Nicotine patch during pregnancy

Safety of Nicotine Treatment Not Known

Why were so many highly motivated women unable to quit smoking to protect their babies from harm?

“These women had high-quality behavioral support, yet most of them only stayed on the treatment for two to four weeks,” Coleman says. “This suggests that either they did not trust that the treatment was safe for their babies or that it wasn��t working for them.”

He cites findings from a previous study suggesting that pregnancy alters the metabolism of nicotine so that more may be needed to get the same effect.

If this is true, Coleman says higher doses of nicotine than are delivered in most patches may be needed during pregnancy, but the safety of this approach is not known.

University of Connecticut School of Medicine professor of medicine and Ob-Gyn Cheryl Oncken, MD, says more research is needed to determine if nicotine replacement at any dose is safe during pregnancy.

Even though the new study was four times larger than any previous trial, she says low adherence kept it from addressing the safety question.

“We need a study where women use the patch as directed for enough time to determine its safety,” she says.

MONDAY, Jan. 28, 2002 (HealthDayNews) — Women who just can’t quit smoking during pregnancy can now safely turn to nicotine patches for help.

A new study has found this popular anti-smoking strategy is safe for both baby and mom, particularly during the third trimester, which is when most smoking-related complications occur.

“We found that, at the very least, the patches are no more dangerous than cigarettes and certainly appear to be less hazardous, particularly in terms of baby’s health,” says Dr. Paul Ogburn, lead author and director of maternal-fetal medicine at State University of New York at Stony Brook.

Smoking during pregnancy has been known to dramatically increase the risk of premature delivery and perinatal mortality, says Ogburn. It can also cause low birth weight and, in the mother, a condition known as abruptio placentae — where the birth sac that nourishes the baby pulls away from the mother’s uterus, increasing the risk of miscarriage and premature birth.

While the nicotine patch lets at least one of the potentially harmful chemicals found in cigarettes enter a woman’s body, Ogburn believes it’s still far less harmful than smoking.

“Nicotine is not the most harmful chemical associated with cigarettes, and if you can avoid all the others you are at least giving your baby some protection,” says Ogburn, who presented the study at the recent annual meeting of the Society for Maternal-Fetal Medicine in New Orleans.

At the same conference, investigators from the University of Ottawa in Canada offered new proof that smoking also increases the baby’s risk of neural tube defects. This is a serious congenital malformation that often leads to infant death.

Obstetrician Dr. Andrei Rebarber agrees with Ogburn’s assessment: “Certainly, if you can avoid the nicotine as well, that would be best; but if you can’t stop smoking and you are smoking a lot, then the patch can be a good idea.”

The small but significant study involved 21 pregnant women who, despite advice from their doctors, continued to smoke at least 15 cigarettes a day into their third trimester. The women were offered a nicotine patch on the first of a four-day hospital stay, and they continued to use the therapy at home for eight consecutive weeks.

During this same time period, the women underwent weekly ultrasound exams to check on the health of the baby. They were also asked to regularly take an exhalation test, which was used to determine whether they were still smoking.

The final result: Ogburn reports all the babies had normal birth weights. However, all the babies were also born a few weeks premature. Ogburn admits the study did not take into account any damage that may have occurred during the first two trimesters when the women were still smoking. Only eight of the 21 women — 38 percent — were smoke-free at the time of delivery.

Still, the study did prove what it set out to accomplish: “That the nicotine patch is safe for pregnant women — even during the third trimester when the risk of smoking-related complications are highest,” says Ogburn.

For Rebarber, the finding is important, but he won’t suggest all pregnant smokers look to the patch to help them have a safer pregnancy.

“I think the decision to use the patch must be made on a case-by-case basis,” says Rebarber. For the woman who smokes only a few cigarettes a day, he says, continuing to smoke is probably safer than using the patch, which would obviously deliver far more nicotine than she is getting from her cigarettes.

“On the other hand, if she’s smoking a lot — 15 cigarettes a day or more — as the women in the study were doing, then the patch should be considered,” he says.

Still, Rebarber says the first line of defense should always be to stop smoking as naturally as possible before you get pregnant.

Ogburn agrees: “The patch is safe, but it should be reserved for those women who find they cannot quit on their own.”

Although other nicotine replacement products, such as nicotine gum, have not been similarly tested, both Rebarber and Ogburn agree the safety profile should be similar to that found with the nicotine patches.

“Obviously a pregnant woman must consult with her doctor before using any nicotine replacement product,” cautions Rebarber.

What To Do

For facts on pregnancy and smoking, visit the Centers For Disease Control and Prevention or The American Lung Association.

For more stop-smoking strategies, visit QuitNet.

To get a fact sheet on nicotine replacement products, try The American Lung Association.

Nicotine Pregnancy and Breastfeeding Warnings

Nicotine is also known as: Commit, Habitrol, Leader Nicotine Polacrilex, Nicoderm CQ, Nicorelief, Nicorette, Nicorette DS, Nicotrol Inhaler, Nicotrol NS, Nicotrol TD, ProStep

Medically reviewed by Last updated on Aug 8, 2019.

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Nicotine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: D
US FDA pregnancy category: D

-Patients should attempt to achieve smoking cessation through behavioral interventions first; patients who are unlikely to/cannot quit without pharmacological support may use nicotine replacement therapy (NRT), with the goal of discontinuation as soon as possible.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Patients receiving NRT should begin with intermittent nicotine products (e.g., gum, lozenge, inhaler, nasal/oral spray). Patch formulations may be used by patients with significant nausea/vomiting, but should be removed before going to bed.
-Patients using nicotine bitartrate lozenges after second trimester should be supervised by a healthcare provider.

Animal studies have revealed evidence of decreased litter size with use, and skeletal abnormalities occurred at maternally toxic doses. There are no controlled data in human pregnancy; however, spontaneous abortions have been reported in patients using NRT.
Human studies have revealed evidence of growth retardation, premature birth, stillbirth, spontaneous abortion, and low birth weight when exposed to tobacco smoke. Male animal studies exposed to tobacco smoke have revealed evidence of decreased sperm production, increased oxidative stress, DNA damage, and lower fertilization ability.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Nicotine Breastfeeding Warnings

Use of nicotine replacement therapy (NRT) during breastfeeding produced a milk to plasma ratio of 2.9. NRT exposure was shown to be less harmful to the breastfed infant than second hand smoke exposure.

Nicotine patches: Use is not recommended.
Intermittent nicotine formulations: Use is generally considered acceptable; benefit to the mother should outweigh risk to the infant.
Excreted into human milk: Yes
-Patients should breastfeed prior to using intermittent formulations of this drug.

See references

References for pregnancy information

References for breastfeeding information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Pregnancy news, 20/07/2018

This week, the media have reported that mothers who use nicotine patches or e-cigarettes (vapes) during pregnancy increase their baby’s risk of SIDS. This is in response to new research published in the American Journal of Physiology.

The animal study from Geisel School of Medicine at Dartmouth was carried out on rats and aimed to investigate whether nicotine exposure during pregnancy is linked with an increased risk of SIDS.

The researchers found that the rats were more likely to respond negatively to lower oxygen levels when they had been exposed to nicotine in pregnancy, where they were also serotonin-deficient. Seratonin is a hormone that controls mood and is also important for regulating breathing.

Our advice

It is important to remember that this was an animal study, not a human study. The findings from animal studies can’t always be applied to humans.

Current research conducted on women using nicotine replacements – like vapes or patches – during pregnancy has not shown an increased risk of SIDS.

Cigarettes contain chemicals that pass through the placenta and into the baby’s blood stream when a pregnant woman smokes. The same toxins are not found in e-cigarettes or nicotine patches, therefore they are thought to be a safer alternative to smoking.

Watch the effects of cigarette smoke on an unborn baby

Because vaping does not produce smoke it is also a safer option than cigarettes once a baby has been born too. However, the Lullaby Trust advise parents who smoke e-cigarettes not to share their bed with their baby, due to a lack of research about the risk of SIDS. Read more safer sleep advice.

Staying smokefree is the most important thing for the whole family. Although quitting all products containing nicotine is safest for mums, dads and babies, if vaping or other nicotine replacement therapies help parents to remain smokefree then this is a much better alternative to smoking.

We do not recommend pregnant women stop using nicotine replacements, including vapes or patches, after seeing these headlines. Speak to a doctor or midwife for advice and support to stay smokefree.

More information and smoking and vaping during pregnancy

See more information about smoking and pregnancy.

by the Smoking in pregnancy challenge group, of which Tommy’s is a member.

If you’re a smoker and planning a pregnancy, we have information for you too.

Smoking While Pregnant, Fertility, & Breastfeeding

If you’re a smoker who’s planning a family or who’s pregnant, you need to know that the chemicals in cigarette smoke have adverse effects on sexual health, fertility, and the fetus.

If you’re a smoker who’s pregnant and want to quit, that’s great news. As soon as you quit, you increase your chances for a healthier pregnancy. Also, you should know about Nicotine Replacement Therapy (NRT) – both when you’re pregnant and when you’re breastfeeding, so you can make informed decisions about quitting smoking.

Men and Fertility

Smoking is directly responsible for erectile dysfunction and increases the risk of impotence by 27% (even in young people) because cigarette-smoke chemicals decrease your blood pressure rate. Even when consumed moderately, nicotine and carbon monoxide affect erectile capacity.

Cigarette smoke slows the secretion of testosterone, causing a decrease in libido. As well, sperm are fewer and less mobile, so fertility is decreased. Smoking also impairs sperm DNA, increasing the risk of complications during pregnancy and birth defects.

Women and Fertility

Smoking causes hormonal changes and reduces fertility by about a third. On average, smokers take twice as long as non-smokers to conceive a child.

Smoking while on the contraceptive pill promotes clot formation, damages and narrows the walls of blood vessels, and significantly increases your risk for cardiovascular complications – even a stroke.

Cigarettes sometimes disturb women’s menstruation cycles, making them irregular and more painful.

Smoking While Pregnant

Some of the effects smoking could have on your pregnancy include:

  • Poisonous chemicals in cigarette smoke pass through you to your baby.
  • Cigarette smoke disrupts the amount of oxygen that reaches your baby.
  • The risk of congenital defects, such as cleft lip or limb deficiencies, increases.

The good news is that stopping smoking at any stage of pregnancy is beneficial. So the moment you quit, you start increasing your chances of a healthier pregnancy and a healthier baby.

Ideally, you should quit smoking when you’re pregnant without using NRT. Stopping smoking completely is by far the best option. But if you think you need NRT, please ask your doctor or healthcare professional.

Smoking While Breastfeeding

If you’re breastfeeding, you should try to give up smoking without NRT. But if you can’t manage that, your best option is an NRT product which is taken intermittently. However, you should talk with your doctor or healthcare professional for advice.

Use of nicotine during pregnancy may increase risk of sudden infant death syndrome

Sudden infant death syndrome (SIDS) is the sudden and unexpected death of an infant under 12 months of age that occurs typically while sleeping. Failure of autoresuscitation, the ability to recover normal heart rate and breathing following gasping caused by lack of oxygen in the brain, has been recorded in human SIDS cases.

Smoking increases risk for SIDS. Over the last decade, use of cigarettes has declined significantly, however, over 10% of pregnant women still smoke during pregnancy. Over recent years nicotine replacement therapies, such as nicotine patches or e-cigarettes, have been prescribed to women who wish to quit smoking during their pregnancy. However these nicotine replacement therapies may not protect infants from SIDS. With increasing numbers of nicotine patch and electronic cigarette users during pregnancy, there is an increasing urgency to better understand the impact of nicotine exposure on the development of babies during pregnancy.

The researchers showed that exposure of the mother to nicotine during pregnancy can affect the baby’s central nervous system and impair the baby’s cardiorespiratory responses to stressful environments, e.g. asphyxia, especially in babies who have both serotonin and serotonin receptors deficiency in the brain. This can damage a key biological mechanism called autoresuscitation that protects the infant from a severe lack of oxygen. Such failure of autoresuscitation increases the likelihood of SIDS because the infant is unable to recover from environmental stresses that cause lack of oxygen, such as getting tangled in bedding, a minor illness or a breathing obstruction.

This research suggests that the use of nicotine, e.g. nicotine patches or electronic cigarettes, are not a safe alternative to cigarettes during pregnancy, because exposure to nicotine by any route may be harmful to a baby’s cardiorespiratory function and increase the risk of SIDS.

The research conducted by the Geisel school of Medicine at Dartmouth, Lebanon, New Hampshire, tested whether use of nicotine during pregnancy and nursing is more likely to elicit autoresuscitation defects in developing animals. They exposed rats to nicotine through maternal blood or milk and then looked at their response to repeated periods of severe low oxygen.

Stella Lee, the corresponding author of the study, commented on future research “Sudden infant death syndrome is such a distressing tragedy for families. We still don’t fully understand the causes, but this research is important because it helps mothers reduce the risk.”

Aihua Li, a senior author on the project added “We will continue to identify the possible predictors of risk and consider how we can treat infants who have a compromised autoresuscitation mechanism.”

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