The Bitter Pill

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ACE Inhibitors and Birth Defects – More Expensive and Less Effective

Evelyn Pringle November 9, 2006

About one in every four American adults has high blood pressure which is a major risk factor for heart and kidney disease, as well as stroke and heart failure, but often occurs with no warning signs.

Blood pressure is the force of blood pushing against blood vessel walls. The heart pumps blood into the arteries which carry the blood throughout the body. High blood pressure makes the heart work harder to pump blood and contributes to hardening of the arteries or atherosclerosis, according to WebMD.

Sometimes chronic hypertension or gestational hypertension leads to preeclampsia, a serious condition characterized by high blood pressure and protein in the urine, which often indicates kidney problems.

One in four pregnant women with chronic high blood pressure develops preeclampsia. In addition to increased blood pressure and protein in the urine, hand and facial swelling, sudden weight gain, persistent headaches, blurred vision, dizziness and abdominal pain, may also occur in women with the condition.

In pregnant women, high blood pressure can also decrease the blood flow to the placenta, which affects the supply of oxygen and nutrients to the fetus and increases the risk of preterm delivery.

Persistent high pressure can damage the smaller blood vessels that transport blood to and from the cells and tissues, including the tissues of the heart, lungs, brain, kidneys, liver, and the uterus.

A common class of medications used to treat high blood pressure are ACE inhibitors (angiotensin converting enzyme inhibitors). These drugs arrived on the market about 25 years ago, and they are currently the second most commonly prescribed class of drugs in the US.

The drugs act by inhibiting the production of angiotensin II, a substance that both induces constriction of blood vessels and retention of sodium, which leads to water retention, and an increased blood volume.

According to WebMD, ACE inhibitors dilate blood vessels to improve the amount of blood the heart pumps and lower blood pressure. They also help decrease the amount of work the heart has to do and protect the kidneys from the effects of hypertension and diabetes. Examples of ACE inhibitors include:

* Capoten (captopril)
* Vasotec (enalapril)
* Prinivil, Zestril (lisinopril)
* Lotensin (benazepril)
* Monopril (fosinopril)
* Altace (ramipril)
* Accupril (quinapril)
* Aceon (perindopril)
* Mavik (trandolapril)
* Univasc (moexipril)

Numerous studies have shown that ACE inhibitors can have adverse effects on the developing fetus, and for years, experts have said they should not be prescribed to pregnant women.

The most recent study documenting their harm to the fetus was conducted by researchers from Vanderbilt University, and published in the June 8, 2006, New England Journal of Medicine. The study found that fetal exposure to ACE inhibitors in the first trimester of pregnancy nearly tripled the risk of serious birth defects.

According to the research, one-third of the birth defects identified in newborns born to women who were prescribed ACE inhibitors in the first trimester, involved the heart, one-quarter involved the limbs or face, and one-tenth of the defects involved the brain or spinal cord.

In the study, the researchers examined pharmacy records and data from the Tennessee Medicaid database for the years between 1985 and 2000, which allowed them to review records of ACE inhibitors prescribed for women during the first trimester as well as infant outcomes.

In reaching their results, the researchers compared newborns exposed to ACE inhibitors with a cohort of infants whose mothers received other high blood pressure drugs in the first trimester, and a group of newborns who were not exposed to any hypertension medications.

Some experts expressed alarm at finding such serious adverse events in a study on drugs that have already been on the market for a quarter of a century. In an editorial accompanying the study in JAMA, Dr J M Friedman, MD, PhD, from the University of British Columbia in Vancouver, Canada, said more research on the teratogenic potential of ACE inhibitors in pregnancy is called for.

“This is not the last word on the subject,” he wrote, “but it is shocking to realize that it is almost the first.”

“Birth defects caused by teratogenic treatments are preventable,” Dr Friedman states, “and babies and their mothers are being harmed unnecessarily because we do not know enough about which treatments to use and which to avoid.”

“Further study is needed to determine the precise risk and its relationship to individual drugs,” he advises, “but the increase appears to be great enough to require discussion with all women of reproductive age who are prescribed ACE inhibitors.”

“Detailed fetal ultrasonography and echocardiography at about 18 weeks of gestation,” he says, “should be offered to women who have taken such drugs in the first trimester of pregnancy.”

“A woman who learns she is pregnant while taking an ACE inhibitor,” he warns, “should immediately be switched to another antihypertensive agent to minimize the risk of fetopathy.”

But the findings of this study are not actually new. A surveillance study in 2002, of Michigan Medicaid recipients involving 86 newborns exposed to captopril during the first trimester found 4 newborns (4.7%) had major birth defects, including one cardiovascular anomaly, one polydactyly, one limb reduction defect, and one hypospadias.

In addition, ACE inhibitors have long been associated with serious birth defects in infants born to mothers who used the drugs during the second and third trimester of pregnancy. Back on March 13, 1992, the FDA announced that all ACE inhibitors, “will be required to carry a “boxed warning” on the label for women in the advanced stages of pregnancy.”

“At the agency’s request,” the FDA said in a press release, “six pharmaceutical companies are simultaneously sending out a “Dear Doctor” letter emphasizing that women who take the drug in the second and third trimesters of pregnancy are running the risk of causing significant harm to fetuses, including kidney failure and face or skull deformities.”

For several years before that announcement, the labeling on ACE inhibitors had warned about the dangers of their use by pregnant women, but nonetheless, additional cases of birth defects continued to be reported. “More than 50 cases of fetal harm have been reported over the past several years,” the FDA stated.

“The warnings in the labeling,” its press release stated, “are therefore being strengthened by including a boxed warning and other changes.”

At the time, pharmacists were also alerted to the label changes and were provided stickers to paste on ACE inhibitor prescription bottles that read, “If you become pregnant consult your doctor promptly about switching to a different drug.”

Critics say that in light of all the previous studies, the use of ACE inhibitors with pregnant women should have ended long before the latest Vanderbilt study. Clearly, they say, resistance to the use of other hypertension drugs stems from the heavy promotion of ACE inhibitors to prescribing physicians.

For instance, diuretics and beta-blockers are recommended as the first-line of treatment for uncomplicated hypertension by the Joint National Commission on High Blood Pressure Treatment, yet a survey conducted on 1,700 primary care doctors, published in the December 2003, Journal of General Internal Medicine, showed that doctors believed that diuretics were less effective, and that beta-blockers had more side effects than calcium channel blockers and ACE inhibitors.

In addition, the survey found that doctors who favored prescribing the more expensive medications were more likely to pass out free drug samples provided by pharmaceutical sales representatives. Patients diagnosed with hypertension become life-long customers for Big Pharma and critics say sales reps will use whatever means necessary to lock in a new patient.

“These new, more expensive medications are being more heavily promoted by the drug companies, and one way or another that information influences how people perceive the drug’s effectiveness,” according to the Journal’s study author, Peter Ubel, MD, associate professor of internal medicine at University of Michigan Medical School.

In the hypothetical patient used in the survey, Dr Ubel says, there would be no advantage to taking ACE inhibitors over diuretics or beta-blockers. He also points out that ACE inhibitors tend to have more side effects than diuretics or beta-blockers.

Critics say there is a huge incentive for drug companies to convince doctors to prescribe ACE inhibitors instead of the more effective hypertension drugs that sell for fraction of the cost. According to IMS Health, a pharmaceutical information tracking firm, in 2005, sales of ACE inhibitors brought in more than $3.8 billion.

Chronic heart failure is a debilitating condition in which the heart’s ability to pump blood is impaired. Patients with heart failure experience a continuing decline in their health, resulting in an increased frequency of hospitalization and in premature death.

There are often no symptoms in people with hypertension. In fact, according to WebMD, nearly one-third of those who have the condition do not know it. The only way to know for certain whether hypertension is present, is to be tested.

Blood pressure is recorded as two numbers: the first, or the high number, shows the pressure during a heartbeat, and the second lower number shows the pressure between heart beats. The categories of blood pressure include:

* Normal: Less than 120/80
* Prehypertension: 120-139/80-89
* Stage 1 hypertension: 140-159/90-99
* Stage 2 hypertension: 160 and above/100 and above

An estimated 5% of pregnant women have high blood pressure before pregnancy, although many women are not diagnosed with the condition until they begin prenatal care. This is known as “essential hypertension,” but it is reportedly no different from the high blood pressure that affects many people who are overweight and inactive.

Another 5 to 8 percent of women develop high blood pressure during pregnancy, known as “gestational hypertension.” Although this condition usually goes away after delivery, gestational hypertension may increase the risk of developing chronic high blood pressure in the future.

Filed under: 2006, ACE Inhibitors, Birth Defects, prices

No Excuse for Marketing Ace Inhibitors to Pregnant Women

Evelyn Pringle October 20, 2006

In the wake of a study published in June 2006, in The New England Journal of Medicine found a higher rate of birth defects in infants born to mothers who filled prescriptions for Angiotensin-Converting Enzyme Inhibitors (ACE inhibitors), during the first trimester of pregnancy.

The FDA advised women to reconsider the use of those drugs before becoming pregnant.

“These are preliminary data,” Sandra Kweder, MD, deputy director of the FDA’s Office of New Drugs at the Center for Drug Evaluation and Research, told reporters in a teleconference when discussing the study. “But nonetheless,” she said, “women should seek to change their medicine as soon as they become pregnant.”

“I think what’s most important about the study,” Dr Kweder stated, “is that it just brings to light the importance of women carefully reviewing medication information with their health care providers before becoming pregnant or as soon as they become pregnant, and being aware of the potential risks of certain medicines.”

Drugs used in the treatment of hypertension are real money makers for the pharmaceutical industry because they need to be taken for life, once a patient is diagnosed with the condition and ACE inhibitors are the most commonly prescribed.

According to Web MD, there are currently 10 ACE inhibitors marketed in the US. In 2005, they collectively brought in $5 billion in sales, up 13% from 2004, according to the pharmaceutical market research firm IMS Health. They are the second most commonly prescribed class of drugs, and 149 million prescriptions for ACE inhibitors were written in 2005. The top three sellers are Lotrel, Altace, and Lisinopril.

Women typically represent a considerable portion of the hypertension market. A national survey reported by MSNBC, found that the number of ACE inhibitor prescriptions written for women of childbearing age rose from 1.4 million in 1995, to 2.7 million in 2002.

The American Heart Association defines high blood pressure as:

“Blood pressure is the force in the arteries when the heart beats (systolic pressure) and when the heart is at rest (diastolic pressure). It’s measured in millimeters of mercury (mm Hg). High blood pressure (or hypertension) is defined in an adult as a blood pressure greater than or equal to 140 mm Hg systolic pressure or greater than or equal to 90 mm Hg diastolic pressure.”

Blood pressure is regulated by the kidneys which act as filters to make sure that the body’s nutrients and water are in balance and that harmful chemicals are filtered out. The kidneys release hormones which tighten or widen arteries as needed to keep that balance in tact.

When blood vessels tighten, high blood pressure results and the heart has to work harder to keep blood flowing at the correct rate. High blood pressure also puts a strain on the blood vessels and kidneys, and persistent high pressure eventually weakens the entire cardiovascular system.

According to WebMD, ACE inhibitors widen or dilate blood vessels to improve the amount of blood the heart pumps and lower blood pressure.

The October 7, 2006 article “High Blood Pressure – Type of Medications,” in Market Day Word News, defines the other classes of drugs available for the treatment of hypertension and discusses their functions.

Diuretics, it says, are sometimes called “water pills” because they work in the kidney and flush excess water and sodium from the body.

Beta-blockers reduce nerve impulses to the heart and blood vessels which makes the heart beat slower and with less force so that blood pressure drops and the heart works less hard.

Angiotensin antagonists shield blood vessels from angiotensin II and as a result, the vessels become wider and blood pressure goes down.

Calcium channel blockers, the article explains, keep calcium from entering the muscle cells of the heart and blood vessels which causes the blood vessels to relax and pressure goes down.

Alpha-blockers reduce nerve impulses to blood vessels, which allows blood to pass more easily, causing blood pressure to go down.

Alpha-beta-blockers work the same way as alpha-blockers, it notes, but also slow the heartbeat, as beta-blockers do so that less blood is pumped through the vessels and the blood pressure goes down.

Nervous system inhibitors relax blood vessels by controlling nerve impulses which causes the blood vessels to become wider and the blood pressure to go down.

Vasodilators, it says, directly open blood vessels by relaxing the muscle in the vessel walls and cause the blood pressure to go down.

Medical professionals agree that untreated hypertension can lead to serious health problems for expectant mothers and their unborn infants. During pregnancy, according to experts at the Mayo Clinic, high blood pressure can decrease blood flow to the placenta, which affects a baby’s supply of oxygen and nutrients. This may slow the baby’s growth and increase the risk of preterm delivery. High blood pressure also increases the risk of placental abruption, in which the placenta prematurely separates from the uterus, the Mayo Clinic’s web site advises.

Preeclampsia, sometimes referred to as toxaemia, is the most common of the serious complications of pregnancy related to hypertension. The condition is characterized by increased blood pressure and protein in the urine, which is a sign of kidney problems.

According to the Mayo Clinic, it “is potentially life-threatening to mother and baby if allowed to develop and progress undetected.”

Even before the June 2006 study, ACE inhibitors already carried a “black box” warning, the strongest available, about birth defects when infants were exposed to the drugs during the second and third trimester of pregnancy.

“The reason for that is that we’ve known for at least a decade, if not longer,” Dr Kweder said, “that these drugs, when exposure occurs in the second half of pregnancy, are associated with abnormal kidney functions in infants, as well as sometimes abnormalities of the kidney anatomy itself.”

The warning was added in the early 1990s, after the FDA received numerous reports on babies with birth defects associated with the drugs. The label warned that ACE inhibitors could cause skull deformities, kidney failure, lung problems and even fetal death when taken in the last two-thirds of pregnancy.

The warning did not mention the first trimester, but it stated that use of ACE inhibitors should be stopped or discontinued as soon as possible when pregnancy is detected.

In light of the more than a decade old black box warning, critics say, there was no excuse for the drug makers marketing or doctors prescribing ACE inhibitors to pregnant women because another class of drugs was known to be as effective or better in treating hypertension.

According to an April 25, 2005 analysis, in the Archives of Internal Medicine, of the “Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial,” the much cheaper diuretics work as well or better in protecting against heart attacks, than the expensive ACE inhibitors, and in fact the analysis showed that diuretics offered more protection against congestive heart failure.

The study first reported in 2002, said that diuretics were more beneficial as initial treatment for high blood pressure for protecting against adverse cardiovascular outcomes.

This latest analysis showed that even among diabetics, and those with mildly elevated fasting glucose, which is a sign of pre-diabetes, diuretics were at least as effective, and possibly even more beneficial for some patients.

This ten-year study was the largest ever conducted to compare the different classes of drugs used to treat high blood pressure. The study was led by Jeffrey Cutler, a senior adviser at the National Institute of Health’s National Hear, Lung and Blood Institute. Based on the results of the analysis, the National Institute of Health announced that it intended to use about 600 medical professionals to spread the word to doctors that diuretics should be the first line of treatment for hypertension.

The latest birth defect study was conducted at Vanderbilt University in Nashville by Dr William Cooper, MD, MPH, and colleagues. The team studied the records for 29,507 infants who were enrolled in Tennessee’s Medicaid program and born between 1985 and 2000.

The researchers first identified mothers who filled prescriptions during the first trimester of pregnancy for ACE inhibitors or other high blood pressure medications and then checked the babies’ records for major birth defects not linked to genetics.

By reviewing the files, the researchers found 411 infants who were exposed to high blood pressure drugs during the first trimester of pregnancy only, and of those babies, 209 were exposed to ACE inhibitors. Of the 209 babies in the Ace inhibitor group, the researchers found that 18, or about 7%, were born with birth defects.

That number represents more than twice the rate of birth defects in babies born to mothers who did not use any kind of high blood pressure medication.

“We found that fetal exposure to ACE inhibitors restricted to the first trimester of pregnancy,” Dr Cooper wrote in the study, “an exposure that was previously considered to be safe, was associated with a risk of a major congenital malformation that was 2.7 times as great as the risk with no fetal exposure to ACE inhibitors or other antihypertensive medications.”

The mothers in the study ranged in age from 17 to 41, and the infants were born between 32 and 41 weeks of gestation. Some of the details on the birth defects seen in newborns exposed to ACE inhibitors during the first trimester included:

1. Cardiovascular malformations were the most common, affecting 9 infants;

2. Malformations of the central nervous system were the second most common in 3 babies; and

3. 7 infants had more than one malformation.

“We knew ACE inhibitors were a possible cause of adverse fetal outcomes when exposure occurred later in pregnancy,” Dr Copper said, “but it has not been well studied in the first trimester.”

“We were very surprised that even after controlling for other risk factors,” he noted, “the TennCare records we examined showed a clear increase in a broad range of birth defects following first-trimester-only exposures.”

The alternatives to ACE inhibitors that doctors should consider when treating pregnant women with high blood pressure, are diuretics, alpha-methyldopa, some beta-blockers, and the calcium-channel blocker nifedipine, according to the FDA.

In the meantime, the pharmaceutical companies, along with the doctors who helped them peddle the highly profitable ACE inhibitors to pregnant women, should be held accountable for the life-time care of any infants born with birth defects after the FDA added the black box warning to the drugs in March 1992.

Filed under: 2006, ACE Inhibitors, Birth Defects

ACE Inhibitors Should Have Been Banned for Pregnant Women

Evelyn Pringle June 10, 2006

In a group of 209 babies born to women taking ACE inhibitors in the early stages of pregnancy, a recent study published in the June 8, 2006 New England Journal of Medicine, reported that 18 or 7.1% of the infants, were born with serious birth defects.

Data for the study were obtained from the Tennessee Medicaid database for the years between 1985 and 2000, which allowed for the examination of the prenatal record as well as infant outcomes.

Pharmacy records were also reviewed and the fetus was considered to have an exposure to an ACE inhibitor if the mother filled a prescription for the drug during the first trimester of pregnancy. Mothers with evidence of diabetes were excluded from the study, and infants exposed to antihypertensive medications after the first trimester or to other teratogenic agents during gestation were also excluded.

To reach the outcome, the study’s authors compared infants exposed to ACE inhibitors with a cohort of children whose mothers received other antihypertensive drugs and a group of infants not exposed to any antihypertensive drugs. Most of the infants in the ACE group had been exposed to at least 2 months of the drug.

The study determined that infants exposed to ACE inhibitors were almost 4 times more likely to suffer cardiovascular problems and nearly 5 times more likely to have central nervous system malformations when compared to infants exposed to other medications or no antihypertensives drugs at all.

The study employed the definitions of the Centers for Disease Control and Prevention for major malformations. The cardiovascular malformations observed were mainly atrial and ventricular septal defects and patent ductus arteriosus. The CNS malformations included spina bifida and significant eye defects. Two cases of renal dysplasia and some intestinal malformations were also present.

One-third of the birth defects involved the heart, one-quarter the limbs or the face, and one-tenth involved the brain or spinal cord. Some defects, such as the heart problems, might be curable with surgery or other treatment, but others resulted in retardation or permanent disability.

The study’s findings were corroborated by blinded investigators reviewing the medical records, and the comparison of the 3 groups was adjusted for other risk factors for malformation.

Based on these findings, taking ACE inhibitors during early pregnancy “cannot be considered safe and should be avoided,” according to Dr William Cooper, a pediatrician at Vanderbilt Children’s Hospital in Nashville, and leader of the study.

Critics say the fact that such serious findings are only first recorded 25 years after the ACE inhibitors came on the market demonstrates the inability to collect safety data on the ill-effects of drugs used during pregnancy.

Prior to FDA approval, new drugs are tested on pregnant animals to see whether they cause birth defects because it is considered unethical to include pregnant women in clinical trials unless the drug is intended to treat a pregnancy-related condition.

Studies of large databases such as Medicaid records that show pregnant women already taking a medication are about the only means available to measure risks to the fetus from a particular drug.

In an editorial accompanying the study in the NEJM, Dr J M Friedman, MD, PhD, a medical geneticist at the University of British Columbia, said the ACE study highlights the larger problem about the lack of safety data. “Birth defects caused by teratogenic treatments are preventable,” he wrote, “and babies and their mothers are being harmed unnecessarily because we do not know enough about which treatments to use and which to avoid.”

“Further study is needed,” he said, “to determine the precise risk and its relationship to individual drugs but the increase appears to be great enough to require discussion with all women of reproductive age who are prescribed ACE inhibitors.”

“A woman who learns she is pregnant while taking an ACE inhibitor,” Dr Friedman warns, “should immediately be switched to another antihypertensive agent to minimize the risk of fetopathy.”

“Detailed fetal ultrasonography and echocardiography at about 18 weeks of gestation,” he said in the NEJM, “should be offered to women who have taken such drugs in the first trimester of pregnancy.” ACE inhibitors include:

Capoten (captopril)
Vasotec (enalapril)
Prinivil, Zestril (lisinopril)
Lotensin (benazepril)
Monopril (fosinopril)
Altace (ramipril)
Accupril (quinapril)
Aceon (perindopril)
Mavik (trandolapril)
Univasc (moexipril)

The alternatives drugs that doctors should prescribe for pregnant women with high blood pressure are diuretics, alpha-methyldopa, some beta-blockers, and the calcium-channel blocker nifedipine, according to FDA officials and Dr Friedman in his editorial.

But the fact remains that drug companies have known that these drugs posed a danger to the fetus and they should have been banned from use by all pregnant women 15 years ago. Claiming the drugs were not dangerous in the first trimester of pregnancy even though they were known to be lethal in the second and third trimesters, was just plain silly.

This is just another blatant example of drug companies putting profits over the lives of patients.

Besides there have been previous studied that have shown ACE inhibitors to cause birth defects in the first trimester of pregnancy. For instance, in the results of a surveillance study reported in 2002, on Michigan Medicaid patients, involving 86 newborns who were exposed to captopril during the first trimester of pregnancy, four or 4.7% of the infants, were found to have major birth defects, including one cardiovascular anomaly, one polydactyly, one limb reduction defect, and one hypospadias, as reported on the Canadian Family Physician web site.

In a review published by Briggs et al in 1998, of 40 newborns exposed to enalapril during the first trimester, four or 10% of the babies, had major birth defects, including two cardiovascular anomalies and one polydactyly.

The results of a study reported in 1998, on 15 newborns exposed to lisinopril during the first trimester, showed two, or 13.3% the infants, to have major birth defects, including one polydactyly, according to Briggs GG, Freeman RK, Yaffe SJ, Drugs in pregnancy and lactation, Baltimore, Md: Williams & Wilkins; 1998.

Intrauterine growth restriction, prematurity, persistence of patent ductus arteriosus, severe neonatal hypotension, neonatal anuria, and neonatal or fetal death have all been observed with the use of ACE inhibitors, reported by Barr M Jr, Teratogen update: angiotensin-converting enzyme inhibitors, Teratology 1994;50:399-409.

In 1997, animal data revealed increased morbidity and mortality in fetuses exposed to ACE inhibitors in utero. Decreased uteroplacental blood flow, low birth weight, hypotension, preterm delivery, and fetal death were noted by Mastrobattista JM. Angiotensin-converting enzyme inhibitors in pregnancy, Semin Perinatol 1997;21:124-34.

In 1994, a prospective placebo-controlled study of baboons was reported that showed a significant increase in fetal death or fetal growth restriction in 4 out of 13 baboons in the group treated with enalapril compared with no events among the controls, according to Harewood WJ, Phippard AF, Duggin GG, Horvath JS, Tiller DJ. Fetotoxicity of angiotensin-converting enzyme inhibition in primate pregnancy: a prospective, placebo-controlled study in baboons (Papio hamadryas), Am J Obstet Gynecol 1994;171:633-42.

The FDA reported known risks back in a 1991 summary of 85 pregnancies during which women were exposed to ACE inhibitors, where 11 deaths occurred, including 6 stillbirths and five neonatal deaths, reported in the Journal Obstet Gynecol 1991;78:128-35.

Twenty-nine cases of perinatal renal failure in association with maternal use of ACE inhibitors were listed by the FDA in 1991. On March 13, 1992, the FDA announced that all ACE inhibitors, “will be required to carry a “boxed warning” on the label for women in the advanced stages of pregnancy.”

“At the agency’s request,” the FDA said, “six pharmaceutical companies are simultaneously sending out a “Dear Doctor” letter emphasizing that women who take the drug in the second and third trimesters of pregnancy are running the risk of causing significant harm to fetuses, including kidney failure and face or skull deformities.”

For several years, labeling for ACE inhibitors had warned of the risks, but the FDA noted that additional cases continued to be reported.

“More than 50 cases of fetal harm have been reported over the past several years,” it noted. “The warnings in the labeling are therefore being strengthened by including a boxed warning and other changes.”

Pharmacists were also alerted to the labeling change and were asked to counsel women of child bearing age who were taking ACE inhibitors. They were also provided stickers that read, “If you become pregnant consult your doctor promptly about switching to a different drug,” to place directly on prescription bottles.

Companies required to send “Dear Doctor” letters were Bristol-Myers Squibb (Capoten, Capozide, Monopril), Ciba-Geigy (Lotensin), Hoechst-Roussel Pharmaceuticals (Altace), ICI Pharmaceuticals Group (Zestril, Zestoretic), Merck Sharp and Dohme (Vasotec, Vasotec I.V., Vaseretic, Prinivil, Prinzide), and Parke-Davis (Accupril).

There is absolutely no reason whatsoever that would justify prescribing ACE inhibitors to pregnant women other than to make more money because other drugs were found to be superior in treating hypertension four years ago.

In 2002, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, or ALLHAT, compared the three major classes of drugs used to treat high blood pressure, and reported that diuretics were the most beneficial as the initial treatment.

In addition, the results of the new analysis of ALLHAT, were published in the April 25, 2005 Archives of Internal Medicine, by lead author Jeffrey Cutler, a senior adviser at the National Hear, Lung and Blood Institute a unit of the National Institute of Health which determined that patients on diuretics had better blood pressure control, fewer strokes and less congestive heart failure than patients who were not on diuretics.

ALLHAT was a randomized, double-blind trial involving 42,418 patients, ages 55 and older. Of those, 31,512 subjects were assigned to a diuretic (chlorthalidone); a calcium channel blocker (amlodipine); an angiotensin converting enzyme (ACE) inhibitor (lisinopril). 13,101 had diabetes, 1,399 had elevated fasting glucose and 17,012 had normal glucose levels. Compared with the ACE inhibitor and the calcium channel blocker, the diuretic was:

More protective against congestive heart failure in patients both with and without diabetes (by about 1/6 compared with the ACE-inhibitor, and by about 1/3 compared with the calcium channel blocker).

More effective in lowering systolic blood pressure — the measure of blood pressure when the heart beats — among those with and without diabetes.

At least equally protective against fatal coronary heart disease or non-fatal heart attacks in people with diabetes, those with elevated fasting glucose, and non-diabetics.

Equally protective against death from all causes, end-stage kidney disease, or cancer in people with diabetes, those with elevated fasting glucose, and non-diabetics.

In the price comparison, a diuretic was found to cost as little as $36-$96 annually, while a calcium channel blocker such as Novarsc costs about $724 a year, and Accupril, an ACE inhibitor costs about $470 a year. Beta-blockers, which are earlier medications than the ACE inhibitors cost between $240-$667 per year.

In response to the new analysis of ALLHAT, the National Institute of Health announced that it would use about 600 medical professionals to spread the word to doctors that diuretics should be the first line of treatment used in the battle against hypertension.

Some states adopted the plan to fight the cost to Medicaid programs of expensive drugs being prescribed by doctors when other cheaper drugs can accomplish the same results.

The pharmaceutical industry has been very successful in convincing doctors to prescribe ACE inhibitors instead of less expensive drugs. In a survey conducted on 1,700 primary care doctors in 2003, diuretics were rated less effective at lowering blood pressure and beta-blockers were thought to have more side effects than calcium channel blockers and ACE inhibitors.

“These new, more expensive medications are being more heavily promoted by the drug companies, and one way or another that information influences how people perceive the drug’s effectiveness,” according to lead author Peter Ubel, MD, associate professor of internal medicine at University of Michigan Medical School.

The study, published in the December 2003 Journal of General Internal Medicine, presented doctors with a hypothetical patient whose blood pressure was 170/105, who had unsuccessfully tried to control his blood pressure for a year using diet and exercise and had no other medical problems.

Doctors were asked to estimate the effectiveness of diuretics, ACE inhibitors, beta-blockers, and calcium channel blockers and to say what drug they would prescribe to the patient.

Despite numerous studies to the contrary, the majority of doctors rated diuretics significantly less effective than the other 3 drugs, and said beta-blockers were more likely to cause side effects, and would prescribe ACE inhibitors as the first choice for treatment.

Even though, according to Dr Ubel, with the hypothetical patient, there would be no advantage in taking ACE inhibitors over diuretics or beta-blockers, and ACE inhibitors tend to have more side effects than diuretics or beta-blockers.

“They’re also more expensive,” Dr Ubel noted, “which could drive up the patient’s bill at the drug store – or ultimately drive up insurance costs.”

The survey found that physicians who favored prescribing the more expensive drugs were more likely to pass out free drug samples provided by drug company sales representatives.

“It may seem like the doctor’s helping patients get more affordable medicine,” Dr Ubel says, “but it’s not a lifetime supply.”

After the free samples run out, he notes, the patient is left to pay for a more expensive drug.

“The industry influence is pervasive,” says Dr Ubel, who is also a research investigator at the Ann Arbor Veterans Administration Health Center. The University of Michigan Hospitals and Health Centers prohibits distributing drug samples to patients.

Another study presented at the March 4, 2004 American Heart Association’s 44th Annual Conference on Cardiovascular Disease, Epidemiology and Prevention, determined that a third of the increase in the cost of treating high blood pressure between 1990 and 2002, was related to physician prescribing habits.

To reach this outcome, Randall Scott Stafford, MD, PhD, an assistant professor of medicine at the Stanford University Prevention Research Center, conducted an analysis of data from IMS Health’s National Disease and Therapeutic Index, which included information on physician office visits, and the National Prescription Audit Plus, a survey of pharmacies.

The physician data included information on 17,318 office visits for the treatment of hypertension in 1990, and 21,885 patient visits in 2002. The pharmacy survey included information provided by 20,000 retail pharmacies.

The study looked at the total cost of drugs used in the treatment of hypertension and fond that in 2002, Americans spent $12 billion on drugs for high blood pressure, slightly more than double what was spent in 1990.

The two types of expensive drugs that contributed most to the cost increase were ACE-inhibitors and angiotensin receptor blockers (ARBs).

In 2002, a month’s supply of ACE inhibitors was about $44, and a month of ARBs was about $56, compared to $9 for a diuretic. While ACE inhibitor and ARB use increased from 1990 to 2002, “the prescription of diuretics declined by about 50 percent during the same period,” Dr Stafford determined.

Filed under: 2006, ACE Inhibitors, Birth Defects, prices

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  • I haven't been on in awhile thanks to all those who followed 3 years ago
  • @LindsayRush yay IOWA! 4 years ago
  • Another rainy day here in IOWA. Well at least i had a good time swimmin yesterday. 4 years ago
  • Hey everyone hope you have a great day! THanks to all the new followers :) and for those that continue to follow 4 years ago
  • srry if I dont get on here much I mostly just look at my facebook acct. thanks to all the new followers! 4 years ago

The Indiana Star

Christiane Schultz

  • Is not coping well at all. Loss sucks! 4 years ago
  • is scared to bond with this baby, just in case. 4 years ago
  • Happy 6 months today baby. I love you Matthew. 4 years ago
  • Living with loss, sucks. 4 years ago
  • Thinking I need to discuss plans for this baby soon or I will be having it in my doctors office. Where do I deliver? 4 years ago

Amery Schultz

Seeking Parents in Missouri for Celexa / Lexapro Class Action – Call 800-827-0087

TWEET FOR LIFE

BREATH – The Official Blog of MADNAP – momsandmeds.com

RSS BREATH

  • Untitled
    Originally posted on The Bitter Pill:Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, “ADDicted” which basically gives Ritalin, Adderall, Concerta and the like a…
  • Untitled
    Originally posted on The Bitter Pill:In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman…
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

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