victory, the FDA's actions still display willingness to compromise with the drug industry. As noted by Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group, "The FDA made progress by highlighting the risks of using Avandia and severely restricting its use, but it didn't go far enough. Too many people could still be exposed to this dangerous product.

As New Mexico personal injury attorneys concerned about dangerous drugs, we agree. Restricting Avandia is a major step forward for consumers. However, the fact that the drug remains on the market and that the dangers of Avandia would not have come to life but for litigation underscores how far we still have to go to protect citizens from corporate greed and conflicts of interests that place profits ahead of consumer 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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