Some Inland university health centers have stopped writing new prescriptions for the only birth-control patch on the market since the U.S. Food and Drug Administration warned of increased hormone exposure and possible serious health risks from its use.
Local Planned Parenthood clinics and many doctors continue to prescribe the popular and convenient form of contraception, although they said they are careful to screen patients for risk factors and inform them of possible complications.
The FDA in November required a new, boldfaced warning on the label of the Ortho Evra patch stating that users are exposed to about 60 percent more estrogen than is in the typical birth-control pill, which contains 35 micrograms of the hormone. Increased estrogen exposure is linked to deadly blood clots, stroke and heart attacks, and the risk grows for women who smoke, especially those older than 35.
Several lawsuits have been filed nationally by the families of women who died or suffered blood clots while using the patch.
Clinics at the University of Redlands and UC Riverside no longer start women on the patch. Health centers throughout the California State University system sent a letter to students who have patch prescriptions to notify them of the new warning.
Kathleen Brown, director of the University of Redlands Student Health Center, asked the dozen or so students who have prescriptions for the Ortha Evra patch to come in to discuss the risks and other birth-control options.
“I have not had one student request to renew it,” said Brown, a family nurse practitioner authorized to write prescriptions. “Even an individual who bought five months in advance, she went ahead and switched. Just knowing it’s a significant increase in risk, they’re just not willing to take that risk, and I, as a provider, would not be willing to (prescribe) it knowing there’s something safer.”
The contraceptive patch revolutionized birth control for many women because it is as effective as the pill but has to be applied to the upper arm, torso, abdomen or buttocks only once a week. It is waterproof and looks like a small, square Band-Aid.
The patch has been used by more than 5 million women since it hit the market in 2002, according to the manufacturer, Johnson & Johnson’s Ortho-McNeil Inc. The company says it is a safe and effective method of birth control but, like all hormone-based contraception, is not appropriate for all women.
Patch vs. Pill
Company and government news releases say the drug was tested on 3,300 women in clinical trials, and the stronger warning label was “a result of further analysis” by the FDA and manufacturer.
In 2000, FDA doctors reviewing the clinical trials noted that two of the women were treated for blood clots that had traveled to their lungs and warned that blood clots could be a problem if the drug were approved, according to The Associated Press.
“At that point, it wasn’t statistically significant,” said FDA spokeswoman Susan Cruzan, who said it isn’t unusual for the agency to approve a drug and request further testing.
“What you are depending on is the clinical trials to alert you to any problems or adverse reactions,” she said.
The company now warns that hormones from the patch enter the bloodstream and are metabolized differently than those in birth-control pills, which are absorbed through the stomach.
Previously, the FDA and Ortho-McNeil said the risks associated with the patch were expected to be similar to those with birth-control pills.
The FDA said it is not known whether patch users are at greater risk of blood clots. The agency is tracking reports of possible problems associated with the patch.
Under a Freedom of Information Act request, The Associated Press received federal drug-safety reports showing that between 2002 and 2004, 17 women, mostly in their late teens and early 20s, died from blood clots believed to be related to the patch. Dozens more survived strokes and other clot-related problems, according to The Associated Press.
“It probably should be taken off the market,” said a lawyer who filed negligence lawsuits against Ortho-McNeil on behalf of two Los Angeles-area women, alleging they suffered clotting-related injuries because of the patch.
“Studies are pending on exactly how much estrogen is delivered,” she said. “At the very least, women need to know this convenience comes with a price.”
The attorney said she has evidence that Ortho-McNeil knew about the higher estrogen levels but kept it from consumers.
The company declined to comment because of the pending litigation.
Rienica Gillory-Ayala, 25, of Grand Terrace in southern San Bernardino County, started using the patch 10 months ago, after the birth of her daughter. She said she started suffering sporadic chest pain after about four months on the patch before the revised warning was issued.
Gillory-Ayala said she also suffers dizziness occasionally and feels like she is going to pass out. “I get short of breath, and my heart races,” she said.
Gillory-Ayala visited her gynecologist recently and asked to switch to birth-control pills.
She learned of the label warning from her husband, who had seen it on the news. “I didn’t know anything about it,” said Gillory-Ayala, a dental assistant.
Shahla Mansouri, the family nurse practitioner at UC Riverside’s health center, stopped prescribing Ortho Evra a few months ago. Many of the 35 students using the patch have switched to another method of birth control, she said.
“My concern is we don’t have all the facts, and since there’s a question and some issues have come up there’s many other options. We can do without (the patch) for a while, until we know for sure,” she said.
Mansouri discourages students from using the patch, though she said she would prescribe it if someone insisted. So far, no one has.
Some doctors make it clear that the patch has not been removed from the market and is therefore safe to prescribe for women considered to be low-risk nonsmokers younger than age 35 who have no history of blood clots, high blood pressure, heart attack, stroke or certain kinds of cancer.
Such warnings make doctors more aware that they should prescribe the product with caution, said Dr. Ava Mahapatra, a Palm Springs gynecologist and president-elect of the Riverside County Medical Association.
“Every medication has risks and benefits. You have to be careful and counsel your patients,” she said.
Women also are at greater risk of blood clots when they are pregnant, Mahapatra added.
She and other local doctors said their patients on the patch have not had problems, though many of them did switch to the pill after the warning was issued.
Doctors at Planned Parenthood continue to prescribe the patch, spokesman Vince Hall said.
“Where there’s been an alleged serious consequence from the use of the patch, it is so massively offset by the millions of women who have used it successfully without serious consequences (that) the debate is already over,” he said. “I wouldn’t want this to get blown out of proportion.”
After Cal State San Bernardino’s campus health center wrote to the approximately 30 students to whom it provided the patch about the label change, few switched to another method, director Patricia Smith said.
Many young women don’t understand the importance of not smoking while using the patch, she said. “In the college setting, when you ask a student if they smoke, they say, ‘only on the weekend’ or ‘only sometimes,’ and that doesn’t qualify them as a smoker in their mind.”
‘Think They’re Invincible’
Christine Gailey, chairwoman of the UC Riverside Women’s Studies Department, said it is often hard to get informed consent from young women because convenience with birth control is such a factor.
“Women in their late teens and early 20s think they’re invincible. (They think) ‘so what if you get a little more estrogen?’ There’s not a good understanding of what the consequences could be,” she said.
Gailey wants the FDA to pull the patch off the market until the effects are known. She is reminded of the early birth-control pills, which contained more than twice the amount of estrogen found in most pills today and caused dizziness, breast sensitivity, swollen lymph nodes, phlebitis, hypertension and blood clots.
Gailey is angry that estrogen levels weren’t considered, since the patch has such a novel delivery method. Women shouldn’t have to risk their health to prevent pregnancy, she said.
But the FDA said it doesn’t know whether the increased estrogen exposure “has an additional adverse effect. We just know there is additional exposure and people need to take that into consideration,” spokeswoman Cruzan said. “The FDA has a very thorough review process, and we continue to monitor all drugs after they’re put on the market.”
Ortha Evra is among 184 drugs on the “worst pills” list of Public Citizen’s Health Research Group, a watchdog nonprofit.
The group’s director, Dr. Sidney Wolfe, said the deaths and high rate of clots are “worrisome” and should be investigated, but he stopped short of saying the drug should be removed from the market.
“There is no medical reason for women to use the more dangerous Ortha Evra rather than one of the older, better understood and equally effective oral contraceptives.”