OTC Focus Case Studies: Influenza

CASE 1: OSCILLOCOCCINUM

Q: MR is a 43-year-old woman looking for an OTC medication that prevents influenza. She heard on the news that this is a bad flu season, with many hospitalizations and deaths from flu-related complications. MR is concerned and would like to take a drug to prevent the flu. She says that she is relatively healthy and takes no medications. MR received the influenza vaccination 2 months earlier. A friend told her about a medication called Oscillococcinum, and MR wants to know if she could take this.

A: Let MR know that Oscillococcinum is a homeopathic agent, made from the heart and liver of wild duck. The product is likely safe because it contains no measurable amount of active ingredient.¹ Although MR is relatively healthy and has no chronic conditions, she may get no real benefit from taking Oscillococcinum. The authors of a 2015 Cochrane review that evaluated 2 prevention studies and 4 treatment studies concluded that there is insufficient evidence to recommend Oscillococcinum for preventing or treating influenza and flulike illness. In the review, the authors mentioned that the trials evaluated were of low quality.² If MR decides to take the medication, the drugs facts label recommends that patients 2 years and older dissolve 1 tube of the agent in the mouth every 6 hours, up to 3 times a day.³

CASE 2: FLU AND DIABETES: EFFECTS ON BLOOD SUGAR AND TREATMENT OPTIONSQ: RD, a 66-year-old man, wants something to treat his fever. He has had chills, a cough, and a fever for the past 12 hours and feels tired and weak. He asks for an OTC recommendation, mentioning that he has diabetes and hypertension. RD takes metformin 1000 mg twice daily and lisinopril 10 mg once daily. He got the influenza vaccination a month earlier.

A: RD’s symptoms are similar to those caused by influenza. Most people can recover from the flu, but some are at higher risk of hospitalization and death. Those patients should be referred immediately to a doctor, who can determine if they would benefit from antiretroviral medications. It is important to advise RD that the risk of complications rises with certain conditions, such as asthma; blood disorders such as sickle cell disease; chronic lung disease such as chronic obstructive pulmonary disease and cystic fibrosis; endocrine disorders such as diabetes; heart conditions such as congenital heart disease, congestive heart disease, and coronary artery disease; kidney and liver disorders; metabolic issues such as inherited metabolic disorders and mitochondrial disorders; and neurodevelopment and neurologic conditions. Other patients at risk include native Americans (Alaskan or American Indian), children younger than 2 years, people who are 65 years and older or live in a long-term-care or nursing home facility, pregnant women and individuals who have given birth within the past 2 weeks, and those with a body mass index of 40 or above or a weakened immune system.4 Because RD has both diabetes and is over 65 years of age, refer him to a physician. He can get a rapid influenza diagnostic test performed and, if he has the flu, be treated with antivirals to reduce the risk of hospitalization and death.

CASE 3: ELDERBERRYQ: OS, a 30-year-old woman, is looking for elderberry. She says that a colleague uses it to prevent influenza. OS works at a day care center and has been getting sick often. Now that it is flu season, she is concerned about developing the illness and missing workdays. OS is healthy and has no medical conditions. She wants to take a preventive product because she forgot to get her influenza vaccination.

A: The findings of some studies show that elderberry may reduce flulike symptoms. Two trials demonstrated that 1 teaspoon of elderberry syrup (Sambucol) 4 times daily reduced the symptoms and duration of influenza infection when given within 2 days of symptoms onset. Symptom relief occurred within 2 to 4 days of treatment for most patients.^5,6 Although these studies showed benefit in patients who had influenza, minimal data support long-term use of elderberry to prevent the flu. Most formulations in clinical trials have been safe for up to 12 weeks. However, it may not be helpful for OS to take elderberry for influenza prevention long term.¹ Sambucol original contains 3.8 g of elderberry extract. The recommendation dosage for adults and children over 4 years is 2 teaspoons daily. Again, it is important to advise OS that elderberry has not proved beneficial in preventing flu. She can take other preventive measures, such as getting the influenza vaccination. OS can also practice regular handwashing to decrease her exposure to illnesses such as influenza.

CASE 4: OTC TAMIFLUQ: UT is a 46-year-old woman seeking something over the counter for her husband, MT, who has been experiencing flulike symptoms for the past 24 hours. He went to an urgent care center last night and tested positive for influenza, and the doctor there suggested a medication called oseltamivir phosphate (Tamiflu). MT, who is 48 years old and has no medical conditions, declined the prescription and said he would deal with the illness at home without a medication. Now he has changed his mind and wants to take oseltamivir. UT heard on the news that Tamiflu will soon be available over the counter.

A: In July, Sanofi signed an agreement with Roche for the exclusive OTC rights to oseltamivir for the prevention and treatment of influenza. Sanofi will be responsible for leading FDA negotiations for the OTC switch. However, tell MT that the switch has not occurred yet and Tamiflu still requires a prescription. Under the agreement, Sanofi will have exclusive marketing, scientific engagement, and distribution of OTC Tamiflu in the United States.⁷ The FDA has the final word on reclassifying medications from available by prescription to over the counter. However, OTC medications such as analgesics, antipyretics, cough medications, and decongestants can provide relief from the common symptoms that MT might be experiencing, such as body aches, chills, cough, fever, headache, and nasal congestion.

Rupal Patel Mansukharni, PharmD, CTTS, FAPhA is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey, and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey.Ammie J. Patel, PharmD, BCACP, is a clinical assistant professor of pharmacy practice at the Ernest Mario School of Pharmacy and an ambulatory care specialist at RWJBarnabas Health, part of the Barnabas Health Medical Group.

REFERENCES

• Oscillococcinum. Natural Medicines [database online]. Somerville, MA: Therapeutic Research Center; 2017. naturalmedicines.therapeuticresearch.com. Updated February 13, 2019. Accessed January 2, 2020.
• Mathie RT, Frye J, Fisher P. Homeopathic Oscillococcinum for preventing and treating influenza in influenza-like illness. Cochrane Database Syst Rev. 2015;1:CD001957. doi: 10.1002/14651858.CD001957.pub6.
• Oscillococcinum. Oscillococcinum. Boiron website. oscillo.com/about/facts-about-oscillo/. Accessed December 10, 2019.
• People at high risk for flu complications. CDC website. cdc.gov/flu/highrisk/index.htm. Updated August 27, 2018. Accessed December 10, 2019.
• Zakay-Rones Z, Varsano N, Zlotnik M, et al. Inhibition of several strains of influenza virus in vitro and reduction of symptoms by an elderberry extract (Sambucus nigra L.) during an outbreak of influenza B Panama. J Altern Complement Med. 1995;1(4):361-369. doi: 10.1089/acm.1995.1.361.
• Zakay-Rones Z, Thom E, Wollan T, Wadstein J. Randomized study of the efficacy and safety of oral elderberry extract in the treatment of influenza A and B virus infections. J Int Med Res. 2004;32:132-140. doi: 10.1177/147323000403200205.
• Sanofi signs strategic deal for exclusive US over-the-counter rights to Tamiflu in flu care [news release]. Paris, France: Sanofi; July 23, 2019. sanofi.com/en/media-room/press-releases/2019/2019-07-23-07-00-00. Accessed December 10, 2019.