By: Nancy Simon, PharmD Candidate 2016
Many of you may have seen Kim Kardashian West’s Instagram posts – most of which are ‘selfies,’ but recently, a particular post caught the attention of the Food and Drug Administration (FDA) this past August 2015. Kim posted a picture with Diclegis® (doxylamine succinate and pyridoxine hydrochloride), claiming that it has been the cure to her morning sickness. When it comes to promoting prescription drug products, it is great to state the benefits, but the risks must also be mentioned as per FDA regulations. None of the risks were mentioned in the social media post, which was additionally also posted on Twitter and Facebook—other social media outlets. The post includes a link to safety information, but that is not enough – the risks must be mentioned, thereby putting Duchesnay, Inc. at fault for not clearly listing all safety information in the drug advertisement posted by Kim. Diclegis® is manufactured by Duchesnay, Inc.—the company which prompted Kim with the exact advertisement she posted. They are at fault for not providing her all the necessary information. It is the responsibility of the drug manufacturer to make sure all efficacy and safety information are mentioned in any advertisements, including those posted on Instagram, Facebook, and Twitter.
The Office of Prescription Drug Promotion (OPDP) of the FDA reviewed the social media post this past August. The FDA filed a warning letter to Duchesnay, Inc. regarding the misbranding of Diclegis®2. The post also misbrands Diclegis® according to the Federal Food, Drug, and Cosmetic Act (FD&C Act).2 This post is false or misleading due to the fact that it presents efficacy claims, but fails to state any risks associated with the drug.2 Pharmaceutical companies sometimes allow celebrities to endorse their drugs, but it is the obligation of the drug company to include all pertinent information in the advertisement. Kim posted what was given to her and the Instagram post suggests that Diclegis® is safer than it has been demonstrated.2 The Code of Federal Regulations, (CFR) Section 202.1 discusses regulations and violations of prescription-drug advertisements2. The CFR is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government and this Instagram post infringes on the statutes set in place.1
Diclegis® contains doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, which is also known as vitamin B6.5 It is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.4 Conservative management includes eating small meals throughout the day, and having bland foods in the morning, such as crackers. The limitations of the drug is that it has not been studied in women with hyperemesis gravidarum.3 Hyperemesis gravidarum is a condition which consists of severe, persistent nausea and vomiting during pregnancy, often leading to weight loss.6 Some other symptoms may consist of light-headedness, weakness, headaches, fainting, or constipation.6 Diclegis® is contraindicated in women with hypersensitivity to the components of Diclegis® – doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the formulation.4 Another contraindication is women, who were on any monoamine oxidase (MAO) inhibitors.5 MAO inhibitors intensify and prolong the central nervous system effects of doxylamine–pyridoxine, such as drowsiness.4 In a double-blind, randomized, multi-center trial, the only adverse reaction that occurred at an incidence of greater than or equal to 5% and at a higher incidence with doxylamine–pyridoxine as compared to placebo was somnolence.4 Due to this side effect, women should not drive, operate heavy machinery, or participate in other activities that would need their full attention.5 Regarding concomitant medical conditions, because doxylamine–pyridoxine has anticholinergic properties, it should be used with caution in women with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.4 Anticholinergic properties of antihistamines include reducing the volume of bronchial secretions which can cause thickening and can result in obstruction of the respiratory tract. Also, women should not breastfeed while using doxylamine–pyridoxine,4 due to the fact that it can pass into breast milk and can cause harm to the baby.5 These are some of the safety concerns with taking Diclegis®-none of which were mentioned on the Instagram post.
Duchesnay, Inc. should know the regulations when it comes to prescription drug advertising. Advertisements must have a balance of efficacy information as well as safety and risk information. Failure to mention any of the risks of Diclegis® allows patients to assume that the medication does not have a lot of safety risks. Duchesnay, Inc. received an untitled letter from the FDA back in 2013, due to an announcement letter OPDP had reviewed. The OPDP reviewed an announcement letter submitted by Duchesnay, Inc who alerted the general public regarding the approval of Diclegis®.7 The letter also presented various efficacy claims, but failed to communicate risk information.7 The letter states, “Today I am pleased to inform you that the U.S. Food and Drug Administration has approved Diclegis® indicated for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. Millions of pregnant women could benefit from an approved NVP treatment and Diclegis® represents a much needed FDA-approved treatment option.”7 The letter omitted all risk information, including the contraindications, warnings and precautions, and the most frequently reported adverse event for Diclegis®.7 The letter falsely suggests that Diclegis® is safer than has been demonstrated.7
The OPDP requested that Duchesnay, Inc. immediately stop misbranding Diclegis®. OPDP requested this after they released the announcement letter to the public, as well as when the Instagram post was released. The company was told to submit a written response replying to the warning letter, on or before August 21, 2015, stating whether they intend to comply with the FDA request. They were to list all promotional materials for Diclegis® that contain presentations such as those described in the warning letter and explain their plan for discontinuing use of such materials, or cease distribution of Diclegis® itself.2 Because Duchesnay, Inc. has repeated serious violations, the FDA wants a comprehensive plan of action from them.2 To clearly identify the violative promotional piece and focus on the corrective message, the OPDP recommended that the corrective piece include a description of the violation, provide information to correct the violation, and corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was distributed.2 As per request, in late August, Duchesnay, Inc. issued a corrective advertisement via Instagram fixing their mistake. Besides the violations discussed in the warning letter, Duchesnay. Inc is responsible to ensure that any distribution of Diclegis® complies with each applicable requirement of the FD&C Act and FDA regulations.2
All pharmaceutical companies are held accountable for accurately depicting the efficacy as well as the toxicity of their drug products through any promotional advertising they may have. Duchesnay, Inc. is fully responsible for stating facts regarding their product, Diclegis®. It is legally and ethically not right for pharmaceutical companies to misinform patients of the benefits, and especially the risks associated with any drug.
- Code of federal regulations (annual edition). U. S. Government Publishing Office Web Site. http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR. Accessed August 22, 2015.
- Dean RT. Duchesnay, Inc. warning letter. U.S. Food and Drug Administration Web Site. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM457961.pdf. Published August 7, 2015. Accessed August 22, 2015.
- Diclegis. https://www.diclegis.com/en/. Published 2013. Accessed August 22, 2015.
- Diclegis® (doxylamine succinate and pyridoxine hydr chloride) [Package Insert]. Bryn Mawr, PA; Duchesnay USA, Inc.; 2013.
- Diclegis patient information. https://www.diclegis.com/pdf/Diclegis_Patient_Information.pdf. Published April, 2013. Accessed August 22, 2015.
- Hyperemesis gravidarum. https://www.nlm.nih.gov/medlineplus/ency/article/001499.htm. Last updated August 16, 2014. Accessed August 22, 2015.
- Newcomer CA, Thompson TN. Duchesnay, Inc. Untitled Letter. U.S. Food and Drug Administration Web Site.. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda/warninglettersandnoticeofviolationletterstopharmaceuticalcompanies/ucm376300.pdf. Published November 12, 2013. Accessed August 22, 2015.