Posts Tagged ‘FDA’

Pregnancy Exposure Registries Help Moms-To-Be Share Their Experiences with Medicines

Monday, January 29th, 2018

Are you pregnant and taking medicines? FDA encourages women like you to participate in pregnancy exposure registry studies that track the outcomes of pregnancies in which medicines were taken during pregnancy.

We are joined today by Dr. Marjorie Jenkins, Director of Scientific Engagement and Medical Initiatives for FDA’s Office of Women’s Health. Dr Jenkins joined the FDA Office of Women’s Health (OWH) in 2015. In her role as OWH Director of Medical Initiatives and Scientific Engagement, Dr. Jenkins provides sex and gender-specific women’s health scientific expertise within research, health education, and communications initiatives.  Dr. Jenkins will tell us why pregnancy exposure registries are so important.

What are pregnancy exposure registries?

A pregnancy exposure registry is a study that collects health information from women who take prescription medicines or vaccines when they are pregnant. The study also collects information on the health of the newborn baby. This information is compared with women who have not taken medicine during pregnancy. The information is used to learn more about the effects of medicines and vaccines taken during pregnancy.

Why are pregnancy exposure registries important?

About half of all pregnant women report taking at least one medication during pregnancy. Many women have health problems like high blood pressure, arthritis or epilepsy, and they need to continue to take prescription medicine when they are pregnant. Other women take medicine before they realize they are pregnant.

Pregnancy exposure registries are one way that we can learn more about the safety of medicines and vaccines.

By enrolling in a pregnancy exposure registry, you can help other pregnant women and doctors find out more about medicines’ and vaccines’ safety in pregnancy. The safety information collected in the registry may be used to update medical product labeling.

Does FDA conduct pregnancy exposure registries?

No. FDA does not run the pregnancy exposure registry studies. The drug company that makes the medicine/vaccine or a research institution is usually in charge of the pregnancy exposure registry.

FDA keeps a list of ongoing registries on the FDA Pregnancy Registry website. The website may not represent a comprehensive list of all available pregnancy exposure registries. FDA does not endorse any registry and is not responsible for the content of registries listed.

Where can a pregnant woman find more information about a registry and how to participate?

It is a requirement that prescription medicine and vaccine labeling include information about the existence of a pregnancy registry. The Pregnancy subsection includes the contact information for the pregnancy exposure registry.

The FDA Office of Women’s Health created a website to help connect pregnant women and health professionals to pregnancy registries. The website includes a list of registries with the contact information that you can use to sign up for each registry.

There are instructions on the website to help you find out if there is a registry for your medicine or vaccine. You can search for a registry using the name of the medicine or vaccine or your medical condition.

What happens when you sign up for a registry?

Each registry has its own procedures about how they contact you and what you need to do to participate. The registry may contact you a few times during pregnancy and after you have had your baby to ask questions about you and your baby’s health. The calls can be as short as 10-15 minutes.

You will not be asked to take any new medicines to participate in the registry. The pregnancy exposure registry is only interested in medicines that you are already taking.

Thank you for the opportunity to talk about pregnancy exposure registries. I hope that you will visit www.fda.gov/pregnancyregistries to learn more about how you can sign up to share your experiences.

Have questions? Email us at AskUs@marchofdimes.org.

Changes in prescription drug labeling offer new safety information about pregnancy and breastfeeding

Wednesday, October 18th, 2017

Today’s guest post is written by Leyla Sahin, MD, U.S. Food and Drug Administration Division of Pediatric and Maternal Health.

Thank you for inviting me to talk with you about FDA’s new prescription medicine labeling system which provides information on the benefits and risks of using medicines during pregnancy and breastfeeding.  This new system is one way that FDA works to support healthy pregnancies.

Why has the FDA decided to change their system of labeling prescription medications for use during pregnancy and breastfeeding?

FDA wants women and their health care providers to have useful and up-to-date information to help them make decisions about the benefits and risks of using prescription medicines during pregnancy and breastfeeding. The decision to change the labeling was based on several years of careful consideration and listening to healthcare providers, organizations and the general public about the pros and cons of the old system. We learned that the old system was somewhat confusing and not used consistently. The new Pregnancy & Lactation Labeling for prescription medicines will include more helpful information about a medication’s risks to pregnant women, the developing baby, and babies that are breastfed. Over-the-counter (also called, OTC) medicines that you get without a prescription are not affected by the new labeling rules.

How is the new labeling system different from the older system? What new information will I see on my prescription labels?

The biggest change for the new labeling system is that the letter categories are being phased out. The old system used five-letters (A, B, C, D and X) to categorize what is known about the risks of taking a medicine.  Instead of the letters, the new labeling will have a description of the known risks in sentence format.  The new labeling will also include information about the background risks of having a birth defect or miscarriage. Background risks  are risks that every woman starts out with, even if she does not take any medication.  Information about the risks of the medical condition on the pregnancy will be included, if known. In addition, there will be information on dose adjustments that may be needed in pregnancy.

FDA decided to eliminate the pregnancy letter categories because they were often misinterpreted as a grading system. Medications could have the same letter categories but have very different risks. People sometimes focused so much on the letters and did not focus on what the risk data actually said.

Will the new labels tell me if the medication will affect fertility?

The new labeling format includes a subsection called “Females and Males of Reproductive Potential”. This new section will include recommendations about birth control and pregnancy testing, if it’s a medication that should not be used in pregnancy because of a known or suspected risk. It will also include information about what is known about a medication’s effects on fertility if this information is available.

Some medications are more dangerous at certain times in pregnancy. Will the new labeling provide specific information for each trimester of pregnancy?

If there is information about effects in a specific trimester, it will be included in the labeling. The labeling will also include medical and disease factors that should be considered.

I’m breastfeeding. How can I find out if the medication I’m taking will be found in my breastmilk and if it will affect my baby?

The “Lactation” subsection will provide information, when it is known, about the amount of medication that is transferred into breastmilk and potential effects on the breastfeeding infant.

Will it be clear when a medication should be completely avoided during pregnancy or breastfeeding?

If a medicine should not be used during pregnancy or breastfeeding, this information will be clearly stated in the labeling.  If there are ways to minimize exposure to the breastfed infant, this information will be included as well.

When can I expect to see these changes?

The changes have already started. The new prescription labeling system went into effect on June 30, 2015.  New prescription medications approved on or after that date will immediately have the new format. For products approved on or after 2001, but prior to 2015, the changes will occur over the next several years.  Some products are not required to change to this new format but all prescription medications will be required to remove the pregnancy letter category.

The risk information included in drug labeling often comes from research. How can I participate in research?

The new labeling will include information about pregnancy exposure registries. A pregnancy exposure registry is a study that collects health information from women who take prescription medications or receive vaccines when they are pregnant. There are registries for a number of medications and vaccines. By signing up for a pregnancy exposure registry, you can help other pregnant women and prescribers find out more about the safety of medicines used during pregnancy.

If there is a pregnancy exposure registry available for a medication, you will see contact information in the medication labeling. FDA’s Office of Women’s Health keeps a web listing of registries that you can search by medication name or medical condition. Here’s the link: www.fda.gov/pregnancyregistries

In addition to the research information that will be included in the prescription medication labeling, FDA has information on the participation of women in clinical trials. FDA is also participating in a multi-Agency task force to address the participation of pregnant and lactating women in research.

Repeat lead tests are advised for certain children, pregnant women and breastfeeding moms

Wednesday, May 17th, 2017

blood-testsToday, the FDA and CDC issued a notice that some lead tests done by Magellan Diagnostics may be incorrect.

The FDA says “certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.”

If you have a child age 6 years old or younger, are pregnant or breastfeeding, speak with your healthcare provider or local health department to determine if retesting is needed.

The dangers of lead

Lead is a metal that comes from the ground, but it can be in air, water and food. You can’t see, smell or taste it. High levels of lead in your body can cause serious health problems for you and your family.

Children younger than 6 years of age can be severely affected by lead. It can cause developmental problems, hearing loss, vomiting, irritability, belly pain and weight loss. Very high levels of lead may even cause death.

Lead poisoning (high levels of lead in your body) can cause serious problems during pregnancy, such as premature birth, miscarriage, and high blood pressure. It can also cause fertility problems, mood disorders, headaches, muscle or joint pain, trouble concentrating, belly pain, anemia and fatigue in adults.

Where is lead?

Most lead comes from paint in older homes. When old paint cracks or peels, it makes dust that has lead in it. The dust may be too small to see. You can breathe in the dust and not know it.

Lead may be found in drinking water, at construction sites, in arts and crafts materials used to make stained glass, lead crystal glassware, and some soil.

For more information on lead poisoning, see our web article and the CDC’s information.

Bottom line

If you have a child age 6 or younger, or you are pregnant or breastfeeding, contact your healthcare provider to determine if a lead test should be repeated.

Have questions? Contact our health education specialists at AskUs@marchofdimes.org.

You can find more news on our News Moms Need blog.

 

Fish safety during pregnancy: what to eat or avoid

Monday, February 13th, 2017

Mercury is a metal that can harm your baby. Fish get mercury from the water they swim in and from eating other fish that have mercury in them. By eating fish that contain mercury, the metal can pass to your baby during pregnancy. This can cause brain damage and affect your baby’s hearing and vision. However, it can be difficult to know which fish is safe to eat and which should be limited or avoided. Fortunately, the FDA (US Food and Drug Administration) and EPA (Environmental Protection Agency) have created a chart that classifies fish into three categories:

  • Best choices: eat 2-3 servings a week
  • Good choices: eat 1 serving a week
  • Choices to avoid: high mercury levels, best to avoid completely

Nearly 90 percent of fish eaten in the United States fall into the best choices category, according to the FDA and EPA. So make sure you get the recommended 2-3 servings of fish per week from the “Best choices” category, or 8 to 12 ounces total (12 ounces maximum).

 

FDA

 

FDA bans antibacterial soaps and body washes

Monday, September 12th, 2016

HandwashingFrequent and thorough hand washing is still the best way to ward off germs and to prevent the spread of infections. There is no need to buy antibacterial soaps; regular bar or liquid soap will do the job just fine. In fact, the U.S. Food and Drug Administration (FDA) has banned antibacterial soap products containing certain chemicals.

What makes soap antibacterial?

Antibacterial soaps, also called antimicrobial or antiseptic soaps, contain different ingredients than plain soap. Antibacterial soaps contain one or more of 19 specific active ingredients with the most common ingredients being triclosan (liquid soaps) and triclocarban (bar soaps). These products will have ‘antibacterial’ on the label.

Why the ban?

The FDA asked manufacturers to research and provide evidence that antibacterial soap ingredients, including triclosan and triclocarban, were safe for daily use over a long period of time. The manufacturers failed to prove their safety. Animal studies on triclosan show that this ingredient alters the way some hormones work in the body and raises concerns on its effect on humans. There is also concern that this ingredient contributes to making bacteria resistant to antibiotics. There is not enough research to know how triclocarban affects humans.

The FDA’s new rule applies to all consumer antibacterial soaps and body washes that are used with water. Manufacturers have one year to comply with the FDA’s new rule.

The ban does not include hand sanitizers, hand wipes or antibacterial soaps used in health care settings. The FDA says “Health care antiseptics are being evaluated separately from consumer antiseptics because they have different proposed use settings and target populations, and the risks for infection in the different settings varies.” More scientific research is needed to determine the safety and effectiveness of certain over the counter hand sanitizers.

Avoid mercury in skin care products

Thursday, July 28th, 2016

rubbing-nosesMost pregnant women know to avoid mercury from certain fish as it could harm a developing baby. But did you know that some skin care products contain mercury? Mercury may be found in skin creams, lotions and certain soaps. It is also found in some skin-lightening creams made outside of the U.S.

According to the FDA, “Some people – including pregnant women, nursing babies and young children – are especially vulnerable to mercury toxicity…Babies may be particularly sensitive to the harm mercury can cause to their developing brains and nervous systems. Newborns who nurse are vulnerable because mercury is passed into breast milk.”

FDA senior medical advisor Arthur Simone, M.D. says “Your family might breathe mercury vapors released from these products. Your children might touch washcloths or towels that are contaminated with mercury. It could be as simple as touching someone’s cheek or face.”

How do you know if your product contains mercury?

Check the list of ingredients, and do not use the product if any of these words are listed: “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury.”

The FDA further warns that if there is no product label or list of ingredients, do not use it. They say “Federal law requires that ingredients be listed on the label of any cosmetic or nonprescription drug, so do not use a product that doesn’t have a label.”

Why is mercury dangerous?

Mercury is a metal which can damage many parts of your body, including your lungs, kidneys and nervous system (brain, spinal cord and nerves). It also can cause hearing and vision problems. How serious the damage is depends on how much mercury you’re exposed to. Babies exposed to mercury in the womb can have brain damage and hearing and vision problems.

Where else is mercury found?

You can be exposed to mercury through your skin (lotions or creams), the air (by breathing it) and eating or drinking food or water that contains mercury. See our article for more details about where mercury may be found and ways to stay safe.

Have questions? Text or email our health education specialists at AskUs@marchofdimes.org.

FDA approves folic acid fortification of corn masa — a great day for babies!

Thursday, April 14th, 2016

Hispanic mom and babyToday the U.S. Food & Drug Administration (FDA) announced that it will allow corn masa flour to be fortified with folic acid. This announcement is a victory for America’s mothers and babies, and caps more than 20 years of work by the March of Dimes to prevent serious birth defects of the brain and spine known as neural tube defects (NTDs).

Scientists have long recognized that folic acid can prevent NTDs.  After wheat flour and related products were required to be fortified with folic acid in 1996, the incidence of neural tube defects dropped by about one-third.  The Centers for Disease Control and Prevention (CDC) estimates folic acid fortification in the U.S. has saved about 1,300 babies each year from these fatal or devastating birth defects – a total of 26,000 babies born healthy since folic acid fortification began in 1998.

But corn masa flour wasn’t part of that rule, and that may be part of the reason that neural tube defect rates have remained higher among Hispanic babies. Foods like tortillas, tamales, pupusas, chips and taco shells can now be fortified. Adding folic acid to corn masa will help to prevent neural tube defects.

The March of Dimes looks forward to the prevention of even more NTDs in the U.S. — giving more babies a chance for a full, happy life, and giving their families the joy of a healthy child.

Please join us in thanking the FDA by tweeting to @US_FDA or posting on their Facebook wall with messages like these:

Join our Advocacy Action Center for updates about how you can make a difference for healthy pregnancies and healthy babies.

You’re pregnant, can you drink eggnog?

Monday, December 14th, 2015

eggnogThe answer is yes and no. It depends. Here’s the scoop:

Store-bought eggnog

Traditionally, eggnog was made with raw eggs, which is not good for pregnant women due to the health concerns of salmonella. Salmonella causes salmonellosis, a kind of food poisoning that can be dangerous during pregnancy . However, currently, the U.S. Food and Drug Administration (FDA) restricts the use of raw eggs to less than 1% in products.

  • If you’re buying eggnog at the store, be sure to check the ingredient label to ensure it is egg-free or contains less than 1% egg product.
  • Also it is important that your eggnog be pasteurized. Pasteurization is a heat process that destroys salmonella that might be in eggs.

Homemade eggnog

Many families make a batch of home-made (and alcohol-free!) eggnog as part of their holiday traditions, but homemade eggnog causes many cases of salmonella each year due to raw or undercooked eggs. If you’re going to make your own eggnog, here are some tips:

  • Use egg substitute products or pasteurized eggs.
  • If you are using pasteurized eggs, the FDA recommends starting with a cooked egg base to ensure your safety.
    • To make a cooked egg base, combine eggs and half the milk as indicated in the recipe. (Other ingredients, such as sugar may be added at this step.) Cook the mixture gently to a temperature of 160°F, stirring constantly. The cooking will destroy Salmonella, if present. At this temperature, the mixture will firmly coat a metal spoon. After cooking, chill the mixture before adding the rest of the milk and other ingredients.

You can keep your eggnog holiday traditions, but remember to read all the labels on eggnog containers or carefully prepare your homemade eggnog.

Thalidomide and Dr. Frances Kelsey

Friday, August 21st, 2015

Dr. Frances Kelsey & President KennedyThere aren’t many people who can singlehandedly claim that they prevented thousands of children from being born with serious birth defects. Yet, Dr. Frances Oldham Kelsey is one woman who is famous for that reason.

You may have heard of thalidomide. It is a drug that is used to treat a skin disease caused by leprosy, but in the 1950’s and 60’s it was given to pregnant women to lessen morning sickness. Unfortunately, thalidomide caused serious limb (arms and legs) defects in thousands of children around the world. But, due to the vigilance of Dr. Kelsey, medical officer at the FDA (Food and Drug Administration) thalidomide was never allowed to be licensed in the U.S.

On August 7th, Frances Oldham Kelsey, MD, PhD, passed away at the age of 101. She was a wife, mother, and a highly educated woman. She earned a doctorate degree (PhD) in pharmacology and was one of seven women in her class of 100 to graduate from the University of Chicago Medical School in 1950. She joined the FDA in 1960.

In her autobiography, she writes “I had been hired as a medical officer and this meant that I would review the medical part rather than the pharmacology of new drug applications.” Despite considerable pressure to allow thalidomide to be available in the U.S., Dr. Kelsey followed her instinct (aided by her excellent education and training) to not allow the drug to be licensed. She says it was particularly important to investigate this drug because “When you give a drug to a pregnant woman you are exposing, in fact, two people to the drug, the mother and the child.” Dr. Kelsey felt that until it was established that the drug was safe for pregnant women, it should not be given to them. “Our objections… were really on theoretical grounds, largely based on the fact that there was no evidence that it was safe. Until we had such evidence we had to question the safety.”

Dr. Kelsey recalls that this near-miss disaster “caught the eye of the persons who were pressing for drug reform… In next to no time, the fighting over the new drug laws that had been going on for five or six years suddenly melted away, and the 1962 amendments were passed almost immediately, and unanimously.”

Later, an important amendment to the law provided that patients must know about and consent to taking a new, unapproved drug in a clinical trial – a very important aspect in drug testing that continues to this day.

Dr. Kelsey notes that “Nowadays we know exactly what is being tested and who is testing it and we get results back as soon as possible. Then if we get reported adverse reactions, we may stop the studies…”

Dr. Kelsey received the President’s Award for Distinguished Federal Civilian Service in August 1962, from President John F. Kennedy. She received numerous other awards, commendations and honorary degrees. According to the FDA, “in October 2000 Dr. Kelsey was inducted into the National Women’s Hall of Fame, and in 2010 Commissioner Hamburg conferred the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health on Dr. Kelsey herself.”

We are grateful for Dr. Kelsey’s vigilance and tireless efforts in protecting babies, women and all individuals in the United States. Her honorable legacy will never be forgotten.

 

Photo: Courtesy of US National Library of Medicine. Frances O. Kelsey receives the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy, 1962.

Questions?  Text or email them to AskUs@marchofdimes.org.

 

Ice cream and listeria

Thursday, April 30th, 2015

Jeni’s Splendid Ice Cream® is recalling all of its ice creams, frozen yogurts, sorbets and ice cream sandwiches because the products may have listeria. Listeria is a kind of bacteria that can cause the food poisoning, listeriosis. This recall follows the Blue Bell ice cream recall from a couple weeks ago, also due to listeria.

You can get listeriosis and other kinds of food poisoning from harmful germs in something you eat or drink. Listeriosis can cause nausea, vomiting, diarrhea, fever and headache. Most healthy people don’t get sick from listeriosis. It mostly affects people with a weak immune system, including pregnant women, newborns, elderly people and people with health conditions, like diabetes or HIV. If you get listeriosis during pregnancy, it can cause serious and even life-threatening health problems for your growing baby.

If you have the recalled ice cream, throw it out. You also can return or exchange the recalled ice cream at the same store where you bought it. Contact Jeni’s Splendid Ice Cream at (614) 360-3905 or at jenis.com/recall if you have any questions.

For more information about this ice cream recall, visit the Food and Drug Administration’s (FDA) website. Learn more about listeriosis and pregnancy.