Tag: pregnancy complications

Tylenol’s maker pushes back against possible label change linking pain reliever’s use in pregnancy to autism

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(CNN) — Kenvue, the American company that makes Tylenol, sa y s the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible connection between its use in pregnancy and diagnoses of autism or ADHD in children.

Kenvue says that acetaminophen, the generic name for the painkiller and fever reducer also known as paracetamol, is “one of the most studied medicines in history” and that “adoption of the proposed labeling revisions would be arbitrary, capricious, and contrary to law.”

Tylenol generates $1 billion annually for the company and is considered the company’s biggest-selling brand, according to the brokerage Morningstar.

The current label instructs people who are pregnant or breastfeeding to “ask a health professional before use.”

The push for a label change came after President Donald Trump held a news conference last month in which he told pregnant women who are in pain to try to “tough it out” instead of taking Tylenol, even though acetaminophen is the one over-the-counter pain reliever considered safe for pregnant people to take.

The president claimed without evidence that Tylenol use during pregnancy was linked to a “very increased risk of autism.”

“Fight like hell not to take it,” Trump urged.

Most people use acetaminophen at some point during their pregnancy, studies show. Other common pain or fever treatments like ibuprofen or regular-dose aspirin can increase the risk of serious complications when used during pregnancy.

Untreated pain or fever can be dangerous for the mother and the fetus, possibly leading to problems like miscarriage, birth defects or high blood pressure.

Beginning the process to change the safety label on acetaminophen products was just one action the Trump administration planned to take.

US Health and Human Services Secretary Robert F. Kennedy Jr. said at the news conference last month that his agency would launch a public service campaign about the issue.

The FDA also sent a letter to physicians saying that the choice to take Tylenol “still belongs with parents” but that use during pregnancy may cause an “increased risk of neurological conditions such as autism and ADHD in children.”

However, the letter also noted that “a causal relationship has not been established” and that studies about a link are “contradictory.”

The Informed Consent Action Network, an anti-vaccine nonprofit with close ties Kennedy, said in a letter dated the day of Trump’s news conference that it had filed a citizen’s petition with the FDA. Such filings are a way for individuals, industry or consumer groups to ask the agency to take action on a specific issue.

The petition says that because of the “urgent public health implications,” the FDA should act quickly to add a more detailed warning to the labels of over-the-counter drug products that contain acetaminophen to spell out that “studies show that frequent use of this product during pregnancy may increase your child’s risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder.”

On Friday, Kenvue asked the FDA to deny the petition, saying that suggested changes to the label are unsupported by scientific evidence “and would represent an unexplained departure from FDA’s longstanding position on acetaminophen during pregnancy.”

The company said it met with Kennedy in early September, after the HHS secretary reached out to say he believed there was a connection between acetaminophen use during pregnancy and autism, and it told him there was no such link.

An HHS spokesperson said Monday that the FDA doesn’t comment on product-specific matters.

The FDA website on acetaminophen has not changed to reflect the Trump administration’s views. It says it was last updated in August and specifies, “to date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”

Acetaminophen has been studied for decades to find any problems it may cause in pregnancy, according to the American College of Obstetricians & Gynecologists. Not one reputable study has concluded that acetaminophen use in any trimester of pregnancy causes neurodevelopmental disorders in children.

That group points to a study published last year of more than 2 million children that found no significant associations between acetaminophen use during pregnancy and children’s risk of autism, ADHD or intellectual disability.

Ano t her study published in August analyzed 46 studies on acetaminophen use during pregnancy and neurodevelopmental disorders. Six of the studies specifically examined acetaminophen use and autism. Overall, the analysis concluded that there was “strong evidence of an association” between acetaminophen use during pregnancy and autism, but the authors were careful to say that the paper could only show an association, the research could not show that acetaminophen caused autism.

“We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk–benefit assessments, rather than a broad limitation,” the researchers wrote in that analysis.

After the Trump news conference, medicine regulatory agencies for the European Union and the United Kingdom and Health Canada quickly issued statements confirming that taking the over-the-counter pain-reliever during pregnancy remains safe.

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October 20, 2025
A nonprofit is racing to get its portable baby incubators into Israel and Gaza as crisis deepens | CNN Business

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New York
CNN
—

Jane Chen is racing against the clock, again. She knows well how every minute that passes is crucial for a new life that emerges prematurely into the world in the most vulnerable of circumstances — in the midst of war, in the aftermath of a natural disaster or in a remote village far away from a medical center.

Acutely aware of the deepening crisis between Israel and Gaza, Chen is mobilizing her team at Embrace Global, a nonprofit she co-founded to help save babies’ lives, in a way that’s become second nature to her.

Embrace, based in San Francisco, California, makes low-cost portable baby incubators that don’t require a stable electricity supply.

The Embrace incubator resembles a sleeping bag, but for a baby. It’s a three-part system consisting of an infant sleeping bag, a removable and reusable pouch filled with a wax-like phase-change material which maintains a constant temperature of 98 degrees F for up to eight hours at a stretch when heated, and a heater to reheat the pouch when it cools.

Chen said the pouch requires just a 30-minute charge to be fully ready for reuse. “This is really ideal for settings that have intermittent access to electricity, which is a lot of places where we work in the world,” she said.

According to the UN Population Fund (UNFPA), an estimated 50,000 pregnant women currently reside in Gaza, 5,500 of whom are due to give birth in the coming month.

The stats are startling to Chen, who is bracing for a swell of need there. She’s learned how access to incubators becomes critical in conflict areas through the organization’s efforts to donate 3,000 Embrace incubators with the help of UNICEF to doctors and hospitals in Ukraine where a war with Russia rages on. The nonprofit also sent the devices to Turkey and Syria after devastating earthquakes there earlier this year.

Medical experts point to elevated stress as a potentially serious factor that could trigger preterm deliveries in these situations.

“There’s been plenty of data that show stress not only causes preterm birth but also low-birth-weight,” said Dr. Veronica Gillispie-Bell, an obstetrician-gynecologist and associate professor with Ochsner Health in New Orleans, Louisiana

In general, babies born preterm or before 37 weeks, have difficulty maintaining their body temperature, said Bell. “Specifically, if we are speaking of disasters…. in my own experience of being here during [Hurricane] Katrina, in those very stressful situations, we have seen an uptick during those times in preterm birth and low birth weight,” she said.

Because preterm and low-birth-weight babies don’t have as much body fat, it’s harder for them to maintain their body temperature, which for a healthy baby is between 96.8 and 99.5 degrees F, she said. “The lower it is below that, the more oxygen and energy they need to stay warm. So they would have use even more energy.”

In both cases of preterm and low-birth-weight infants, quick and constant access to an incubator is vital.

In Ukraine, Chen said doctors have indicated that preterm births are on the rise across the country at the same time that intermittent power outages have made the use of conventional incubators very challenging. Several doctors and nurses, she said, also must consistently take babies and mothers to basement shelters as bombings continue.

Dr. Halyna Masiura, a general practitioner, is experiencing this first hand at the Berezivka Primary Healthcare Center in the Odesa region of Ukraine.

“Half of the babies being born in this area need more care,” Masiura told CNN. “They are being born early and with low birth weight. When air raids happen, we all have to go into shelters.” Masiura said her staff members have been relying on donated Embrace incubators for babies born with a birth weight of 2 kg (4 lbs) and up.

In the Palestinian exclave of Gaza, Israel has instructed more than half of the more than 2 million residents in the north to evacuate to the southern region ahead of an anticipated ground operation in Gaza by the Israel Defense Forces (IDF) in response to Hamas’ deadly October 7 attack on Israel.

That attack killed more than 1,400 people.

In Gaza, where half of the overall population are children, access to medical aid, food, water, fuel, electricity and other normal daily necessities of life have evaporated in recent days amid sustained Israeli bombardment.

Over the weekend, after days of a complete siege of the exclave by Israel, the first trucks reported to be carrying medicine and medical supplies, food and water entered Gaza on Saturday.

For Chen, the most pressing problem is to figure out how to get the incubators to where they are most needed on the ground there. “As we did for Ukraine, we’re looking for partnerships with organizations that can get into the region effectively and also for funding,” she said. As a nonprofit, Chen said donations are sought through GoFundMe and a mix of individual donors, foundations and corporate donations.

Her team is working on a partnership with a humanitarian relief organization to respond in Gaza. “We’re also reaching out to organizations in Israel to assess the need for our incubators there,” she added.

A couple of hundred incubators are ready to immediately be sent to Israel and Gaza. Said Chen, “Depending on the need, we would go into production for more. But the big question is, can we get into those areas? We don’t want to ship products and then have them sit there.”

Linus Liang, along with Chen, was among the original team of graduate students at Stanford University who, as part of a class assignment in 2007, were given a challenge to develop a low-cost infant incubator for use in developing countries.

Liang, a software engineer who had already created and sold two gaming companies by then, was intrigued. “This class deliberately brought together people from different disciplines – law, business, medical school, engineers – to collaborate to solve world problems,” he said.

“Our challenge was that about 20 million premature and low-birth-weight babies are born globally every year,” he said. “Many of them don’t survive, or if they do, they live with terrible health conditions.”

The reasons why came down to factors such as a shortage of expensive conventional incubators or families living far away from medical centers to access quickly for their newborns.

The team formed their company in 2008 and then took a few years to engineer and produce the solution, with Liang and Chen both moving to India for a few years to get it off the ground and market test it there. Chen said the incubators, made in India, underwent rigorous testing and are CE certified, a regulatory standard that a device must meet to be approved for use in the European market and in Asia and Africa.

“We chose that route instead of seeking FDA approval because the need really is outside of the US,” said Liang. The cost per incubator is about $500, including cost of the product, training, distribution, shipping, implementation, monitoring and evaluation, said Chen. That compares to as much as $30,000 or more per conventional incubators, she said.

Chen estimates some 15,000 babies benefited from Embrace incubators in 2022.

Dr. Leah Seaman has been using Embrace incubators for three years in Zambia. Seaman is a doctor working in pediatrics for the last 12 years, including six years focusing on neonatal care at the Kapiri Mposhi District Hospital in the Central Province of Zambia.

Seaman has also been busy setting up a new specialized neonatal ward in the rural district hospital. “When I first came to Zambia, we had one old incubator that would draw a lot of power,” she said. “We often struggle with power cuts here, so even the voltage can be too low for the incubator to function well. Having enough space to set up conventional incubator was an issue as well.”

So she reached out to Chen in late 2020 after researching solutions that would work for the specific conditions in Zambia.

“In Zambia, 13% of births are premature, and that’s not even including low-birth-weight babies born at term,” she said. “We needed an effective solution.”

Embrace Global donated 15 incubators to the hospital. The new neonatal ward, set to open this month, is built around the Embrace incubator stations with Kangaroo mother care, or skin to skin contact between mother and baby.

“Last year we had 800 babies through the ward and maybe half of them used the Embrace incubator,” said Seaman. “This year we’ve had over 800 already. We haven’t asked for any conventional incubators because from 1 kg (2.2 lbs) and above, the Embrace incubator does the work.”

Because of their heavy use, Seaman said the main challenge with the incubators is making sure that the heating pad is kept warm and reheated in a timely manner. “We’ve built a mattress station where we will be teaching the new mothers how to do that,” she said.

“Why do we keep babies warm? It’s not just a nice thing. It literally does save lives,” Seaman said.

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October 27, 2023
Opinion: Mifepristone saved my life | CNN

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Editor’s Note: Roxanne Jones, a founding editor of ESPN The Magazine and former vice president at ESPN, has been a producer, reporter and editor at the New York Daily News and The Philadelphia Inquirer. Jones is co-author of “Say it Loud: An Illustrated History of the Black Athlete.” She talks politics, sports and culture weekly on Philadelphia’s 900AM WURD. The views expressed here are solely hers. Read more opinion on CNN.

CNN
—

The ruling earlier this month by a Texas federal judge to suspend the US Food and Drug Administration’s approval of a drug that is used frequently for medication abortions, is very personal for me.

That’s because I took mifepristone years ago during a miscarriage, and it saved my life.

When I was prescribed mifepristone, it had not yet taken center stage in America’s abortion wars. I did not have to make a rushed road trip across state lines to get my medicine, unlike many women who need the drug but live in one of the many states that have restricted access to medication abortion or passed near-total bans on abortion.

I was not forced to set up a secret meet-up with a stranger in order to buy my medicine on the black market, as several women I spoke to recently said they planned to do. Nor did I have to order mifepristone online and find myself navigating the many scammers taking advantage of the current patchwork of state abortion laws in the US.

Mifepristone is one of two drugs used in a medication abortion and the other, misoprostol, was not subject to the ruling by the Texas judge. The two drugs can be administered to someone having a miscarriage, allowing them to terminate the pregnancy when the fetus is not viable.

It happened some years ago: After experiencing more than a day of hemorrhaging during the first trimester of my pregnancy, I visited my ob-gyn, who explained after examining me that my blood pressure was dropping rapidly and the heavy bleeding I was experiencing was an unmistakable sign of a miscarriage.

For many women, being prescribed mifepristone is part of their routine medical care. Not so in my case: As my doctor explained, I was facing a dire medical emergency. I was grateful for the medication that saved my life.

My miscarriage took me by surprise. I had loved being pregnant the first time around, about a decade earlier. And as a healthy woman, I had no reason for fear when I became pregnant again. By the time I was administered mifepristone, I was losing a life that I had already begun to love. And like many other women, despite my level of education or economic status, I could not outrun the statistics that put Black women at higher risk.

Up to one in four known pregnancies will end in a miscarriage. And for Black women, the numbers are alarmingly higher. According to an analysis of 4.6 million pregnancies in seven countries, the risk of a miscarriage for Black women is 43% higher than for White women.

In the Black community, women have traditionally been taught to bear their burdens silently — keep your business to yourself — even after something as devastating as pregnancy loss. We are conditioned to do as I did back then, and keep it moving as we try to outrun the long list of statistics that tell us our lives are in danger from every direction, whether it be from health care risks to societal injustices or other stressors.

During my miscarriage, I was a woman who was afraid, hemorrhaging and in excruciating pain, in desperate need of safe, emergency medical care. Thanks to the administration of mifepristone, I was allowed dignity during my miscarriage. It’s what every woman deserves — whether it be facing a potentially life-threatening miscarriage or seeking an abortion.

I learned from my experience that every miscarriage matters. Women must have access to whatever medicines and counseling we need to help us heal and that includes mifepristone. What we don’t need is to be criminalized by politicians and punitive reproductive laws that have long been out of step with public opinion. Despite the continuing political attacks on women’s reproductive rights, more than 61% of US adults say abortion should be legal in all or most cases, according to Pew Research Center.

After the US Justice Department asked the Supreme Court to intervene, Justice Samuel Alito issued a temporary order to preserve the status quo, ensuring access to the drug while giving the justices more time to study the issue.

I am hoping the justices can put politics aside and focus on the science surrounding the safety of mifepristone, a drug that, thankfully, I had access to when my life was in danger. Mifepristone, a synthetic steroid, is even safer than common prescription drugs including penicillin and Viagra.

Following the science demands that, regardless of where you stand on the issue of abortion, consideration must be made for cases like mine and the millions of other women who for years have safely used this medication for complications surrounding miscarriages.

We do not know how the legal fight over medication abortion will unfold. But women across the nation – in blue and red states alike – are watching. Punitive laws like the one signed last week by Florida Gov. Ron DeSantis seek to criminalize reproductive care providers. And worse, they are stripping us of rights that men take for granted – it’s unlikely they will be prohibited by the law from making health care decisions about their own bodies.

It must end. And I’m betting that whether it be with our voice or our votes, women will have the last word.

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April 18, 2023
Prince Harry says William ‘screamed’ at him over royal split with Meghan, in final episodes of Netflix documentary | CNN

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CNN
—

Prince Harry said it was “terrifying” to have his brother, Prince William, scream at him during his bitter split from the royal family, in the final installments of the Duke and Duchess of Sussex’s controversial Netflix documentary that were released Thursday.

The fourth, fifth and sixth episodes of “Harry & Meghan” cover the pair’s challenges since their 2018 wedding, Meghan’s deteriorating mental health and her 2020 miscarriage, and ultimately their decision to quit as working members of the family.

Harry said he initially asked for a “half in, half out” arrangement, where Harry and Meghan would have their own jobs but still work in support of the Queen, during a crunch family meeting. “But it became very clear very quickly that that goal was not up for discussion or debate,” Harry said.

“It was terrifying to have my brother scream and shout at me, and my father say things that just simply weren’t true, and my grandmother quietly sit there and take it all in,” he said, recalling the conversations with Prince William, then-Prince Charles, and Queen Elizabeth II.

“But you have to understand that from the family’s perspectives, especially from hers, there are ways of doing things. And her ultimate mission and goal, responsibility, is the institution … she’s going to go on the advice that she’s given,” Harry said.

The pair describe throughout the new episodes how, in their view, their position within the royal family became untenable after constant hounding from Britain’s media and repeated disregard for the couple’s wellbeing inside palace walls.

Buckingham Palace reiterated it will not comment on the documentary on Thursday. Royal engagements are meanwhile continuing, with King Charles and Camilla, the Queen Consort, set to visit a community kitchen in London and attend a carol service with the Prince and Princess of Wales and other members of the family.

Harry hinted that there was jealousy from other royals towards Meghan given the amount of media attention she was initially receiving. “The issue is when someone who is marrying in, who should be a supporting act, is then stealing the limelight or is doing the job better than the person who is born to do this,” he said.

“That upsets people. It upsets the balance. Because you have been led to believe that the only way that your charities can succeed and your mission can grow is if you are on the front pages of those newspapers.”

The series also touches on Meghan’s deteriorating mental health and her miscarriage in July 2020. “I was pregnant. I really wasn’t sleeping. The first morning that we woke up in our new home is when I miscarried,” Meghan said.

She described experiencing suicidal ideation, telling the filmmakers she believed “all of this will stop if I’m not here. And that was the scariest thing about it, it was such clear thinking.”

“The lies, that’s one thing. You kind of get used to that when you live within this family,” Harry added. “But what they were doing to her, and the effect it was having on her… enough. Enough of the pain, enough of the suffering.”

“I just did everything I could to make them proud, and to really be a part of the family,” Meghan said in the fifth episode, speaking of her relationship with the other royals. “And then the bubble burst.”

“I realized that I wasn’t just being thrown to the wolves, I was being fed to the wolves,” she said.

The highly anticipated Netflix documentary marks the Sussexes’ latest attempt to reclaim the narrative surrounding their departure from royal life.

It features details on the increasingly tense relationships between Harry and his brother, WIlliam, and his father, King Charles III. And it emphasizes the suggestion that the royals wanted to sideline and isolate the couple, often through the planting of negative media reporting, rather than have them dwarf more senior royals in popularity.

“My dad said to me: ‘Darling boy, you can’t take on the media. The media will always be the media,” Harry said, describing the palace’s relationship with news outlets as a “dirty game.”

The culmination of the breakdown between the royal institution and Harry and Meghan, who were once touted by parts of the media as the modernizing force the monarchy needed, was their historic and controversial decision in early 2020 to quit as working royals and leave the UK.

Harry said he spoke to Queen Elizabeth II and arranged to meet her, with Meghan, before that split was finalized.

“She knew that we were finding things hard. I’d spoken to her many times about it,” Harry said. But as the meeting approached, Meghan said they received a message from an aide telling them they were not allowed to see the monarch.

“I’ve actually been told that I’m busy all week,” the Queen then told Harry, according to his recollection. “I was like, wow,” Harry said. “This is when a family and a family business are in direct conflict … really what they’re doing is blocking a grandson from seeing his grandmother,” added Meghan.

The couple were critical of the Queen’s aides but again were again complimentary of the late monarch herself, who died aged 96 in September, shortly after filming concluded for the series.

Their documentary, and Harry’s upcoming memoir, focus more attention on the difficult relationship between the prince and his father, King Charles.

Thursday’s release follows last week’s batch of episodes, in which Prince Harry criticized “unconscious bias” inside the family.

It remains to be seen whether the venture will enhance the reputation of the couple as they look to sculpt their post-royalty personas.

Six in 10 Brits believe it was a bad idea for the duke and duchess to release the Netflix documentary, according to a Savanta poll of 2,250 British adults carried out online between December 9 and 11, between the release of the first and second parts of the series.

The same poll found that Harry and Meghan both have negative approval ratings among the British public – -3 and -19 respectively, when subtracting those with a negative opinion from those with a positive one – unlike the high popularity of Prince William (+60) and Charles III (+36).

If you or someone you know is struggling with suicidal thoughts or mental health matters, please call the National Suicide Prevention Lifeline at 800-273-8255 to connect with a trained counselor or visit the NSPL site. The International Association for Suicide Prevention and Befrienders Worldwide also provide contact information for crisis centers around the world.

Sign up for CNN’s Royal News, a weekly dispatch bringing you the inside track on the royal family, what they are up to in public and what’s happening behind palace walls.

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December 15, 2022