The Food and Drug Administration (FDA) says Kim Kardashian’s social media posts violate federal drug-promotion rules.
Kim Kardashian, who is 5 months pregnant with her second child, recently began promoting a prescription pill to treat morning sickness through her social media accounts. Such endorsement deals are relatively common for celebrities.
In posts to Instagram and Facebook earlier this month Kim Kardashian talks about her struggles with nausea due to pregnancy.
The reality star wrote: “I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor.
“He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby.”
Kim Kardashian, 34, has over 42 million followers on Instagram and 25 million on Facebook.
The posts link to a company website that includes the FDA-approved labeling information.
Photo Instagram
However, FDA regulators say the posts violate rules for promoting drugs because they don’t mention side effects of Diclegis, which include sleepiness that can make it dangerous to drive or perform other activities that require mental alertness. The drug label warns that Diclegis should not be combined with alcohol or other medications that cause drowsiness, such as sleeping aids or certain pain relievers.
FDA regulations require manufacturers to balance benefit claims with information about drugs’ risks, even when space is limited.
The posts also fail to mention that Diclegis is not approved for women with a form of prolonged vomiting that causes dehydration, the FDA notes.
The FDA posted its warning letter online on August 11, addressed to the CEO of Canadian drugmaker Duchesnay Inc., which markets the drug. The letter notes that the privately held company received a similar warning in 2013 for omitting risk information from a letter to doctors.
FDA regulators are “concerned that Duchesnay is continuing to promote Diclegis in a violative manner,” states the letter dated August 7.
The agency calls on the company to remove the social media posts immediately and outline a plan for preventing future violations by August 21
The Quebec-based company said in a statement it “will take quick action in responding to the FDA’s letter and immediately and effectively address any issues”.
The FDA approved Diclegis in 2013 to treat vomiting and nausea in pregnant women who do not respond to more traditional measures. It is the only prescription drug approved in the US for morning sickness.
A different version of the drug was recalled by the agency in 1983 following a series of lawsuits alleging links to birth defects. However, FDA investigations never established any link between the drug and the reported problems.
Kim Kardashian’s posts cited by the FDA no longer appeared on her accounts on August 11.
Anti-thalidomide hero Frances Oldham Kelsey has died at the age of 101.
The Canadian doctor played a central role in preventing the drug being distributed in the US.
Frances Oldham Kelsey refused to approve thalidomide while working for the FDA in the 1960s.
It was later found that thalidomide – prescribed to pregnant women to ease morning sickness – was causing thousands of babies to be born with missing limbs or organs. Many died.
Photo Wikipedia
Dr. Kelsey was lauded by citizens’ groups and was awarded honorary degrees.
She passed away in London, Ontario, on August 7, Canada’s CBC reported.
Her daughter Christine Kelsey was by her side.
Frances Oldham Kelsey is seen as a hero by many across the US for raising concerns about the safety of thalidomide, which is also known as Kevadon.
She continued to press the manufacturer – who complained about her attitude – for information.
The side-effects of the drug then became apparent as the battle of wills dragged on.
Frances Oldham Kelsey was given the award for distinguished federal civilian service by President John F. Kennedy.
Last month Frances Oldham Kelsey was appointed to the Order of Canada.
2Day FM, the Australian radio station whose DJs made a hoax call to nurse Jacintha Saldanha who was later found dead, is to give at least 500,000 AUD to a fund for her family.
Sydney broadcaster 2Day FM said it would donate the money from its advertising profits.
Jacintha Saldanha transferred the call to a colleague who gave information about Kate Middleton, who was a patient at the London hospital.
Her post-mortem examination is to take place later.
Jacintha Saldanha answered the Australian presenters’ call in the early hours of the morning on December 4th and, believing they were members of the Royal Family, put them through to another nurse, who gave an update on the duchess’s condition in detail.
Kate Middleton was being treated in the King Edward VII’s Hospital for hyperemesis gravidarum, an extreme form of morning sickness.
Jacintha Saldanha, 46, was pronounced dead on Friday morning at staff accommodation close to the hospital. An inquest into her apparent suicide is due to be opened in the next few days.
The company which owns the station, Southern Cross Austereo, said all profits from advertising on 2Day FM for the rest of the year would be donated to an appropriate memorial fund that would directly benefit the family, with at least 500,000 Australian dollars being donated.
Rhys Holleran, SCA’s chief executive, said: “We are very sorry for what has happened. It is a terrible tragedy and our thoughts continue to be with the family.
“We hope that by contributing to a memorial fund we can help to provide the Saldanha family with the support they need at this very difficult time.”
It also cancelled its Christmas party, saying it would be “inappropriate” to go ahead.
2Day FM, the Australian radio station whose DJs made a hoax call to nurse Jacintha Saldanha who was later found dead, is to give at least 500,000 AUD to a fund for her family
Lord Glenarthur, chairman of King Edward VII’s Hospital, welcomed the media company’s decision and said it could contribute to the hospital’s own memorial fund.
He added that it had received many donations from around the world.
Jacintha Saldanha’s family made a private visit to King Edward VII’s Hospital in London, where she worked, on Monday.
MP Keith Vaz, who met Jacintha Saldanha’s family in Parliament on Monday night, said they had been left “devastated” by the loss of “a loving mother and a loving wife”.
Flanked by Jacintha Saldanha’s husband Benedict Barboza and her two teenage children, Keith Vaz said: “They just want me to say that they are extremely grateful to the public here in the United Kingdom and throughout the world who have sent them messages of condolences and support following the death of Jacintha.
“This is a close family. They are devastated by what has happened. They miss her every moment of every day, but they are really grateful to the support of the British public and to the public overseas for the messages of support and kindness.”
Keith Vaz had earlier criticized the hospital for not giving the family more support.
He said: “The hospital has sent them a letter, which I have seen, but I’m surprised that nobody has made the journey to Bristol to sit with them and offer them the counselling that I think they need.”
In response, the hospital said its chief executive, John Lofthouse, had spoken to Benedict Barboza on Friday by phone and offered to meet him whenever he wanted.
The hospital has launched a memorial fund to support the nurse’s family and a private memorial service will be held later this week.
In the hoax call, the presenters, Michael Christian and Mel Greig, had pretended to be Prince Charles and the Queen asking about the duchess in hospital.
They said in a tearful interview with Australian television broadcast on Monday that they were “gutted and heartbroken” Jacintha Saldanha’s death.
Christian said: “It was something that was just fun and light-hearted and a tragic turn of events no-one could have predicted or expected.
“We are shattered, heartbroken and our deepest sympathy goes to the family, friends and all those people affected. Mel and myself are incredibly sorry for the situation and what’s happened.”
Meanwhile, Kate Middleton has cancelled an appearance at the premiere of the Hobbit on Wednesday. Her office says she will continue to “rest privately” at home. Prince William is due to attend.
Kate Middleton was being treated in the hospital for hyperemesis gravidarum, an extreme form of morning sickness.
Yet science and folklore both give us clues that suggest Prince William and Kate Middleton will have a girl.
For starters, Kate Middleton’s debilitating morning sickness, hyperemesis gravidarum, is more commonly found among women expecting girls.
And her slim build may also hint at a royal daughter. A 2008 study at the University of Exeter showed women who consumed lower-calorie diets were more likely to have girls because female foetuses can survive on fewer nutrients.
Then William’s occupation as an RAF search-and-rescue pilot could also play its part. An American study found pilots had an 80% chance of having girl babies.
One theory is that exposure to radiation on planes reduces the number of sperm carrying male chromosomes, but sperm carrying hardier female chromosomes are unaffected.
And if Kate Middleton is spotted leaving a Kensington dermatologist, it’s odds-on for a daughter.
French researchers found that mothers who suffered acne while pregnant were 90% more likely to give birth to a girl due to excess levels of the female hormone oestrogen.
On the other hand, there may be some truth in the idea that women who suffer cold feet will have a son.
Yet science and folklore both give us clues that suggest Prince William and Kate Middleton will have a girl
Cold feet are a symptom of poor circulation – and German scientists have found that this condition during pregnancy is often experienced among women expecting boys, though they haven’t yet been able to explain why.
If all else fails, there is one final method of prediction: ask the Duchess whether she thinks she is expecting a boy or a girl.
According to scientists from Arizona, women’s intuition is the most accurate gender predictor of all.
Asked to guess the sex of their child, mothers-to-be are correct 70% of the time.
Mel Greig and Michael Christian, the Australian radio hosts at the centre of Kate Middleton hospital hoax, say they are “gutted and heartbroken” over the death of nurse Jacintha Saldanha.
Jacintha Saldanha was found dead on Friday, three days after taking the hoax call.
Mel Greig and Michael Christian wept as they said “not a minute goes by where we don’t think about her family”.
They had pretended to be members of the Queen and Prince Charles asking about Kate Middleton, who was being treated in hospital for acute morning sickness.
In an interview for Channel Nine’s A Current Affair programme Michael Christian told presenter Tracy Grimshaw: “When we thought about making a call it was going to go for 30 seconds we were going to be hung up on, and that was it. As innocent as that.”
Mel Greig said: “We thought a hundred people before us would’ve tried it. We thought it was such a silly idea and the accents were terrible and not for a second did we expect to speak to Kate let alone have a conversation with anyone at the hospital. We wanted to be hung up on.”
The pair said they heard about Jacintha Saldanha’s death in the early hours of Saturday morning.
“It was the worst phone call I’ve ever had in my life,” said Mel Greig.
Asked what his immediate reaction had been, Michael Christian wept and said: “Shattered, gutted, heartbroken and obviously you know. Our deepest sympathies are with the family and the friends.”
Mel Greig said: “There’s not a minute that goes by where we don’t think about her family and what they must be going through, and the thought that we may have played a part in that is gut-wrenching.”
Michael Christian added: “Prank calls are made every day, on every radio station in every country, around the world and they have been for a long time and no-one could’ve imagined this to happen.”
They were also interviewed for Channel 7’s Today Tonight programme and Mel Greig said of the moment she heard of Jacintha Saldanha’s death: “Unfortunately I remember that moment very well because I haven’t stopped thinking about it since it happened and I remember my first question was <<Was she a mother?>>”
Mel Greig and Michael Christian say they are gutted and heartbroken over the death of nurse Jacintha Saldanha
Michael Christian said there was “no malice” in the prank call and “no harm intended” to the nurses, to the duchess or to Prince William.
Mel Greig said they had expected to be hung up on and she said: “The accents were terrible. You know it was designed to be stupid. We were never meant to get that far from the little corgis barking in the background – we obviously wanted it to be a joke.
“If we played any involvement in her death then we’re very sorry for that. And time will only tell.”
Mel Greig said she would give evidence at the inquest if she was required and she played down questions about her and Michael Christian’s career.
Asked about whether she felt there was a “witch hunt” against them, she said: “There’s nothing that can make me feel worse than what I feel right now. And for what I feel for the family. We’re so sorry that this has happened to them.”
Kate Middleton was taken to King Edward VII Hospital in central London last Monday, suffering from an extreme form of morning sickness called hyperemesis gravidarum.
Jacintha Saldanha had answered the presenters’ call and, believing they were members of the Royal Family, put them through to another nurse, who described the Duchess of Cambridge’s condition in detail.
She was pronounced dead on Friday morning at staff accommodation close to the hospital. An inquest into Jacintha Saldanha’s apparent suicide is due to be opened in the next few days.
Earlier the presenters’ employer, Sydney radio station 2DayFM, said at least five attempts were made to obtain the permission of the two nurses involved before airing the call.
The radio station said it was going to review its broadcasting practices.
In an interview with a Melbourne radio station 3AW, Rhys Holleran – whose company Southern Cross Austereo owns 2DayFM – said his staff had tried several times to make contact with Jacintha Saldanha and another nurse at the King Edward VII’s Hospital to get their permission to use the prank conversation before it was transmitted.
Rhys Holleran said the death of Jacintha Saldanha was “tragic” and “regrettable”, but that it “could not have been foreseen”.
Some legal experts in Australia have said if the radio station did not tell the nurses they were being recorded, or received their permission to broadcast the conversation, they may be in breach of a number of laws.
Jacintha Saldanha’s husband, Ben Barboza, wrote on his Facebook page: “I am devastated with the tragic loss of my beloved wife Jacintha in tragic circumstances.”
The family was being comforted by relatives and friends at their home in Bristol, where they were visited by Labour MP Keith Vaz on Sunday.
He said the family are “grief stricken and shocked” at Jacintha Saldanha’s death and were grateful to the hospital for establishing a memorial fund in her name.
Prince William has pulled out of attending the British Military Tournament tonight so he can spend time with wife Kate Middleton, who is recuperating after spending three nights in hospital.
The royal couple had both originally been due to attend tonight’s event but all of Kate Middleton’s forthcoming public engagements were cancelled after she received treatment for severe morning sickness.
It comes after Prince William, 30, joked at an event yesterday evening that morning sickness should be renamed as Kate Middleton suffered it all day and night.
It now appears unlikely that the Duchess will attend the premiere of The Hobbit: An Unexpected Journey film in the West End on Wednesday, and may not make another public appearance for several weeks.
A St James’s Palace spokesman said: “The Duke of Cambridge will no longer attend the British Military Tournament at Earl’s Court this evening, but will spend Sunday privately with the Duchess instead.
“It is well known that hyperemesis gravidarum often recurs and, until further notice, to allow the Duchess a degree of privacy during her pregnancy, we do not intend to offer regular condition checks or advise of routine developments associated with it.”
Prince William has pulled out of attending the British Military Tournament tonight so he can spend time with wife Kate Middleton, who is recuperating after spending three nights in hospital
The cancellation of Prince William’s attendance at the event, billed as “the largest display of military theatre in the world”, comes after he last night attended a charity event.
He went solo for the first time since the pregnant Duchess of Cambridge, also 30, was discharged from hospital.
The Duke of Cambridge attended a glittering charity tennis gala, the Winter Whites Gala, held in aid of homeless charity Centrepoint, at the Royal Albert Hall in London.
He was due to be accompanied by the Duchess, but she is resting after suffering from hyperemesis gravidarum, an acute – and potentially dangerous – form of morning sickness.
Prince William, who is patron of Centrepoint, was congratulated by many on the news that a baby is on the way.
Pregnant Kate Middleton smiled this morning as she left hospital after four days of treatment for severe morning sickness.
The Duchess of Cambridge told reporters outside King Edward VII Hospital in London: “I’m feeling much better, thank you!”
Kate Middleton, 30, was discharged from the King Edward VII Hospital following three nights under observation and will now head to Kensington Palace for a period of rest, St James’s Palace said.
She emerged from the private hospital looking relaxed, carrying a bouquet of yellow flowers and giving a brief smile to the waiting press before being driven away with her husband Prince William.
Kate Middleton, who is less than 12 weeks pregnant, was wrapped up against the cold in a coat and scarf, and the royal couple will now spend time at their London home to allow for the Duchess to recuperate.
She was admitted on Monday after developing the condition known as hyperemesis gravidarum, and was suffering from the effects of dehydration.
For medical staff to allow Kate Middleton to go home, her severe vomiting must be under control and they are likely to have given her anti-sickness medication.
Kate Middleton emerged from the King Edward VII Hospital looking relaxed, carrying a bouquet of yellow flowers and giving a brief smile to the waiting press with Prince William
A St James’s Palace spokesman said: “The Duchess of Cambridge has been discharged from the King Edward VII Hospital and will now head to Kensington Palace for a period of rest.
“Their Royal Highnesses would like to thank the staff at the hospital for the care and treatment the Duchess has received.”
Kate Middleton looked immaculate today, wearing a navy coat and knee high low-heeled black suede boots.
Prince William, 30, had arrived at the hospital a few minutes earlier in a green Land Rover, dressed in a light blue jumper, checked shirt, dark jeans and suede shoes.
Yesterday Kate was also visited by her sister, Pippa Middleton, and brother James, at 3:45 p.m. They were followed by Carole Middleton who arrived at the hospital to see her elder daughter at 7:30 p.m.
Kate Middleton is being treated in hospital for a very severe form of morning sickness called hyperemesis gravidarum.
Hyperemesis gravidarum (HG) is a rare condition believed to affect up to 2% of women in pregnancy and is a severe form of morning sickness.
It tends to be more common in young mothers, women who are in their first pregnancy, and those with multiple pregnancies.
Women with HG often lose weight – usually over 10% of their body weight – and feel tired and dizzy.
They may also find they are passing water less often than usual, and the main risk is dehydration which can lead to headache, palpitations and confusion.
There is also a risk of nutritional deficiencies.
Then symptoms are severe, admission to hospital may be needed for observation and to treat dehydration with intravenous fluids.
This usually only means a few days in hospital.
Kate Middleton is being treated in hospital for a very severe form of morning sickness called hyperemesis gravidarum
Unlike most morning sickness, HG usually persists past the first trimester of pregnancy, and typically subsides by week 21 of pregnancy – although it can last much longer.
However, leading doctors say that along with more ordinary morning sickness, it is a sign the pregnancy is progressing.
Dr. Peter Bowen-Simpkins, consultant obstetrician and medical director of the London Women’s Clinic, says: “It is almost always a positive sign that the pregnancy is progressing well.
“The sickness is thought to be due to a rise in hormone levels. It normally occurs during weeks six and eight of pregnancy, when the placenta takes over production of hormones from the ovaries.
“It generally continues until around 12 or 14 weeks, but if it stops before, it can – although not always – be a sign that all is not well.”
Kate Middleton was on a drip at King Edward VII Hospital in central London this evening after falling ill with acute morning sickness as she is pregnant with the royal couple’s first child.
Prince William drove Kate, 30, to hospital today and spent hours at her bedside. He left tonight looking tense but sources said the duchess had been admitted as a precautionary measure. She is expected to be kept in for several days.
Sources said the royal couple are “incredibly happy but nervous” after being rushed into announcing the happy news because of Kate’s illness.
In a statement on their website, the couple said they are “delighted with the news”.
Members of the Royal Family – including the Queen – were only told about the pregnancy this afternoon after the decision was made to take Kate to hospital.
However, the Middletons were already aware their eldest daughter was expecting because she was taken ill while staying at their family home in Berkshire this weekend.
“The pregnancy is in its very early stages – the couple only found out very recently that they were expecting. But because she has been admitted to hospital and will have to stay in for a few days, they made the difficult decision to make things public,” said one.
Kate Middleton was on a drip at King Edward VII Hospital in central London this evening after falling ill with acute morning sickness
It is understood that the Duchess began to feel ill at her parents’ home in Bucklebury, Berkshire, where the couple were spending the weekend. She was unable to keep any food or water down.
Concerned Prince William finally took the decision, after consulting his doctor, to get her to hospital this afternoon. William left his wife’s bedside at about 8:15 p.m. after ensuring she was comfortable.
William drove his wife into London from Berkshire with their personal protection officers, declining the offer of an ambulance in favor of using their own, more low-key car.
Sources suggested that the Duchess was hooked up to an intravenous drip to increase her fluid and nutrient levels.
Hyperemesis gravidarum (HG) is a rare condition believed to affect up to two per cent of women in pregnancy and is a severe form of morning sickness.
It tends to be more common in young mothers, women who are in their first pregnancy, and those with multiple pregnancies.
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