FDA Approves New Rotavirus Vaccine
GlaxoSmithKline Biological's live oral rotavirus vaccine, Rotarix, has been FDA-approved for the prevention of rotavirus gastroenteritis in infants. The vaccine will offer protection against the most commonly circulating rotavirus types in the United States, and it allows infants to complete the vaccination series by 4 months of age. Current CDC guidelines recommend the series be completed by 6 months of age. According to the manufacturer, the vaccine could help prevent many of the 55,000 to 70,000 hospitalizations of young children each year that result from rotavirus in the United States.
Rotarix is a liquid given in a 2-dose series. Clinical trials show the vaccine provides broad and sustained protection in preventing illness caused by G1, G3, G4, and G9 when given as a two-dose series in infants and children. Data show that Rotarix sustained protection through the first 2 years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%).
The most common adverse reactions seen in studies of Rotarix in over 24,000 infants were fussiness, irritability, cough, runny nose, fever, loss of appetite, and vomiting.
Possible Stroke Risk with Spiriva
Boehringer Ingelheim and the FDA have notified healthcare practitioners of a possible increased risk of stroke in patients who take tiotropium (Spiriva HandiHaler). Based on safety data from 29 placebo-controlled clinical studies, the preliminary estimates of the risk of stroke are 8 patients per 1,000 patients treated for 1 year with Spiriva, and 6 patients per 1,000 patients treated for 1 year with placebo. According to the FDA, this means there is an estimated excess risk of any type of stroke due to Spiriva of 2 patients for each 1,000 patients using Spiriva over a 1-year period.
The FDA has not yet confirmed the analyses and notes that further investigation is required. It is important to interpret these preliminary results with caution, the agency states, and patients should not stop taking Spiriva HandiHaler before consulting their healthcare provider. The FDA is working with the manufacturer to further evaluate the potential association between Spiriva and stroke.
New Indication for Colesevelam: Improved Glycemic Control
The FDA approved the use of colesevelam (Welchol) for adjunctive therapy to improve glycemic control in adults with type 2 diabetes. The drug can be added to metformin, sulfonylureas, or insulin either alone or in combination with other antidiabetic agents.
Clinical trials showed that add-on colesevelam therapy provided a significant reduction in mean glycosylated hemoglobin (A1C) of 0.5% versus placebo. The reduction in A1C occurred when the drug was added to treatment with metformin, sulfonylurea, or insulin monotherapy, or to combinations of these drugs with other antidiabetic agents.
The most common adverse events reported in the studies included constipation, dyspepsia, and nausea. Consult product labeling for detailed prescribing information.
Neupro Patch Recalled
UCB and Schwarz Pharma announced the recall of the Parkinson's disease treatment rotigotine transdermal system (Neupro) in the United States because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin, and the efficacy of the product may vary.
Healthcare providers should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product. Patients should not discontinue therapy abruptly, as this can cause a syndrome resembling neuroleptic malignant syndrome or akinetic crisis.