People are always quick to jump to positive conclusions about products the moment their favourite celebrity starts endorsing it. And while most of these fads or hacks can be bizarre, often they are potentially dangerous, and sometimes pretty ineffective too.
Along those lines – in a recently conducted research, it was revealed that Diclegis – the Kim Kardashian endorsed morning sickness pill is as useless as a dummy pill.
About 90 percent of women suffer from morning sickness during their early stages of pregnancy and Diclegis – which gets prescribed to 33 million worldwide – happens to be the only FDA-approved drug on the market to ease the symptoms.
The pill gained popularity when the 37-year-old reality TV and social media icon promoted it on her Instagram account three different times – in August 2015, April 2017, and July 2017. But the latest study shows a medical report that labels Diclegis as ineffective and a waste of money.
Despite her getting slammed by the FDA for not warning her millions of followers of the potential side effects of the drugs, the new study has gone a step further and stated that the 2010 clinical trial used by the FDA to approve Diclegis in 2013 has missing data.
This data – as claimed by the new research, if utilized differently, would show that there's no 'statistically significant' difference between the drug and placebo's effectiveness.
#Ad #DYK 4 million babies are born each year in the US. That means a lot of my US followers are mommies2B who could have morning sickness like I did! I want to share what helped me: Diclegis® (doxylamine succinate/pyridoxine HCl), the only FDA-approved medication for morning sickness when diet & lifestyle changes fail. My doctor assured me that it’s safe & effective for mom & baby. It’s also easy to recognize - it has the cutest pregnant lady on it! #DontSufferinSilence you’re not alone! If you have morning sickness, ask your healthcare provider if #Diclegis is right for you. The most common side effect of Diclegis is drowsiness. Diclegis.com US Residents Only Diclegis is a prescription medicine used to treat nausea & vomiting of pregnancy in women who haven’t improved with change in diet or other non-medicine treatments. Limitation of Use: Diclegis hasn’t been studied in women with hyperemesis gravidarum. Important Safety Information Don’t take Diclegis if you’re allergic to any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors, as these medicines can intensify & prolong the adverse CNS effects of Diclegis. Don’t drive, operate heavy machinery or other activities that need your full attention unless your healthcare provider says that you may do so. Don’t drink alcohol or take other central nervous system depressants such as cough & cold medicines, certain pain medicines & medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents. It is not known if Diclegis is safe & effective in children under 18 years of age. Keep Diclegis & all medicines out of the reach of children. Tell your healthcare provider about all of your medical conditions, including if you’re breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk & may harm your baby. You shouldn’t breastfeed while using Diclegis. Additional safety information can be found at DiclegisImportantSafetyinfo.com. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or
The results of this trial – which were based on the PUQE or pregnancy-unique quantification of vomiting/nausea score, pregnant mothers from the placebo group saw a 3.9 drop in their PUQE score from 8.8, while the ones on morning pill saw a 4.8 point drop down from 9.0.
Researcher Dr Navindra Persaud, of the Department of Family and Community Medicine at St. Michael's Hospital, claims that without a three-point difference in PUQE score between the drug and placebo groups, it's practically insignificant.
"I was surprised that important information about the trial was hidden until now," Dr Persaud told Medical News Today. "Although some results were published in 2010, the earlier reports did not mention the fact that a difference of three points on the 15-point symptom scale was pre-specified as the smallest difference that a patient would deem as important."
Yet Diclegis was approved by the FDA following this trial, and despite the current findings, Dr Persaud isn't certain if the FDA will withdraw Diclegis from the market anytime soon.
"It is very unusual for medications to be removed from the market because of ineffectiveness," he said. "Medications are withdrawn when they are found to be harmful after approval but even this is quite rare. So it is unlikely that this medication will be withdrawn."
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At the same time, not every doctor believes Diclegis is totally ineffective. Dr Siripanth Nippita, a researcher at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston shared that since the trial, studies have shown that "doxylamine and pyridoxine [the combination] are an effective treatment for nausea and vomiting in pregnancy."
A spokesman for Duchesnay, Inc. – the company that sells the medication, shared: "We have complete confidence in the safety and efficacy of Diclectin and are very proud to provide it as a safe and effective treatment option for women suffering from nausea and vomiting of pregnancy."