Archive for March, 2008

Singulair and Possible Suicide Risk

Sunday, March 30th, 2008

Singulair is a prescription drug manufactured by Merck & Co. that is used as maintenance treatment for those suffering from asthma, but also used to relieve symptoms of those suffering from seasonal allergies. With millions of asthma sufferers worldwide, Singulair has been touted as a drug that can help prevent the symptoms of asthma before they even start. Over 50 million Americans alone suffer from nasal allergies and Singulair has been helpful in preventing those symptoms as well. It was approved for treating asthma in 1998 and for seasonal allergies in 2003. Singulair is used by millions and resulted in $4.3 billion in sales last year for Merck. It has been prescribed by physicians to both adults and children over the age of two.

However, the Food and Drug Administration (FDA) is looking into a connection between Singulair and suicidal behavior. The FDA called the possible connection an “emerging safety issue” after it was reported to them that “3 or 4” patients who were taking Singulair committed suicide. Currently, the FDA is doing an investigation to see if there is a link between taking Singulair and experiencing extreme mood or behavior changes, including suicidal behavior.

Within the past year, Merck has told physicians that possible side effects of Singulair could be tremors, depression, suicidal thinking or behavior and anxiety. The FDA has asked Merck to look at study data for more information on the patients who experienced depression, suicidal thinking or behavior, but it may take up to nine months for such an evaluation to be completed.

Until the study is complete, the FDA is not recommending that patients stop taking Singulair, but rather talk to their physicians if they have concerns. The FDA also advised physicians to monitor all patients taking this medication as well as Zyflo and Dey, two other drugs in the same class as Singulair. Merck officials issued a statement saying that the FDA based its concerns about Singulair on reports, not clinical findings, which is what is normally used to test drug safety. Of the 11,000 patients that have enrolled in 40 Singulair trials, Merck points out that none have committed suicide.

Avandia Lawsuits

Friday, March 28th, 2008

Avandia (rosiglitzaone) is a drug that has been used to treat type 2 diabetes. Avandia, the brand name drug manufactured and marketed by GlaxoSmithKline, is used along with diet and exercise to help lower blood sugar levels. Since 1999, Avandia has been prescribed to over 4 million people with type 2 diabetes. Avandia was intended as a safer alternative to Rezulin, which was recalled in 2000 for being linked to fatal liver diseases.

However, in May 2007, the Food and Drug Administration (FDA) issued a safety alert on Avandia. The FDA said that data from controlled clinical trials showed that there is an increased chance of heart attack or heart-related illnesses for patients taking Avandia. The reason that the drug was not immediately removed from the market is that other long-term clinical trials showed contradictory evidence about the risks of taking Avandia. The FDA did said in it’s safety alert that patients who have heart disease or are at a higher risk for heart attack should talk to their physician about these clinical trial findings to decide if they should proceed with taking Avandia to treat their diabetes.

Dr. Steven Galson, the director of the FDA’s Center for Drug Evaluation and Research department, said, “FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia. We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened.”

GlaxoSmithKline provided the FDA with a pooled analysis of 42 randomized, controlled clinical trial results. Those showed that Avandia used for six months by patients could have raised their risk of heart attack or other heart illnesses by as much as 30-40 percent.

Avandia lawsuits are starting to pop up as some patients who have taken it are suffering from heart attacks, congestive heart failure, hepatitis, and liver failure. A new study was reported in the September 9, 2007 issue of Mayo Clinic Proceedings that suggested that Avandia could cause fluid accumulation that results in congestive heart failure. In the study, six men between the ages of 66 and 78 who were taking Avandia had to go to the Dallas Veterans Affairs Medical Center for congestive heart failure.

Since being approved, many FDA officials have questioned whether Avandia should stay on the market or not, but put off a ban on the medication until the results of further research are established. If you or someone you know has been taking Avandia and suffered liver failure, hepatitis, congestive heart failure, a heart attack, or any other type of heart ailment, you should contact a lawyer to find out your legal rights.

Prempro Lawsuit

Monday, March 24th, 2008

When going through menopause, women often suffer many side effects such as hot flashes, night sweats, and vaginal itching and dryness. Prempro is a hormone therapy made by Wyeth Pharmaceuticals that will help lessen those symptoms. Women who are going through a natural menopause can benefit from Prempro’s hormone replacement therapy, which is a combination of estrogens and a progestin.

Since 1995, millions of women have taken Prempro, making it one of the leading hormone replacement therapy drugs on the market. In 2001 alone, Prempro resulted in $890 million dollars in sales for Wyeth Pharmaceuticals.

However, there have been studies that have shown that while Prempro does relieve the symptoms of menopause, it can also increase the risk of stroke, blood clots, ovarian cancer, endometrial cancer, and breast cancer. A study of the drug’s usage began in 1991 and it was conducted by the Women’s Health Initiative (WHI). It started as a 15-year study to find a way to prevent heart disease, breast cancer, colorectal cancer, and osteoporosis. Over 161,000 postmenopausal women were involved in the study. One part of the study involved almost 17.000 women taking an estrogen plus progestin therapy (Prempro) or a placebo. The idea was to determine if Prempro would help prevent heart disease but also determine if the benefits of using Prempro outweighed the risks.

After only 5 years, the study was stopped. So risky was this study that the National Institute of Health (NIH) decided to cancel it to protect the participants. A result showed that not only was Prempro not helpful in preventing heart disease, but it increased the chances of breast cancer. It is believed that women who have taken Prempro have a 29% higher chance of having a heart attack, are 41% more likely to suffer a stroke, and have a 26% higher chance of getting breast cancer.

As a result of this study, there are now lawsuits being filed against Wyeth Pharmaceuticals. The lawsuits claim that Wyeth knew that Prempro had hazardous side effects and failed to describe them in their packaging. In addition, Wyeth failed to remove the drug from the market after the study results became known.

In July 2002, a class action suit was filed against Wyeth Pharmaceuticals by women who were prescribed Prempro. The lawsuit seeks not only compensation for women who suffered side effects such as heart attacks or breast cancer due to Prempro use, but also to get medical monitoring to screen for breast cancer and dementia for all patients who have taken the drug. The lawsuit also hopes to make the risks of taking Prempro known to the public as it has yet to be taken off the market. In May 2005, a woman from Baltimore filed a multi-million dollar lawsuit against Wyeth, claiming that her breast cancer resulted from having taken Prempro. She is asking for $30 million in damages.

If you, a family member, or a friend has taken Prempro, you may be eligible to get in on the class action suit. Even if you have not suffered any side effects from the drug, you will still want to get future medical monitoring for potential side effects. Contact a lawyer for more information about the Prempro class action lawsuit.

Trasylol for Surgery

Saturday, March 22nd, 2008

Trasylol is the brand name used by Bayer to sell the drug Aprotinin. Also known as bovine pancreatic trypsin inhibitor or BPTI, Trasylol is a protein that is used in medication to reduce bleeding during a complicated surgery. It works by slowing down the process fibrinolysis, which leads to the breakdown of blood clots. Trasylol is used to keep down the number of blood transfusions need while also decrease end-organ damage due to low blood pressure that can result due to major blood loss. Initial studies showed that in the case of cardiac surgery that might cause a great loss of blood, Trasylol significantly reduced the bleeding.

However, during the fourteen years it was on the market, there was controversy surrounding the use of Trasylol. In September 2006, the Food and Drug Administration (FDA) found the Bayer did not reveal during testimony that one of their studies showed the use of Trasylol carried great risks. The study showed that the use of Trasylol could increase the risk of death due to heart attack, strokes, kidney or renal failure and encephalopathy. The FDA was tipped off to these findings by one of the study researchers. On October 3, 2006, the FDA issued a statement of concern and asked physicians consider limiting use of Trasylol, especially in cases where the associated risks would outweigh any benefits.

On October 25, 2006, the FDA said that the use of Trasylol may increase the risk of death and on October 29, 2006, the FDA issued a warning that Trasylol may have serious kidney or cardiovascular toxicity. Bayer reported to the FDA that additional studies showed that using Trasylol might increase the chances of death, serious kidney damage, congestive heart failure, and strokes. On November 5, 2007, Bayer decided to withdraw Trasylol from the market after a Canadian study showed that the use increased the risk of death during heart surgery. Studies published in early 2008 showed that the increased risk of death could be between 32% and 64% higher.

On February 17, 2008, “60 Minutes” aired an episode that showed that as far back as the early 1980s, there were concerns about the use of Trasylol. Dr. Nicholas Kouchoukos, a top heart surgeon, conducted his own study of 20 patients given Trasylol and found that of those, 13 patients experienced problems with their kidney function after being give the medication. It is believed that as many as 22,000 deaths may have occurred due to the use of Trasylol.

Approximately 4.5 million people worldwide were given Trasylol during the fourteen years the drug was on the market, with a third of those patients residing in the United States. The widow of open-heart surgery patient Joseph Randone filed suit against Bayer after her husband died from the effects of Trasylol only eight months after his surgery. It was after this first lawsuit that Bayer finally decided to pull Trasylol off the market. Since then, there have been many more lawsuits filed by people who have lost loved ones due to the use of Trasylol and also by people who survived being given Trasylol, but have suffered kidney or renal failure or had a heart attack or stroke.

If you have undergone heart surgery and were given Trasylol then later developed kidney or renal failure and now require dialysis treatment or suffered from a heart attack or stroke, you should contact a lawyer to see if you have a suit against Bayer. If a loved one passed away after being given Trasylol before heart surgery, you may want to talk to a lawyer about the specifics to see if you have a case against Bayer.

Airborne Lawsuit

Tuesday, March 4th, 2008

The company that created Airborne, a dietary/herbal supplement once touted to prevent or ward off the common cold, settled a class action lawsuit for 23.3 million dollars. The suit was brought against them in March 2006, with the non profit group the Center for Science in the Public Interest (CSPI) joining the suit in late 2006 as co-counsel.

Airborne has sales of more than $300 million a year. The product was created by a teacher, Victoria Knight-McDowell. Many people purchased the product based on claims made by the company that were described in the class action lawsuit as false. In the words of the CSPI it just doesn’t work.

The ABC morning program Good Morning America launched an investigation into the product and its claims and into a supposed scientific study that was performed to evaluate the effectiveness of Airborne. It turns out that the study was done by two people who formed a venture to perform this study. In fact the one individual who claimed to be a graduate of Indiana University never graduated. This detail was revealed in today’s report on Good Morning America.

Airborne said they settled the class action lawsuit to avoid further distractions. Claims that the product can prevent or cure the common cold have been removed from packages. The company will pay for advertising in major media outlets to describe how consumers can get a refund for purchase of the product.

If you have receipts for your purchase of Airborne, the company will refund all of your purchases no matter how many made. If you don’t have receipts, the company will refund you for the purchase of six packages, estimated to be about $63 by the reporter on Good Morning America. Instructions and details of how to obtain your refunds will be included in the advertising done by Airborne.

The Federal Trade Commission and several states have initiated their own investigations into the company that produces Airborne based on the lawsuit.