Posts Tagged ‘prescription drugs’

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.

Can your meds cause drug withdrawal in your baby?

Friday, May 15th, 2015

pillsNeonatal abstinence syndrome (NAS) is a group of conditions a newborn can have if he’s exposed to addictive street or prescription drugs before birth. If you take drugs during pregnancy, they can pass through the placenta to your baby. After birth, the baby is still dependent on the drug, however, now that the drug is no longer available, the baby experiences drug withdrawal. Today, one of the most common causes of NAS is maternal use or abuse of opioids during pregnancy.

Using these drugs during pregnancy can cause NAS:

• Opioids, including the prescription medicines codeine, hydrocodone (Vicodin®), morphine (Kadian®, Avinza®) and oxycodone (Oxycontin®, Percocet®). The street drug heroin also is an opioid.
• Barbiturates, like phennies, yellow jackets and Amytal®
• Benzodiazepines, like sleeping pills, Valium® and Xanax®

Signs and symptoms of NAS:

• Body shakes (tremors), seizures (convulsions), overactive reflexes (twitching) and tight muscle tone
• Fussiness, excessive crying or having a high-pitched cry
• Poor feeding, poor sucking or slow weight gain
• Breathing fast
• Fever, sweating or blotchy skin
• Trouble sleeping and yawning frequently
• Diarrhea or vomiting  (throwing up)
• Stuffy nose or sneezing

Signs and symptoms of NAS can be different for every baby. Symptoms may appear within a few minutes after birth or as much as two weeks later. NAS can last from 1 week to 6 months after birth.

Testing and treatment:

Your provider can see if your baby has NAS by testing his first bowel movement or urine. Your provider can also use what is called a neonatal abstinence scoring system which gives points for each NAS symptom depending on how severe it is. Treatment can include medicines to manage severe withdrawal symptoms, getting fluids through a needle into the vein, or giving higher-calorie baby formula to newborns that have trouble feeding or slow growth.

How can I prevent NAS?

If you’re pregnant and you use any of the drugs that can cause NAS, tell your health care provider right away. But don’t stop taking the drug without getting treatment from your provider first. Quitting suddenly (sometimes called cold turkey) can cause severe problems for your baby, including death.

If you’re addicted to opioids, medication-assisted treatment (also called MAT) during pregnancy can help your baby. NAS in babies may be easier to treat for babies whose moms get MAT during pregnancy. Medicines used in MAT include methadone and buprenorphine.

Even if you use a prescription drug exactly as your provider tells you to, it may cause NAS in your baby. If you are pregnant or think you may be pregnant, talk to your provider about any drug or medicine you are taking.

Our website has more information on where you can find help.

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

Painkillers and pregnancy don’t mix

Friday, January 23rd, 2015

pregnant2Did you know that a significant number of women of childbearing age fill prescriptions for narcotic painkillers each year? If a woman becomes pregnant while taking these medications, she is at an increased risk of having a baby with birth defects.

Opioid-based (narcotic) pain medications, such as codeine, oxycodone, hydrocodone, or morphine, are used to treat moderate to severe pain. Many women are unaware that the use of these medications during pregnancy, even when used as directed, may increase their chance to have a baby with a serious birth defect of the brain, spine, or heart. They also have an increased risk of preterm birth.  Use of opioid-based painkillers during pregnancy can also cause babies to suffer withdrawal symptoms when they are born. This is a condition known as neonatal abstinence syndrome or NAS, and it is a growing problem in U.S. birthing hospitals.

A new report from the CDC found that on average, about 28% of privately insured and 39% of Medicaid-enrolled women of child-bearing age filled a prescription for an opioid between 2008-2012.

Since half of all pregnancies are unplanned, women may be prescribed opioid-based pain medications before they know they are pregnant.  “This highlights the importance of promoting safer alternative treatments, when available for women of reproductive age. We must do what we can to protect babies from exposure to opioids,” stated Coleen A. Boyle, PhD, MSHyg, Director of CDC’s National Center on Birth Defects and Developmental Disabilities (NCBDDD).

“If you are using an opioid painkiller, you should also be practicing effective birth control, “ says José F. Cordero, MD, MPH, a pediatrician, birth defects expert formerly at CDC, and member of the March of Dimes Board of Trustees. “If you decide to get pregnant or do become pregnant, tell your health care provider about all the medications you are taking, right away. You may be able to switch to a safer alternative.”

The CDC’s Treating for Two: Safer Medication Use in Pregnancy initiative offers information to women and their healthcare providers about medication use during pregnancy. Go here to get more information.

Prescription drugs: new FDA labeling rules will help pregnant women

Friday, December 5th, 2014

prescription medsCurrent FDA guidelines about medication safety during pregnancy can be very confusing for women and their health care providers. Soon, however, doctors will have access to more information about the safety of prescription drugs during pregnancy.

When you are pregnant, you try to avoid anything that may harm your baby. But sometimes, you need to take medications for your own health. Managing chronic conditions like diabetes, asthma, and high blood pressure is very important, especially during pregnancy. But it is often difficult to know what medications are safe. And current FDA safety categories can be very confusing and difficult to understand.

However, in the summer of 2015, drug manufacturers will need to start providing additional details about medication safety in pregnant and breastfeeding women. The new labels will have to state how the safety information was obtained and whether the data was the result of scientific studies in people, or if it was obtained through study of animal models. The manufacturers must also include how much of the drug is excreted in breast milk and whether it affects the nursing baby, as well as how the drug may affect future fertility for both men and women of reproductive age.

These changes in labeling will provide doctors with more information about a medication’s safety during pregnancy. The information will not be on the actual medication bottle. It will be included in the official drug labeling information that doctors use when prescribing medications. It may also be included in the printed materials that pharmacies often include when filling prescriptions. This change in labeling does not apply to over-the-counter medications, though.

The new guidelines will allow doctors and patients to weigh the pros and cons of which medication is best to take during pregnancy for a given condition based on scientific evidence. And it will provide doctors and patients with more safety data than has previously been readily available.

The March of Dimes hails the release of the FDA’s final rule on pregnancy and lactation drug labeling information for prescription drugs. According to Dr. Jennifer Howse, president of the March of Dimes the new rules “will drive critical improvement to prescription drug labels regarding known effects on pregnancy, breastfeeding, and fertility.  The rule takes vital steps to improve the organization, readability, and usefulness of this information, which will enable women and their providers to find it and use it more readily….It is important to note, however, that this rule is only a first step, and it does not address other crucial issues related to pregnancy, lactation, and prescription drugs. The March of Dimes looks forward to working with the FDA and other interested stakeholders to ensure that appropriate research is performed and data generated to allow women and their health providers to make fully informed decisions about medication and its expected impact on pregnancy, lactation and childbearing.”

Saturday is Prescription Drug Take-Back Day

Friday, September 26th, 2014

pillsEvery year hundreds of thousands of children take a trip to the hospital because they have taken medications they have found in their house and are way too easy for them to get their hands on. Often, old prescriptions are sitting around, forgotten, and these pose a risk to children who may find and ingest them.

Saturday, September 27th is National Prescription Drug Take-Back Day. This effort, organized by the Drug Enforcement Administration (DEA), aims to provide a safe, convenient, and responsible means of disposing expired, unused, or unwanted prescription drugs.

Last April, Americans turned in 390 tons (over 780,000 pounds) of prescription drugs.  When those results are combined with what was collected in its eight previous Take Back events, DEA and its partners have taken in over 4.1 million pounds—more than 2,100 tons—of pills.

This event will be held throughout the country from 10am-2pm. You can locate a collection site near you here.