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This article is intended for primary care clinicians, ophthalmologists, and other specialists who care for patients aged 5 to 49 years requiring influenza vaccination and those aged 3 years and older with allergic conjunctivitis.
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January 11, 2007 — The US Food and Drug Administration (FDA) has approved a refrigerated version of a trivalent intranasal influenza virus vaccine for the prophylaxis of disease caused by influenza A and B viruses in individuals aged 5 to 49 years, and a nonprescription formulation of ketotifen fumarate 0.025% ophthalmic solution for the temporary relief of symptoms associated with allergic conjunctivitis.
On January 8, the FDA approved a cold-adapted formulation of a trivalent intranasal influenza virus vaccine (FluMist, made by MedImmune, Inc). The product is indicated for active immunization to prevent disease caused by influenza A and B viruses in healthy children and adults aged 5 to 49 years.
According to a company news release, the formulation can be conveniently stored in a standard refrigerator rather than a freezer, as required by the currently available trivalent product. It is expected to improve access to the vaccine in settings such as physician offices, schools, pharmacies, and grocery stores, where availability of freezers can be limited. It is expected to be available for the 2007-2008 influenza season.
The recommended dosing regimen for previously unvaccinated children aged 5 to 8 years is 1 dose (0.5 mL) followed by a second dose, given at least 6 weeks later. All other healthy individuals (including children who have previously received at least 1 dose) should receive 1 dose.
The most commonly observed adverse events associated with use of the refrigerated and frozen formulations in randomized, placebo-controlled trials included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, myalgias, decreased appetite, abdominal pain, and decreased activity/tiredness/weakness.
Because of the association of Reye syndrome with aspirin and wild-type influenza infection, use of the vaccine is contraindicated in children or adolescents aged 5 to 17 years who are receiving treatment with aspirin or aspirin-containing products.
Individuals at high risk for severe disease from wild-type influenza infection should likewise not receive the intranasal vaccine. Those considered at high risk include adults and children with chronic disorders of the cardiovascular and pulmonary systems, including asthma; pregnant women; adults and children who have required regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies; and adults and children with congenital or acquired immunosuppression caused by underlying disease or immunosuppressive therapy.
The Centers for Disease Control notes that, although not studied, a potential exists for interference between concomitant use of the influenza vaccine and influenza A and/or B antiviral compounds. The FDA therefore advises that a period of 48 hours elapse between cessation of antiviral therapy and vaccine administration; a 2-week period after vaccination is recommended before initiation of antiviral therapy.
On December 1, the FDA approved a nonprescription formulation of ketotifen fumarate 0.025% ophthalmic solution (Alaway, made by Alimera Sciences, Inc [recently acquired by Bausch & Lomb]) for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair, and dander. Packaged in 10-mL bottles, it is expected to be commercially available in time for the spring 2007 allergy season.
According to a company news release, clinical studies have shown bioequivalence between the over-the-counter (OTC) drug and the prescription product (Zaditor, made by Novartis Pharmaceuticals, Inc). Zaditor was approved for OTC use on October 19, 2006.
Unlike currently available OTC products that offer no more than 4 hours of relief and must be applied 4 times daily, ketotifen fumarate 0.025% ophthalmic solution combines antihistamine and mast-cell stabilizer actions to provide relief within minutes that lasts for up to 12 hours.
The recommended dose of the product is 1 drop in the affected eye(s) twice daily, every 8 to 12 hours. Use of ketotifen ophthalmic solution is not recommended in children younger than 3 years, or for the treatment of contact-lens irritation. Its use is likewise contraindicated in patients with hypersensitivity to the active ingredient or other excipients, including glycerol and benzalkonium Cl (preservative).
Adverse events most commonly associated with its use in clinical studies include conjunctival infection, headaches, and rhinitis (incidence, 10% to 25%). The majority of cases were mild, and some resembled the underlying condition being treated.
Ocular adverse events, occurring at a rate of less than 5%, include allergic reactions, burning/stinging, conjunctivitis, discharge, dry eyes, eye pain, eyelid disorder, itching, keratitis, lacrimation disorder, mydriasis, photophobia, and rash.
Patients should be advised to discontinue treatment and contact their healthcare professional if they experience eye pain, changes in vision, redness in the eye, or if itching worsens or extends beyond a 72-hour period.
To prevent contamination, patients should be advised to refrain from touching the eyelids or surrounding areas with the dropper tip of the bottle. Because benzalkonium can be absorbed by soft contact lenses, a period of 10 minutes should elapse between treatment and lens insertion.
http://www.fda.gov/cder/whatsnew.htm
