Yourlawyer.com (ACE Inhibitors News)

Health Canada reminds women not to use ACE inhibitors during pregnancy

Thu, 29 Jun 2006 00:00:00 -0700

Health Canada is advising women not to use blood pressure medication known as ACE (angiotensin-converting enzyme) inhibitors during pregnancy due to the risk of birth defects. These drugs are used alone or with other medicines to treat high blood pressure in adults.

A recent study in the New England Journal of Medicine suggests that ACE inhibitors may be associated with increased risk of birth defects when used in the first three months of pregnancy.

There are many Health Canada-approved drugs to treat high blood pressure that do not contain ACE inhibitors. Women with high blood pressure who are pregnant, or who plan to become pregnant, should discuss the use of an appropriate blood pressure drug with their physician.

All ACE inhibitors approved by Health Canada already include warnings in the labelling information against use of these products during pregnancy. Even before the study, it was known that taking ACE inhibitors during the last six months of pregnancy can harm an unborn child.

ACE inhibitors include:

Quinapril HCI (sold under the brand name Accupril)
Ramipril (sold under the brand name Altace)
Captopril (sold under the brand names Captopril, Apo-Capto, Capoten, Gen-Captopril, Novo-Captopril, Nu-Capto, PMS-Captopril, Dom-Captopril,Med Captopril, Ratio-Captopril, Captopril Tablets by Pharmel Inc., Captopril Tablets by Pro Doc Limited, Captopril Tablets by Zymcan Pharmaceuticals Inc.)
Perindopril Erbumine and Perindopril Arginine (sold under the brand name Coversyl)
Cilazapril Monohydrate (sold under the brand names Inhibace and Novo-Cilazapril)
Benazepril HCI (sold under the brand names Lotensin and Apo-Benazepril)
Trandolapril (sold under the brand name Mavik)
Fosinopril Sodium (sold under the brand names Monopril, Gen-Fosinopril, Riva-Fosinopril, Novo-Fosinopril, PMS-Fosinopril and n Ratio-Fosinopril)
Lisinopril (sold under the brand names Prinivil, Zestril and Apo-Lisinopril)
Enalapril Maleate (sold under the brand names Vasotec, Apo-Enalapril and Novo-Enapril)
Enalaprilat (sold under the brand name Vasotec I.V.)

Drugs containing ACE inhibitors include:

Quinapril HCI - Hydrochlorothiazide (sold under the brand name Accuretic)
Perindopril Erbumine - Indapamide (sold under the brand names Preterax and Coversyl Plus)
Cilazapril Monohydrate - Hydrochlorothiazide (sold under the brand name Inhibace Plus)
Lisinopril - Hydrochlorothiazide (sold under the brand names Zestoretic and Prinzide
Enalapril Maleate - Hydrochlorothiazide (sold under the brand name Vaseretic)
Trandolapril - Verapamil Hydrochloride (sold under the brand name Tarka)

Health Canada recommends that:

Women who are pregnant should not take any of the above drugs.
Women who are taking any of the above drugs should tell their doctors if they are planning to become pregnant.
Women who are taking any of the above drugs and are pregnant should contact their physician for advice.

In light of the study, Health Canada will send letters by the end of June 2006 to all manufacturers of ACE inhibitors to ensure standardized wording on all product labels.

Consumers requiring more information about this advisory can contact the Health Canada public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
Email: cadrmp@hc-sc.gc.ca

Blood Pressure Drugs Linked To Birth Defects

Tue, 20 Jun 2006 00:00:00 -0700

ACE inhibitors, drugs commonly used to treat high blood pressure, have been linked to birth defects if taken by the expectant mother during the first trimester of her pregnancy, according to a new study carried out by researchers at Vanderbilt University and Boston University.

Researchers gathered data from the medical records of 29,507 newborns. 209 of their mothers had taken ACE inhibitors during the first trimester of pregnancy. 18 of them were born with birth defects, of which 9 had heart defects.

Of 209 newborns who had been exposed to ACE inhibitors during the first three months of their mothers' pregnancy 18 had birth defects, about 9% of total, of which 9 had heart defects.

Expectant mothers taking ACE inhibitors during their first trimester were 2.7 times as likely to have a baby with a birth defect than mothers who did not take the drug during their first trimester.

In the USA alone, 149 million ACE inhibitor prescriptions are dispensed each year, in total - not just to pregnant mothers. ACE inhibitors have been prescribed to patients for over 25 years. They are the second most popular prescription drugs in the developed world today.

The researchers say that any woman who is pregnant, or planning to start a family should avoid taking ACE inhibitors. It is vital that all women of child-bearing age know about this, as well as their health care providers, so that alternative medications to treat hypertension can be identified.

Here is a list of some commonly used ACE inhibitors:

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

Medication risky in first trimester, study shows

Thu, 08 Jun 2006 00:00:00 -0700

A popular class of blood pressure medicines thought to be safe in the first trimester of pregnancy appears to cause serious birth defects in about 7 percent of babies whose mothers took them, a new study has found.

ACE inhibitors already carry a warning that pregnant women should not use them in the last two trimesters because they can cause kidney damage to the fetus. The number of women taking them early in pregnancy is unknown but probably small, the study suggests.

ACE inhibitors are the second-most commonly prescribed class of pharmaceuticals in the United States, with 149 million prescriptions dispensed last year.

"It would be important for a pregnant woman and her health-care provider to be aware of this, so they can identify an alternative medicine to treat her hypertension," said William Cooper, a pediatrician at Vanderbilt Children's Hospital who headed the study, published in today's New England Journal of Medicine.

Exposure to ACE inhibitors early in pregnancy nearly tripled the risk of birth defects, the study showed.

"We all believe that we want to see more data. But this is important enough and impressive enough to tell people about," said Robert Temple of the Food and Drug Administration.

The agency will consider broadening the current warning against taking ACE inhibitors late in pregnancy, he said. The immediate message is that women trying to become pregnant should switch to a different blood pressure drug, Temple said. The FDA will send letters to American clinicians with that advice.

About one-third of the defects involved the heart, one-quarter the limbs or face, and one-tenth the brain or spinal cord, the study found. Many are curable with surgery or other treatment. Others, however, cause permanent disability or retardation.

Cooper and his colleagues looked at 29,507 births to women covered by Medicaid in Tennessee between 1985 and 2000.

Of that group, 209 babies were born to women who took an ACE inhibitor during the first trimester, and 18 had birth defects. Among 202 babies born to mothers taking some other blood-pressure medicine, only four had defects.

ACE inhibitors, the acronym stands for "angiotensin-converting enzyme" have become more popular over time. A government survey of visits to doctors' offices found their use doubled from 1995 to 2002.

Angiotensin-Converting Enzyme Inhibitor (ACE inhibitor) Drugs and Pregnancy

Thu, 08 Jun 2006 00:00:00 -0700

On June 8, 2006, the New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated (see below for more information about the study).

According to the approved labels, ACE inhibitor drugs are labeled as pregnancy category C for the first trimester of pregnancy, though they are labeled pregnancy category D during the second and third trimesters and the existing prescribing information recommends discontinuing the ACEI as soon as possible if a patient becomes pregnant. Because of the preliminary nature of the newly published data, the FDA does not plan to change the pregnancy categories at this time, but healthcare professionals should take these findings into consideration with other information about a patient’s medical situation during early pregnancy.

ACE inhibitor drugs include Benazepril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik).

ACE inhibitors linked to birth defects

Wed, 07 Jun 2006 00:00:00 -0700

Some blood pressure drugs previously thought to be safe when taken early in pregnancy now appear to substantially raise the risk of major birth defects, doctors say.

Babies whose mothers took ACE inhibitors in their first trimester were more than twice as likely to be born with serious heart and brain problems than those not exposed to any pressure-lowering medicines, a large study in Tennessee found. Other types of blood pressure drugs did not raise the risk to babies.

The research raises troubling questions about the lack of safety data for many drugs prescribed to pregnant women.

About 8 percent of pregnant women develop high blood pressure, which can lead to a heart attack or stroke.

Exactly how many pregnant women take ACE inhibitors or another blood pressure medication is unclear. However, a national survey found the number of ACE inhibitor prescriptions given to women of childbearing age increased from 1.4 million in 1995 to 2.7 million in 2002, the latest data available.

ACE inhibitors already carry a strong Food and Drug Administration "black box" warning about their dangers in the later stages of pregnancy, and the label says the drugs should be discontinued when pregnancy is detected. But little has been known about their early effects.

Based on the new findings, taking these drugs during early pregnancy "cannot be considered safe and should be avoided," lead researcher Dr. William Cooper, a Vanderbilt University pediatrician, said in Thursday's New England Journal of Medicine.

The FDA said more research is needed before it considers changing the warning label to specifically include the risks during the first trimester. But the agency is notifying doctors and patients about the dangers through its Web site.

Doctors said expectant mothers should not stop treatment, because uncontrolled high blood pressure can harm them and the fetus, but should immediately switch to other drugs. Women contemplating pregnancy were advised to ask their doctors about their options.

"This is a wake-up call. We need to learn more about these drugs to offer better advice to pregnant women," said Dr. J.M. Friedman, a medical geneticist at the University of British Columbia who had no role in the study.

ACE inhibitors have been on the market for 25 years, but little research has been done on their effects during early pregnancy with the exception of animal experiments and small human studies. The drugs work by relaxing blood vessels and increasing blood flow to the heart.

Last year, U.S. sales of ACE inhibitors topped $3.8 billion, with about 150 million prescriptions filled, according to IMS Health, a pharmaceutical information company. The top-sellers include Lotrel, Altace and Lisinopril.

In the study, researchers studied Medicaid records on 29,507 Tennessee infants born between 1985 and 2000. Of those, 411 had mothers who took a blood pressure drug at least once during their first trimester, including 209 who took ACE inhibitors.

About 7 percent of babies exposed to ACE inhibitors developed major birth defects compared with about 2 percent whose mothers took no drugs or other blood pressure medication, such as water pills, calcium channel blockers or beta blockers.

The most common defects included holes in the heart and neurological and kidney problems.

Researchers found no increased risk among babies whose mothers took another type of blood pressure medication. But they said it is premature to declare those drugs safe to use during early pregnancy.

"It's a sobering finding," said Dr. Robyn Barst, a pediatric cardiologist at Columbia University and spokeswoman for the American Heart Association. "It highlights our lack of data on many drugs that we think are perfectly safe."

The study was partly funded by the FDA. Three co-authors reported receiving support or fees from Novartis AG or Pfizer Inc. Novartis makes Lotrel. Pfizer makes the calcium blocker Norvasc.

In an accompanying editorial, Friedman of the University of British Columbia said the ACE inhibitor study points to a larger problem about the lack of safety data available on most new drugs when they receive government approval.

The FDA acknowledged it was imperfect system. Dr. Robert Temple, the agency's associate director for medical policy, said the government is trying to improve its detection of harmful effects through patient registries and other studies.

"The only way to discover (risks) is through long-term use. That's a little uncomfortable. It means you only learn about what drugs do to pregnancies after the drug's been used for a long time," Temple said.

In the early 1990s, the FDA required pharmaceutical companies to put warning stickers on ACE inhibitors after the agency received a few reports from women whose babies were harmed. The label warned that ACE inhibitors can cause skull deformities, kidney failure, lung problems and even fetal death when taken in the last two-thirds of pregnancy.

ACE Inhibitors Pregnancy Birth Defects Injury Lawyer

Wed, 07 Jun 2006 00:00:00 -0700

ACE Inhibitors Linked to Birth Defects

ACE inhibitors (angiotensin-converting enzyme) are used for monitoring blood pressure, treating heart failure and preventing kidney damage in people with hypertension or diabetes. ACE inhibitors have been on the market for 25 years, and work by relaxing blood vessels and increasing blood flow to the heart. Sales of ACE inhibitors last year in the United States topped $3.8 billion, with about 150 million prescriptions filled, according to IMS Health, a pharmaceutical information company. The top-selling ACE Inhibitors include Lotrel, Altace and Lisinopril.

New Data
On June 7, 2006 results from a new study determined that children whose mothers took ACE inhibitors within their first trimester were more than twice as likely to be born with severe brain and heart ailments, as compared to those not exposed to any blood pressure-lowering medicines. The latest statistics from a national survey found the number of ACE inhibitor prescriptions given to childbearing women enlarged from 1.4 million in 1995 to 2.7 million in 2002. In the report, researchers examined Medicaid records on 29,507 Tennessee infants born between 1985 and 2000. Out of the 29,507, 411 babies had mothers, who took a blood pressure drug at least once during their first trimester.

FDA Warnings
ACE inhibitors currently bear a strong FDA black box warning about their dangers in the later stages of pregnancy. ACE Inhibitors labels also state that the drugs should be stopped upon pregnancy. Hardly any research or data to date is available regarding the side effects of ACE Inhibitors within the first trimester of pregnancy. After this study was released, the FDA said more research is needed before it considers changing the warning label to specifically include the risks during the first trimester.

During the 1990s, the FDA made it mandatory for pharmaceutical companies to put warning stickers on ACE inhibitors after the agency received a few reports from women whose babies were harmed. 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.

Based on the new findings, taking these drugs during early pregnancy "cannot be considered safe and should be avoided," lead researcher Dr. William Cooper, a Vanderbilt University pediatrician, said in Thursday's New England Journal of Medicine.

Statistics & Birth Defects
The study was able to determine that approximately 7% of babies exposed to ACE inhibitors developed major birth defects compared with about 2% whose mothers took no drugs or other blood pressure medication, such as water pills, calcium channel blockers or beta-blockers. Holes in the heart and neurological and kidney problems are the most common birth defects.

Other ACE Inhibitors
Capoten (generic: captopril)
Lotensin (generic: benazepril)
Vasotec (generic: enlapril)
Aceon (generic: perindopril)
Accupril (generic: quinapril)
Univasc (generic: moexipril)
Mavik (genric: trandolapril)
Monapril (generic: fosinopril)

Legal help for ACE Inhibitors users
If you or a loved one took ACE Inhibitors while pregnant and your baby was born with a birth defect, contact Parker & Waichman, LLP for a free and confidential consultation about your potential case. Call 1-800-LAW-INFO (1-800-529-4636) or fill out the short form to the right.