Recalls and warnings
A warning and labeling changes related to accidental overdoses of morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL). Serious adverse events and deaths have resulted from accidental overdoses, caused in most cases by products being ordered in milligrams but mistakenly interchanged for milliliters. The stronger concentration was recently approved under the FDA's unapproved drugs program and the product will now be more clearly labeled to differentiate it from 20 mg/5 mL morphine sulfate.
A contraindication added to the label of dolasetron mesylate (Anzemet) noting that the injection form of the drug should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy because it can increase the risk of developing torsade de pointes. The injection may still be used for the prevention and treatment of postoperative nausea and vomiting because the lower doses are less likely to affect the electrical activity of the heart. Dolasetron mesylate tablets may still be used to prevent chemotherapy-induced nausea and vomiting, although a stronger warning about abnormal heart rhythms is being added to the packaging of the tablets.
A recall of more than 300 lots of Abbott glucose test strips (marketed as Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima) because they may provide falsely low results.
Several recalls of intravenous drugs related to potential for particulates:
- dexamethasone sodium phosphate injection, 4 mg/mL (30-mL multiple dose vial),
- sodium bicarbonate injection, 7.5% and 8.4% (50-mL single-dose vials), and
- acetylcysteine injection (Acetadote), 200 mg/mL (30-mL single-dose vials).
A limit on the amount of acetaminophen permitted in prescription combination products to no more than 325 mg in each tablet or capsule. The change will be phased in over three years, and the FDA also is requiring manufacturers to update labels of combination medications to warn of the potential risk for severe liver injury.
An expanded approval of the human papillomavirus (HPV) vaccine Gardasil to prevent anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people ages 9 through 26 years. In a randomized, controlled trial of men who self-identified as having sex with men, Gardasil was shown to be 78% effective in the prevention of HPV 16- and 18-related anal intraepithelial neoplasia.
A new FDA website lists all recent approvals, both of novel drugs and new generics.
The FDA is calling for clinical trials to verify and describe the clinical benefit of midodrine hydrochloride (HCl). Since the drug was approved under the agency's accelerated approval regulations, data submitted by the manufacturer have not verified the clinical benefit that the drug was expected to have. In a new public docket, the FDA has recommended a design for a new clinical trial of the drug, called for submission of any existing controlled studies, and invited physicians who treat orthostatic hypotension and would like to work with any sponsors of new clinical trials to submit correspondence.
An ongoing safety review of insulin glargine (Lantus) has found inconclusive results thus far, the FDA recently reported. In July 2009, the agency informed the public that it was reviewing four published observational studies, three of which suggested an increased risk of cancer associated with the use of the drug. The FDA review found the studies to be inconclusive, due to limitations in design and available data. The agency is continuing to work with the manufacturer to further evaluate the long-term risk, if any.