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Caution Against Cough/Cold Meds

The CDC has described three deaths in U.S. infants less than 12 months of age that were associated with cough and cold medications. The CDC said these medications were the underlying cause of death. The CDC notes that dosages at which cough and cold medications can cause illness or death in children under 2 years of age are not known. Dosing recommendations for clinicians prescribing cough and cold medicines do not exist for this age group. The FDA states that because of the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children younger than 2 years, parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting a healthcare provider and following the provider's instructions precisely. Clinicians should always ask caregivers about their use of nonprescription medications to avoid overdose in children from multiple medications that contain the same ingredient.

 

Acne Indication for Oral Contraceptive

The FDA has approved the use of drospirenone/ethinyl estradiol 24-day regimen (Yaz) for treatment of moderate acne in women who choose to use an oral contraceptive for birth control. Yaz is a product of Bayer Schering Pharma AG.

 

Approval of the new indication was based on data from two clinical trials of over 1,000 patients, which showed that treatment with Yaz resulted in significant reductions in total lesion counts and in inflammatory/noninflammatory lesion counts.

 

The most commonly reported adverse events in the acne trials were upper respiratory tract infection, irregular bleeding, headache, nausea, sinusitis, and yeast infection.

 

Drospirenone/ethinyl estradiol should not be used by patients with conditions that predispose them to hyperkalemia, such as renal insufficiency, hepatic dysfunction, or adrenal insufficiency. Consult product labeling for other prescribing instructions.

 

In addition to the contraceptive and acne indications, drospirenone/ ethinyl estradiol is approved for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder.

 

Insulin Aspart Safe for Pregnant Women

The FDA approved a pregnancy Category B rating for insulin aspart [rDNA origin] injection (NovoLog). The rating indicates that adequate clinical studies of its use in pregnant women have not revealed increased risks to the fetus, further validating NovoLog as a safe and effective treatment for pregnant women with type 1 diabetes. NovoLog was previously classified as a Category C drug.

 

The FDA's changed rating was based on a review of the largest ever randomized controlled trial using an insulin analog in pregnant women with type 1 diabetes.

 

The study showed fewer preterm deliveries, reduced risk of neonatal hypoglycemia requiring treatment, consistently low rates of major hypoglycemia, and reduced risks to the fetus, with outcomes at least comparable to human regular insulin.

 

Updated Claim for Calcium and Osteoporosis

The FDA proposed a new claim on foods and dietary supplements containing calcium and vitamin D to show their potential to reduce the risk of osteoporosis. The rule would allow manufacturers to include new information on their food and supplement labeling and eliminate other information to shorten the required claim language.

 

The proposed rule would add a claim for calcium and vitamin D together and a reduced risk of osteoporosis. The current wording of the rule would be changed to: drop the reference to sex, race, and age since the benefits of calcium and vitamin D apply to everyone; to drop the requirement that the claim must state that there are limits to the benefit of calcium intakes above 200% of the daily value; and to drop the requirement that the claim identify the mechanisms by which calcium reduces the risk of osteoporosis.

  
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