Last December, I sought your help regarding a couple of tranquilizers I had taken within the first few weeks of my pregnancy.... As a result of your advice, my husband and I are the ecstatic parents of a beautiful, healthy baby girl. I cannot thank you enough.
- Motherisk Caller
When it comes to pregnancy, it seems everybody's an expert. Family, friends, neighbors -- even total strangers -- all have advice for the pregnant woman. And though all of it may be entirely well meaning, very little of it is likely to be clinically sound -- especially when it comes to the use of medications and the exposure to potentially toxic substances during pregnancy. That's why when there's a question about the risk or safety of medications, chemicals, alcohol, infectious disease, or other exposures during pregnancy, the only good advice is to consult your physician and a teratogen information center.
Teratogens are substances or environmental factors that can cause birth defects. In order for a drug, chemical, or infection to be considered a teratogen, there must be substantive evidence that being exposed to it causes birth defects.
In a recent article in The New York Times, several concerned pregnant women listed among suspected teratogens underwire bras, thongs, hair dryers, acrylic nails, cellphones, chocolate mousse, bikini waxes, farmed salmon, blue cheese, hair dye, Botox, deli meats, champagne, tanning beds, hot dogs, albacore tuna... and more. Some of their fears were well founded in evidence-based medical research; others were old wives' tales and urban legends.
Part of the purpose of this book is to sort out the facts from the myths. A related purpose is to counsel women who are considering conceiving or who are now pregnant. Not all exposures to teratogens pose the same risk in fact, there are many that are unlikely to cause harm. What's more, a woman who has relied on medications to control medical conditions, such as hypertension and depression, may do more harm than good by suddenly going off her medication once she learns that she is pregnant.
The key to a safe pregnancy, then, is sound counseling based on up-to-date, evidence-based research.
FACT -- Thalidomide Tragedy
Perhaps the most well-known and feared teratogen is thalidomide. The use of thalidomide for the treatment of morning sickness caused major malformations among nearly 10,000 exposed children born in the 1950s and early 1960s. The thalidomide tragedy (as many came to call it) was so frightening that it was not long before every medication, environmental exposure, and virus in pregnancy was viewed with alarm.
The Motherisk Program
Since 1985 Motherisk, a program of The Hospital for Sick Children in Toronto, has offered sound counseling based on up-to-date, evidence-based research. The only teratogen information program in Canada, Motherisk is also one of the largest programs of its kind in the world. To date, the program has counseled more than 400,000 women.
Synonymous with 'motherhood', Motherisk is an invaluable international resource and service. Every day, Motherisk counselors answer calls from hundreds of women and their doctors, seeking important information about the safety or risk of common medications, drugs, medicinal plants, chemicals, infections, and other agents that might affect their unborn children. Some of the questions are easy -- our information reassuring. Others are a lot harder.
As you might guess, not every question has a ready answer. Each day, women and their doctors are faced with new drugs and exposures that simply have not been studied for their potential risk to the unborn. If they are to make informed choices that will affect them and their children for life, mothers-to-be need to know.
That's why at Motherisk, laboratory and population research is a vital part of what we do. Right now, pioneering research is underway to establish the risks of diseases and their treatment during pregnancy, to determine the safety of herbal products, and to establish once and for all the devastating effects of acute morning sickness in pregnancy -- just to name a few.
- To provide authoritative information and guidance to pregnant and breastfeeding women and their health-care providers regarding the fetal risks associated with drug, chemical, infection, disease, and/or radiation exposure during pregnancy and lactation.
- To research unanswered questions on the safety of drugs, chemicals, infection, disease, and radiation during pregnancy and lactation.
- To maintain a vital training and educational program in the areas of reproductive and developmental toxicology at the undergraduate, graduate, and postgraduate levels.
The research, education, and counseling that we're doing are paying off. Since 1985, Motherisk's multidisciplinary team of physicians, pharmacologists, toxicologists, geneticists, pharmacists, epidemiologists, and psychiatrists has achieved the following:
- Delivered authoritative and often reassuring information about the safety of important drugs for women with chronic conditions, such as epilepsy, arthritis, and depression.
- Disproved traditional 'wisdom' that debilitating morning sickness is "all in a woman's head" and advocated safe and effective treatment.
- Established the Province of Ontario's first diagnostic program for Fetal Alcohol Spectrum Disorder.
- Created Canada's first pilot program to diagnose and treat chicken pox in pregnancy.
- Helped hundreds of women avoid termination of wanted pregnancies.
This book contains much of the information that Motherisk counselors share with nearly 200 callers each day. In so doing, we hope to help ensure rational treatment for women during pregnancy and while breastfeeding -- and a healthy start for newborn children.
We invite you to consult this book as a reference throughout your pregnancy and once your baby is born and nursing.
Calling a Teratogen Service Helpline
Motherisk receives approximately 3,000 telephone calls each month from Canadians and Americans. Combined with emails and visits to the Motherisk website, these calls to Motherisk helplines demonstrate the growing sensitivity among not only pregnant and breastfeeding women but also their physicians regarding the safety/risk of drugs, chemicals, radiation, and infections.
Motherisk Helpline counselors answer these calls and email inquiries. Motherisk hears from women planning their pregnancy, pregnant women, and breastfeeding women, as well as their partners, physicians, pharmacists, and other health professionals. Calls are also received from the general public and from the healthcare media -- newspapers, magazines, radio, television -- seeking authoritative information on the safety of new drugs and therapies during pregnancy and breastfeeding.
Counselor's Role and Referrals
Each call is handled by a Motherisk counselor -- a trained, information specialist with a background in clinical pharmacology. With each question, Motherisk counselors decide whether the caller should be referred for a clinic appointment or to the physician on call, or whether there is appropriate information that can be shared with the caller at the time of the call. The counselor conducts a careful interview to determine all potential risk factors before providing the latest, evidence-based information available. The counselor also completes a detailed Telephone Call Report Form. Daily summary sheets are retained for reference and follow-up.
Each week pregnant women are scheduled for the Motherisk clinic following exposure to known or suspected teratogens, new drugs about which little is known, chronic drug therapy, or drugs of abuse. Still others are referred to the Motherisk clinic to address their extreme anxiety.
To make the most of your call to Motherisk or other teratogen center, make sure that you have some basic information handy before you dial. If you are calling about the use of a medication during pregnancy, know the exact name of the drug and why you are taking it. For example, if you are taking Tylenol for a cough or cold, be prepared to tell the counselor which one you are taking (there are about 10 different Tylenol brands of cough and cold medication on the market). The best thing is to have the medicine bottle or prescription in your hand when you call. That way, you will be able to provide important information about what the drug contains and how much you are taking. If you are calling about a workplace exposure, it is not enough to tell the Motherisk counselor where you work or what kind of work you do. Know the name of the chemical or other agent that you are concerned about.
Risk Assessment and Management
How do we judge the safety or risk of exposure to drugs, chemicals, and infections during pregnancy and breastfeeding? This is a question of 'risk assessment and management'. In fact, it's something we all do every day. For example, when driving a car along a residential street, we face the risk that a child or the neighbor's cat may suddenly dart across the street. We manage that risk by driving more slowly. But we don't quit driving down all residential streets simply because that risk exists.
The same can be said about medications, chemicals, and infections during pregnancy and breastfeeding. Some substances pose a greater risk than others, but that doesn't mean you must avoid all important medication, quit your job, or stop treatment of a disease condition for the full 9 months of your pregnancy.
We live in an imperfect world. There are no guarantees in life -- or pregnancy. That said, there is plenty of available, evidence-based information that can help us make sound choices.
So when it comes to determining whether or not to take a particular medication during pregnancy, for example, the best you and your doctor can (and must) do is balance the therapeutic benefit to you against what is known about the potential effect on the fetus. What's more, you must be sure that this balancing act is not tipped by misinformation, undue fear of unproven risks, or pressure from uninformed sources.
SAFETY/RISK -- Consult with Your Doctor
Before making any decision based on the information you find in this book, be sure to consult with your doctor. The information contained here is not meant to replace the advice your physician or other health-care providers. Always be sure to consult your physician before taking medications or changing any current treatment.
Using this Book
This book begins by raising and answering a series of frequently asked questions about safety/risk in pregnancy and breast-feeding, then expands on each answer in successive chapters. Within chapters, you will find quick reference charts and lists of medications, chemicals, and infections 'graded' according to their safety/risk. We also provide a comprehensive Index identifying all medications, chemicals, and infections mentioned in the book for quick reference. If you are especially worried about any one medication, chemical, or infection, you might start with the Index.
Several health regulatory agencies have developed different ways to express 'safety' and 'risk' when evaluating drugs taken during pregnancy and breastfeeding. The most widely used categories have been developed by the United States Federal Drug Administration (FDA), with 'A' assigned to the safest drugs and 'X' assigned to drugs contraindicated in pregnancy. However, this system has been criticized because it is confusing and often inaccurate. The FDA is currently in the process of changing this system entirely.
At Motherisk, we have established a system for grading the risk of prescription and over-the-counter drugs in pregnancy, ranging from 'Safe' to 'Unsafe'. This does not mean that everything that is not deemed 'Safe' is 'Unsafe' and must be avoided during pregnancy. There are degrees of safety that should be considered, especially if the medication is important for the health and well-being of the mother. These degrees of safety are vital to balancing the benefit and the risk of various medications.
Safe means that a convincing and authoritative body of scientific evidence, accumulated over time, through sound scientific research, shows no adverse effects on the fetus.
Probably Safe means that there is no evidence the drug is dangerous to the fetus and that the information showing it to be safe is rather large. Here, the benefit/risk assessment will be weighted, in most cases, in favor of using the medication.
Possibly Safe means that there is no evidence that the drug is dangerous for the fetus, but the information showing it to be safe is limited. By 'limited' we mean that only a few studies have been published in the medical literature, or the studies that are available do not meet all of the rigorous standards of critical scientific appraisal.
Unsafe means that there is evidence to show that the medication may cause harmful effects during pregnancy or during a particular trimester of pregnancy. This does not mean that the harm is certain to happen in each and every case of exposure, but there is enough risk of harm to justify careful use or avoidance in pregnancy.
Unknown or Unclear
Unknown or Unclear means that there is simply not enough reliable information for us to be able to determine safety or risk in pregnancy. This may change over time as evidence-based research uncovers more information about the effects of these drugs.