READ the stories of Real Women Effected by NuvaRing

Read about real women and what happened to them by clicking HERE.

Posted in Uncategorized | Leave a comment

Combined hormonal contraception raises VTE risk fivefold : OBGYN News

Combined hormonal contraception raises VTE risk fivefold : OBGYN News.

Posted in Adverse Events, VTE | Tagged , , | Leave a comment

WTVC NewsChannel 9 :: News – Top Stories – Birth Control Concerns

WTVC NewsChannel 9 :: News – Top Stories – Birth Control Concerns.

Posted in NuvaRing, NuvaRing Death, NuvaRing Risks, NuvaRing Safety | Leave a comment

How health risks of the NuvaRing disappeared from the graphs

The Dutch pharmaceutical company Organon left crucial data that pointed at increased health risks out of their research findings of birth control product Nuvaring. Also, the company did everything [possible] to minimize the risks of thrombosis in the ‘enclosed’ pamphlet accompanying the product. This shows up in the documents in possession of ‘De Correspondent’ a Dutch on-line investigative blog post.  Read the translation of the post by clicking here.

Posted in Adverse Events, Blood Clots, DVT, FDA, Pulmonary Embolism | Tagged , , , , , | Leave a comment

Doctors Don’t Know What Women Want to Know About Birth Control

June 10, 2014:  NPR had an interesting article about what doctors don’t know about what women want to know about birth control.  You can read the entire article here, or go directly to the NPR site to also hear this story.

Doctors tend to think it’s most important to discuss how to use contraceptives and which methods are most effective at preventing pregnancy, according to the poll, which was published in the journal Contraception. Women, on the other hand, are often more concerned about safety, side effects and how the contraceptives work.

Doctors Don’t Know What Women Want To Know About Birth Control
June 10, 2014 3:35 PM ET
MAANVI SINGH

Corbis
Women have choices in contraception, from pills and injections to intrauterine devices and the NuvaRing. But when women discuss birth control with their doctors, they may not be getting all the information they want, a survey finds.
Doctors tend to think it’s most important to discuss how to use contraceptives and which methods are most effective at preventing pregnancy, according to the poll, which was published in the journal Contraception. Women, on the other hand, are often more concerned about safety, side effects and how the contraceptives work.

Researchers surveyed 417 women, aged 15 to 45, and 188 health care providers. The women were either using contraceptives or interested in using them. While 41 percent of them ranked questions about safety as one of their top three concerns, only 20 percent of the doctors thought discussing safety was a top priority. That may be because providers know that for a healthy woman, contraceptives are usually safer than pregnancy, the study says. But women may still worry about complications caused by hormonal birth control, like blood clots, though they are relatively rare.

Numbers represent the percent of patients and doctors who ranked each issue in their top three concerns to discuss during consultations.

Those considering permanent contraceptive option may be worried about safety as well. Recently, the safety of Essure, a device that’s permanently inserted into the fallopian tubes to block them, came under question when a number of women who used it complained about pain, hemorrhaging and headaches.
“The main takeaway is really that it’s very important for providers to speak about what’s most important to women,” says Kyla Donnelly, a reproductive health researcher at the Dartmouth’s Institute for Health Policy and Clinical Practice, who led the study.
Yet providers don’t always know what what’s most important to their patients, she tells Shots. “And doctors are increasingly having to manage very short consultation periods.”
These results aren’t the final word — the participants were mostly white, and they had to have Internet access in order to complete the survey. But it does show that doctors and patients aren’t always on the same page.
Donnelly says she’s working with other researchers to developing guides — called option grids — to help health care providers and patients discuss contraceptives. “That way providers can feel supported with the right information.”

Link to NPR website

 

Posted in Adverse Events, Blood Clots, DVT, NuvaRing Death, NuvaRing Risks, NuvaRing Safety | Leave a comment

Dr. Jennifer Ashton – Some Pills are Safer than Others

Dr. Ashton

Dr. Jennifer Ashton discussed the different varieties of birth control and how there is a difference in safety.  Click on the image.

 

Posted in Blood Clots, NuvaRing, NuvaRing risks and side effects, NuvaRing Safety | Tagged , , , , | 2 Comments

Listen | Wisconsin Public Radio

Listen | Wisconsin Public Radio.

Posted in Adverse Events, Blood Clots, FDA, NuvaRing, NuvaRing Risks, NuvaRing Safety | Tagged , , , | Leave a comment

NuvaRing investigation: Could the side effects include death?

Click on this to see the full article and news video:  NuvaRing Investigation on AZFamily.com

by Carey Peña  azfamily.com Posted on May 6, 2014 at 7:10 AM Updated yesterday at 10:36 PM

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.”

Posted in Adverse Events, Blood Clots, FDA, NuvaRing, NuvaRing Death, NuvaRing Safety, Pulmonary Embolism, Video Reports | Tagged , , , , , | Leave a comment

“In the drug industry, killing people is not bad for business. As long as it’s not too many.”

Terence Endorses Vanessa’s Law in the House of Commons On March 28, 2014 

More about Terence Young, Member of the Canadian Parliament for Oakville, Ontario, Canada

Excerpts from his speech:

What They Never Talk About

The drug industry representatives who infest parliament hill love to talk about when doctors make errors, or patients take the wrong drug, or too much of a drug.

What they never talk about is when a drug used the right way injures or kills a patient, causing 10,000 deaths a year in Canada.

In fact one in nine patients in Canada suffer serious drug reaction in hospitals.

1. All drugs are poisons. Any drug can be toxic. It’s just a matter of dose. And all drugs cause adverse effects. Some people think OTC drugs are totally safe. Yet ordinary Acetaminophen (Tylenol) causes hundreds of deaths every year, and more cases of acute liver failure than all other medications combined. Too much taken with alcohol, and it can destroy one’s liver.

Yet has your doctor ever mentioned that?

2. Twenty seven drugs have been pulled off the Canadian market since 1997 for injuring and killing patients. Propulsid is one. Another, painkiller Vioxx, killed 55,000 to 65,000 patients worldwide in four years on the market. Why don’t most Canadians know that? Because the drug companies never admit their drug harmed anyone; they spends months and months investigating serious reactions. Then they attempt to blame the patient, concluding –
“He must have taken too much;”
“She must have had a previous undiagnosed and unknown condition;”
“It must have been the combination of our great drug with the other drug he was taking. We hereby contraindicate our great drug with their drug.”

3. Drug companies refuse to provide the true number of serious adverse drug reactions to health Canada. They report what they hear about, but what does NOT appear on the label is this crucial fact: only 1% of serious adverse drug reactions are actually reported by doctors. Most doctors have never reported an ADR! In fact, outside of the doctors I’ve met who specialize in drug safety, I’ve never met a doctor who reported an ADR. And despite my advocacy in this matter for 14 years – that reporting adverse drug reactions saves lives by providing a widely based early warning system for dangerous drugs – the Canadian Medical Association and Ontario Medical Association to this day do not support making adverse drug reaction reporting a standard practice or mandatory.

4. Over half of the serious side effects of new drugs won’t be revealed during testing. In fact, in the first two years on the US market, one in five –20%– of new drugs will be pulled off the market for injuring or killing patients, or be assigned the highest level of warning – a Black Box warning to be handed to each patient with their prescription – a more effective warning Canada has never had.

5. In 2003 Dr. Allan Roses, World-Wide Vice President of genetics at GSK – the world’s second largest Big Pharma company – made this statement at a scientific meeting, not knowing a journalist was present: “The vast majority of drugs, more than 90%, only work in 30 or 50% of people.” What this means is, with a worldwide market of $800 billion for prescription drugs, as much as $400 billion a year is not only wasted on drugs, but millions of patients are exposed to the dangers with no chance of benefitting.

“In the drug industry, killing people is not bad for business. As long as it’s not too many.”  Nothing has changed since that time.

Big Pharma companies put the legal costs from injuries and deaths right in their business plans.

Here are some more examples of Big Pharma corporate crimes:

  • Merck has paid $1.6 billion in settlements since 2008 in part for paying illegal kickbacks to health care providers;
  • Ely Lilly paid $ 1.3 billion in 2009 for illegally promoting Zyprexa, leading to the deaths of many seniors;
  • Novartis paid $422 million in 2010 for off-label promotion of Trileptal;
  • Forest Labs paid $313 million in 2010 for off-label promotion of Celexa and Levothyroid;
  • Allergan paid $825 million in 2010 for off-label promotion of Botox;
  • AstraZeneca paid $520 million in 2010 for misleading doctors and patients about the safety of Seroquel;
  • Johnson and Johnson paid $81 million in 2010 for off-label promotion of Topomax;
  • Elan paid $203.5 million in 2010 for illegally marketing Zomegran;
  • Sanofi-Aventis paid $ 96.5 million in 2009 for illegal pricing of a nasal spray;
  • Abbott paid $22.5 million in 2010 for blocking 23 states from getting a cheaper alternative for Tricor;

And these offences are just some of those that occurred since 2008.

How do they get away with all this?

Power. And influence. They are some of the wealthiest companies in the world, with no loyalty to any country.

Read his entire speech at the link below.

Terence Young’s speech to House of Commons

Posted in Adverse Events, FDA, NuvaRing, NuvaRing Safety, Risks and Side Effects | Tagged , , , , , | Leave a comment

The Continuous Low Dose that Isn’t a Continuous Low Dose

‘Continuous low dose’?

Excerpt from Best Pills, Worst Pills April 2014 Newsletter:

NUVARING continues to be marketed as delivering a “continuous low dose,” suggesting greater safety relative to other hormonal contraceptives, but there is little evidence actually supporting this implication.[35] Surprisingly, this first-of-its-kind product was tested in a small clinical trial involving only 16 human subjects to determine the blood levels of estrogen and progestin achieved with the product.[36] Only data from this trial regarding average blood levels of estrogen and progestin, which were relatively low, appear on the current product label.[37] However, the trial also demonstrated that there was significant variation in estrogen blood levels between subjects and over time for individual subjects. Most shocking of all: Four of the 16 subjects (25 percent) who participated in the small trial experienced an unexplained surge of estrogen, between two and four times the average levels, either at the start of their 30-day menstrual cycles or randomly in the middle of their cycles.

The drug’s original manufacturer, Organon, chose to cover up data from the two patients who experienced mid-cycle surges, neglecting to discuss the surges in a summary report for the trial the company submitted to the FDA in 1999, and omitted the data from the NUVARING professional label. The company explained that concentrations for certain patients were “considered to be … too high” to include in the analysis. The drug label did include data from the two women who experienced surges at the start of their cycles, but the figure that contained this information was compressed, making it difficult to see the surges clearly.

As of October 2013, the NUVARING label had not been updated to reveal the unexplained mid-cycle surges of estrogen.[38] Unfortunately, correcting the label may do little to assist doctors in prescribing the product safely: Without conducting further large studies to provide better data on relative risk, it is difficult to know what impact these surges actually have on the chance of developing blood clots.

http://www.worstpills.org/recent_postings.cfm (Accessed 4/21/2014)

Posted in Blood Clots, DVT, FDA, NuvaRing, NuvaRing Death, NuvaRing Risks, NuvaRing risks and side effects, NuvaRing Safety, Stroke, What Your Don't Doesn't Tell You | Tagged , , , , , , , , | Leave a comment