NMA: Nonprescription Medicines Academy

Quick Takes

May 29th, 2013

  • The FDA is allowing manufacturers of nonprescription nicotine replacement therapy (NRT) smoking cessation products to make several changes to the warnings and limitations in the directions for use, to allow some flexibility on how they are used and for how long. Currently, consumers are instructed to stop smoking when they begin using a nicotine replacement product and to discontinue product use after 12 weeks. The changes include removing the warning that consumers should not use an NRT product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine—including another NRT. Consumers will be encouraged to pick a “quit day” and begin using the NRT product on that day, even if they aren’t immediately able to stop smoking. They also will be advised to consult their health care professional if they feel the need to use an NRT product for a longer than the time period recommended in the label.
  • On March 19, Sen. Mike Johanns (R-Neb.) and Rep. Erik Paulsen (R-Minn.) introduced the Family Health Care Flexibility Act to repeal restrictions placed on health savings accounts (HSA) and flexible spending accounts (FSA) by the Patient Protection and Affordable Care Act. The new legislation would repeal the $2,500 FSA contribution cap that went into effect this year and restore the provision allowing HSA and FSA account dollars to be used for purchasing nonprescription medications. When it was introduced, the Johanns-Paulsen legislation had 11 cosponsors in the Senate and 35 in the House.
  • A small (17 patients) retrospective clinical study found a relationship between glucosamine supplementation and increased intraocular pressure (IOP) in patients with glaucoma who supplemented with glucosamine. Although the changes in IOP appeared to be reversible, the possibility of permanent damage resulting from prolonged use of glucosamine supplements could not be eliminated. The authors concluded that the connection between glucosamine supplementation and IOP deserves further exploration; in the interim, monitoring IOP in patients choosing to supplement with glucosamine may be indicated. (JAMA Ophthalmol. 2013 May 3. [Epub ahead of print])
  • The safe range of serum calcidiol is 20 to 36 ng/mL (50 to 90 nM), based on the results of a large, population-based, historical, prospective cohort study that included data for more than 400,000 Israeli citizens. Patients with vitamin D levels in that range had the lowest risk of the combined study outcome (mortality or acute coronary syndrome.) In comparison, the adjusted hazard ratios among patients with levels of <10, 10–20, and >36 ng/mL were 1.88 (95% CI, 1.80–1.96), 1.25 (95% CI, 1.21–1.30), and 1.13 (95% CI, 1.04–1.22) (P < .05), respectively. (J Clin Endocrinol Metab. 2013;98:2160-7. Epub 2013 Mar 26.)
  • A recent “Aches & Claims” column in The Wall Street Journal addressed the use of valerian for insomnia. After reviewing existing evidence—including information provided by Natural Standard—the column offered the following verdict: “Some studies find valerian root helps combat insomnia, while others find it’s no better than a placebo. Doctors say it’s relatively safe so there’s no harm in trying it.” The column can be accessed online at http://online.wsj.com/article/SB1000142412788732448500457842473013990686....
  • An article in the May 20, 2013, issue of USA Today addressed the question, “Are SPF ratings on sunscreen ‘just a gimmick?’” The article discusses recent changes to sunscreen labels. The title refers to a comment made by Marianne Berwick, professor of epidemiology at the University of New Mexico, that high sunscreen numbers are just a gimmick. “Most people really don’t need more than an SPF 30 and they should reapply it every couple of hours,” Berwick opined. The article is available on the USA Today website at http://www.usatoday.com/story/news/health/2013/05/19/sunscreen-spf-ratin....
  • The Council of Better Business Bureaus National Advertising Division has recommended that Matrixx Initiatives discontinue advertising claims suggesting that its homeopathic Zicam Cold Remedy products prevent users from catching a cold. Claims at issue were featured in an advertising campaign that depicted a “Cold Monster” and encouraged treatment with Zicam products at the “pre-cold” stage.
  • An article in the May 2013 issue ofPediatrics addresses the “Cinnamon Challenge”: swallowing a tablespoon of ground cinnamon in 60 seconds without drinking fluids. According to the article, more than 50,000 YouTube videos depict children and teens attempting this activity as of August 2012. The subjects are shown coughing and choking as the spice triggers a severe gag reflex in response to a caustic sensation in the mouth and throat. Some adolescents have gone to the emergency department after taking the Cinnamon Challenge, and some have required hospitalization for collapsed lungs. At least 30 youth in the United States have needed medical attention. There also were 178 calls to U.S. poison control centers in 2012 related to this stunt. (Pediatrics. 2013;131:833-5.)
  • The new U.S. Preventive Services Task Force (USPSTF) recommendation statement on vitamin D and calcium supplementation to prevent fractures in adults appears in the May 7, 2013, issue of Annals of Internal Medicine. According to the statement, current evidence is insufficient to assess the balance of the benefits and harms of combined vitamin D and calcium supplementation for the primary prevention of fractures in premenopausal women or in men. Current evidence also is insufficient to assess the balance of the benefits and harms of daily supplementation with greater than 400 IU of vitamin D3 and greater than 1,000 mg of calcium for the primary prevention of fractures in noninstitutionalized postmenopausal women. The USPSTF recommends against daily supplementation with 400 IU or less of vitamin D3 and 1,000 mg or less of calcium for the primary prevention of fractures in noninstitutionalized postmenopausal women. (Ann Intern Med. 2013; 158:691-6.)
  • In a telephone call with financial analysts on May 7, 2013, Perrigo chairman and CEO Joseph Papa speculated that as much as $10 billion in branded pharmaceutical sales could make the Rx-to-OTC switch over the next 5 years, with as much as half of that occurring within the next 3 years. As reported by Drug Store News (http://drugstorenews.com/article/perrigo-10-billion-rx-sales-may-switch-...), Papa identified overactive bladder and pain relief as prime categories for potential switch candidates.