New Dosage Available for IBS Treatment
An 8-mcg capsule of Amitiza (lubiprostone) is available for the treatment of irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older.
Amitiza works locally in the intestine to increase fluid secretion, resulting in increased passage of stool and alleviating symptoms associated with chronic idiopathic constipation. Although it is not well understood how Amitiza works to reduce symptoms in patients with IBS-C, studies in animals suggest that it stimulates recovery of mucosal barrier function.
Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Its safety during pregnancy has not been evaluated in humans and should be used in pregnancy only if the benefit justifies the potential risk to the fetus. The drug should not be prescribed to patients who have severe diarrhea.
Patients taking Amitiza may experience dyspnea within an hour of first dose. This symptom generally resolves within a few hours, but may recur with repeat dosing. In clinical trials of Amitiza in patients with IBS-C, the most common adverse reactions were nausea, diarrhea, headache, abdominal pain, abdominal distention, and flatulence.
Consult labeling for more detailed prescribing information.
FDA Proposes Pregnancy-Based Drug Label Revisions
The FDA has proposed major changes to the healthcare provider labeling for prescription drugs and biological products to provide better information about the effects of medicines used during pregnancy and breastfeeding. The changes would give healthcare professionals more comprehensive information on which to base prescribing decisions and help them counsel women who are pregnant, breast-feeding, or of child-bearing age about the use of prescription medications.
The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling, which describes risks of drug use during pregnancy. This system has been criticized as leading to an inaccurate and overly simplified view of these risks and does not facilitate updating information as new data becomes available.
New Aranesp Starting Dose for Anemia of CRF
The FDA approved a new regimen for Amgen's darbepoetin alfa injection (Aranesp) for the de novo correction of anemia in adult patients with chronic renal failure who are not receiving dialysis. The new starting dose is a 0.75 mcg/kg subcutaneous injection once every 2 weeks.
The approval was based partly on data from an 18-week study showing that 92% of patients receiving this starting dose of darbepoetin alfa achieved a hemoglobin concentration of 11 g/dL or greater. A second study lasting 24 weeks found that 85% of patients achieved a hemoglobin concentration ranging from 11 to 13 g/dL.
Certain Lots of Solodyn Tablets Recalled
Medicis and the FDA announced the recall of lot numbers B080037 (exp: 12/09) and B080038 (exp: 12/09) of Solodyn Extended Release Tablets because one of the bottles contained azathioprine (Azasan) tablets 75-mg instead of Solodyn 90-mg tablets.
Taking Azasan instead of Solodyn presents a health hazard and safety risk to patients, the FDA states. Side effects associated with the use of Azasan, particularly in the elderly, can include myelosuppression, infection, bleeding, chills, nausea, vomiting, and diarrhea. Joint and muscle pain are also common side effects.
Furthermore, unanticipated interactions with other drugs may also lead to serious adverse events, the FDA notes.
The recall is limited to the lots noted. The product may be returned to the manufacturer if it is one of the affected lots.