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Oct 14

Bayer Warned by FDA for YAZ Testing Problems

The birth control Yasmin or Yaz has caused much controversy and concerns since it was first brought on the market back in March. Many people are concerned about the serious side effects of the pill and how Bayer seemed to have made these side effects not seem as serious as they are. Another thing that Bayer was warned about by the Food and Drug Administration or the FDA that they did not think was a serious problem was the testing of the quality of the pills. It measured the quality of its ingredients based on an average of several samples instead of reporting the individual test results of each sample like they should. Bayer then continued to ship eight batches of pills tested using this unapproved method to the U.S. The drug patches were reviewed after the FDA’s warning to Bayer, but Bayer says the batches shipped between 2007-2009 were not affected by this unapproved testing method. Since this warning, the FDA now requires that Bayer provide a full list of the shipments to the U.S. that may have used this average testing method and to require Bayer to come up with a plan to prevent the problem from happening again.  Bayer has produced many important medications that many people use and depend on daily. Maybe this method has not caused any real problems, but when it comes to the medicines we give ourselves as well as those we love, double checking does not hurt. It seems like this time Bayer may have gotten overwhelmed by the money they were making that they overlooked some safety measures. Safety however always needs to and should come first each and every time.

For more information on the Bayer testing methods for Yasmin, you may visit: http://www.app.com/article/20090915/NEWS/90915067/FDA+warns+Yaz++Yasmin+manufacturer+over+testing+problems or www.fda.gov

 

If you or a loved one has suffered possibility due to the side effects of Yaz or Yasmin, please contact a personal injury attorney right away. They will help get your case heard and help you get the care you need and deserve.

Oct 6

Yasmin: Are the Benefits worth the Serious Risks?

There have been many concerns and about the birth control pill Yasmin or Yaz.  Reports claim that it has many other benefits in addition to helping to prevent pregnancy.  Those benefits include claims that it helps with the symptoms of PMDD or premenstrual dysphoric disorder, helps with moderate acne and has been effective for Premenstrual Disorder or PMS, ovarian cysts, and ovarian cancer. What Yaz’s commercials and website apparently failed to disclose and understated were the serious potential side effects that can occure with this birth control pill. These risks and potential side effects include: blood clots, stroke, heart attack, weight gain, depression, and even in some very severe cases death.  Were these downplayed risks really worth the overstated benefits of taking Yaz?  The drugs manufacturer, Bayer clearly had its own bottom line in mind when it marketed this drug in the way it did and failed to inform people of the seriousness of the risks. Thankfully, Bayer is now paying the price by having new FDA regulations and recalls. So, the next time you see a Yaz commercial or information, make sure you consider whether the real benefits are really worth all the real risks.

For additional information on the Yaz pill, you may visit: http://www.yaz-us.com/index.jsp or http://www.drugs.com/sfx/yaz-side-effects.html

If you or someone you love has been a victim of a serious side effect due to the Yasmin or Yaz birth control pill, please contact a malpractice attorney right away. They will help you get your case heard and get the care you deserve.

Oct 1

Yaz Birth Control Concerns Continue

The birth control pill Yaz that once was all over commercials and online has being not only an effective form of birth control but also claimed to help with the symptoms of Premenstrual Dysphoric Disorder or PMDD has now made the news because of serious side effects and possible false claims. Yaz contains drospirenone and ethinyl estradiol. These levels of hormones have been known to cause some serious side effects that the Yaz commercials did not really seem to tell consumers enough about. Bayer’s company intentions were good and the marketing was great, but has it really been worth all the concern and controversy over the Yaz birth control pill now? Some consumers on Yaz are now scared or afraid to take it based on reports they have read or seen. Some people that are taking it now even say that it did not help them with their PDD symptoms as much as the ads and commercials claimed it would. Marketing is important and money is important, but consumer’s right to accurate information and proper warnings should always come first. Without a consumer’s trust, there is no product to sell. I believe Bayer has to regain their trust in many consumers that trusted the Yaz ads and commercials. They have a long way to go before they do.

For more information about the yaz pill, you may visit:  http://www.yaz-us.com/index.jsp or http://www.drugs.com/yaz.html

 

If you feel you or a loved one has suffered similar effects due to taking Yaz Birth control, please contact a personal injury attorney right away. They will hear your case and help you get the care and help you need.

Sep 30

Death Being Investigated of Woman who Took Yaz Birth Control

The Bayer AG company in Germany is having its Yaz Pill  investigated by the Swiss Health regulator has part of the reason a woman may have died. The woman was said to die from the effects of a pulmonary embolism and had been taking the pill for ten months. These types of problems are the rare but serious side effects of taking hormone-based contraceptives such as Yaz. It is true that just because this one woman may have died due in part as a result of Yaz, that not all woman are at risk by taking Yaz. This story though among others makes people start to wonder why the Bayer Company tried to cover up the serious side effects of this pill. Is it because money truly talks and Yaz is a huge money maker for Bayer? Or is it because all birth control pills have their risks so they did not see the need to mention them? Or finally is it because they really did not think the risks of this Yaz Birth Control pill were that serious? Whatever the case, people should know all the risks of any medicine they take, big or small, no matter how good the medicine may be or how much money the company may make. Consumers have the right to know what they are consuming.

For more information on this specific story, you may visit:

http://www.bloomberg.com/apps/news?pid=20601085&sid=aPSvNPx7m.n4

 

If you or a loved one has suffered due to the possible effects of Yaz, make sure to contact a personal injury attorney right away. They can help you get your case heard and get you the care you deserve

Sep 29

Yasmin Birth Control is a Money Maker but is it truly Safe?

Every one might remember the catchy “We’re Not Gonna Take it” and “balloons” commercials for the Yasmin or Yaz Birth Control pill. We may even remember all the benefits the pill was said to provide the consumer with, but what we may not remember is the listing of the dangerous side effects the Yasmin or Yaz pill could cause. This is because the commercials for Yaz overstated the pill’s effectiveness and understated the serious side effects that go along with it. This violates the Food, Drug, and Cosmetic Act as well as the Food and Drug Administration’s guidelines.

The marketing by Bayer Healthcare for Yaz or Yasmin was great. It brought in millions of dollars for the company and it may have been some of the company’s best marketing. What the company failed to market or to take into consideration is that all birth control pills including this one have serious side effects including: blood clots, stroke, heart attack, and even death. These commercials failed to let consumers know the seriousness of these side effects and now the company may pay in a big way.

For more information on Yasmin or Yaz you may visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf

http://humanrights.foreignpolicyblogs.com/2009/09/27/yaz-birth-control-controversy-pharmaceutical-profits-unnecessary-risks-and-the-gendered-distribution-of-family-planning/

 

If you or someone you love may have experienced a serious side effect from taking Yaz or Yasmin, please contact a malpractice lawyer right away. They will make sure you get the care you deserve and that your voice is heard.

Sep 28

Tylenol voluntarily recalls Some Medications due to Possible Contamination

Tylenol has recently decided to voluntarily recall more than a dozen infant and children’s medications due to possible contamination.  Bacteria was detected in one of the inactive ingredients and though it was not detected in the finished product, Tylenol decided to recall the products after consulting with the Food and Drug Administration as just a precaution.  B cepacia bacteria was detected in a portion of raw material that was not used in the finished product, but as a precaution Tylenol decided to pull any product containing this raw material from the shelves and recall it. These recalls were made between April and June of 2008 and include the following Tylenol products: Children’s Tylenol plus Cold MS suspension grape, Children’s Tylenol Suspension Grape, Children’s Tylenol Suspension Bubble Gum and Strawberry, Infant’s Suspension Drop 1 ounce grape, and Children’s Tylenol plus Cough and Runny Nose Cherry. The recall is only on liquid Tylenol products.

 

If you have questions about this recall, please call the McNeil Consumer Call Care Center at: 1-800-962-5357.

For more information about this and other recalls you may visit: www.tylenol.com or http://www.msnbc.msn.com/id/33000550/ns/health-kids_and_parenting/?ns=health-kids_and_parenting

www.fda.gov

 

If you feel that you or a loved one has suffered due to a defective consumer product, please contact a defective product attorney right away. They will make sure you have your voice heard and advocate for your rights.

 

 

 

Sep 21

FDA requires Strongest Warning Label on Nausea Drug

On Thursday September 17th the Food and Drug Administration required that the strongest warning label be placed on a nausea drug known as Phenegran. This new warning label is due to the fact that after Diane Levine took this drug through an IV push for migraine related nausea and it then led to infection and gangrene. This caused her to have to have her lower right arm amputated. She sued the drug company Wyeth claiming that the warning label was not sufficient enough to warn against the effects of this drug especially in an IV push. This case made it to the Supreme Court and won Diane 6.7 million dollars. This then led to the FDA requiring this strong warning. This will warn users and medical professionals about the possibility of gangrene and also to let them know that IV drugs should be used in low doses and low concentration. This warning is the FDA’s strongest and is called a “black box” warning. The Court agreed that having the Food and Drug Administration’s approval and new warnings help cut down on medical device lawsuits.

For more information on Food and Drug Administration and  improper warning labels you may visit:

http://www.fda.gov/

If you or a loved one have experienced a situation similar to this or have been injured due to a medical device or product, please contact a defective product lawyer right away. They will help you fight for your rights to be heard and get the care you or loved one  deserve.

May 5

Legal Side Effects or Legal Remedy?

In May’s issue, Kate Wilcox stated that a recent U.S. Supreme Court’s decision left drug companies “wide open for lawsuits” because it allowed juries to hold negligent drug companies accountable for harm they cause. The principles expressed by the Supreme Court in the Wyeth decision require federal regulations to improve transparency and public participation in the FDA regulatory process. Also, the decision recognized the state civil justice system provides an additional protection against billion dollar pharmeceutical companies when government regulations fail, and therefore agencies must limit their attempt to preempt state law, except in cases when Congress has explicitly stated its intent to do so. The decision upholds laws that are much needed, especially in light of the long standing practice of pharmaceutical companies to sponsor and pay for the, “research,” of the drugs they make. This practice allows the companies to market the drug’s positive effects while concealing the dangerous side effects that harm patients. The Court’s decision upholds important constitutional rights afforded to all citizens in this country and should be welcomed by a journal that promotes scientific study.

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Apr 23

Supreme Court Decision Allows for Compensation

Posted on Thursday, April 23, 2009 in Dangerous Drugs, Politics

A March 4th Supreme Court decision has allowed juries to award damages for the harmful side effects of drugs, even if the drug had the proper FDA approved warning labels. This ruling comes in the wake of recent discovery that many drugs widely used on the market over the past decade were the result of falsified medical research (For more information, see last weeks article on medical research.) Thousands of cases against the makers of drugs like Vioxx, will now have a higher probabilty of settling, after the drug has been shown to cause serious heart related problems, as well as hinder bone growth.

If you or a loved one has had their quality of life decline due to the harmful side effects of a prescription medicine, then they may be entitled to compensation. Please contact an attorney immediately.

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Apr 14

THE RESEARCH RECESSION: 12 years of Anesthesiology progress in question

Posted on Tuesday, April 14, 2009 in Consumer Safety, Dangerous Drugs, Malpractice, Politics

Over the past 12 years, anesthesiologist Scott Reuben revolutionized the way physicians provide pain relief to patients undergoing orthopedic surgery for everything from torn ligaments to worn-out hips. (Brendan Borrell, Scientific American)

Rueben’s drug studies were responsible for convincing orthopedic surgeons to move away from the first generation of non-steroid anti-inflammatory drugs to a new method, known as COX2 inhibitors. He claimed that these new drugs, made popular under the names Vioxx, Celebrex, and Bextra, in combination with anticonvulsants could be effective in decreasing postoperative pain and reduce the use of addictive pain killers, such as morphine, after surgery. What seemed to be a break through, Reuben’s findings were hailed as a great step forward in redesigning anesthesiology.

12 years later however, the profession is in a state of crisis after an investigation by the Baystate Medical Center revealed that at least 21 of Reuben’s papers were entirely made up, faking the beneficial results and in some cases, masking possible dangers. The investigation found that the data in these 21 studies had been partially doctored, and in some cases, entirely fabricated by Dr. Rueben.

Although this most recent investigation has brought the wall tumbling down for Dr. Rueben, signs of cracks had leaks had begun to rear their ugly head over the past five years. In the early part of the decade, orthopedic surgeons began to distrust Rueben’s COX2 inhibitors, when animal testing found that the drugs might actually hinder bone healing. Soon there after, in 2004, Vioxx and Bextra, and Celebrex were pulled from the market because of their link to an increased risk of heart attacks and strokes. All the mean time, Dr. Rueben continued to present positive “findings” for the use of these COX2 inhibitors in his research.

So, even with the public at risk, what motivated Dr. Rueben continue his campaign for these drugs? Simple. Money. It was discovered during the course of the Baystate investigation that Dr. Rueben’s research was entirely funded by Pfizer; the maker of both Celebrex, and the anticonvulsants lauded by Dr. Rueben’s study to be used in conjunction with the COX2 inhibitors. Baystate however could not find any records of the payments, suggesting that the payments were made not to Dr. Rueben’s research group, but instead directly to Dr. Rueben.

Although we may think of doctor’s as always having the best intentions, one must always remember the power of money. Pharmaceutical corporations are some of the richest and most powerful companies in the world, and they need doctors on their side. It is much easier today for these drug companies to pay off a doctor to get the results they need rather than go back to the drawing table and leave behind an unsuccessful product. Because of this, remember to always remain informed when consulting with your doctor about possible medication options. An informed patient is always the safest patient.

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