Yourlawyer.com (Cytotec News) http://www.yourlawyer.com/topics/overview/cytotec Sat, 21 Nov 2009 02:30:33 -0800 pixel-app en Off-label disclosure on drugs proposed http://www.yourlawyer.com/articles/read/11424 Sat, 25 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11424
Hancock said the death of a constituent's daughter spurred her to draft the legislation, which would create a list of specific disclosures doctors must make to obtain patients' informed consent to treatments never evaluated by the
FDA.

"We make the assumption that drugs that are prescribed or given in the hospital are certified for that use by the FDA,'' Hancock said. "If that's not the case, people have the right to know.''

Many medicines that enter the market after being approved for one disease are later legally prescribed for other illnesses. Doctors may use an off-label drug because no approved medicine exists for an ailment or because some research has raised the possibility that an unapproved treatment is as good or better than an FDA-sanctioned remedy.

While such prescribing is widespread, off-label drugs at times have been linked to serious side effects and deaths. Hancock said she knows of no state, including California, that orders doctors to tell patients when they are receiving an unapproved treatment.

Her bill would obligate doctors and surgeons to inform patients when the FDA has never evaluated the recommended treatment and that "a division of opinion exists as to the efficacy of the use of the medication.'' It would also require doctors to disclose what is known about the side effects of the off-label drug, to outline other possible remedies and to give their reasons for recommending the unapproved treatment instead.

Hancock constituent Maddy Oden of Oakland said she is thrilled by the proposed bill. Oden began a campaign for wider disclosure requirements after her 32-year-old daughter, Tatia Oden French, died during childbirth in 2001. Her labor had been induced by the drug Cytotec an ulcer treatment not approved for that use. Oden said doctors may feel that Hancock's legislation challenges their judgment. But patients, not doctors, live with the consequences of treatment, she said.

"It is their own health that they're making a decision about,'' Oden said.

A spokeswoman for the California Medical Association, Karen Nikos, said the organization will reserve comment on the bill until it has had time to evaluate its language.

The drug industry's main trade association, Pharmaceutical Research and Manufacturers of America, also declined comment. The FDA does not regulate doctors, a role left to the states. But the FDA restricts the promotion of off-label uses by drug manufacturers.]]> FDA Launches Site to Warn Patients, Doctors of Drug Risks http://www.yourlawyer.com/articles/read/9749 Fri, 20 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9749
The new site, called Drug Watch, marks a significant change in how the agency communicates risks to the public. In the past, the FDA has spent months or years privately weighing and debating risk information with drug companies until a final determination was made on the scientific significance of the danger.

After being bashed by Congress and consumers for its slow response to emerging information about heart risks posed by blockbuster pain medications such as Vioxx, the FDA now is beginning to make risk information available to the public much sooner.

"This is really a fundamental change," said Dr. Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research. "We do intend to give companies a heads up before posting something new about their drugs, but we're not going to discuss it with them. They're not going to review it."

The safety alerts posted so far on the site http://www.fda.gov/cder/drugSafety.htm are notable also because they emphasize risks posed by doctors prescribing drugs for purposes never approved by the FDA. It's a practice called "off-label prescribing" because it involves using drugs in ways and to treat conditions not covered by the safety and effectiveness determinations on their FDA-approved labels.

"That's a very important aspect of this," Galson said. "As you know, we don't regulate the practice of medicine. We have no way of preventing physicians from using drugs off label."

But Galson said the agency does have a responsibility to let people know about known risks of off-label uses. "This is very controversial, of course," he said.

Some off-label drug uses are beneficial and based on good science, others have little proof of effectiveness and still others have been proved worthless in studies.

Officials at the American Medical Association, which represents doctors, and the Pharmaceutical Research and Manufacturers of America, which represents drugmakers, declined to comment, saying they are evaluating the Drug Watch site and will submit formal comments to the FDA.

Ed Sagebiel, a spokesman for Indianapolis-based drugmaker Eli Lilly, said the company generally supports the FDA's new effort. The site includes alerts for Eli Lilly drugs Prozac, warning of suicide risks related to it and other antidepressants, and Zyprexa, warning of an increased risk of death when it and other atypical antipsychotics are prescribed off-label to treat dementia in elderly patients.

"We just want, from our standpoint, to properly balance warning people and patients of safety concerns without frightening them or inadvertently making them stop taking their medicines," Sagebiel said.

Galson said others in the drug industry have expressed similar concerns. "They're worried we may be over-warning and dissuading patients from using products that may do good," he said. "We expected we would get that sort of push-back."

Advocates for patients called the site an incremental move in the right direction, even though it requires patients to seek out the information on the Internet, rather than it being given to them when they pick up their medicines. The emphasis on early and off-label risk information is a departure for the FDA, they said.

"I don't think they had the political courage even a few years ago to take these kinds of steps," said Larry Sasich, a pharmacist with Public Citizen's Health Research Group, a consumer watchdog that publishes a searchable database of drug risks at www.worstpills.org.

Sasich said he thinks the FDA is realizing that the only way to change risky prescribing is for consumers to know more about the drugs they take. Changing the official labeling on drugs and sending letters to doctors about new risks hasn't worked, he said.

Sasich expressed concern that elderly patients who are the biggest consumers of prescription drugs won't have enough access to Drug Watch information that's available only on the Web.

Cynthia Pearson, the executive director of the National Women's Health Network in Washington, praised the direct communication of risks listed atop several drugs on the site.

"Our position always has been: Get people access to good information and they can make good decisions," Pearson said.

The Drug Watch site, still being developed, lists information on about 200 drugs. Most of them include routine prescribing information. Among those tagged with an "FDA Alert:"

Accutane, a drug for severe acne. "The FDA continues to assess reports of suicide or suicide attempts" associated with this drug. All patients "should be observed closely for symptoms of depression or suicidal thoughts," the alert warns.

Cytotec, also called misoprostol, a drug approved to prevent ulcers. The alert warns of risks in its off-label use in labor and delivery. "These uses are not approved by the FDA. No company has sent the FDA scientific proof that (Cytotec) is safe and effective for these uses. There can be serious side effects, including a torn uterus..." the alert warns.

Zyprexa, Risperdal and several other psychiatric drugs called atypical antipsychotics. The FDA warns that when prescribed off label as a treatment for dementia, older patients "had a higher chance for death than patients who did not take the medicine."

Amiodarone, marketed also as Cordarone and Pacerone, a popular heart drug approved only to treat a specific life-threatening rhythm disorder. It is widely prescribed off label for non-life-threatening atrial fibrillation. The alert warns of potentially fatal side effects including lung toxicity, liver injury and worsened heart rhythm problems.

Gabitril, a drug approved to treat seizures. The alert warns that it risks causing seizures when used off label. Gabitril's "safety and effectiveness have not been established for any other use," the alert notes, adding that the drug's maker, Cephalon, will be educating doctors "to discourage off-label use."

Sheryl Williams, a Cephalon spokeswoman, said through Drug Watch, the FDA appears to be trying to do a better job of communicating and addressing the increasing prevalence of off-label prescribing.

A Knight Ridder investigation published in 2003 found that patients are being injured and killed when doctors routinely prescribe medications in ways that the FDA has never approved as safe and effective. Off-label prescriptions for top-selling drugs accounted for nearly a quarter of their retail sales.

Williams said most of the prescriptions that doctors write for Gabitril are to treat psychiatric conditions - not epileptic seizures. Bipolar disorder is a particularly popular use, she said.

"The problem is there is no guidance for them to do so. We haven't done double-blind studies. We haven't even done single-blind studies," Williams said. "Our scientific team doesn't believe there is sufficient evidence that a drug like Gabitril would be effective in bipolar disorder."

While Gabitril is effective in reducing the frequency of seizures in people with epilepsy, she said, when used off label the drug has been associated with seizures in people without epilepsy.]]> Labor Induction Drug Under Fire http://www.yourlawyer.com/articles/read/8936 Tue, 30 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8936
"We believed what happened to our daughter could have been prevented had we been informed about the medication beforehand," says her mother Marlana Cruts.

The medication is called Cytotec. The tiny pill has been hailed as one of the most popular and effective labor inducing drugs, ever.

But what Kelsey's mother didn't know and what most women are never told is that Cytotec isn't approved by the FDA for labor induction. It's meant to treat ulcers.

Even the drugs own manufacturer says it should never be used on pregnant women.

"I was shocked," says Cruts.

You only need to look at the label to see why.

"I can look at this and say you shouldn't use it on a pregnant woman, but apparently the doctor didn't care," says Kelsey's father, Phillip.

Dr. Marsden Wagner is a retired chief of neonatology for the World Health Organization. He says one in every five pregnant women will be induced and Cytotec increases their risk of a uterine rupture.

"Think blownout tire," says Wagner. "The uterus actually ruptures wide open during the labor and when this happens it's an obstetrics catastrophe.

"Many women die and one out of four babies will die if that happens."

Others, like Kelsey, suffer severe brain damage. Mark Mueller is the Cruts' attorney.

"We call it 'Cytobomb' because the effects on the uterus are like a small bomb going off," says Mueller. "It's dangerous. We think it should be done away with."

But the American College of Obstetrician and Gynecologists disagrees. It's published its own guidelines supporting the use of Cytotec and says doctors who violate those procedures are the ones whose patients have problems.

If it's not FDA approved and the drug manufacturer says don't use it, why is it being used?

"The short answer is it works and works better than the other available agents and in the right context it seems to be safe," said Dr. Charles Lockwood of Yale University.

Ultimately, it's up to the doctors, not the FDA. What you might not know is that any doctor can use any drug on the market anyway they see fit. It's called "off label use" and it's quite common.

"Almost no drug used in obstetrics is labled for use in obstetrics," says Lockwood.

Lockwood says drug companies fear liability so they often don't test for use on pregnant women. That keeps the cost of the drug down. The FDA approved drugs for induction cost hundreds of dollars. Cytotec costs just 20 cents.

"I think I would have paid a whole lot more money for something else," says Phillip Cruts.

But the Cruts say they were never given that choice and now it's Kelsey that continues to pay. ]]> Teen Dead After Abortion Pill http://www.yourlawyer.com/articles/read/7302 Tue, 23 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/7302
The death of the Livermore, Calif., girl on Sept. 17 is believed to be the third U.S. fatality connected with the drug.

"She just turned 18," Holly's father, Monty Patterson, told the San Jose Mercury News. "They told her it was safe and it killed her."

The Alameda County Coroner's Office has yet to determine the cause of death.

What is known is that Holly's secretive visit to Planned Parenthood resulted in her being given RU-486, a drug that induces abortion. She was seven weeks pregnant the latest point in pregnancy for which RU-486 is recommended by the Food and Drug Administration.

The death of Holly, who dreamed of being a make-up artist to movie stars, reignited the debate over RU-486 on talk shows, Web sites and newspapers around the San Francisco Bay area.

Critics say Holly was the victim of errors by those who should have warned her of the pill's hazards.

When she visited the Planned Parenthood clinic in Hayward on Sept. 10, she was given mifepristone, the first part of the two-drug regimen. Mifepristone, which is manufactured in China by Danco Laboratories of New York, breaks up the lining of the womb and destroys the supply of nutrition to the embryo.

Three days later, Holly took two tablets of misoprostol, which induces contractions to expel the embryo and the uterine lining. Misoprostol causes symptoms similar to a miscarriage, including nausea, bleeding and severe cramps.

Misoprostol, originally developed as an ulcer drug, is sold under the brand name of Cytotec. Its maker, Pfizer Inc., sent out a letter a month before RU-486 was approved in September 2000, warning doctors against using Cytotec for abortion. Off-label use of the drug can cause adverse effects such as a ruptured uterus, vaginal bleeding and "maternal or fetal death," Pfizer warned.

But off-label use may have been what happened in Holly's case. Her father, who did not learn of his daughter's abortion until four hours before her death, said the girl was instructed to take misoprostol vaginally, although Danco and the FDA have recommended the pill be taken orally.

Soon after taking misoprotol, her family says, Holly experienced such severe bleeding and cramps that she was unable to walk. But when her boyfriend rushed her to a hospital in nearby Pleasanton on Sept. 14, she was given painkillers and sent home.

By the night of Sept. 16, she was back in the hospital. Her father says doctors told him that his daughter's death the following day was the result of a massive infection caused by fragments of the fetus left inside her uterus that caused her to go into septic shock.

"RU-486 is a chemical way of killing babies that has never been adequately tested," said Jim Sedlak, executive director of Stop Planned Parenthood. "It's trumpeted as an easy, simple thing until something like this happens and then they say it's a random event."

The National Abortion Federation, which has said RU-486 is safer than aspirin, had no immediate comment on Holly's death. The FDA said it is investigating the case. Holly's father has said he does not intend to file any lawsuits over her death.

A statement by Danco Laboratories, which called Holly's death "a tragic event," said more than 200,000 American women and more than 1 million women worldwide have used RU-486.

But a year ago, Danco reported 400 "adverse events" resulting from its use. Plus, a Canadian woman died of a rare bacterial infection during a clinical trial of the drug. In 2002, another woman died after using the drug to abort an ectopic pregnancy, where the fertilized egg implants in the fallopian tube instead of the uterus. ]]> Abortionist Involved in Woman's Death Awaits Word on Medical License http://www.yourlawyer.com/articles/read/6248 Mon, 30 Jun 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6248
Candace Cohen, spokeswoman for the medical board, refused to discuss specifics of the case or when the board might decide the fate of abortionist Mark Maltzer. She did say the board could decide to revoke Maltzer's license, suspend him or clear him of any wrongdoing.

A wrongful death lawsuit has also been filed in Los Angeles Superior Court against Maltzer and the Planned Parenthood clinic where Maltzer performed the abortion on Diana Lopez Feb. 27, 2002.

The California Department of Health Services (CDHS) last month issued its report dealing with the clinic's health code violations. Since the release of the report, the clinic has addressed the deficiencies, according to the CDHS, and no further action is planned.

Lopez went to the clinic for what was to be a two-day dilation and evacuation (D&E) procedure to terminate her pregnancy of 18 weeks. According to CDHS findings, Lopez developed post-operative bleeding a day later, was rushed to a hospital and died later on Feb. 28.

The Los Angeles County Coroner's Office concluded that the cause of death was a hemorrhage due to "traumatic anterior cervical perforation" while Lopez underwent the D&E procedure. In simpler form, she bled to death due to a punctured cervix.

Maltzer and Planned Parenthood of Los Angeles referred comment to their attorney, Gary Fields, who refused to discuss the case.

The National Abortion Federation (NAF) maintains that abortion is one of the safest and most common surgical procedures, also that "perforation of the wall of the uterus occurs in less than 1/2 of one percent of cases."

The California Department of Health Services, in its May 21 report, cited the Planned Parenthood clinic for:

-- Failing to institute a necessary change in medical protocol relating to the use of laminaria (used to expand the cervix) in the dilation and evacuation procedure.

-- Lacking the evidence to show a completed assessment of the competency and credentials of the physician who carried out the abortion.

-- Inadequately advising against a potentially dangerous second-trimester D&E procedure based on low hemoglobin levels.

-- Failing to follow proper surgical abortion policy and procedure by administering Cytotec to the patient on day one of the two-day abortion procedure, when policy requires it to be administered 90 minutes before the abortion procedure.

-- Failing to inform Planned Parenthood's governing body of any adverse outcome related to patient care within the facility.

-- Failing to notify the Health Department of a patient's death within 24 hours of the occurrence.

-- Keeping incomplete records describing the services provided to Lopez.

The findings worry those who see the Lopez case as an example of the inconsistent medical guidelines and poor physician care at abortion clinics.

"Abortion by its nature does not attract the best practitioners," said Mark Krutcher, founder and president of Life Dynamics, a Texas pro-life organization that emphasizes the use of malpractice suits in its fight against abortion clinics.

Planned Parenthood claims abortion is less threatening than childbirth. The group's website claims death occurs in "one of 100,000 abortions," while "childbirth carries seven times more risk."

But Krutcher said Planned Parenthood's statistics are misleading.

"Prior to 16 weeks, an abortion is safer than childbirth," Krutcher admitted. "After 16 weeks, child birth is safer," he added. "If you look at the data from the [Centers for Disease Control and Prevention] or from all the medical research that has been done, that's what it consistently shows."]]> NMH Sued Over Death http://www.yourlawyer.com/articles/read/6020 Thu, 29 May 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6020
Among the claims made by Marcia Downs in her lawsuit is that she was given the drug Cytotec to induce labor. The drug's only approved use is for peptic ulcer disease and it is not approved by either the Food and Drug Administration or the drug's manufacturer for labor induction, according to the lawsuit.

Northern Michigan Hospital spokesman Thomas Spencer said the facility has not yet been served with the lawsuit and declined comment.

Downs, said in the lawsuit that the hospital, doctors and nurses involved in the delivery should have known that Cytotec has "potentially dangerous and serious side effects, and acute risks, such as fetal death."

Downs' infant daughter, Natasha, lived for a few hours after delivery by Cesarean section before dying on Oct. 23, 2000, at the hospital. The cause of death, according to the lawsuit, was hypoxia and severe birth asphyxia.]]> Searle Warning Letter Concerning Cytotec as Birth Inducer http://www.yourlawyer.com/articles/read/71 Thu, 23 Aug 2001 00:00:00 -0700 http://www.yourlawyer.com/articles/read/71 FOR INDUCTION OF LABOR OR ABORTION



Dear Health Care Provider:

The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or
abortion.

Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.

The uterotonic effect of Cytotec is an inherent property of prostaglandin E1(PGE1), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to
termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.

Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or
salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore,
Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established.

Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec.

Further information may be obtained by calling 1-800-323-4204.

Michael Cullen, MD
Medical Director, U.S.
Searle
5200 Old Orchard Road
Skokie, Illinois, 60077
Phone: (847) 982-7000
Fax: (847) 470-1480
]]> Labor induction: Cytotec alert http://www.yourlawyer.com/articles/read/73 Mon, 14 May 2001 00:00:00 -0700 http://www.yourlawyer.com/articles/read/73
There are growing concerns about the safety of this drug when used for labor induction. A November 1999 Committee Opinion of the American College of Obstetricians and Gynecologists (ACOG) warns: "There have been reports of uterine rupture following misoprostol use for cervical ripening in patients with prior uterine surgery. Thus, until reassuring studies are available, misoprostol is not recommended for cervical ripening in patients who have had prior cesarean delivery or major uterine surgery" (1).

Cytotec's only FDA-approved use is treating ulcers. In August 2000, Searle, Cytotec's manufacturer, sent physicians a letter reminding them that Cytotec was not approved for use as a cervical ripening agent and that it was contraindicated for use in pregnancy (14). The letter listed serious adverse effects associated with using Cytotec, including maternal or fetal death, uterine rupture, and severe vaginal bleeding and shock.

Cytotec is no more effective, and much less safe than Prepidil or Cervidil ( prostaglandin E2), another agent used in the hope of reducing the cesarean rate in labors induced with an unripe cervix. An analysis of 16 trials, in which women were randomly assigned to receive either Cytotec or Prepidil/Cervidil, showed similar cesarean rates (8). Two additional randomized controlled trials comparing the two, and published after the analysis, also found similar cesarean rates (10, 12). Among all 18 trials, totaling 2,550 women who received one labor induction drug or another, cesarean rates were 19 percent with Cytotec and 20 percent with Prepidil/Cervidil. As for safety, a review of 10 studies, totaling 832 VBAC women given Prepidil, reported no uterine ruptures. (4)

Cytotec's sole appeal is price. Cytotec costs pennies per induction, whereas Prepidil and Cervidil cost close to $100 per dose, and more than one dose may be needed (3). Cytotec also reduces the need for intravenous oxytocin (Pitocin), the hormone that stimulates contractions, another savings.]]> Pharmaceutical Giant Issues Abortion Drug Warning http://www.yourlawyer.com/articles/read/72 Sat, 21 Apr 2001 00:00:00 -0700 http://www.yourlawyer.com/articles/read/72
One such medical facility reportedly using Cytotec is Christ Hospital and Medical Center in Oak Lawn, Illinois which has been at the center of a controversy concerning the use of what some call the "live-birth abortion" method.

In a letter written by Dr. Michael Cullen, Searle's Medical Director, the company warned health care providers nationwide that Cytotec should not be used on pregnant women. "The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion," Cullen wrote. "Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during
pregnancy."

Searle also stated no research has been conducted, "concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses."

Searle's letter was issued on August 23rd of last year. However, it is reported Christ Hospital continues using Cytotec to induce labor in women seeking abortions and, reportedly, to induce normal full-term deliveries. The abortion procedure sometimes results in the birth of a live baby, which is then left to die without any medical assistance or intervention.

Christ Hospital is part of the Advocate Health Care System of hospitals that includes eight other medical facilities in the Chicagoland area. The "live-birth abortion" method, used by Christ Hospital and another Advocate facility, Lutheran General in Park Ridge, is also performed by numerous abortion providers across the nation and in Canada.

There have been multiple lawsuits nationwide concerning the use of Cytotec. Searle's warning to health care providers that, "Serious adverse events reported following off-label use of Cytotec in pregnant women include
maternal or fetal death," is seen by some legal experts as a means to escape liability in future litigation.

Cytotec was originally developed for the treatment of ulcers. Yet despite the warning from Searle, some abortion providers are still using Cytotec. It is estimated ten women nationwide have died because of the improper use of Cytotec.]]> Cytotec: Dangerous experiment or panacea? http://www.yourlawyer.com/articles/read/70 Tue, 11 Jul 2000 00:00:00 -0700 http://www.yourlawyer.com/articles/read/70
Before consenting to the induction, Holly's midwife says, she asked one of the obstetricians in her group practice if Holly would be a good candidate to try a new induction drug. He approved the prescription.

Holly disputes her midwife's story, asserting that the midwife recommended induction against Holly's better judgment. "My body was made to have babies," she told me. With five vaginal births to her credit, Holly had confidence in her ability to labor.

Whatever the truth, both parties agree that over the next several hours the nurse-midwife gave Holly three 25-microgram doses of Cytotec. (Because of legal considerations, both parties requested anonymity.) What Holly didn't know and the midwife never told her was that it was an unapproved drug with potentially disastrous side effects.

One hour after the third dose, labor began, with contractions every two and a half minutes. According to Holly's 19-year-old daughter, Ann, who was present throughout labor, Holly handled herself very well.

Thirty hours later, her cervix not yet fully open, Holly stood up and walked around. Then her bag of water broke. A little later she heard a popping sound from her body. The midwife monitoring her labor noticed that the baby's heart rate had dived from a normal 130-140 beats to a frightening 40 beats per minute.

She exhorted Holly to push, and within five minutes, Holly's 8-pound, 13-ounce daughter was born, followed by a huge gush of blood. The baby was blue and didn't breathe on her own, so the resuscitation team intubated her.

Holly, meanwhile, continued to bleed. Frightened, she told her midwife that something was wrong. The midwife assured her that her blood loss was not enough to warrant a doctor's presence. Later, realizing that Holly was bleeding excessively, the midwife removed several huge clots from her vagina, gave her medication to stop the bleeding and left her in the care of nurses.

Ann and Darryl, Holly's husband, were far from reassured. By this time, Holly lay unconscious, white as a ghost. They helplessly watched her struggle for breath. Darryl begged the nurses to get a doctor and the midwife directed a nurse to call for a doctor on the intercom. The physician who entered the birth room two minutes later was shocked at Holly's condition. "This lady is dying," he shouted. "I'm taking her to the O.R.!"

Holly's heart stopped twice during the surgery. At one point, the doctor told Darryl that he did not expect her to survive. Her uterus had ruptured from the top down through the cervix. This kind of wound is characteristic of Cytotec-related ruptures, according to obstetricians I've since spoken to. (One doctor described them to me as "totally exploding.") Surgeons removed Holly's uterus along with one of her ovaries and a fallopian tube. Thirty-seven units of blood, plasma and platelets were required to replace the blood lost during her ordeal. Gone forever was her chance to have another baby.

Was Holly's labor a nightmare fated to happen, with or without intervention? Or did Cytotec cause her uterine rupture, thereby threatening her and her daughter's life? As with so many forms of obstetric intervention, even hindsight isn't 20/20. Every birth is unique, and the influences on labor are far more numerous than most studies can account for. And even with large, long-term, controlled studies, it is sometimes complicated to ferret out the facts about the efficacy or safety of a given medical procedure.

Cytotec, however, doesn't have the benefit of such scientific debate, because it is still essentially an experimental birth drug that is being tested ad hoc by trial and error. But most patients are never informed of this fact.

As a midwife of 30 years and one of the founders of the natural childbirth movement, I have overseen more than 2,000 births at my birthing center in Summertown, Tenn. Over the years I've listened to innumerable anecdotes about the dangers of medical intervention. But the stories I was hearing about Cytotec I found especially unsettling.

Over the past three years I have watched in increasing dismay as this once little-known ulcer medication has become a popular obstetric drug -- one with potentially horrifying side effects and a frightening lack of safety protocols. Buried in study after study, reports show that the drug has been connected to numerous cases of ruptured uteri and even a few maternal deaths, stillbirths and newborn deaths. Despite these reports, however, tales like Holly's -- in labors attended by practitioners who appear to have little understanding of the drug's potential dangers -- continued to reach me. In fact, the widespread use of Cytotec essentially amounts to a massive medical experiment carried out on thousands of unsuspecting women -- a situation, sadly, that is all too common in the world of modern obstetrics.

Most Cytotec-induced labors do not cause adverse effects like those in Holly's labor -- in fact, for a significant number of women Cytotec seems to work amazingly well. In a way, that's what scares me the most. Since it works so efficiently for a majority and can be prescribed obstetrically without Food and Drug Administration approval, there's less motivation for learning why for some women the drug has a catastrophic effect. Aside from the oft-cited though widely ignored warnings against giving it to women who have had Caesarean sections, we know very little about which women are at risk.

What we do know about Cytotec is that it is dirt cheap: A single 25-mcg dose costs roughly 13 cents; Pitocin, in contrast, necessitates hundreds of dollars in high-tech intervention. Since Cytotec is made in 100-mcg tablets to be taken orally, its quarter-tab dosages are necessarily inaccurate: Nurses or doctors have to literally cut up the pills with little knives. Furthermore, there is still no agreement as to the dosage size or interval or even most appropriate route of administration. The most common means of administration, by placing a quarter-tablet next to the cervix, is so easy that some doctors and midwives give the pills to women to take home and insert themselves. As a result, some women who experience emergency complications like Holly's do so without a hospital staff to care for them.

Unlike a Pitocin drip, which has a half-life in the body of about 10 minutes and can easily be turned off if the woman responds to it violently, once Cytotec is administered, you can't get it out and nobody knows its half-life. This gives Cytotec an unpredictable, stealthy quality. Sometimes even when it is doing serious damage to the uterus, the woman has no awareness that something's wrong; other times it creates immediate violent contractions. Moreover, the ruptures can occur many hours after a single dose in which the drug seemed to have caused no adverse effects. No one understands how this works, but it has been the subject of discussion both in the medical literature and in physician chat rooms.

Finally, in an era of managed-care obstetrics in which doctors are seeing patients in their offices at the same time that they monitor other women's labors across town in the hospital by telephone, Cytotec's great claim to fame -- prompt, timely labors -- is a phenomenal boon. In most cases an obstetrician must be present at the time the baby is born to be paid in full for a birth. So financial factors may influence some doctors to induce labor at a convenient time. Moreover, most cases of malpractice litigation involve situations in which doctors were not present and an adverse outcome occurred. Hence doctors have ulterior motives for using drugs like Cytotec, which help speed labor and thereby ensure that they won't miss the big event.

How many women are being given Cytotec? Marsden Wagner, a Washington, D.C., perinatal epidemiologist, estimates that every year at least 150,000 U.S. women (about 3 percent of all births) are given Cytotec to start labor. But based on my conversations with other doctors and nurses, I sense that the number may be much higher. Its usage is certainly growing rapidly. Wagner also notes that the Oregon State Health Department recently told him that Cytotec is now the state's most common method of induction.

How did Cytotec become so widely used and yet remain so underresearched? In 1992 and 1993 the first reports of the obstetric use of the small white tablet -- generically known as misoprostol -- indicated that it could be highly effective for starting labor in women, whether or not their cervixes were ripe. (In contrast Pitocin, the most common induction drug, often doesn't work unless the cervix is already primed and therefore affords doctors fewer choices.) Cytotec had already been used in combination with other drugs as a chemical abortive -- why not use it as an induction medicine? Lacking other information, many physicians began incorporating it into their practices.

A few years passed before the first published reports appeared detailing Cytotec's adverse effects on labor induction. By then, word of mouth in medical circles had made Cytotec the new darling of American obstetrics. Cost-effective, quick and easy to administer, Cytotec was fast becoming a popular alternative to Pitocin, which requires a full high-tech approach, including I.V., continual fetal monitoring and often (because of its reputation for triggering especially painful contractions) an epidural. Cytotec, in contrast, can be administered (though it shouldn't be) in virtually any setting.

Just how many women have been hurt by Cytotec? The question is nearly impossible to answer. No one has done large-scale studies of the drug, and the doctors and midwives who administer it do so with such vastly different protocols that mixing and matching results from various studies would not render reliable data. The most rigorous scientific authority in English on the effects of healthcare, the Cochrane Library, cautions that too few well-designed studies have been carried out to assess the risk factors associated with using Cytotec for labor induction. While conceding that Cytotec is more effective than conventional methods of cervical ripening and labor induction, it cautions that "the apparent increase in uterine hyperstimulation is of concern."

Unable to find large-scale, comprehensive reporting on obstetric use of the drug, I decided to do a little statistical sleuthing (however unscientific) on my own. My research, and my gut sense, based on years of experience as a midwife, indicate that there are significant risks associated with Cytotec, certainly higher risks than those associated with other forms of induction like Pitocin. Combining the results in 20 studies of Cytotec-induced labors published in peer-reviewed journals and papers presented at professional meetings -- a total of 1,958 births -- I discovered a total of two maternal deaths, 16 baby deaths, 19 uterine ruptures and two life-threatening hysterectomies.

To make sense of these figures, consider the normal incidence of uterine rupture, the most common serious side effect of Cytotec. Uterine rupture virtually never occurs in spontaneous (unaugmented) labor in women who've had no previous uterine surgery. Probably because of differing practices surrounding labor induction and augmentation, the rate of uterine rupture varies widely from hospital to hospital. Uterine rupture is less likely to happen in an out-of-hospital birth. Most midwives providing these services do not use drugs to augment labor. The complication has been reported as frequently as one in every 100 births and as rarely as one in every 11,000 births. In my own group practice at the Farm Midwifery Center in Summertown, Tenn., in approximately 2,100 births we have had no uterine ruptures.

By contrast, approximately one in 100 Cytotec-induced births in the 20 studies I looked at resulted in uterine rupture. About half occurred in women having vaginal birth after Caesarean, the others among women who had had no previous uterine surgery.

In fact, it is women who have had Caesareans who are at greatest risk from Cytotec. An article published in 1999 in the American Journal of Obstetrics and Gynecology reported that uterine rupture occurred in five of 89 women with previous Caesarean delivery whose labors were induced with Cytotec -- about one out of 16, a shockingly high figure, representing a more than 28-fold increase over those who did not have Cytotec induction for VBAC (vaginal birth after Caesarean). One of the five ruptures also caused a baby to die.

According to epidemiologist Wagner, "It can be reliably estimated that between 1990 and 1999, as a result of the widespread off-label use of Cytotec for vaginal birth after Caesarean section, well over 3,000 women in the United States suffered a ruptured uterus, resulting in at least 100 dead newborn babies."

Amniotic fluid embolism, or AFE, is perhaps the most frightening complication associated with powerful labor-inducing drugs like Cytotec and Pitocin. AFE, which occurs when the amniotic fluid enters the mother's bloodstream, is one of the most dangerous complications that can happen in birth. More than 60 percent of women and their babies die when it occurs, with survivors usually suffering neurological impairment.

The rate of occurrence of AFE, once thought to occur only once in 80,000 births, seems to be rising in the United States. Chicago writer Deanna Isaacs, whose daughter died from AFE in 1994, found that the incidence of AFE at the Phoenix, Ariz., hospital where her daughter died in labor was 1 in only 6,500 births. AFE is now one of the leading causes of maternal death in the United States. Two cases of fatal AFE are associated in the medical literature with the use of Cytotec; a midwife told me about a third.

Alarmingly high as these figures are, they almost certainly don't reflect all of the adverse outcomes associated with Cytotec. I also gathered information -- much of it hair-raising -- from Internet chat-room discussions involving physicians who signed their names to their comments, as well as from obstetricians and midwives. This is anecdotal evidence, yes. But we can't afford to ignore anecdotes because current medical studies are inadequate, the drug has not been subject to FDA approval and mothers' and infants' lives are at stake.

The enthusiastic discussion of Cytotec in medical chat rooms sheds light on why the drug has become so popular in the United States. "You can almost count on a delivery 12 hours after inserting the Cytotec tablet," said one doctor. Another doctor added a cautionary note: "I must say that I have heard some great things about Cytotec myself. I know some people who have used it and say that they have pretty good luck with it. It sounds like your ladies are pretty happy with its effects -- two-hour labors and such. Just be careful. I would have to say that the biggest danger is leaving the woman alone. The stuff turns the cervix to complete MUSHIE [emphasis in original] and opens it with a couple of contractions. So whatever you do, remember that you must not stay gone too long."

Over the past 30 years, I have watched as wave after wave of medical fads have washed over the institution of modern childbirth. But one thing, unfortunately, hasn't changed: The push to discover a panacea to cure the pain and inconvenience of childbirth drives doctors to experiment -- and the women are usually the last to know.

In this case, to be sure, the demands of the women themselves are part of the problem. The Cytotec controversy is inextricably tied up with the increasing rate of induced labor in the U.S. Until fairly recently, induced labors were fairly rare: Now, one birth in five is induced, with only a small percentage of these inductions being medically necessary. Harried doctors in the HMO age are driving some of this, but women, too, are demanding faster labors. (This is not surprising, considering that the United States has the shortest maternity leave in the industrialized world.) If this trend increases, we can expect to see an accompanying rise in the medical problems that result when the strongest muscle in the human body -- which is also paper thin -- is stimulated to contract violently.

How was it that Cytotec came to be used as an obstetric drug in the first place? Misoprostol was originally developed by G.D. Searle & Co. of Chicago to prevent gastric ulcers in people who take anti-inflammatory drugs such as aspirin for arthritis pain. In 1988, it was approved by the FDA solely for this use. Yet it is quite legal for physicians to prescribe drugs for indications other than those for which the drug has received FDA approval.

This common practice, known as "off-label" use, usually involves prescribing one drug for another purpose. (Incidentally, no such loopholes exist for the use of pharmaceutical drugs in most Western European countries.) With misoprostol the practice seems particularly egregious: taking a medication meant for oral ingestion and inserting it vaginally.

According to Claudia Kovitz, public affairs specialist for Searle, the company does not intend to apply for FDA approval of Cytotec's use in starting labor. Indeed, why should it? At 13 cents a dose, with women taking no more than three doses per birth, the drug is too cost-effective to waste a heap of money on research whose primary result might only be to make the drug illegal to prescribe.

So what protection do pregnant women have when it comes to drugs that are prescribed for another purpose? Very little, according to Laura Bradbard, spokeswoman for the FDA. "People think we have more authority than we have. We approve a product for a particular indication, based on the data we receive. A physician is free to use a drug for any use he or she feels will benefit a patient. There are no safe drugs. You need to do your homework, ask a lot of questions and speak with your physician about your case and the medications," Bradbard said.

And even when the FDA approves a drug, there are no guarantees. "Once a drug reaches the marketplace, that's when we find out all the adverse events, because we have only seen it in 3,000 to 6,000 people perhaps," said Bradbard. "Then it goes into the marketplace, where you have a million prescriptions. Then a reporter will say to me, 'You are approving things too fast. You didn't find it.' Well, we can't find it. It's mathematically impossible. We have to have it in the marketplace and then we have to make warnings."

But Holly and her husband, like most patients who receive Cytotec, never received any warning. "We didn't know it wasn't FDA approved," she said. "We would have never let them use me or my baby as guinea pigs." ]]> Cytotec Labor Side Effects Lawyer http://www.yourlawyer.com/topics/overview/cytotec Tue, 11 Jul 2000 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/cytotec DOWNLOAD OUR CYTOTEC INFORMATION PACKAGE 

Injured by Cytotec?

The FDA approved Cytotec, manufactured by Searle, on March 17, 1999. Cytotec is approved to treat ulcers. With the increasing off label usage of Cytotec as a labor-inducing drug, Searle sent physicians a letter in August 2000 reminding them that Cytotec is not approved to induce labor. Cytotec's sole appeal for inducing labor is price; Cytotec costs pennies per induction.

There are growing concerns about the safety of this drug when used for labor induction. A November 1999 Committee Opinion of the American College of Obstetricians and Gynecologists (ACOG) warns: ″There have been reports of uterine rupture following Cytotec use for cervical ripening in patients with prior uterine surgery. Thus, until reassuring studies are available, Cytotec is not recommended for cervical ripening in patients who have had prior cesarean delivery or major uterine surgery.″

Mothers seldom die as a result of ruptures, but babies often do. Obstetricians generally react to a rupture by performing a complete hysterectomy, eliminating all possibility of future biological children. Other risks of Cytotec include increased incidence of jaundice in the baby, fetal distress caused by uterine hyper stimulation, fluid overload from the IV use, increased blood loss post-partum, amniotic fluid embolism, uterine rupture, and an overall increased risk of instrumental or surgical delivery, death and birth defects.

If you or your baby were adversely affected by Cytotec, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>