How Rosacea Patients Can Take Action Against the Threat of Antibiotic Resistance

(BPT) - With the COVID-19 pandemic on the minds of people worldwide, the spotlight on public health is more present than ever before. But before COVID-19 became a top public health concern, we were already in the throes of one of the biggest public health challenges of our time: antibiotic resistance. The Centers for Disease Control and Prevention (CDC) noted that annually at least 2.8 million people get an antibiotic-resistant infection in the United States, and more than 35,000 people die as a result.¹ The threat of antibiotic resistance grows stronger as more antibiotics are used, yet the CDC estimates 30 percent of all antibiotics prescribed in outpatient clinics are “unnecessary.”^2,3 Who are the top prescribers of antibiotics in the U.S.? Dermatologists.⁴

To treat chronic inflammatory skin conditions — like rosacea — dermatologists will often employ antibiotics because of their anti-inflammatory properties.⁵ The issue? While antibiotics are life-saving drugs used to treat infections caused by bacteria, rosacea is not a bacterial condition.^6,7

Once bacteria become resistant, antibiotics cannot fight the resistant infection and bacteria begin to multiply.⁸ Resistance doesn’t mean the body is becoming resistant to antibiotics; ultimately, the bacteria become resistant to the treatments designed to kill them.⁸ Infections then become longer lasting, surmounting to a public health concern of global scale.⁶ The threat has become so widespread that the CDC has identified 18 “urgent, serious and concerning” antibiotic resistant threats.⁹

As rosacea afflicts an estimated 16 million Americans, the treatment decisions rosacea sufferers make today can greatly impact the fight against antibiotic resistance.¹⁰ It’s important not to take antibiotic treatments unless a physician deems it necessary.

Thankfully, not all rosacea treatment options are created equally. There is a non-antibiotic dose option that can help reduce the symptoms of rosacea without contributing to antibiotic resistance, as seen in a long term study.^5[*] ORACEA^® (doxycycline, USP) 40mg* Capsules, a convenient, once-daily oral prescription treatment, combats inflammation from the inside out to reduce the bumps and blemishes of rosacea through its anti-inflammatory properties.^5,11,12 The safety and efficacy of ORACEA Capsules in the treatment of bumps and blemishes of rosacea was evaluated in two randomized, placebo-controlled, multi-centered, double-blind, clinical trials which found many people taking ORACEA Capsules started to see significant improvements (reduction in inflammatory lesions) in as little as 3 weeks, and improvements continued through the full 16-week course of the study.^12,13[†] In controlled studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase.^[†]

Unlike the most commonly prescribed 100mg dose of doxycycline, which demonstrated microbial resistance as early as day seven, ORACEA Capsules’ formula proved to not contribute to antibiotic resistance, in a nine-month study.^12,13 The choices patients make today impact their health tomorrow. So, it’s important for people with rosacea to engage in the conversation with their dermatologists about an effective option to treat the bumps and blemishes of rosacea with a non-antibiotic dose.

Aside from safe and effective treatment options like ORACEA Capsules, people can join the fight against antibiotic resistance by following these tips:

• Follow doctor’s orders: When prescribed, complete an antibiotic course as instructed. Unfinished antibiotic regimens can allow bacteria to survive (even if symptoms are relieved) and adapt to the treatment, increasing rates of resistance.¹⁴ If doctors don’t prescribe antibiotics, patients should not push for them. It’s important for patients to trust their doctor’s expertise when told that antibiotics won’t help.
• Don’t save or share leftover antibiotics: Self-medicating may not treat the illness properly and could lead to adverse side effects.^6,15 Taking antibiotics when not required allows bacteria to grow stronger.⁶
• Focus on the long-term: For rosacea patients, consider that a long-term action plan may be a better option to treat the bumps and blemishes of rosacea rather than a short-term course of antibiotics.¹¹

For more information about antibiotic resistance, connect with a dermatologist today. Visit Oracea.com to learn about rosacea and this non-antibiotic dose treatment option. With proper care, it’s possible to treat rosacea and help limit the risk of antibiotic resistance for a clearer and healthier future.

Important Safety Information

Indication: ORACEA Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established.

*30 mg immediate release & 10 mg delayed release beads

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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¹ Centers for Disease Control and Prevention. Antibiotic / Antimicrobial Resistance. https://www.cdc.gov/drugresistance/index.html. Accessed on October 8, 2020.

² Centers for Disease Control and Prevention. Antibiotic use in the United States, 2018 update: progress and opportunities. Atlanta, GA: US Department of Health and Human Services, CDC; 2019.

³ Centers for Disease Control and Prevention. Be antibiotics aware: smart use, best care. https://www.cdc.gov/features/antibioticuse/index.html. Accessed on October 8, 2020.

⁴ Penn Medicine News. Dermatologists prescribe the most antibiotics, but which uses are driving the trend? https://www.pennmedicine.org/news/news-releases/2019/january/dermatologists-prescribe-the-most-antibiotics-but-which-uses-are-driving-the-trend/. Accessed on October 8, 2020.

⁵ Del Rosso, J. and Zeichner, J. The clinical relevance of antibiotic resistance: thirteen principles that every dermatologist needs to consider when prescribing antibiotic therapy. Dermatology Clinics: 2016. 34, pp. 167-173.

⁶ World Health Organization. Antibiotic resistance. https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance. Accessed on October 8, 2020.

⁷ National Rosacea Society. All About Rosacea. https://www.rosacea.org/patients/all-about-rosacea. Accessed on October 8, 2020.

⁸ Centers for Disease Control and Prevention. Antibiotic resistance questions and answers. https://www.cdc.gov/antibiotic-use/community/about/antibiotic-resistance-faqs.html. Accessed on October 8, 2020.

⁹ Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States. Atlanta, GA: US Department of Health and Human Services, CDC; 2019.

¹⁰ National Rosacea Society. What is rosacea? https://www.rosacea.org/. Accessed on October 8, 2020.

¹¹ Oracea (doxycycline) capsules for oral use. Prescribing information. 2014.

¹² Valentin, Sheila, et al. Safety and efficacy of doxycycline in the treatment of rosacea. Clinical, cosmetic and investigational dermatology: CCID 2 (2009): 129.

[*] 9-Month Study

[†] The safety and efficacy of ORACEA Capsules in the treatment of inflammatory lesions (papules and pustules) of rosacea was evaluated in two randomized, placebo-controlled, multi-centered, double-blind, 16-week Phase 3 trials involving 537 subjects (total of 269 subjects on ORACEA from the two trials) with rosacea (10 to 40 papules and pustules and two fewer nodules).1,5

Mean change in lesion count ORACEA Capsules vs Placebo : Study 1 -11.8 vs -5.9, Study 2 -9.5 vs -4.3

Most common adverse events (>2%) were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase.