Oral Suspension Heartburn Medication
Wyeth Pharmaceuticals has received FDA approval of pantoprazole sodium (Protonix) delayed-release oral suspension. The medication is approved for the treatment and maintenance of erosive esophagitis with associated gastroesophageal reflux disease (GERD) symptoms. According to Wyeth, the new formulation provides comparable acid suppression to Protonix tablets.
Protonix for Delayed-Release Oral Suspension provides an effective treatment for erosive GERD in adult patients who cannot swallow medications.
The new formulation can be administered orally in applesauce or apple juice or through a nasogastric tube.
The adverse reaction profile for the new formulation is similar to the profile for Protonix delayed-release tablets. The most frequently reported adverse events in clinical trials were headache, diarrhea, and flatulence.
Stronger Warnings on ESAs
The FDA has approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs). The new labeling addresses the risks posed by Aranesp, Epogen, and Procrit to patients with cancer and with chronic kidney failure.
The warnings stress that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid, and non-small cell lung cancer when they received doses that attempted to achieve a hemoglobin level of 12 g/dL.
The new boxed warning also clarifies that ESAs should be used in cancer patients only when treating anemia specifically caused by chemotherapy, and not for other causes of anemia, and should be discontinued once chemotherapy has been completed.
For patients with chronic kidney failure, the warning states that ESAs should be used to maintain a hemoglobin level between 10 and 12 g/dL. Maintaining higher levels in this group of patients increases the risk of death and serious cardiac events such as stroke, myocardial infarction, or heart failure. The new labeling also emphasizes that there are no data from controlled studies showing that ESAs improve symptoms of anemia, quality of life, fatigue, or well-being in patients with cancer or patients with HIV undergoing AZT therapy.
Aminotadalafil Recall Announced
The FDA has notified healthcare professionals and consumers of a nationwide recall of Encore tablets, a dietary supplement sold in health food stores and via the Internet and mail order in the United States and Canada. The recall was announced because the product contains potentially harmful undeclared ingredients.
One lot of the product contained aminotadalafil, an analog of tadalafil, the active ingredient of an FDA-approved medication for erectile dysfunction. The undeclared chemical may interact with the nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels, according to the FDA.
High Blood Pressure Treatment in Children
Novartis Pharmaceuticals Corp. has received FDA approval to market valsartan (Diovan) for the treatment of hypertension in children and adolescents ages 6 to 16 years. The medication is not indicated for treatment in children under age 6 years and it is not recommended for children with glomerular filtration rates below 30 mL/min/1.73 m2. Patients with allergies to any of the ingredients in valsartan should not take the drug.
According to the company, there were no differences between the adverse event profile for pediatric patients ages 6 to 16 years and those previously reported for adults.
The most serious side effects reported with valsartan are hypotension and kidney problems. Other side effects with valsartan have generally been mild. In hypertensive patients, the most common side effects with valsartan are headache and dizziness.