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Examining Truth in Drug Advertising

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Examining the Truth in Drug Advertising
Vanessa Buchannon
Clayton State University

Duloxetine (Cymbalta) is an FDA approved selective serotonin norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD). Television commercials for Cymbalta can be viewed on major and cable networks, during daytime and early evening hours. The television commercials are run during the broadcast of soap operas and other daytime programming. Advertisements also appear on home improvement channels such as Home and Garden (HGTV) and the Food Network. The commercials depict active, attractive women and men that appear to be in their mid-forties and fifties participating in enjoyable life activities. The emphasis of the message in the advertisement for major depression disorder is depression is treatable and manageable by the use of Cymbalta. Cymbalta commercials also advertise the treatment of Fibromyalgia pain. The television commercial briefly describes the major side effects of Cymbalta such as nausea, dry mouth and constipation. The commercial also states that Cymbalta should not be taken by patients that take monoamine oxidase inhibitor (MAOI) and in patients with uncontrolled narrow angle glaucoma. Even with air time being limited, I believe the television advertisement to be truthful however, the focus of the advertisement is on the benefits of the medication and they do not give adequate time to disclose side effects, adverse reactions or contraindications.
Duloxetine (Cymbalta, Ariclaim, Xeristar, Yentreve, Duzela,Dulane) is a serotonin reuptake inhibitor (SNRI) manufactured and marketed by Eli Lilly. It is prescribed for major depressive disorder and generalized anxiety disorder. Duloxetine has also been approved for treatment in osteoarthritis and musculoskeletal pain (Drugs.com, 2013). Duloxetine failed US approval for stress urinary incontinence because of concerns of liver toxicity and suicidal events; however, it was approved for this indication in Europe, where it is recommended as an additional medication in stress urinary incontinence instead of surgery. It can also relieve the symptoms of painful peripheral neuropathy, particularly diabetic neuropathy and it is used to control symptoms of fibromyalgia. (Dhillion, 2013)
The October issue Oprah Magazine contains a three page advertisement for the drug Cymbalta. According to the website for “O” Magazine the demographic of its readers are career women, fifty percent of whom hold professional and/or managerial jobs. The magazine is geared towards affluent readers and it is a desirable marketing venue for advertisers.
Cymbalta is indicated for treatment in the advertisement for several purposes including, depression, generalized anxiety disorder, diabetic nerve pain, fibromyalgia and chronic musculoskeletal pain caused by chronic low back pain, or chronic osteoarthritis pain. The medication should not be used by anyone with recent use of MAO inhibitors or uncontrolled narrow angle glaucoma. The advertisement provides a summary of the most common and the most serious side effects. This list is not complete but the fact is disclosed (Lilly 2013). Also contained in the advertisement is the advice to report negative side effects to the Federal Drug Administration (FDA), and contact information is provided. Listed are the following common side effects: nausea, dry mouth, sleepiness, decreased appetite, dizziness, fatigue, and increased sweating. The ad warns that antidepressants can increase suicidal thoughts and behaviors in children, teens and young adults. The medication is approved for age eighteen years and over. Older adults above sixty five who took this medication reported a higher incidence of falls, some of the falls produced serious injury. The three page advertisement discusses warnings, side effects and safety information in two of the three pages (Lilly, 2013).
The Nursing Drug Handbook 2013 contains a black box alert for Cymbalta that was also stated in the advertisement, warning against the potential for increased suicide thoughts in children and young adults and others with psychiatric disorders ( Hodgson & Kizior, 2013). The drug book provides more complete information regarding side effects: erectile dysfunction, decreased libido, failed or delayed ejaculation information was completely omitted from the advertisement however that information is contained in the drug book (Hodgson & Kizior, 2013).
Overall the advertisement was truthful with the exception of the sexual dysfunction side effects that were completely omitted in the print advertisement. Perhaps because the public has easy access to a wide range of information advertisements appear to provide more data.
Cymbalta is also advertised in WebMD Little Blue Book Rheumatology edition. The advertisement can target any age group on the internet and because it is associated with WebMD seems creditable because consumers assume a physician is writing the material that is published. The Blue Book Message is false or misleading because it minimizes the risks associated with the drug. The advertisement states that Cymbalta is indicated for the management of fibromyalgia. The product labeling contains a boxed warning regarding suicide and anti-depressant drugs as well as contraindications for use with a monoamine oxidase inhibitor (MAOI) and in patients with uncontrolled narrow angle glaucoma. There are numerous warning states such as hepatotoxicity, orthostatic hypotension and syncope, serotonin syndrome or neuroleptic malignant syndrome (NMS) like reactions, abnormal bleeding, discontinuation of treatment with Cymbalta, effect on blood pressure, clinically import drug interactions. The most common adverse reactions were nausea, dry mouth, constipation, somnolence, hyperhidrosis and decreased appetite. (WebMD, 2010)
The Print Ad is misleading because it presents various efficacy claims for Cymbalta, but fails to communicate any risk information in the main part of the ad. The advertisement prominently presents a picture of a woman curled up on a coach with the statement “FIBRO PAIN” on her right knee. However, the main body of the Print AD entirely omits risk information; including contraindications, warnings and precautions, and the most frequently reported adverse reactions. The advertisement does include a statement to see left page for important safety information at the bottom of the page. The risk information is placed in a single column in a single spaced paragraph on the page with unrelated advertisements or magazine content. The side effect and adverse reaction warnings appear unconnected to the main body of the Print Ad and is not likely to draw readers’ attention. The Federal Drug Administration (FDA) cited Lilly for omitting and minimizing risk information about the drug and overstating the drug efficacy (Covington & Burling LLP, 2010).
After reviewing Cymbalta advertising in three different advertisement mediums, print, television, and the internet, I found the information consistent and detailed in most cases with the exclusion of the Little Blue Book. The drug manufacturer has an official website that offers helpful patient support and information. Each advertisement provided instruction for side effects and adverse reactions. Consumers’ easy access to data may indeed impact the quality and quantity of pertinent information drug companies choose to provide. A more knowledgeable and informed consumer will be a safer patient. While there was truth found in most of the advertising for the drug reviewed, advertisements are aimed at specific groups and strongly suggest the ability to vastly improve the quality of life for the product user.

References
Covington & Burling LLP. (2010). Summary of FDA advertising and Promotion Enforcement Activities. Retrieved from http://www.cov.com/files/Publication/
Dhillion, S. (2013). Duloxetine: A Review of Its Use in the Management of Major Depressive Disorder in Older Adults. Drugs Aging, 30, 59-79.
Drugs.com. (2013). http://www.drugs.com/cymbalta.html
WebMD (2010). Little Blue Book (1 ed.). Retrieved from http://amazon.com/WebMD-Little Blue-Book/

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