What’s Your NuvaRing Story?

What’s Your NuvaRing Story?.

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

Blood clot teaches Ballwin woman to be her own health advocate : Lifestyles

Blood clot teaches Ballwin woman to be her own health advocate : Lifestyles.

Excerpt from the article:

Dr. Vedantham and others who study deep vein thrombosis say a major problem is how often it’s misdiagnosed. Vedantham said that’s not an indictment. Front-line general practitioners see hundreds of simple cases, and only a tiny fraction turn out to be more complicated than the initial diagnosis. “Sometimes it’s hard to tell a small thing is a big thing,” he said.

Still, that’s why patients need to be their own advocates, Vedantham said. “When people come in with one leg hurting and swelling, (physicians) should at least think about a blood clot as a possibility,” he said. “Even a low-level of suspicion, you should get an ultrasound at least.”

Also, it’s essential to check risk factors such as a history of cancer, hormonal changes including birth control pills and a family history. Considering 350,000 to 600,000 people a year develop deep vein thrombosis and related conditions, it’s worth being aware, he said.

Vedantham’s interest in the condition peaked in 2008-09 after the U.S. surgeon general called for a major push to prevent it because of the rate of fatalities. The National Institutes of Health soon afterward funded Vedantham’s study.

Stagoski will get regular checkups because people who have had clots are at risk of getting them again. However, she says the surgery fixed her condition. “I don’t have swelling or pain; no compression stocking; life back to normal,” she said.

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The Doctors TV Show on Monday, May 20, 2014 – Special Segment on NuvaRing

Tune into The Doctors show on Monday May 20, 2014 for a special segment highlighting the life threatening risks linked to the NuvaRing.

Visit The Doctors website

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RxISK.org data on NuvaRing

RxISK.org has great information about prescription drugs, especially on NuvaRing. RxISK is collecting data for both the US and Canada adverse event reporting systems.

Click on the various side effects to see the statistics about each type of event.  Deaths are reported under each category.  For example, under Pulmonary Embolism, there were 186 deaths and under Hypercoagulation there are 22 deaths.

Also, remember that less than 10% of all adverse events are ever reported .

This link will take you to the NuvaRing data, but you can search the database for other drugs.

NuvaRing on RxISK.org

 

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DVT and PE statistics

Important information posted on another blogger’s site.

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Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs

Download the full paper here: Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs Journal of Law, Medicine and Ethics, Vol. 14, No. 3, 2013 Donald W. Light, Rowan University, Harvard University; Joel Lexchin, York University; Jonathan J. Darrow, Harvard Medical School

 

 

 

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The Courage to Look at the Evidence

We congratulate you. It takes a lot of courage to look at the facts yourself and not let advertising; a friend or even your doctor or clinic to tell you what is a safer birth control to use. We love our own doctors, but in reality they don’t always have time to read all the studies themselves and most will admit that they often rely on information provided to them through professional journals, drug representatives and professional contacts.  Some even get discounts to sell you a specific product or incentives to prescribe a specific product to you.

Do you know that the FDA approves drugs that appear to be safe and then waits for the effects to be known as things go badly for people using the product?

When the FDA approves a drug, the pharmaceutical company submitted an application with clinical evidence that the drug does what it says it is supposed to do and is basically safe. This evidence comes from testing the drug on animals and then in small trials  on humans.   The birth control methods approved by the FDA do prevent pregnancy, but what are their true risks? There are a lot of unknowns about a drug’s side effects until after it enters the market and more people start using it. The FDA has a surveillance program, which asks for reports from the drug manufacturer and voluntary input from health care professionals and consumers on the “real world” adverse affects. Somewhere between 1% and 13% of adverse events are actually reported to the FDA.

Studies are confusing. One study says this; another study says that. Who are you to believe?

We’d like to ask you to consider using information from studies that show the highest incidents of adverse reactions because this is the information that will give you the clearest picture of the worst that can happen.  The studies that show the least risks are often funded by the drug manufacturer. The problem with some of the use of studies is that some people don’t mind if 12 women per 10,000 women (for example) have a really bad reaction (such as death, deep vein thrombosis, thrombosis in other parts of the body, pulmonary embolism,  hypercoagulation, or a stroke), but your husband or boyfriend, your children, your parents and your friends will care that it is YOU. Those 12 (or more) women are the cost that the drug company is willing to pay to continue to sell their product and make money from you or your friends.  Those women mean nothing to them.

Don’t let statistics confuse you.

It is true that your risk of blood clots is higher if you are pregnant or postpartum.  You are not taking a birth control to get pregnant.  You are most likely trying not to get  pregnant. The reason the high risk of blood clots during pregnancy is used is that the medical community (and the pharmaceutical companies) want you to use some form of birth control.  The higher rates for blood clots during pregnancy and postpartum are true.  Unfortunately, this approach minimizes the risks taken when you use hormonal birth control that has higher risks. Our intent isn’t to scare you from using birth control.  We believe you deserve to know the truth, so you can choose wisely. Don’t be afraid of birth control; just be careful about the birth control you decide to use.

Choosing a birth control method is a serious decision.

You will hear that all hormonal birth control has risks.  Yes, that is true, but that statement implies that all hormonal birth control are equal in risk.  This is not true.  Some hormonal birth control, including NuvaRing, has MORE risk for these events according to several large studies.  In addition, some of the risks about NuvaRing aren’t adequately advertised. You may hear It’s safe, but ask yourself, How safe is it really?  Does it mean that 5 women suffer a really bad medical event or do 12 women suffer one?  If more bad things happen to women while on that particular drug, how can it be safer?

Sources: http://www.webmd.com/a-to-z-guides/drug-side-effects-explained (last accessed 3/6/2014)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1494803/ (last accessed 3/6/2014)

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What is a Serious Adverse Event? An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:

Death

Life-threatening

Hospitalization (initial or prolonged)

Disability or Permanent Damage

Congenital Anomaly/Birth Defect

Required Intervention to Prevent Permanent Impairment or Damage (Devices)

Other Serious (Important Medical Events) Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. Source: http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm (last accessed 4/6/2014)

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The Real Danger of NuvaRing

Excerpt from the article:

Cindy Pearson, National Women’s Health Network’s Executive Director, and a strong advocate for close review of drug safety, has responded to the concerns, saying:

The most heartbreaking part of the Vanity Fair article are the accounts of women who never knew that the contraceptive ring delivered a higher dose of hormones and is slightly more risky than pills. No clinician should offer women these products without fully disclosing the risks, and encouraging women to try alternative, safer forms of contraception if they haven’t already done so.14

Agreed. While the risk to an individual woman may be low with any of these birth control methods, women must be informed that some options — including the ring, the patch, and the drospirenone-containing pills — may be more risky than older combined oral contraceptive pills. And, health care providers need to stay on top of the evidence so that they can actively discuss the benefits and risks of all options with the women they see. All women should have the information they need to make the best choices for their own health.

To read the entire article, click on the link below:

The Real Danger of NuvaRing.

 

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Did One Little Sentence Just Change Drug Safety Forever?

Bar Chart

Read the full article from RxScore here:

Did One Little Sentence Just Change Drug Safety Forever?.

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