nicotine patches

Are Nicotine Patches and E-Cigarettes Safe in Pregnancy?

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Guidelines consistently advise that the best thing a pregnant woman can do is to stop smoking. Now, new research has found that regular use of nicotine replacement products to assist smoking cessation is not associated with adverse events or poor pregnancy outcomes.

“Using nicotine products to stop smoking during pregnancy appeared safe,” Professor Peter Hajek of the Wolfson Institute of Population Health, Queen Mary University of London, and lead researcher of the study told Medscape News UK.

The scientists found that pregnant women who stopped smoking cigarettes and used e-cigarettes and nicotine patches had infants with significantly higher birth weight than smokers, and “not different from abstainers not using nicotine”. The researchers wrote that they “did not detect any risks to pregnancy” from e-cigarettes or nicotine patches used by smokers trying to quit.

The study was funded by the National Institute for Health and Care Research (NIHR) and led by scientists at Queen Mary University of London. It was published in the journal Addiction.

Current Guidance

The prevalence of smoking during pregnancy has been decreasing over time. The smoking rate for pregnant women at the time of birth fell to 9.1% in 2021-2022, the lowest annual rate on record. In 2022-2023, the prevalence had dropped slightly further to 8.8%, but was still higher than the government’s target of 6%.

A landmark review in 2015 led by King’s College London and commissioned by Public Health England found that e-cigarettes had the potential to reduce smoking. It also found that nearly half the population (44.8%) did not realise that e-cigarettes or vapes were much less harmful than smoking. 

Both the Royal College of Obstetricians and Gynaecologists (RCOG) and the NHS currently recommend that pregnant women stop smoking completely, ideally before the fact.

They also suggest that nicotine replacement therapy (NRT) can be an effective aid for pregnant women who want to stop smoking. NICE points out in its recommendations on treating tobacco dependence in pregnant women that “any risks from using NRT are much lower than those of smoking”. 

In 2019, the Royal College of Midwives released a position statement that stated that “E-cigarettes contain some toxins, but at far lower levels than found in tobacco smoke. If a pregnant woman who has been smoking chooses to use an e-cigarette (vaping) and it helps her to quit smoking and stay smokefree, she should be supported to do so”.

Still, Professor Tim Coleman, Smoking in Pregnancy research group, University of Nottingham, who was also involved in the study, said in a press release that “some clinicians are reticent about providing NRT or e-cigarettes in pregnancy”.

Hajek explained that, in animal studies, chronic forced large doses of nicotine led to a range of adverse pregnancy outcomes. This has led to caution among some healthcare professionals. However, he said that studies have shown that this does not translate to self-regulated nicotine doses in humans. 

Building a Foundation of Evidence

Knowledge gaps remain, though. A Cochrane review in 2020 concluded that there was no evidence that NRT had positive or negative impacts on birth outcomes. In 2021, a systematic review concluded that NRT seemed to be associated with higher risk of infantile colic at 6 months similar to that associated with smoking during pregnancy. It also found an association with higher risk of attention-deficit/hyperactivity disorder. The review did not find associations were reported between the use of NRT during pregnancy and other infant health disorders or major congenital anomalies.

In 2023, a study suggested that aerosols from e-cigarettes may contain several newer, potentially toxic compounds, including some known developmental toxicants that may adversely impact both the mother and foetus. However, the authors found that research was limited, with large knowledge gaps regarding the effects of e-cigarette use on maternal and foetal health and birth outcomes.

Hajek said that vapes are more effective for smoking cessation than NRT, but the impacts of their extended use is currently unclear.

NICE emphasises that most smoking-related health problems are caused by other components in tobacco smoke, not by the nicotine.

“The harms to pregnancy from smoking, in late pregnancy at least, seem to be due to other chemicals in tobacco smoke rather than nicotine,” Hajek explained.

Hazel Cheeseman, deputy chief executive at Action on Smoking and Health told Medscape News UK: “Given the significant risks of smoking during pregnancy, it is vital that pregnant smokers are supported to stop.” She said the new study added to the evidence that e-cigarettes are safe and effective for use by pregnant women to quit smoking. 

“There are widespread misperceptions about the risks of nicotine in pregnancy. While smoking is deadly, nicotine on its own does not cause the same harms. These findings should provide reassurance that vaping products and nicotine replacement therapy do not increase the risk of harms during pregnancy and can be safely recommended for smoking cessation,” said Cheeseman.

Pregnant smokers more likely to quit with e-cigarettes vs. nicotine patches

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Compared with nicotine patches, e-cigarettes were more effective in helping pregnant women stop smoking, according to data published in Nature Medicine.

Researchers also determined e-cigarettes and nicotine patches had similar safety profiles.

Data derived from Hajek P, et al. Nat Med. 2022;doi:10.1038/s41591-022-01808-0.
Data derived from Hajek P, et al. Nat Med. 2022;doi:10.1038/s41591-022-01808-0.

‘Objective data… are urgently needed’

Previous studies have shown nicotine replacement therapy (NRT) — including patches — and bupropion are limited in helping pregnant women stop smoking, according to the researchers. However, use of e-cigarettes for smoking cessation in pregnancy has become more popular than NRT, despite a lack of data on the safety and efficacy for women and their fetuses.

“Given that the issue [of safety] has not been definitively settled, and given that e-cigarette aerosol contains other chemicals in addition to nicotine, objective data on pregnancy outcomes in women who switch from smoking to e-cigarette use are urgently needed,” Peter Hajek, PhD, director of the health and lifestyle research unit at Queen Mary University in London, and colleagues wrote.

Study methodology

Hajek and colleagues randomly assigned pregnant women (median age, 27 years) from England and Scotland with a gestational age of 12 to 24 weeks (average, 15.7 weeks) who smoked daily and wanted to quit to either e-cigarettes or NRT patches. They instructed participants to use only their assigned product for at least the first 4 weeks of their attempt to quit.

The researchers conducted follow-up through phone calls near the end of pregnancy — upon first contact between 35 weeks’ gestation and 10 weeks after estimated delivery — and at 3 months postpartum. Calls took place between April 2018 and September 2020.

Participants were asked to provide saliva and carbon monoxide readings to validate self-reported smoking cessation.

Efficacy, safety of nicotine products

In total, 571 women in the e-cigarette arm and 569 women in the NRT arm completed follow-ups, with 196 participants reporting abstinence — 66 in the e-cigarette arm and 42 in the NRT arm. However, validation with saliva and/or carbon monoxide readings showed only 39 women (6.8%) in the e-cigarette arm and 25 (4.4%) in the NRT arm were abstinent (RR = 1.55; 95% CI, 0.95-2.53). The difference between the groups was not significant.

Of note, some women in the NRT arm also used e-cigarettes during the study. Sensitivity analyses excluding abstinent women who used products other than what they were assigned showed that e-cigarettes were significantly more effective than NRT patches (6.8% vs. 3.6%; RR = 1.93; 95 CI%, 1.14-3.26).

“However, if e-cigarette use were to persist in the long term, it is likely to carry some health risks, as well as maintaining nicotine dependence,” the researchers wrote. “In this scenario, e-cigarettes would represent a harm reduction approach.”

Adverse events and maternal and birth outcomes were similar between groups except for low birth weight, which was significantly less frequent among women in the e-cigarette arm (14.8% vs. 9.6%; RR = 0.65; 95% CI, 0.47-0.9).

“Given the questions that remain about the potential risks of nicotine in pregnancy, stopping smoking without nicotine-containing aids is preferable to switching to such products,” Hajek and colleagues concluded. “Only when the choice is between using nicotine products such as NRT or e-cigarettes or continuing to smoke, the use of NRT or e-cigarettes would be the recommended option.”

Varenicline, nicotine patch treatment effectively curbs smoking among heavy drinkers

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Among smokers who drank heavily, treatment with both varenicline and a nicotine patch more effectively curbed smoking than nicotine patch and placebo, according to results of a study published in JAMA Network Open.

“Tobacco and alcohol use are among the top three leading contributors to preventable disease and injury in the U.S. and cause significant public health and economic burdens,” Andrea King, PhD, of the department of psychiatry and behavioral neuroscience at the University of Chicago, and colleagues wrote. “Moreover, many people concurrently use both substances, resulting in high rates of cancer and pulmonary and cardiovascular disease, with mortality beyond the risks of each substance individually.”

Smoking cigarette and ashtray

King and colleagues sought to ascertain whether treatment combining varenicline tartrate and a nicotine patch increased abstention from cigarette smoking among smokers who drink heavily.

The double-blind, placebo-controlled, superiority randomized clinical trial was conducted at two outpatient sites in Chicago between March 26, 2018, and Feb. 14, 2020. It included 122 participants who smoked between five and 30 cigarettes per day and drank heavily (more than 14 drinks per week for men or more than seven drinks per week for women; at least one heavy drinking day per month for the previous year) and expressed a desire to quit smoking. During the 12-week trial, participants who were randomly assigned equally between the varenicline/patch group and patch/placebo group were given either 1 mg of varenicline tartrate or matching placebo twice per day. Nicotine patches were used at manufacturer-recommended doses for 10 weeks. Study participants also underwent brief individual smoking cessation counseling the week before quit date and on the quit date.

Results showed higher smoking cessation rates during the final weeks of the study among those treated with varenicline vs. placebo (44.3% vs. 17 participants 27.9%), and decreased probability of relapse for duration of treatment in the varenicline group compared with the placebo group. Although both treatments were well-tolerated, participants in the varenicline group reported more adverse effects, with five participants in the varenicline group discontinuing medication.

“The results support continued investigation of varenicline with nicotine patch as a combination treatment strategy for smokers with hazardous drinking behaviors who have historically experienced worse outcomes with standard approved tobacco cessation treatments,” King and colleagues wrote.

Quit Smoking Drug From Eastern Europe Better Than Nicotine Tx?

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Cytisine, a smoking cessation medication available only in Eastern Europe, worked better than conventional nicotine-replacement therapy in a clinical trial.

The drug yielded a 1-month continuous abstinence rate of 40% compared with 31% among quit line callers provided nicotine patches along with gum or lozenges (P<0.001),Natalie Walker, PhD, of the University of Auckland, New Zealand, and colleagues found.

The number needed to treat with cytisine versus was 11, they reported in the New England Journal of Medicine.

The 25-day course of treatment remained superior to 8 weeks of nicotine replacement at the 6-month follow-up on one of the two typical measures of long-term efficacy (continuous abstinence 22% versus 15%, P=0.002).

The 7-day point prevalence of quitting — defined without any allowance for slip-ups, unlike the continuous measure which allows for up to five cigarettes — showed no difference between groups at 6 months.

The Drug

Cytisine is a partial agonist that binds the nicotinic acetylcholine receptor, similar to varenicline (Chantix), and has been on the market — now as a generic — since the 1960s, largely in Eastern Europe.

Its low cost compared with other quit-smoking medications is a big draw, Walker’s group noted. Cytisine sells for $20 to $30 for a 25-day course compared with $112 to $685 for the required 8 to 10 weeks of nicotine replacement therapy and $474 to $501 for a 12-week supply of varenicline.

Nancy A. Rigotti, MD, of the Tobacco Research and Treatment Center at Massachusetts General Hospital and Harvard in Boston, agreed in an editorial accompanying the NEJMpaper.

“The compelling rationale for bringing cytisine to market is not that its efficacy is superior to that of current pharmacotherapies but that current pharmacotherapies are unavailable to so many smokers — especially those in low-income and middle-income countries — because of their cost,” she wrote.

“Stakeholders in high-income countries seeking to contain healthcare costs would also benefit from a lower-cost pharmacotherapeutic option.”

However, getting the drug to the U.S. market could be a challenge, Rigotti told MedPage Today.

The manufacturer in Bulgaria never saw a market for the drug in the U.S. and so never tried for approval, she explained.

“We’re sort of stuck here,” she said in an interview. “We need to find a sponsor for the drug who can take it through the licensing process, but once it went through the licensing process that sponsor would probably make it more expensive. So we might end up with another drug that is just as expensive as others.”

She called instead for “creative collaboration” among regulators, pharma, research funding agencies, and other stakeholders interested in the public health benefit of smoking cessation in order to find some novel pathway through the system for the drug.

Cytisine Trial

The trial findings were likely widely generalizable, Rigotti added

The pragmatic open-label clinical trial used a real-world setting — smokers calling New Zealand’s national telephone quit line wanting to quit — with minimal behavioral support and few exclusion criteria, Rigotti wrote in the editorial. “The advantage of this design is that an intervention found to be truly effective is likely to work in many settings.”

All 1,310 adult daily smokers got an average of three calls of 10 to 15 minutes each from quit line advisers over a period of 8 weeks for behavioral support.

Those randomized to the nicotine-replacement group got vouchers redeemable from community pharmacies for nicotine patches and for gum, lozenges, or both at a cost of about U.S. $2.50 for an 8-week supply of each item.

The cytisine group got their 25-day course of tablets via mail and were instructed to target day five as their quit date. They also got vouchers for nicotine replacement therapy to use if they hadn’t been able to quit by the end of the 25-day course of treatment.

Adverse events were more common with cytisine than with nicotine-replacement therapy, but only 5% of patients stopped taking cytisine because of them.

The side effect profile mirrored that of varenicline, with the most common symptoms being nausea and vomiting and sleep disorders, but without the psychiatric events.

While the study was too small to detect rare events, decades of use of cytisine in Eastern Europe hadn’t turned up psychiatric risks either, Rigotti noted.

The lack of biochemical verification of self-reported tobacco abstinence was a limitation, she cautioned, though, saying further trials would be needed to determine true superiority over nicotine-replacement therapy, as well as to compare cytisine against other first-line pharmacotherapies.

Other Options

Walker’s group had previously reported that electronic cigarettes were at least as good for smoking cessation as were nicotine patches in a similarly-designed pragmatic trial in New Zealand, although neither helped substantially more than placebo.

A Cochrane review by the group, also released Wednesday, found just one other randomized controlled trial to meta-analyze with theirs but also concluded that e-cigarettes help smokers quit.

Electronic cigarettes increased the 6-month quit rate 2.29-fold in the pooled analysis by the most strict criteria — biochemically-verified continuous abstinence (9% versus 4% on placebo).

More people were able to at least halve their conventional cigarette consumption as well (36% versus 27% on placebo, and 61% versus 44% with patch in the one very low quality study).

Neither of the randomized trials and none of the 11 cohort studies reported any serious adverse events considered to be plausibly related to electronic cigarettes.