What friends of Durango native Erika Langhart seemed to love most about her was her humor.
She had great stories. Ridiculous things always seemed to happen to her, said Jessica Knutzon, 24, a fellow American University alumni.
She had this story where shes asleep in her bed and her dad comes to her room, and goes, Why are there two llamas at our house right now? And she goes, Dad, I swear to God, it wasnt me. I didnt have anything to do with this llama situation, Knutzon said.
Knutzon, like so many who knew her, described Langhart as witty, jovial and incredibly driven. Tall and poised, she was headed to law school at Georgetown University.
Instead, Langhart died on Nov. 24, 2011, at just 24 years old, and her family is blaming a prescription contraceptive whose potentially deadly side effect they say was not adequately disclosed.
After their daughters death, Rick and Karen Langhart, well-known to Durangoans as the former owners of the Red Snapper restaurant, testified to the Food and Drug Administration about the circumstances surrounding her sudden death.
The contraceptive she was using, a Nuvaring, a vaginal ring approved by the FDA in 2002, is known as third generation because it contains a different cocktail of hormones than previous formulations and is supposed to have fewer side effects.
But one component of the contraceptive Desogestrel, a synthetic form of progestin has come under increasing scrutiny.
In 2007, Public Citizen, a nonprofit consumer advocacy organization filed a petition to the FDA to ban third-generation contraceptives containing Desogestrel.
The reason is that some studies have shown it can cause an elevated risk of venous thromboembolism, or deep vein blood clots that make their way to lungs and cause a potentially fatal pulmonary embolism. This is what Langharts family believes happened to her. Merck, the maker of the Nuvaring, says it is committed to ensuring the safety of its contraceptive and is looking at all new, related information.
In October, there was a study led by the FDA and Kaiser Permanente on third-generation contraceptives. The study concluded the risk of embolisms with the vaginal ring is new and raises concern, but needs to be studied further. On Dec. 8 and 9, 2011, the FDA held an advisory committee on the effects of the patch, which allowed five public hearing speakers.
Langharts parents spoke at this meeting, and the transcript is available online. They urged both third- and fourth-generation birth controls be taken off the market because the second-generation of birth controls are just as effective.
Our daughter is gone, but our desire now, in honor of her life because we dont know what else to do, is to do what we can to help protect other young women, said Karen Langhart.
Johnson & Johnson Pharmaceutical Research and Development also testified at the hearing for the patch, also known as Ortho Evra. Johnson & Johnson testified its research showed 20 to 50 percent of spontaneous blood clotting happens with no identifiable risk factors. Risk factors normally include smoking, age, obesity, pregnancy or inheritance of genetic disorders.
Knutzon called it shocking that such a commonly used contraceptive could have deadly side effects.
The fact that my friend literally dropped dead from being on birth control, thats ridiculous, she said. She wasnt hit by a car. She wasnt on a plane that malfunctioned. She dropped dead because she was using birth control, and thats scary to me.
She said Langhart did not suffer from any of the listed risk factors.
While pulmonary embolism causes morbidity, it is rarely fatal in otherwise healthy reproductive age women, according to the Johnson & Johnson study.
The study estimated that of 10,000 women taking the drug, only one per year would die of the condition. The number jumps up to three to four per 10,000 for women taking contraceptives that include 30 to 40 micrograms of ethinyl estradiol. NuvaRing and Ortho Evra both contain more than 30 micrograms in their products.
Megan Wilkinson, a spokeswoman for Merck, the company that makes NuvaRing, said NuvaRing was not the subject of the advisory committee meetings in December. She said the company reviews post-marketing adverse events reports and makes the commitment to monitor the safety of the NuvaRing.
Langharts friends said they are re-evaluating their own contraceptive decisions.
Knutzon said it is troubling that the FDA does not provide more information.
I want to go to these proceedings. I want to go be a part of this movement, and theres no resource for us to reach out to the FDA to figure out what to do, she said.
The FDA has yet to respond to Public Citizens petition to ban third-generation birth controls containing Desogestrel.
They have not responded to it other than to say its complicated and theyre looking at it, said Dr. Sidney Wolfe, director of the health research group of Public Citizen.
The petition lists these birth controls: Desogestrel and ethinyl estradiol, desogen, mircette, velivet, apri-28, kraiva, orto-cept, reclipsen and cyclessa. Other contraceptives that have been investigated by the FDA include: Yaz, Yasmin, Ortho Evra and NuvaRing,
The American College of Obstetricians and Gynecologists gave its professional opinion for the December hearing, saying that birth control is an essential part of womens health. In a written statement, it said more than 80 percent of women will use contraceptives over the course of their reproductive years.
The college concluded though the risk of venous thromboembolism is higher with the patch, it is still very low compared to the risk of it during and after pregnancy. Because of that, The American College of Obstetricians and Gynecologists said the prescribing of third-generation birth control should be between a doctor and patient.
In the Dec. 9, 2011, hearing, voting members of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee voted that the benefits outweigh the risks for Ortho Evra. They also decided the current labeling for the patch is not sufficient in describing such risks.
Kelcie Pegher is an intern for The Durango Herald and a student at American University in Washington, D.C. Reach her at firstname.lastname@example.org.