Amgen, Wyeth revise labeling for Enbrel
PHILADELPHIA and THOUSAND OAKS, Calif. Amgen and Wyeth Pharmaceuticals have informed health care professionals of revisions to prescribing information for their rheumatoid arthritis and psoriasis medication Enbrel.
The revisions include a boxed warning about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel.
Infections have included bacterial sepsis and tuberculosis. The adverse reactions section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel.
FDA approves first U.S. drug for IBS-C
WASHINGTON Takeda and Sucampo Pharmaceuticals’ Amitiza, indicated for treatment of irritable bowel syndrome with constipation, was approved by the Food and Drug Administration for women over the age of 18, according to published reports.
IBS, an ailment characterized by cramping, abdominal pain, bloating, constipation and diarrhea, affects twice as many women as men, the FDA said. The reason for Amitiza’s approval for women only, however, was based on a lack of proof that the drug was effective for men.
“For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities,” said Julie Beitz of the FDA’s Center for Drug Evaluation and Research. “This drug represents an important step in helping to provide medical relief from their symptoms.”
Amitiza (lubiprostone) is already approved for the treatment of chronic idiopathic constipation, though at a much higher dosage than for treatment of IBS-C.
CDC says more than 25% of children not receiving recommended vaccinations
WASHINGTON According to the Centers for Disease Control and Prevention, more than a quarter of children in the U.S. are not meeting childhood vaccinations in accordance with government recommendation, according to Reuters. The study was of children between the ages of 18 months and 3-years-old.
The report went beyond studying if children were getting the recommended number of doses of various vaccines by, examining whether the children were getting them at the right time.
CDC researchers found that 28 percent did not meet vaccination recommendations. The results were based on a 2005 government survey involving 17,563 U.S. children in that age group.
Missed doses accounted for about two-thirds of those not in compliance. The rest of the children got them at the wrong age or too soon after a previous dose to be considered completely effective. Using the usual method of examining only whether children got the right number of doses, 81 percent of the children met government recommendations, according to the CDC.
The CDC recommends a number of vaccines to protect children against diseases like measles, polio, mumps, chicken pox and several others. Some require multiple doses.