FDA Requires Labels of Drospirenone Birth Control, Like Yaz, to Include Increased Blood Clot Risk Warning

The requirements levied against Bayer and its popular birth control Yaz became stricter today. The Food & Drug Administration has issued a safety alert regarding birth control that contains drospirenone, like Yaz and Yasmine, saying that they may be associated with a higher risk for blood clots than other progestin-containing pills.

As a result, Bayer must revise all labels of Yaz and Yasmin to include this FDA warning. Specifically, the labels must include that some epidemiological studies reported as high as a three-fold increase in the risk of blood clots while other epidemiological studies found no additional risk. 

While the labels being updated is a move in the right direction, the warning is watered down by the second half which acknowledges the studies conducted by Bayer which found no additional risk. As a member of the Yaz Multidistrct Litigation Steering Committee and an attorney representing hundreds of women injured due to Yaz and Yasmin, I have seen the harm this drug has caused thousands of woman first-hand.

Thousands lawsuits have been filed against Bayer over Yaz/Yasmin. More than 267 deaths have been linked to drospirenone-containing pills and similar birth controls, according to an FDA study. Plus, it can cause numerous other serious medical problems like stroke, heart attack, kidney failure and gall bladder problems.

Perhaps the FDA recognized including both study results sends consumers a mixed message because it has also required that the label include a summary of the FDA-funded study of the blood clot risk. The FDA study confirmed that women who take contraceptives that contain drospirenone are 75 percent more likely to suffer serious side effects from blood clots compared to older birth control methods.

While the FDA did not include the summary wording that would go on the label in its wording, hopefully it will be enough for women to fully understand the risks.

As one of the firms handling the national cases against Bayer, the Simmons Law Firm and its experienced pharmaceutical attorneys are in a position to help victims of contraceptives.  Learn more in our Yaz/Yasmin section.

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FDA to Review Popular Birth Control Pill Yaz

Women who take birth control know doing so comes with a risk of blood clots, especially if they’re a smoker over 35. However, two new studies by the British Medical Journal found that women who take contraceptives like Bayer’s Yaz or Yasmin have a two to threefold higher risk of blood clots.

As a result of the findings, the Food & Drug Administration issued a statement Tuesday saying it’s conducting a new safety review of birth control pills that contain drospirenone, the hormone that’s alleged to increase blood clot risk. The results of their investigation should be released later this summer.

Drospirenone, in addition to Yaz and Yasmin, is also used in Ocella, Beyaz, and Safyral. For a complete list, click here.

Despite the new findings, Bayer continues to insist its oral contraceptives are safe, according to the NYTimes. Yet, nearly 7,000 lawsuits filed against the company tell a different story. Approximately 200 reported deaths have been linked to Yaz/Yasmine and numerous other serious medical problems such as stroke, heart attack, kidney failure and gall bladder problems.

As one of the firms handling the national cases against Bayer, the Simmons Law Firm and its experienced pharmaceutical attorneys are in a position to help United States victims of contraceptives.  Learn more in our Yaz/Yasmin section. Comments (0)

Consumers continue to be placed at risk as pharmaceutical companies race to market

The FDA recalls & warnings of 2010 reads like a who’s who list in big pharmaceutical companies. It includes household brand names like Tylenol, Johnson & Johnson’s DePuy hip implants, heartburn pills Prilosec OTC & Nexium, Bayer’s Yaz Birth Control, and smoking-cessation drug Chantix.

In early 2010, the Simmons firm claimed a national leadership role in the on-going Yaz litigation when the cases were consolidated and centralized to the Southern District of Illinois in East St. Louis. More than 70 women suffered serious injuries after taking Yaz or Yasmine, a previously popular birth control bill, including heart attacks, pulmonary embolisms, gallbladder disease and sudden death, according to the FDA.

The firm also claimed a leadership spot on the committee to manage national litigation regarding the Chantix cases. Chantix, a drug used to help people overcome their smoking addictions, was linked to suicidal thoughts and actions, as well as behavior and mood disorders, as early as 2008. FDA officials warned that those taking the drug should stop immediately should they experience those behaviors.

Probably the most visual recall thanks to extensive coverage by the media here & here were the Tylenol recalls. The only good news is if you missed the recall of liquid children Tylenol & Motrin when it happened, there’s nothing to be unsure about. Don’t use it! According to Tylenol’s website, they don’t anticipate stocking shelves with safe infant & children’s liquid medicine until the spring.

As the year progressed, so did the FDA’s warnings with the news that long-term use of heartburn pills increased people’s risk of fracturing their wrists, hips and spine. Millions of people this past year bought over the counter versions of Nexium and Prilosec OTC to treat their long-term heartburn. The popular use of antacid drugs motivated FDA officials to re-label the prescription and over the counter versions to warn consumers of the dangers of long-term use longer than a year.

The fall brought yet another recall. An unpublished study revealed new data showing defects in DePuy Orthopaedic hip implants that caused an unexpected increase in the rate of second surgeries needed. The recall involves the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. At least 12 to 13 percent of patients who received either the Acetabular System or the Hip Resurfacing System have required follow-up surgeries and five-year revisions.

The year ended with the FDA pulling Darvon and Darvocet, or propoxyphene, from retailers' shelves because research found it can cause serious heart rhythm abnormalities. European regulatory agencies had banned the popular pain killer drug more than a year ago, while the U.S. medical community has raised concerns about the drug since it was first approved 1957.

As an advocate for consumers’ rights, the Simmons law firm will continue to keep you updated on the FDA’s investigations and its findings as we continue into 2011. Click here to read more about the Simmons pharmaceutical division. Comments (0)

FDA Pulls Darvon, Darvocet from Market for Heart Risks

The maker of the pain killer medicine known as Darvon and Darvocet, or propoxyphene, announced last week it will stop making the popular drugs because it can cause serious heart rhythm abnormalities, according to a new study.

Xanodyne Pharmaceuticals Inc. agreed to the ban Darvocet, Darvon and its generic versions at the request of the Food & Drug Administration. The new ban brings the drug in line with European regulatory agencies that banned the drug more than a year ago.

The new study indicates that even when Darvon or Darvocet is taken at the recommended dosages, “there were significant changes to the electrical activity of the heart.” The new findings outweigh the potential benefit, the FDA said in a statement.

While it’s good the FDA is finally pulling Darvon and Darvocet from the market, it’s disconcerting that it’s taken this long for it to do so. In 2009, an FDA committee voted 14-12 against the continued making of propoxyphene products but noted additional information would be helpful. The FDA required the drug maker to conduct the study, and its results confirm concerns the medical community has raised about the drug since it was first approved by the FDA in 1957.

"We recommend to physicians stop prescribing the drugs. As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay," Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology, told CNN last week.

Since 2009, more than 10 million patients have been prescribed some form of propoxyphene, according to the FDA. The Simmons law firm is currently investigating claims on behalf of those patients injured due to taking Darvon, Darvocet or the generic versions of propoxyphene. Click here to learn more about the Simmons pharmaceutical injury division.
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Doctors on Pharma Payroll Not Always Experts, New Investigation Finds

Do you promise to tell the truth, the whole truth and nothing but the truth, so help you God?

It’s a simple, but significant act on which our entire judicial system rests. When anyone takes the stand – defendant, witness or expert – they have a duty to tell the truth without prejudice.

This is especially necessary when experts testify. If experts are misleading, it can cause our legal system to fail. This happens more than you might think.

An investigation called “Dollars for Docs” by ProPublica has discovered that the experts hired by drug companies to educate consumers and doctors about the pros and cons of their drugs were not always experts. The investigation found that hundreds of these “so called” experts have been accused of professional misconduct, disciplined by state boards or lacked credentials as researchers or specialists, as reported by NPR.

Learn more about the database ProPublica created that lists the pays outs seven drug companies made to doctors.

Companies that hired these drug experts include some well known brands: Johnson & Johnson, Merk, Pfizer, Lilly, Cephalon, AstraZeneca, GlaxoSmithKline.

“Without question the public should care,” Dr. Joseph Ross, a professor of medicine at Yale told reporters. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

I would add, would you want one of these “so-called” experts to testify in court, to swear to tell the whole truth and nothing but the truth, when their very title is based not on their expertise, but on how many paid presentations they gave for the drug companies? Comments (0)

Simmons Law Firm Monitors Tylenol Recalls, FDA Investigation

Due to reports of serious side effects, McNeil, a division of Johnson & Johnson, has made four major recalls of over-the-counter products, including Tylenol, Motrin and Benadryl, in the past seven months.  The most recent occurred May 1.

An article posted Tuesday on CNNmoney.com titled, “Tylenol recall: Serious side effects investigated,” states that the FDA has received at least 775 reports of people who have experienced serious side effects after taking these three drugs. The side effects include stomach pain, vomiting and diarrhea and in the more extreme cases hospitalization and disability, according to the article.

The recalls triggered investigations by the Food & Drug Administration, and now  the House Committee on Oversight and Government Reform has scheduled a May 27 hearing to investigate. Click here to read more.

As an advocate for consumers’ rights, the Simmons law firm will keep you updated on the FDA’s investigation and its findings.  Click here to read more about the Simmons pharmaceutical division.

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SEF Hosts 5th Annual Golf Tournament for Children with Cancer

First things first, I write this post from my position as a board member of the Simmons Employee Foundation (SEF), not as partner of Simmons Browder Gianaris Angelides & Barnerd LLC. It has been my privilege to serve the SEF, a truly respected organization in our community made up of caring, charitable, dedicated, and hard-working employees of the Simmons firm.

The firm’s leadership has recently recognized in this space the extraordinary efforts of the SEF, which has raised over one-half million dollars in just a handful of years. The recognition is much appreciated, as is the complete support the firm provides the employees in their philanthropic endeavors.

Again, as an SEF board member, I’m happy to announce that the organization continues to support those in need.

On Friday, September 18, the SEF will host its fifth annual golf tournament at Sunset Hills Country Club in Edwardsville, Ill. Foursomes are available for four-hundred dollars, single registrations for $100. The entry fee includes greens fee, cart rental, lunch or dinner, soda and beer on the course, and a complimentary gift. There are cash prizes for first- and second-place teams in three flights.

Now, bear with me. According to former American journalist and writer Westbrook Pegler, “Golf is the most useless outdoor game ever devised to waste the time and try the spirit of man.”

With apologies to Mr. Pegler, the SEF’s fifth annual golf tournament can, in fact, be the most useful outdoor activity you can participate in on Friday, September 18, and a true reflection of the spirit each of us bring as we reach out to help the children of H.I.S. K.I.D.S.

This event is for the children and families affected by childhood cancer. H.I.S. K.I.D.S. serves approximately 2,000 seriously ill children and family members each year from its locations in Highland, Ill., and Florida. All services are provided at no charge and without regard to race, creed, color, or financial ability.

I applaud SEF for identifying such a worthy organization. And I invite you to participate in and/or take advantage of sponsorship opportunities. One hundred percent of all net proceeds will benefit H.I.S. K.I.D.S.

I hope to see you on the course.

For more information, contact Lori Smith at 618-259-6102 or Yvette Scott at 618-259-6517. 

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