NuvaRing investigation: Could the side effects include death?

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by Carey Peña

azfamily.com

Posted on May 6, 2014 at 7:10 AM

Updated Thursday, May 8 at 10:31 AM

PHOENIX -- Forty-four million prescriptions filled in the United States alone; 4,000 lawsuits filed; 224 deaths in question. Among those, 24-year-old Erika Langhart.
 
"She was remarkable," said her dad, Rick Langhart.
 
At nearly 6 feet tall, Erika towered over most people, but this beautiful young woman never looked down at anyone.  

"We are grateful that she literally lived every day to the fullest," said her mom, Karen Langhart.
 
Erika had traveled the world and worked for two U.S. senators, including John McCain. She was getting ready to begin law school at Georgetown when her parents got the phone call. The kind of call that changes your life forever.
 
"It's like the world stopped. It will never be the same from that moment on," Karen said when we sat down with her at the family's home outside Phoenix.
 
Rick said that Erika had suffered four heart attacks.
 
The Langharts rushed to Washington, D.C., to be by their daughter's side. They were there with her, but she was already gone. Erika would never communicate with her parents again.
 
They say their daughter, who had no prior history of health problems, suffered a blood clot so massive, it completely clogged her lungs.

Rick said the doctor came out and told them directly, "Your daughter suffered the pulmanary embolism from the NuvaRing."
 
There is a warning about blood clots on NuvaRing's website and in the company's commercial it warns: Serious risks include blood clots, stroke or heart attack.
 
But the Langharts, and thousands of others who have filed legal action against Merck, believe the risk is much higher than is being talked about.
 
"It was never about money," Rick said. "It was about trying to hold Merck responsible."
 
The Langharts took their claims to the FDA. Karen testified on Capitol Hill that "Erika's team of doctors, caring doctors -- identified the NuvaRing as the cause of her massive pulmonary embolism and subsequent death."
 
3TV reached out to Merck and, in a statement, the pharmaceutical company said, "Nothing is more important to Merck than the safety of our medicines and vaccines and the people who use them. Merck employees, and our families, use Merck medicines, too."
 
Dr. Erik Gunderson, who has been practicing obstetrics and gynocology for 28 years, said despite the controversy he has no problem prescribing NuvaRing.

"The NuvaRing does have labeling showing that compared to taking nothing you will have increased risk of blood clots," Gunderson said. "Trying to say that is more dangerous than other contraceptive pills is getting into a gray area."
 
Even Congress is now weighing in on the potential danger. 
 
3TV obtained a letter to the FDA written by six members of Congress, including Rep. Lousie Slaughter from New York. They write, in part, "In 2010, over 5.5 million prescriptions were written for NuvaRing. By 2011, over 1,000 cases of blood clots were reported. Including a healthy 32 year old woman who died from a blood clot that migrated to her lungs."
 
They are pushing for a black box warning, which alerts women that you could die from using it.
 
The FDA doesn't think it is necessary.
 
Rick and Karen Langhart said they are outraged that concerns are not being heard.

"We think Merck has control over the FDA," Karen said. "We think they have undue influence within the FDA."
 
It's been nearly three years since their daughter's death. May 4 was Erika's birthday.  She would have been 27 years old.

Time has not eased the Langhart's pain, nor has it diminished their determination.
 
Karen said they want people to know "every adverse event that happens with a drug so that they have real, true numbers as to the dangers of these drugs."
 
Soft-spoken and heartbroken, Rick adds, "That's what we are going to do the rest of our lives. That's kind of what we've got left."
 
 

 

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