Long-Acting Detemir Insulin Approved
Insulin detemir (rDNA origin) injection (Levemir) has received FDA approval for once- or twice-daily use in adults with type 1 or type 2 diabetes who require basal insulin for the control of hyperglycemia.
Insulin detemir is active for up to 24 hours and has a relatively flat action profile. In pharmacodynamic studies, the mean duration of action of insulin detemir ranged from 5.7 hours at the lowest dose to 23.2 hours at the highest dose. For doses between 0.2 unit/kg and 0.4 unit/kg, detemir exerts more than 50% of its maximum effect from 3 to 4 hours up to approximately 14 hours after dose administration.
The FDA based its approval on the results of clinical studies showing that use of insulin detemir yielded a level of glycemic control similar to that of NPH human insulin or insulin glargine injections, as measured by A1C levels.
Adverse events associated with use of insulin detemir included hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.
Insulin detemir is a product of Novo Nordisk.
Health Advisory Regarding Fentanyl Patch
The FDA has issued a public health advisory to patients, healthcare providers, and caregivers regarding the safe use of the fentanyl transdermal system following reports of deaths and serious side effects in patients using this narcotic for pain management. Deaths and overdoses have occurred in patients using both the brand name product (Duragesic) and the generic product.
The FDA cautions that directions for using this product must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl.
In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches. Safety precautions include information on signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal. The Boxed Warnings and the Warnings sections of the product's labeling have been updated.
The FDA is conducting an investigation into the deaths associated with the fentanyl transdermal patch and is working with manufacturers to help patients avoid accidental fentanyl overdose.
New Diarrhea Remedy for Adults, Teens
Nitazoxanide (Alinia) tablets and oral suspension have been approved for the treatment of diarrhea caused by Cryptosporidium parvum in adults and children 12 years of age and older. Nitazoxanide, a product of Romark Pharmaceuticals, was previously approved to treat the same infection in younger children as well as for the treatment of diarrhea caused by Giardia in patients 1 year and older. Nitazoxanide is dosed for 3 days.
The most common adverse events in clinical trials of nitazoxanide were abdominal pain, diarrhea, headache, nausea, and vomiting. Adverse events were considered transient and mild, with a rate of discontinuations due to adverse events of approximately 1%.
Consult product labeling for dosing and precautions.
Gel Reduces Acne Lesions
Dapsone 5% topical gel (Aczone) has been approved for the topical treatment of acne vulgaris. The approval was based on data from two randomized, double-blind, vehicle-controlled clinical studies in 3,000 acne patients, in which dapsone 5% topical gel achieved statistically significant percentage reductions in the number of acne lesions and better success rates on the Global Acne Assessment Score compared with vehicle alone.
Before using dapsone 5% topical gel, patients will need to be screened to detect if they are predisposed to hemolytic anemia because of a glucose 6-phosphate dehydrogenase deficiency. Patients who have this enzyme deficiency will require monitoring with regular blood counts.
The most common adverse events reported in clinical trials include oiliness/peeling, dryness, and erythema.
Dapsone 5% topical gel is a product of QLT Inc.