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From the Agency for Healthcare Research and Quality www.ahrq.gov/RESEARCH/jun05/0605RA11.htm

Women respond differently to medications than men and should be proactive about their medication use

Women take more medications than men. They also respond differently to medications and are more likely than men to suffer medication-related injuries (adverse drug events). However, women have been underrepresented in clinical drug studies, and much still needs to be learned about the optimal, safe, and effective use of medications by women. Thus, women should be proactive about their medication use, according to Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D., Senior Advisor for Women's Health at the Agency for Healthcare Research and Quality. She recommends that women take responsibility for their own health and ask clinicians questions about diagnosis, treatment, and medication use.

Women should make sure they understand the need for each medication they are taking and take them at the right dosage and time. They should ask their doctor or pharmacist about side effects, as well as potential interactions with other prescription medications, dietary supplements, herbal products, foods, and beverages. Women who are scheduled to undergo surgery should ask about the need to stop taking medications before their surgery, since some drugs (including herbal products) can interfere with anesthesia or blood clotting.

Women should inform doctors and pharmacists about all medications being taken, any allergies to medications, and if they are pregnant or plan to become pregnant in the near future. Finally, women should learn how to do their own research on medications and always read the Food and Drug Administration (FDA)-approved drug package inserts for prescription and nonprescription medicines.


Medicines: Harmful side effects to the heart

All medicines have risks as well as benefits. The reason to take a medicine is that the benefit should be greater than the risk. Some medicines can cause unexpected risk to the heart.

But first, an explanation of how the heart works:

The heart is a muscle about the size of your fist. The heart works like a pump and beats about 100,000 times a day.

A healthy adult heart generally beats 60 to 100 times a minute, but it can beat faster or slower at times. For example, physical activity, strong emotion, certain medicines, fever, or infection can make the heart beat faster. A person's heart rate generally slows down during sleep.

Normal Rhythm ECG

ECG

Understanding the Heart's Electrical System

The heart has an internal electrical system that controls the speed and rhythm of the heartbeat. With each heartbeat, an electrical signal spreads from the top of the heart to the bottom. As it travels, the electrical signal causes the heart to contract and pump blood. The process repeats with each new heartbeat.  A problem with any part of this process can cause an arrhythmia.

What Is an Arrhythmia?

An arrhythmia (ah-RITH-me-ah) is a change in the heart's rhythm that causes the heart to beat too fast, too slow, or irregularly.

Most arrhythmias are harmless, but some can be serious or even life threatening. When the heart rate is too slow, too fast, or irregular, the heart may not be able to pump enough blood to the body. Lack of blood flow can damage the brain, heart, and other organs.

What Causes an Arrhythmia?

An arrhythmia happens when some part of the heart's electrical system doesn't function as it should. Most arrhythmias are harmless, but some can be serious or even life threatening.

Stress, smoking, heavy alcohol use, heavy exercise, use of certain drugs (such as cocaine or amphetamines), use of certain prescription or over-the-counter medicines, and too much caffeine or nicotine can lead to arrhythmia in some people.

How Are Arrhythmias Diagnosed?

Arrhythmias can be hard to diagnose, especially types that only cause symptoms every once in a while. Doctors use several methods to help diagnose arrhythmias, including family and medical history, physical exam, and diagnostic tests and procedures.

  • An EKG (electrocardiogram) is the most common test used to diagnose arrhythmias. An EKG is a simple test that detects and records the electrical activity of your heart. It shows how fast the heart is beating and its rhythm (steady or irregular).

What are the symptoms of arrhythmias

  • Fast or slow heart beat
  • Skipping beats
  • Weakness, lightheadedness, dizziness, fainting
  • Chest pain
  • Shortness of breath
  • Paleness
  • Sweating

Can Medicines affect the heart?

Medicines can change the electrical patterns of the heart. If the electrical patterns change too much, abnormal heart rhythms may occur. These abnormal heart rhythms can be dangerous. These changes can be seen on an electrocardiogram (ECG). One of these changes in the electrical activity of the heart may be a lengthening of the QT interval.

What is a QT interval?

The QT interval is a measurement on the ECG. This measurement reflects the duration of electrical activity that controls contraction of the heart muscle. In a normal, healthy heart the QT interval stays within acceptable limits.

ECG

Many medicines have the potential to prolong the QT interval, such as medicines used to treat abnormal heart rhythms, infections, allergies and mental illnesses.

Sometimes the QT interval becomes prolonged when too high a dose of the medicine is used or if the medicine is combined with another drug that changes how the body processes the first drug.

A long QT interval can lead to an abnormal heart rhythm called Torsades de Pointes (torsades). In very rare circumstances, torsades may cause death.

ECG showing Torsades

Torsades de pointes on an ECG

Long QT Syndrome

Long QT Syndrome (LQTS) refers to a condition in which there is an abnormally long QT interval on the ECG. Long QT Syndrome can be inherited and is called "congenital long QT". On the other hand, LQTS can be induced either by medicines or abnormal levels of the salts (potassium and magnesium) normally found in the blood and is then called "acquired long QT".

Is it alright to take other medicines with a medicine on the QT drugs lists?

Be careful in taking additional medicines with QT drugs on Lists 1,2 and 3. Medicines can interact with each other. These drug interactions may cause serious and harmful side effects. Sometimes the doses of your other medicines may need to be lowered or you may need to be checked more often. Know the medicines you take.  Keep a list of them to show your healthcare professional. Talk to your doctor if you are taking the following medicines with a QT drug.

  • Orap (pimozide)
  • Halfan (halofantrine)
  • Quinaglute, Quinidexm (quinidine)

Some drugs have been removed from the U.S. market or have warnings attached because of concerns on serious rhythm disturbances of the heart especially if these medicines are taken with other medications that raise the blood level of the drugs.

  • Seldane (terfenadine) Removed from the market in the United States.
  • Hismanal (astemizole) Removed from the U.S market
  • Propulsid (cisapride) The U.S. Food and Drug Administration (FDA) issued an urgent warning regarding cisapride (Propulsid) which has been found to cause cardiac arrhythmias (irregular heart rhythms). All patients taking cisapride have been advised to contact their doctors. The manufacturer of cisapride, Janssen Pharmaceutica, will remove cisapride from pharmacies by July of 2000; however, Janssen plans to make the drug available for patients with unusual, debilitating problems for whom there is no alternative therapy

Are there any special concerns for women?

Medicines that cause lengthening of the QT interval are a special concern for women. Lengthening of QT interval and torsades are more common in women than in men after taking certain medicines.

Researchers found that women were at higher risk than men for torsades after taking a several medications. These medicines include antihistamines (terfenadine, astemizole), antibiotics (erythromycin), antimalarials (halofantrine), antiarrhythmics (quinidine, d-sotalol), and psychotherapeutic drugs.

The reasons why women tend to develop torsades are not well understood, but they may be related to the fact that the QT interval is naturally longer in women than in men.

If you notice any of the following symptoms, consult your doctor as soon as possible:

  • Changes in heart rate
  • Fainting or losing consciousness
  • Slowed or stopped breathing

The QT drug lists on this website include medicines for which there is scientific evidence of more occurrences of prolonged QT or torsades in women than in men. These medicines are designated by the terms, Females>Males in the Comments column on the lists. For the medicines without this designation, the scientific evidence for adverse side events in women has not been presented.

Drugs with evidence of more women than men experiencing serious side effects of the heart (QT prolongation and Torsades de Pointes)

Drug List 1: Drugs generally accepted by the QT Advisory Board of the AzCERT to have a risk of causing torsades de pointes:

  • Amiodarone
  • Bepridil
  • Cisapride
  • Disopyramide
  • Erythromycin
  • Halofantrine
  • Ibutilide
  • Methadone
  • Pendamidine
  • Pimoxide
  • Quinidine
  • Sotalol

From the Food and Drug Administration Office of Women's Health www.fda.gov/womens/getthefacts/pregnancy.html on

Medicine and Pregnancy

You still can use many medicines when you are pregnant or nursing. Use this guide and talk to your doctor, nurse, or pharmacist about keeping you and your baby safe.

Know the Facts

  • If you're not pregnant yet, you can help your chances for having a healthy baby by planning ahead. You can make choices about which medicines to use before you get pregnant. Always talk to your doctor, nurse, or pharmacist first! It's very important that you keep getting treatment for any health problems.
  • Your heart and kidneys work harder when you are pregnant. This makes some medicines pass through your body faster than usual. Your doctor might need to give you a higher dose of your medicines or make you take them more often.
  • Some drugs can harm your baby during different stages of your pregnancy. At these times, your doctor might tell you to stop taking your regular medicine until it is safe to go back on it. Your doctor may put you on a different medicine that is safer for your baby.

Read the Label and Ask Questions

  • The law says that all drug labels must list the risks for women who are pregnant or trying to get pregnant.
  • Your doctor, nurse, or pharmacist can help you choose the medicines that are right for you.

Don't take:

Aspirin

  • Don't take aspirin during the last 3 months of your pregnancy, unless your doctor tells you to. Aspirin can cause problems for your baby, or cause problems when you are in labor.

Ibuprofen (Motrin, Advil)

  • Like aspirin, it may cause problems during the last 3 months of pregnancy and when you are in labor.

Products like herbs, minerals, amino acids

  • No one is sure if these are safe for pregnant women, so it's best not to use them. Even some "natural" products may not be good for women who are pregnant or nursing.

Vitamins

  • Women who are pregnant should not take regular vitamins. They can contain doses that are too high.
  • Ask about special vitamins for pregnant women that can help keep you and your baby healthy.

Nov 9, 2007:Important news from FDA on the risk of taking codeine for nursing mothers:

Watch this short video announcement from FDA:

FDA announcement for nursing mothers

To Report a Problem

Contact the FDA Safety Information and Adverse Event Reporting Program:
Website: www.accessdata.fda.gov/scripts/medwatch/
Phone: 1-888-463-6332


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