warningFDA to Add Strictest Warnings to Bowel-Cleansing Drugs
Two prescription bowel-cleansing drugs commonly taken before colonoscopies will receive the sternest safety warnings available after nearly two dozen patients reported suffering severe kidney damage after taking the drugs, the Food and Drug Administration said. The drugs, Visicol and OsmoPrep, are oral tablets made by Salix Pharmaceuticals. The FDA has received more than 20 reports of kidney failure in patients taking the tablets, known as oral phosphate products. The drugs will now have new boxed warnings added to their packaging …
FDA Warns Covidien to Clean Up Manufacturing Safety Problems
Medical-device maker Covidien Ltd. must correct safety violations at its Missouri manufacturing plant or else face fines and other penalties, the FDA said. FDA inspectors have uncovered manufacturing problems at the plant, which makes the Ultra-TechneKow DTE Generator. The machine provides medical isotopes that are used for radiopharmaceuticals injected into patients before imaging tests are performed. In an August 12 letter to the company, the FDA warned that the company had failed to establish appropriate standards and testing procedures for …
Antibiotics Cipro and Levaquin Must Include Warnings About Risk of Tendon Damage
The makers of the popular antibiotics Cipro and Levaquin must warn users about the increased risk of tendon ruptures and tendinitis from taking the drugs, the Food and Drug Administration said. Cipro and Levaquin are two leading brands of fluoroquinolones, a family of prescription antibiotics that is commonly used to kill bacteria or prevent their growth inside the body. The antibiotics are used to treat urinary tract infections, ear infections, bronchitis, pneumonia, tuberculosis, and some sexually transmitted diseases. Federal health …
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