The NuvaRing is a low-dose hormone birth control option that became available to the United States in 2002. This was the world’s first hormone contraceptive vaginal ring, a very different option from the birth control pill.
The NuvaRing is available in over 50 countries and is a popular form of birth control among women. However, the pharmaceutical company that developed NuvaRing, Organon, left out one of the side effects of the NuvaRing; that’s caused some serious side effects in consumers. Some have even lost their life due to this new form of birth control.
NuvaRing Approval: What Happened?
So how did a potentially serious side effect get left off the product label? Well, the United States Food and Drug Administration (FDA) and pharmaceutical companies have always battled it out on what finally goes on the product label.
Pharmaceutical companies want to present their product in the best light possible; however, that isn’t always the safest for consumers. The FDA had some concerns while the NuvaRing was being approved, their biggest concern was over a healthy woman in her 20’s who developed a blood clot during the clinical trial. Most hormonal contraceptives carry a risk of blood clots, but generally the risk is greatest for those who smoke or are over the age of 35.
This woman, however, was young and healthy, and a non-smoker, so the FDA told Organon that they should mention the potential risk of blood clots in the product warning label. Unfortunately, over time, the FDA agreed to leave it off the label, instead accepting a statement that said that it was “unknown” whether the NuvaRing carried a increased risk of blood clots.
NuvaRing: Sales vs. Safety
According to the Huffington Post, David Stern, Organon’s director of U.S. reproductive marketing wrote to his colleagues in an email on December 22, 2000, “The label change looks much better; however, I am still unhappy with the VTE section of the label. Obviously the case that we presented to them has made some impact, in that they have added the statement about [it] being unknown if NuvaRing has this increased risk. What are the chances that this section can be removed altogether?”
The FDA finally gave into Organon’s demands and when NuvaRing was ready for the market, the package insert in 2001 gave a general warning about the risk of blood clots while using hormonal contraceptives. However, it left out the reference to the young woman who developed a blood clot while using the NuvaRing. Doctors were not aware of the risks, and went on to prescribe this contraceptive to millions of women around the world.
What Are Blood Clots?
Blood clots occur when blood hardens from a liquid to a solid. Blood clots that occur in your veins or arteries are called a thrombus; a thrombus can break loose and can travel to another location in the body (this is called an embolus) and can partially or completely block the blood flow in a blood vessel.
This event can affect your heart, kidneys, lungs (when you get a clot in your lung, it’s called a pulmonary embolism), neck, brain, arms, legs (a clot in your leg is called a deep vein thrombosis, or a DVT), and even in your intestines.
A Danish study published in June of 2012 that examined more than 1.6 million women over several years found that on average, women using a vaginal ring had an estimated 6.5 times increased risk of venous thromboembolism, or a traveling blood clot in your vein, compared to women of the same age who did not use the hormonal contraceptive.
Drug Company Studies
Despite the results from the Danish study, the FDA didn’t change the NuvaRing label. Instead they approved a change in label for October 2013 that highlighted the results from Merck’s own clinical study (Merck currently produces NuvaRing) as well as an earlier 2o11 FDA study.
The study from the manufacturer, published in May 2012, showed no increase of having blood clots in women who use the vaginal ring. The FDA study showed only a slightly higher risk of blood clots for those using the NuvaRing.
NuvaRing and Blood Clots
There is a lawsuit against NuvaRing; according to Drug News, the latest court records show that the number of cases that have been filed have increased from 1,502 on October 17, 2013 to 1,563 as of November 18, 2013.
Drug News, is asking anyone who has suffered a stroke, blood clot, pulmonary embolism, or DVT after using the NuvaRing to contact a lawyer.© Copyright 2013 Janelle Vaesa, MPH, All rights Reserved. Written For: Decoded Science