Health24.com | Is it safe for me to take that medication if I’m breastfeeding?

Far too little is known about the safety of medication use during breastfeeding – and it’s time to get some answers, experts say.

It’s a critical gap, given that breastfeeding is the best source of nutrition for babies – and moms are encouraged to do it. But when a woman has questions about the safety of any medication she’s taking, doctors typically have little evidence-based advice to offer.

That’s according to a perspective piece in the New England Journal of Medicine highlighting the dearth of evidence on the matter.

“The point of this article is to raise awareness of the issue,” said co-author Dr Catherine Spong. “We need to encourage more research.”

Spong is vice-chair of obstetrics and gynaecology at the University of Texas Southwestern Medical Center in Dallas.

The need for this kind of research has been recognised for decades, Spong and colleague Dr John Byrne pointed out. In the 1980s, separate reports from the US Department of Health and Human Services and the American Academy of Pediatrics highlighted the gap, for example.

But it took 20 years for the US Food and Drug Administration to issue guidance for industry on how to conduct studies of breastfeeding women. And it was only last year that a federal task force published a report with recommendations on research needs for pregnant and breastfeeding women.

The recommendations said that those women should be included in drug research studies, unless there is “scientific justification” not to – and that regulatory barriers to their participation should be removed.

Change is coming

“There’s been a misperception that you can’t do research in this population,” Spong said. And that has denied women valuable information, she added.

It’s not that studying breastfeeding women is too hard, said Christina Chambers, a professor of paediatrics at the University of California, San Diego (UCSD).

“It just takes time and money,” she said.

Chambers is also president of MotherToBaby, a free service of the non-profit Organization of Teratology Information Specialists. It provides women with information on medication safety during pregnancy and breastfeeding.

Chambers said she hopes the new article brings attention to the lack of research. But she was also optimistic that “hopefully, now, a sea change is coming”.

Chambers is programme director of a breast milk repository at UCSD that is providing the first-ever research database of breast milk samples. It will allow scientists to study, among other things, medication safety.

Recommendations where possible

A first question is whether a given medication even gets into a woman’s breast milk. And, if so, at what amount?

“Then, what parents really want to know is, what does it do?” Chambers said.

Are there any short-term effects on the baby, like fatigue, irritability or diarrhoea? Beyond that, there are the longer-term questions of whether medication exposures can affect growth or brain development in any way.

Even if a medication did have small effects, Chambers noted, that would have to be weighed against the benefits of breastfeeding.

For now, both Chambers and Spong recommended the website LactMed as a good resource on medication safety during breastfeeding. It’s run by the US government and pulls together scientific evidence on individual medications – giving recommendations when possible.

But as of November 2018, only 2% of products on the site had recommendations based on “strong data,” Spong said.

Certain reassurances

She stressed, however, that the intention is not to scare women away from breastfeeding – but to point to a research need.

“I don’t want anyone to come away from this thinking, ‘I shouldn’t breastfeed,'” Spong said.

Chambers agreed. And there are certain reassurances in what scientists know at this point, she noted.

According to LactMed, for example, the painkiller ibuprofen (Advil) gets into breast milk at “extremely low levels” – much lower than the dose that would be given to an infant. So it’s considered a “preferred choice” for nursing moms who need pain relief.

Chambers pointed to the monoclonal antibody therapies used for conditions such as rheumatoid arthritis and Crohn’s disease. They are large proteins that have to be given by IV because they cannot be absorbed orally, so experts believe they are unlikely to be a risk to breastfed babies.

Any woman with worries over her medications should talk to her doctor, Spong said.

To learn more, Chambers added, they can contact a MotherToBaby counsellor for free.

Image credit: iStock

NEXT ON HEALTH24X

Share Button

Health24.com | New ‘cancer vaccine’ attacks tumours from within

A new method of brewing a cancer vaccine inside a patient’s tumour could harness the power of the immune system to destroy the disease, researchers report.

Immune stimulants are injected directly into a tumour, which teaches the immune system to recognise and destroy all similar cancer cells throughout the body, said senior researcher Dr Joshua Brody. He is director of the Lymphoma Immunotherapy Program at the Icahn School of Medicine at Mount Sinai in New York City.

Complete destruction of tumour

“We’re injecting two immune stimulants right into one single tumour,” Brody said. “We inject one tumour and we see all of the other tumours just melt away.”

Eight out of 11 lymphoma patients in a small, early clinical trial experienced partial or complete destruction of the tumour that received the initial injection, according to the report published April 8 in the journal Nature Medicine.

The vaccine also halted overall cancer progression in six patients for three to 18 months, and caused significant regression or actual remission in three patients, the investigators found.

The results were solid enough that the research team is expanding its next clinical trial to include lymphoma, breast, and head and neck cancer patients, Brody said. That trial started in March.

Prior efforts at unleashing the immune system to fight cancer have focused on T-cells, which Brody calls the “soldiers” of the immune army because they directly attack harmful invaders in the body.

Drugs called checkpoint inhibitors help T-cells identify cancer cells as the bad guys and kill them off.

“We call them the ‘Jimmy Carter’ medicines because that’s what Jimmy got when he had very advanced-stage melanoma,” Brody said.

‘Immune generals’

But the checkpoint inhibitors have typically only been able to help about one in five cancer patients significantly, “so there’s lots of room for improvement,” he added.

This new vaccine approach focuses on dendritic cells, which Brody calls the “generals” of the immune system’s army. Dendritic cells guide the response of T-cells to fight off invaders.

“We’re trying to mobilise these immune generals to tell the soldiers what to do,” Brody said.

Patients first received nine daily injections of an immune stimulant intended to “recruit” dendritic cells by teaching them how to recognise cancerous cells, the study authors said.

The patients then received eight injections of a second stimulant that “activates” the dendritic cells, prompting them to instruct T-cells to hunt and destroy the now revealed cancer cells in the body.

Essentially, the method turns the injected tumour into a cancer vaccine factory, the researchers explained.

Teaching the immune system

The approach differs from traditional vaccines for the flu or measles because those are preventive, teaching the body beforehand how to fight off an infectious disease, Brody pointed out.

This vaccine is therapeutic. “We’re trying to teach the immune system to get rid of the thing even after you’ve already got the problem,” he said.

Lab tests involving mice show that this vaccine approach could be at least three times more powerful if combined with checkpoint inhibitors, Brody added.

Because of this, patients in the new trial will receive both the vaccine and checkpoint inhibitors, the researchers said.

Susanna Greer, scientific director of clinical cancer research and immunology for the American Cancer Society, said that “priming” dendritic cells inside a person’s tumour to produce the best anti-tumour immune response “suggests a promising immunotherapy strategy.”

“Additional human studies are warranted to confirm these findings,” Greer said.

‘Indolent lymphoma patients’

Dr Catherine Diefenbach, director of clinical lymphoma at the NYU Langone Perlmutter Cancer Center in New York City, said the vaccine approach is “novel and extremely interesting”, and could help explain why checkpoint inhibitors usually don’t help patients with non-Hodgkin lymphoma.

However, she noted that really only three of the 11 patients in the initial clinical trial had truly meaningful responses to the vaccine.

“These are indolent lymphoma patients,” said Diefenbach, an expert for the American Society of Clinical Oncology. “The fact there was stable disease doesn’t really mean anything because these cancers don’t grow fast.”

Image credit: iStock

Share Button

Private hospitals ‘must do more to keep patients safe’

Rogue surgeons like Ian Paterson must not be able to harm anyone again, surgeons’ leaders say.

Share Button

Children’s mental health services ‘postcode lottery’

Spending on children’s mental health services is up 17% but some areas have missed out on extra funds.

Share Button

Headaches 101: Know your type

Mayo Clinic does not endorse companies or products. Advertising revenue supports our not-for-profit mission.

Advertising & Sponsorship

Mayo Clinic Marketplace

Check out these best-sellers and special offers on books and newsletters from Mayo Clinic.

Share Button

This Plus-Size Influencer’s Stunning Bikini Post Is the Body Positivity Inspiration You Need

ASOS once again proved that they're on the right side of the body positivity movement—and unsurprisingly, the internet is loving it. 

On March 29, ASOS regrammed a photo from plus-size influencer Callie Thorpe’s Instagram account that showed Thorpe and fellow influencer Chastity Garner Valentine posing in matching green and white two-piece swimsuits next to a pool. The clothing line captioned the photo, “First stop: the holiday outfit wall:women_with_bunny_ears_partying:” and tagged both bikini-clad babes and photographer Julianny Casado. 

In typical internet fashion, though, some comments on the post were less than kind. ASOS has since deleted a majority of the blowback, and supportive commenters were quick to call out the trolls for their hateful remarks. 

“Do people realize that overweight people still need clothes to wear?! Just because you don't like the way they look doesn't meant they cease to exist,” one commenter wrote. 

“I’m glad that they found the confidence, even though they get nasty comments. This isn’t about promoting an 'unhealthy' lifestyle. It’s about promoting body confidence and body acceptance,” wrote another. 

RELATED: These Influencers Are Posing in Swimsuits That Show Off Their Scars and Cellulite—and It's the Message We Need for Summer

Thorpe’s husband, Daniel Hetherington, also expressed his opinion about the criticism.

“It's disappointing to see such nasty comments on such a beautiful picture. The woman on the right is my wife and it annoys and upsets me that people can be so mean to others,” Hetherington wrote in a caption. “She is the most kind hearted, caring and loving person I know and someone's size should never be a topic of conversation.”

As for Thorpe? She's focusing on all the appreciative comments she's received on her photo. Thorpe responded to dozens of commenters under her Instagram photo, thanking them for their support.

RELATED: 10 Body Positive Moments of 2018 That Were Major Wins for All Women

Share Button

What We Can Learn from Diana Nyad

Getty Images

 

The list of women athletes I admire is long. When I was 10, I wanted to be FloJo—I remember watching her break her own world record and win the gold medal at the 1988 Olympics in the 200 meters. In high school, I played varsity soccer, so for me, there was no one who could handle the ball better than Mia Hamm.

After the death of a close friend, I turned to long-distance running, and somehow found myself chatting it up with Olympic bronze medalist Deena Kastor a couple of weeks before my first marathon.

She was nice enough to give me some tips for how best to handle the 26.2-mile monster. I also have a bunch of friends—Robin, Chiara, Sheila, and NSQ to name a few— whose monikers mean nothing to you, but whose dedication to their sports and athleticism constantly leave me in a state of awe.

And then there is Diana Nyad—a hall of fame swimmer, born and bred in New York City, who attempted to swim the 103 miles between Miami (my hometown) and Cuba for the fourth time earlier this week. While Nyad was forced to end her swim early, there is much we can learn from her.

If at first you don’t succeed, try, try, again. It may have been over 30 years before Nyad would don a swimsuit after her first attempt to cross the Straights of Florida in 1978 didn’t go as planned, but she did indeed try again. Half of the battle is building up the courage to follow your dreams. One thing is for sure, Nyad will never have to wonder ‘what if?’

See the success in your setbacks. Let’s face it, things won’t always go as planned. In Nyad’s case, stings from box jelly fish and tropical storms pushing her off course made it too tough to complete her swim. But, I’d hardly call this a failure. Why don’t we look at the fact that she braved the open seas for over 60 hours and swam halfway to Key West—that in itself is an accomplishment!

Age is just a number. In the last couple of years we have seen women, particularly those considered past their “prime,” take on incredible athletic feats. A 41-year-old swimmer clutching the sliver medal in the 2008 Olympics—check! A 60-year-old runner who is kicking butt and taking names on the local running scene—check! An endurance swimmer, who at 62, (she just turned 63 on Wednesday. Happy Birthday Diana!) is constantly pushing her body to the limits to do what others deem as impossible—check!

Any way you slice it Diana Nyad is an inspiration. (Did I mention Nyad still holds the world record for the longest ocean swim—102.5 miles from Bimini in the Bahamas to Jupiter, Florida?) I hope I have half of her tenacity when I reach her age. (Want to learn more? Check out this awesome documentary on Nyad.)

So, to all the amazing women out there, I implore you to continue to follow your dreams. And in the famous words of Doree from Finding Nemo—just keep swimming!

 

 

 

 

Share Button

Smallville Actress Allison Mack Recruited Women for a Sex Cult—Why Would a Person Do That?

Nothing fascinates us quite like cults. Documentaries about them have a, well, cult following, and groups that are rumored to have cult-like characteristics repeatedly make headlines. This week's news, however, is about more than just rumors.

On Monday, Smallville actress Allison Mack pleaded guilty to charges related to a group called Nxivm, after she allegedly manipulated and blackmailed women into being "sex slaves" for its leader.

Nxivm is a group based in Albany, New York, that billed itself as a self-help organization. In late 2017, the New York Times published an article about a disturbing internal society within Nxivm (called D.O.S.) that did horrifying things, such as burn founder Keith Raniere’s initials below members' hips with a cauterizing device. The article also alleged that members were told to starve themselves to achieve Raniere’s standard of beauty so they could have sexual encounters with him.

RELATED: College Admissions Scandal: A Psychologist Explains Why a Parent Would Cheat and Lie to Get Their Kids Into School

Since the investigation into the society began, increasingly alarming details have emerged, especially about Mack's involvement. In April 2018, Mack was arrested by the FBI on charges of sex trafficking, conspiracy to commit sex trafficking, and forced labor. At the time, she pleaded not guilty, but this week, she changed her plea.

As Mack tearfully pleaded guilty to racketeering and racketeering conspiracy, she also admitted to recruiting women into the cult by telling them they were joining a female mentorship program. In addition, she confessed to forcing them to give her damaging personal information, or "collateral," so that she could blackmail them if they didn't follow her or Raniere’s orders. Now, Mack faces up to 40 years in prision. She's set to be sentenced in September. 

Sounds like it could be straight out of one of those bingeworthy cult documentaries on Netflix, right?

Mack's involvement in this skin-crawling scheme got us thinking: How does an intelligent, successful young woman get caught up in such a twisted dystopian cult? Alexandra Stein, PhD, author of Terror, Love and Brainwashing: Attachment in Cults and Totalitarian Systems, has many thoughts on this, especially because she was once a member of a cult herself. 

RELATED: Jussie Smollett Lied About Being the Victim of a Hate Crime, Police Say. Why Would Someone Do That?

First, Stein says people don't knowingly join cults. "Someone might go to a yoga class, or to a personal development seminar, or to a church, all for perfectly normal reasons," she says, explaining that cults often have a convincing facade. Nxvim, for example, held so-called professional development seminars. Mack told the judge on Monday that she first joined the group to “find purpose.”

Researchers have tried to create a psychological profile of those who are vulnerable to cults, Stein says, but they've found that there's more than one profile. Cults manage to deceive an array of people. "We do find, though, that people might be situationally vulnerable at a particular point in their lives," she says. "If they've had a normal life change, maybe they've moved, changed jobs, or had a breakup, they're more likely to try something new. You may then, by bad luck, run into a dangerous relationship, whether it's with an individual or a group."

Most people aren't taught the warning signs of coercive relationships, she adds, which makes us vulnerable to cult tactics. Members lure new followers by claiming the group will make you empowered, fulfilled, loved, rich, holy, and more. Then, they slowly isolate you. They say your family and friends will only hold you back, or, in some cases, they may keep you so busy with the group that you don't have any time for your old life. 

After they've cut off a new member from the outside world, it's rather easy for them to convince that person to do illegal things for the good of the group. "It's very hard for us as humans, as isolated humans, to hang onto our own sense of right without any kind of social support," Stein says. In other words, if every single person around you is telling you breaking the law is right, you'll quickly begin to believe it is. 

RELATED: Kidnapped Teen Jayme Closs Escaped Her Abductor. Here’s What She May Be Going Through Now

A member may know in their gut that what they're doing is wrong, but they've been conditioned to see the group as their one and only source of safety. So if they feel scared or stressed, they turn to the group for comfort, but they don't realize that the group is actually what's causing their stress. That creates a dangerous cycle. This "trauma relationship," as Stein calls it, can also cause people to dissociate, or completely disconnect from their thoughts, feelings, memories, and sense of identity.

New members will also be gradually introduced to the idea of doing illegal things, so by the time they're committing crimes that could put them in jail for life, it doesn't feel like as big of a deal. Plus, there's punishment for saying no, such as the release of the "collateral" that Mack collected. 

Those punishments are typically implemented by the leader, who is seen as a god among the cult. Stein compares cult leaders to abusive boyfriends: They manipulate people by pretending to love them, making them dependent on that love by isolating them from the rest of the world, and then controling them by saying they won't get that love unless they do everything that's asked of them. 

Steve Hassan, author of Combating Cult Mind Control: The #1 Best-selling Guide to Protection, Rescue, and Recovery from Destructive Cults, also once belonged to a cult. Hassan tells Health that, while no one is excusing Mack of her criminal actions, we do need to remember that people don't voluntarily join cults. Mack, along with all other members of Nxivm, was brainwashed by the group she joined. Cult members are victims of the people who found such groups, and unfortunately, some remain victims for their entire lives. 

RELATED: What It Means to Be a High-Functioning Sociopath—and How to Tell If You Know One

Share Button

Ovarian cancer patients undertested for mutations that could guide clinical care

Fewer than a quarter of breast cancer patients and a third of ovarian cancer patients diagnosed between 2013 and 2014 in two states underwent genetic testing for cancer-associated mutations, according to a study by researchers at the Stanford University School of Medicine and several other organizations.

The findings indicate that substantial gaps exist between national guidelines for testing and actual testing practices. In particular, the findings show that too few women with ovarian cancer are tested for the presence of mutations that could be used to guide health care decisions.

The study looked at about 83,000 women diagnosed with breast or ovarian cancer in California and Georgia in 2013 and 2014.

“We initiated this study — the largest population-based study of multigene testing in breast and ovarian cancer patients — because we wanted to see what cancer genetic testing and results looked like in the real world,” said Allison Kurian, MD, MSc, associate professor of medicine and of health research and policy at Stanford. “Now we can see that women with ovarian cancer are dramatically undertested. We also learned that between 8 and 15 percent of women with breast or ovarian cancer carry cancer-associated mutations that could be used to drive care decisions and influence family members’ health care and screening choices.”

Kurian shares lead authorship of the study, which will be published online April 9 in the Journal of Clinical Oncology, with Kevin Ward, PhD, MPH, assistant professor in epidemiology at Emory University. Lynne Penberthy, MD, MPH, associate director for the National Cancer Institute’s Surveillance Research Program, and Steven Katz, MD, MPH, professor of medicine and of health management and policy at the University of Michigan, are co-senior authors.

Changing guidelines

Researchers have known for decades that inherited mutations or variations in certain genes, notably BRCA1 and BRCA2, increase the risk of developing breast and ovarian cancers. Genetic tests for mutations in BRCA1 and BRCA2 have been available for several years. But since 2013, genetic tests have incorporated many more potential cancer-susceptibility genes, and results have become much more complicated.

“Integrating genetic counseling and testing into the management of cancer after diagnosis has become much more challenging for patients and their clinicians,” Katz said.

National guidelines recommend that all women with the most common type of ovarian cancer be tested for the presence of cancer-associated mutations; guidelines for testing breast cancer patients have been less expansive. Although the guidelines for genetic testing have expanded to include more patients diagnosed with breast or ovarian cancer and the more extensive multigene panel tests, it’s not been clear to what degree these guidelines are followed in real-world clinical settings. Furthermore, the prevalence of known cancer-associated mutations in breast and ovarian cancer patients who are racial or ethnic minorities, as well as in the overall population, is unknown.

For the study, the researchers tapped the National Cancer Institute’s Surveillance, Epidemiology and End Results Program, which tracks cancer diagnoses and outcomes in large populations across the United States. They linked data on cancer cases in California and Georgia with data from four laboratories conducting the majority of cancer genetic testing from 2013 to 2014. They found that only 24.1 percent of 77,085 women diagnosed with breast cancer and 30.9 percent of 6,001 diagnosed with ovarian cancer underwent any genetic testing.

Disparities in genetic testing

The researchers also observed disparities in testing, particularly among ovarian cancer patients. Although nearly 34 percent of non-Hispanic white women were tested, only about 22 percent of black women and 24 percent of Hispanic women were tested. Income and insurance status played a role in the prevalence of testing among women with ovarian cancer from all racial and ethnic groups, the researchers found. About 20 percent of patients with Medicare were tested compared with about 34 percent of patients with other forms of health insurance. Testing prevalence decreased to about 20 percent in areas where residential poverty equaled or surpassed 20 percent, and it was about 38 percent in regions where the poverty level was less than 10 percent.

The researchers found that among women with breast cancer in the study who underwent testing for a panel of guideline-designated genes, the prevalence of mutation variants of unknown significance was much higher in minority patients: 28.5 percent, 26.6 percent and 19.3 percent in African-American, Asian and Hispanic patients, respectively, versus 14.5 percent in non-Hispanic whites. The prevalence of pathogenic variants also varied along racial and ethnic lines.

“These differences underscore the need to improve the clarity of genetic test results, especially for racial or ethnic minority patients,” Kurian said.

Story Source:

Materials provided by Stanford Medicine. Original written by Krista Conger. Note: Content may be edited for style and length.

Share Button

Virtual reality offers benefits for Parkinson’s disease patients

Researchers are reporting early success with a new tool to help people with Parkinson’s disease improve their balance and potentially decrease falls with high-tech help: virtual reality. After practicing with a virtual reality system for six weeks, people with Parkinson’s disease demonstrated improved obstacle negotiation and balance along with more confidence navigating around obstacles in their path.

For many people with Parkinson’s disease, the simple act of walking through the house or neighborhood can be a treacherous undertaking. The muscle and movement problems caused by the disease decrease a person’s range of motion and impair balance, often leading to falls and injuries.

To help patients manage these challenges, researchers created a virtual reality training system that gives patients a safe space to hone their muscle control and balance. Patients walk on a treadmill while stepping over virtual objects that appear before them. If they are successful in one round, the objects become larger in the next round.

“The primary advantage is that they can encounter multiple obstacles and terrains while a safe environment is maintained using equipment such as a fall restraint tether,” said K. Bo Foreman, PT, PhD, associate professor and director of the Motion Capture Core Facility at the University of Utah. “Participants enjoyed the experience and thought it was fun, not just exercise. They liked training and challenging themselves without the fear of falling.”

Foreman will present the research at the American Association of Anatomists annual meeting during the 2019 Experimental Biology meeting, held April 6-9 in Orlando, Fla.

The researchers tested their training system in 10 patients with Parkinson’s disease who used it for three 30-minute sessions a week for six weeks. After the program, participants showed significant improvements in their ability to negotiate over large and small boxes, better balance and a wider range of motion in the hip and ankle, all of which have been previously shown to correlate with a lower risk of falls.

“We are hopeful that this improved performance relates to decreased falls in their everyday life,” said Foreman. “Parkinson’s disease is a progressive disease, and anything we can do to impact the progression is a step in the right direction.”

The team tested their program in the University of Utah’s Treadport, a CAVE-like virtual environment with a locomotion interface allowing digital scene projection across multiple walls and the floor. Many universities have CAVEs (a term for room-sized immersive virtual reality environments), though medical centers usually do not. The research team is working with the University of Utah’s hospital system to explore adding a Treadport to its rehabilitation facility. In addition, the team hopes to adapt the virtual reality system for head-mounted virtual reality devices, which would make it more widely available and easier to implement for clinical use, Foreman says.

While the initial test did not include any patients who did not undergo the virtual reality training or any people without Parkinson’s disease for comparison, as a next step the team plans to investigate how their outcomes compare to studies in which Parkinson’s patients have undergone traditional training programs or none at all.

Story Source:

Materials provided by Experimental Biology. Note: Content may be edited for style and length.

Share Button