Kim Kardashian West Gets FDA Warning for Drug Promotion

Kim Kardashian West has been put on notice.

The FDA sent Kardashian West a letter requesting the removal of social media endorsements she posted on Facebook and Instagram regarding a drug named Diclegis, which she is using for morning sickness:

“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. 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. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.”
According to the  FDA the post is “false or misleading in that it presents efficacy claims for Diclegis, but fails to communicate any risk information associated with its use.” The posts have now been deleted.

What is Morning Sickness?

Morning sickness, which is nausea and vomiting during pregnancy, is very common. It is estimated that 70-80% of women suffer from some degree of morning sickness. Most complain of nausea, and a third will also have vomiting. Despite its name, morning sickness can occur at any time of the time.  It  usually begins during the first month of pregnancy and continues through the 14th to 16th week (3rd or 4th month).

Conventional treatment for morning sickness include:

  • Eat several small meals instead of three large meals to keep your stomach from being empty.
  • Don’t lie down after meals.
  • Eat dry toast, saltines, or dry cereals before getting out of bed in the morning.
  • Eat bland foods that are low in fat and easy to digest, such as cereal, rice, and bananas.
  • Sip on water, weak tea, or clear soft drinks. Or eat ice chips.
  • Avoid smells that upset your stomach.

Morning sickness is different from hyperemesis gravidarum (HG) a more severe form of morning sickness.   HG is extreme, persistent nausea and vomiting during pregnancy that may lead to dehydration.

It is postulated that both morning sickness and hyperemesis gravidarum are caused by a variety of factors. These include the rise in the hormone human chorionic gonaditropin (HCG), slow emptying of the stomach after eating and genetic factors. Its exact cause is remains unknown. Most cases of HG resolve by 20-21 weeks of pregnancy.

The symptoms of HG include:

  • Severe nausea and vomiting
  • Weight loss of 5% or more of pre-pregnancy weight
  • Dehydration
  • Decrease in urination
  • Aversion to food
  • Headaches
  • Fainting

Severe cases of HG require hospitalization. The pregnant mother will receive IV (intravenous) fluids and may have a small feeding tube placed in the stomach to restore nutrients.

What is Diclegis®?

Diclegis® is a combination medication which consists of two drugs: pyridoxine (Vitamin B6) and an antihistamine called doxylamine. The combination was initially sold back in the 1950’s as the medication Bendectin. It fell out of favor when it was erroneously thought to cause birth defects. The claims were proven untrue, however under the weight of legal costs for multiple lawsuits, the company voluntarily withdrew the drug in 1983. The combination has continued to be used in other countries.

In 2013, the FDA approved the combination pill, marketed as Diclegis® by Canadian company Duchesnay for the treatment of nausea and vomiting associated with pregnancy (morning sickness) which does not respond to conventional treatment. Diclegis has not been studied in patients with hyperemesis gravidarum, so the FDA has not approved it for this use.

The main side effect of pyridoxine/doxylamine is drowsiness. Users should use caution if they are planning to drive or operate heavy machinery. Alcohol or sedating medicines, including other antihistamines (present in some cough and cold medications), opiates, or sleep aids, should be avoided because severe drowsiness can happen or become worse, which can lead to falls or accidents.

According to the FDA safety information, “Diclegis® is a delayed-release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia.”

The FDA granted Diclegis® Pregnancy Category A status, which means that the results of controlled studies have not shown increased risk to an unborn baby during pregnancy.

Diclegis® can be expensive. It can cost as much as $570 for 100 pills. Many patients may require two to four tablets per day. Over-the-counter 25 mg pyridoxine and 20 mg doxylamine cost $5 to $10 for 100 tablets.

For FDA Full Prescribing Information for Diclegis®, click here.

 

 

Michele R. Berman, M.D. was Clinical Director of The Pediatric Center, a private practice on Capitol Hill in Washington, D.C. from 1988-2000, and was named Outstanding Washington Physician by Washingtonian Magazine in 1999. She was a medical internet pioneer having established one of the first medical practice websites in 1997. Dr. Berman also authored a monthly column for Washington Parent Magazine.

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