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Home / Health / Are fertility drugs safe? The industry says yes; Critics fear that they will be over-prescribed.

Are fertility drugs safe? The industry says yes; Critics fear that they will be over-prescribed.

Logan Andreotta and daughter Bonnie Andreotta, 4, at home in Bowling Green, Ky. Although Andreotta was only 24 years old and had begun in vitro fertilization, she suffered a painful attack of ovarian hyperstimulation syndrome. (Carolyn Van Houten / The Washington Post)

Logan Andreotta was said to be an ideal candidate for in vitro fertilization. Although she was unable to get pregnant, Bowling Green's wife, KY., Was just 24 years old and of excellent health. But three days after she started taking fertility drugs, her ovaries became confused and swollen with 50 eggs-four years at a time.

"I felt like my heart was spurting out of my stomach," Andreotta recalls.

This was an ovarian hyperstimulation syndrome – OHSS for short – a potentially fatal complication that the US fertility industry calls extremely rare. However, the incidence of OHSS and the long-term long-term safety of hormone-boosting fertility drugs remain open to debate, even though the clinics have become a multi-billion dollar industry serving hundreds of thousands of women each year.

Industry critics worry that unregulated vendors over-prescribe medications, mask potential dangers, and fail to properly report problems when they occur. For example, in a recent study, "increasingly aggressive treatment protocols" were blamed for OHSS incidents, while another argued that most cases were completely "preventable".

Some researchers have hypothesized that in addition to their association with OHSS the drugs could have a potential impact on heart disease, depression, endocrine disorders, cancer and a host of other disorders. However, the few published studies are contradictory or inconclusive. And unlike many developed-nation industrialized countries, the United States does not seek to track the health outcomes of fertility treatments.

"Every fertility doctor says to every fertility patient:" There are no known risks. "No known risks are known because no one has looked," said Diane Tober, a medical anthropologist at the University of California, San Francisco, who studies reproductive technology.

According to industry representatives, more than 8 million children have been born by IVF worldwide More fertility treatments since the first "test tube baby" 40 years ago. Alan Penzias, associate professor at Harvard Medical School, chairing the practice committee of the American Society for Reproductive Medicine (ASRM), said he had been "reasonably reassured". The drugs are not a long-term threat to women's health.

"We are at a time when we would have seen it if there had been something bigger," said Penzias, who is also a Boston IVF surgical director "Fortunately, we have not seen anything negative."

OHSS is an exception.The most brutal and immediate complication of fertility treatment can hit anyone who uses medications to make the ovaries mature several eggs – a fundamental step in the process Freezing Eggs, In Vitro Fertilization (IVF), and Egg Donation, Approximately 240,000 Times a Year 19659011] Strategies to identify high-risk patients and treat the disease have evolved in recent years. which represents most US hospitals, refers to OHSS as an "uncommon but serious complication," from the assumed one It will be that it occurs in moderate or severe forms in just 1 to 5 percent of the cycles. Fertility physicians often cite studies that show that severe OHSS occurs in just 0.03 percent of the cycles.

Penzias said hospitalization for OHSS was "almost unknown" compared to 20 years ago. However, a Washington Post analysis of the National Emergency Department data revealed that the numbers are still significant. More than 9,000 women were seeking help in hospitals between 2006 and 2014, the last year for which statistics are available, and about 1 000 women a year.

In Sweden, Canada and the United Kingdom – Countries Regulating Assisted Reproduction and Tracking Patients Results – The medical societies explain to patients that an estimated one-third of the procedures trigger at least mild OHSS symptoms.

This year, the British Infertility Regulatory Authority, the Human Fertilization and Embryology Authority, launched a study into a discrepancy between OHSS cases reported by fertility clinics and the larger number logged in the hospital admissions data. While the watchdog group found no evidence of systematic under-reporting, it announced clinical-by-clinic audits, saying that the data raised "significant concerns and questions about the safety of patients with IVF."

Geeta Nargund, a fertility specialist in the UK, calls on Parliament to update reporting requirements to track IVF-administered drugs and dosages, and to link IVF treatment protocols to hospital registries for better tracking to allow for side effects.

. "It is extremely important that we do not make healthy women sick by IVF treatment."

Known deaths are rare but difficult to prosecute, say public health officials. When the ovaries are overstimulated, the body produces excess fluid that literally drowns vital organs, which can lead to a cascade of potentially deadly problems.

In a prominent case in 2005, Temilola Akinbolagbe (33) collapsed a course of IVF medications shortly after the start of a London bus stop. The accumulation of fluid from the OHSS led to a blood clot in a pelvic vein and finally to a heart attack.

The coroner listed the cause of death as a "mishap" – the result of a voluntary risk – a category that is used more frequently Cases of overdose of Blue Moon's medicines and occurrences such as fatal falls while taking selfies.

& # 39; Wonder drugs & # 39;

When fertility drugs first appeared on the market in the late 1960s, they were praised as "miracle drugs" and were originally used to induce ovulation in women were unable to produce eggs on their own. When the first commercial fertility clinic was opened in Norfolk in 1979, the doctors found that the drugs could be used much more aggressively.

Typically, a single egg matures in a woman's ovaries and is delivered to her uterus each month. Only a very small percentage of these eggs are destined to become babies; the rest is abnormal or defective in some way.

Collecting one egg at a time would be irresistibly inefficient for IVF. Therefore, the medications are calibrated so that a batch of eggs ripens – ideally about 10 to 15, according to recent studies. Less and a woman's chances of having a baby are lost. Even more and a woman's own health could be endangered.

However, finding out which and how much medication to use is difficult. Because IVF can cost $ 15,000 to $ 30,000 per experiment, doctors and patients often come under pressure to produce a large number of eggs each round.

Fertility groups have developed standard dosage regimens, but each protocol must be tailored to a woman's individual needs Size and health. In the meantime, there is nothing wrong with stopping doctors who want to use larger doses, and there is no systematic way to track dosages or outcomes.

Specialists have long argued that the short burst of estrogen, which normally lasts for 10 days in IVF, is unlikely to have a profound long-term effect on a woman's body. Researchers have argued for more research and found that estrogen is known to promote some cancers.

The widely academic debate erupted in 2003, when Jessica Grace Wing, a graduate of Stanford University and a triple egg donor, died of metastasis of colon cancer at an unusually young age of 32. Wing's mother, Jennifer Schneider, an internal medicine doctor, urged Congress and states to enact laws that would require better tracking of birth patients and more money to research complications.

"As a scientist, I can not say that I'm 100 percent sure it was the fertility drugs" that caused the cancer, Schneider said in an interview. "All I can say is the sheer lack of other reasons why it makes colon cancer so young."

Schneider also published pieces in medical journals that attracted the attention of researchers abroad. Soon followed large studies involving 50,000 women taking fertility drugs in Denmark and 24,000 in Sweden. The research showed no association between drugs and ovarian cancer.

The latest data presented at a conference in Europe in June also showed no increased risk of ovarian cancer. And a study published in July found no increased risk for two other cancers – the invasive uterus and breast cancer – in 250,000 British women who have undergone fertility treatment.

Current ASRM guidelines state that "there does not seem to be any sense of increased risk" for invasive ovarian, breast or endometrial carcinoma in fertility patients "based on available data". In borderline ovarian tumors, the group admits, "Several studies have shown a low increased risk."

Colon cancer, perhaps because there is no consensus. A study in the Netherlands published in 2016 showed – "reassuring", the researchers wrote that women who undergo IVF do not appear to be at an increased risk for colorectal cancer compared to the general population. In IVF patients, the likelihood of having colorectal cancer was almost twice as high as in women receiving non-IVF fertility treatments such as tube surgery or intrauterine insemination. The researchers called on the researchers, "further research is appropriate".

Schneider finds the studies Women usually do not differentiate between women who use fertility drugs for different reasons. Some are barren. Some are fertile but are treated for their partners. and some are optional egg freezers and donors. Schneider argues that these populations are different – and often very different in age and hormone levels.

"The results are mixed because women in fertility treatment are a diverse group," said Schneider. He added that no studies focused exclusively on elective egg freezers and egg donors.

Bonnie Andreotta has a younger sister who was received without in vitro fertilization. (Carolyn Van Houten / The Washington Post)

Drowning Organs

Unlike cancer, there is little doubt in the link between fertility drugs and OHSS. Complaints about the condition fill up fertility blogs and online support groups.

In an interview, a dozen OHSS patients described confusion and chaos as the symptoms began. Most said they had never heard of ovarian hyperstimulation syndrome before they fell ill.

Asya Ulanova, 22, a New York egg donor, said she was watching TV in November when she suddenly felt a "visceral" abdominal pain had trouble breathing. A doctor in the emergency room told her that fluid had accumulated in her abdomen and she had given her medication for constipation. It was not until much later that Ulanova learned that she suffered from OHSS.

Emily Ley, 34, an entrepreneur from Pensacola, Florida, prepared for the IVF in 2014 when she won 22 pounds in 48 hours. She nearly died and spent eight days in the hospital with a tube in the abdomen to drain the fluid.

"Looking back, I did not know how scary my situation was," said Ley, who learned at the hospital that she was pregnant with twins.

Logan Andreotta said that her fertility physicians described the risk for OHSS as "ridiculously low". As a result, she was "not mentally prepared" when she woke up one morning in the morning of 2014 and her stomach bulged. She was suddenly 20 weeks pregnant.

Andreotta was taken to the fertility clinic, where a doctor used a giant needle to "tap" the fluid in her abdomen.

"It was liters and liters and looked like the Coca-Cola you buy in the store – a brownish-red liquid," she recalls. 19659050] On the first day they filled four to five bottles. They occupied two to three more visits. Andreotta said that her recovery took almost four weeks.

Despite the shocking experience, Andreotta, now 29, said she did not regret taking the medication. Out of 50 eggs from the ovaries, four were tested normally. One of them led to a beautiful daughter, Bonnie, now 4. Two years ago, Bonnie won a sister, Audrey, who was born without IVF.

But Andreotta said that she would advise other women taking fertility drugs to report unusual symptoms immediately.

"I feel very happy," she said. "They said that if I kept waiting, I could literally be dead."

"Echo" Effects

In the early 2000s, so many women turned up in emergency rooms at hospitals that were filled with excess fluids and had heart failure, or another organ failure that affected the situation of Jacob Udell, a medical director Interns in Canada, attracted.

"We were stunned. They did not have many risk factors, but the usual topic was that they got fertility drugs, "Udell recalls." They got high doses and tried to get pregnant. "

Udell and his colleagues wondered if this ER Patients might be "the tip of the iceberg" and high estrogen levels of fertility drugs could damage the lining of the skin Blood vessels that leak from these compromised blood vessel walls could explain the buildup of fluid in the OHSS.

One A study from Sweden may have suggested that there may be higher rates of hypertension and possibly a stroke in fertility patients, but a Canadian study with a similar design did not show any association.

Udell, now assistant professor of medicine at the University of Toronto, and Natalie Dayan from the McGill Univers in Montreal to lead this as the first major institute to analyze the link between fertility drugs and cardiovascular disease.

The study published last year in the Journal of the American College of Cardiology examined data from 42,000 fertility patients. The treatments appeared to have no impact on the risk of heart attack but showed a potential, but not entirely statistically significant, increase in stroke risk.

Udell said it was impossible to say whether the differences were due to the risk of heart attack, fertility drugs, or fertility problems, age, or other factors underlying the women.

The results highlight the need to track fertility patients much more closely.

"We may not see any immediate catastrophic diseases," but "there may be milder, potential long-term echo effects," said Udell.

"Sometimes everyone turns to the baby after pregnancy. But maybe it should also be thought of Mom.

Dan Keating contributed to this report.

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