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Drug News

doi: 10.1097/01.NURSE.0000549734.68304.49
Department: Drug News

First flu treatment approval in 20 years...high number of parents share antibiotics with their children...OTC drugs have little value for treating the common cold... older women with osteopenia benefit from zoledronate...HPV vaccine now available for adults up to age 45

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First flu treatment approved in 20 years

The FDA recently approved Xofluza (baloxavir marboxil), an antiviral medication indicated to treat acute uncomplicated influenza in patients age 12 years and older who have been symptomatic for no more than 48 hours. It is taken as a single oral dose. In two randomized controlled clinical trials involving over 1,830 patients, participants received Xofluza, a placebo, or another antiviral flu treatment within 48 hours of flu symptom onset. In both trials, the time to symptom relief was shorter in patients treated with Xofluza compared with patients who took the placebo. In the trial comparing Xofluza with other flu treatments, no difference was found in the time to alleviation of symptoms. The most common adverse reactions to the new drug included diarrhea and bronchitis.

Because Xofluza has a novel mechanism of action, it provides an important alternative to other antiviral drugs on the market, says Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research. “Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.”

The FDA and CDC emphasize that the best defense against flu is yearly vaccination.

Source: FDA approves new drug to treat influenza. US Food & Drug Administration. News release. October 24, 2018.

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Benefit found for older women with osteopenia

Bisphosphonates such as zoledronate prevent fractures in patients with osteoporosis, but their effectiveness in women with osteopenia is unknown. To investigate this issue, researchers conducted a 6-year, double-blind trial involving 2,000 women age 65 or older with osteopenia. The women were randomly assigned to receive four infusions of either zoledronate at a dose of 5 mg or normal saline at 18-month intervals. The primary end point was the time to first occurrence of a nonvertebral or vertebral fragility fracture.

The results showed that women who received zoledronate had a lower risk of nonvertebral fragility fractures, symptomatic fractures, vertebral fractures, and height loss. The researchers concluded, “The risk of nonvertebral or vertebral fragility fractures was significantly lower in women with osteopenia who received zoledronate than in women who received placebo.”

Source: Reid IR, Horne AM, Mihov B, et al. Fracture prevention with zoledronate in older women with osteopenia. N Engl J Med. [e-pub October 1, 2018].

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“Alarming” number of parents share leftovers

In a nationwide online survey of nearly 500 parents, almost 50% reported saving leftover antibiotics instead of disposing of them, and about 73% of those parents reported subsequently diverting the leftovers to themselves or others, both inside and outside the family, without consulting a prescriber. Taking unnecessary antibiotics, or taking them in the wrong dosage or time frame, increases the risk of antibiotic-resistant infections.

The survey also revealed that:

  • the most commonly diverted dosage forms were liquids and drops.
  • parents most often administered diverted antibiotics in the prescribed dosage, regardless of whether the recipient had changed, or estimated a dosage based on a child's age.
  • 16% reported giving a child medication prescribed for an adult.

Senior author Ruth Milanaik, DO, FAAP, calls for investing more effort and resources in educating families about how antibiotics work, when they are and are not appropriate, and why taking antibiotics without consulting a healthcare provider is risky for both adults and children.

The research was presented at the American Academy of Pediatrics 2018 National Conference & Exhibition in November.

Source: Survey finds alarming percentage of families share leftover antibiotics. American Academy of Pediatrics. News release. November 2, 2018.

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Now available for adults ages 27 through 45

Indications for Gardasil 9 (Human Papillomavirus [HPV] 9-valent Vaccine, Recombinant) have been expanded to include women and men ages 27 through 45. Gardasil 9 was previously approved for use in children and adults ages 9 through 26. Covering 9 HPV types, Gardasil 9 prevents cervical cancer and other diseases, such as genital warts, vulvar and vaginal precancerous lesions, and cervical precancerous lesions.

The safety of Gardasil 9 was evaluated in about 13,000 males and females. The most commonly reported adverse reactions were injection site pain, edema, erythema, and headaches.

Source: FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old. US Food & Drug Administration. News release. October 5, 2018.

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Chicken soup may be just as good

What should nurses tell patients seeking relief from cough, rhinorrhea, and other cold symptoms? A recent review shows that little quality research supports the use of most over-the-counter (OTC) remedies for the common cold, which is usually self-limiting.

Based on the evidence, the authors categorize the safety and effectiveness of an array of products for various indications. For example, decongestants may have a small beneficial effect on nasal symptoms in adults, but the benefit may be outweighed by such adverse reactions as drowsiness and headache. In addition, prolonged use can lead to chronic nasal congestion. No evidence at all has been found to support the use of many popular remedies and treatment strategies, such as vitamin C, zinc, honey, heated humidified air, probiotics, garlic, and increased fluid intake. Antiviral and antibiotic medications are also ineffective and, in the case of antibiotics, likely to be harmful.

The authors write, “Based on the currently available evidence, reassurance that symptoms are self-limiting is the best you can offer patients.”

Sources: van Driel ML, Scheire S, Deckx L, Gevaert P, De Sutter A. What treatments are effective for common cold in adults and children? BMJ. 2018;363:k3786. Limited evidence for OTC preps to treat nasal symptoms of colds. HealthDay News. October 18, 2018.

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