Aseptic meningitis risk with lamotrigine
The FDA is informing the public that lamotrigine (Lamictal) can cause aseptic meningitis, and the agency is revising the Warning and Precautions sections of the labeling and the Medication Guide to include information about this risk.
If meningitis is suspected, patients should be evaluated for other causes of meningitis and treated as indicated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is found.
The FDA identified 40 cases of aseptic meningitis in patients taking Lamictal from December 1994 to November 2009. During this period, over 46 million prescriptions for Lamictal were filled. In most cases, symptoms were reported to have resolved after discontinuation of Lamictal. In 15 cases, symptoms returned when patients restarted Lamictal.
Single-vial Taxotere approved
The FDA approved Sanofi-Aventis new one-vial formulation of the chemotherapeutic agent docetaxel (Taxotere) injection concentrate. The one-vial Taxotere is available in single-use vials of 80-mg/4 mL and 20-mg/mL dosages.
Previously, Taxotere was available in a two-vial formulation: one vial containing docetaxel concentrate and one with the diluent. The new formulation eliminates the need for the initial dilution step with the diluent. The new one-vial Taxotere formulation at the 20-mg/mL concentration is ready to be added directly into the infusion solution.
Taxotere is approved for use in treating patients at specific stages of five types of cancer including: metastatic breast cancer and for adjuvant treatment of breast cancer; metastatic androgen-independent prostate cancer; advanced non-small cell lung cancer; advanced gastric adenocarcinoma; and locally advanced squamous cell carcinoma of the head and neck.
Serious errors result from I.V. nimodipine
The FDA has alerted healthcare professionals that nimodipine (Nimotop) capsules should be given only by mouth or through a nasogastric tube and never by I.V. administration. The agency continues to receive reports of I.V. nimodipine use, with serious, sometimes fatal, consequences. I.V. injection of nimodipine can result in death, cardiac arrest, a severe decrease in BP, and other heart-related complications.
In 2006, a Boxed Warning was added to nimodipine labeling against I.V. use of the drug, and clear instructions are provided as to how to remove the liquid content from the capsules for nasogastric tube administration in patients who are unable to swallow.
The FDA will continue to work with drug manufacturers and outside groups on ways to prevent medication errors with nimodipine.
New Rx emergency contraceptive available
The FDA has approved ulipristal acetate (ella) tablets for emergency contraception. The prescription-only drug prevents pregnancy when taken orally within 120 hours (5 days) after a contraceptive failure or unprotected intercourse. According to the FDA, ella is a progesterone agonist/antagonist whose main effect is to inhibit or delay ovulation. The medication has been available in Europe since 2009 (marketed as ellaOne). ella is not intended for routine use as a contraceptive.
The safety and efficacy of ella were shown in two Phase III clinical trials in the United States and Europe. Adverse reactions more frequently observed in the clinical trials of ella included headache, nausea, abdominal pain, dysmenorrhea, fatigue, and dizziness. The adverse reaction profile of ella is similar to that of FDA-approved levonorgestrel emergency contraceptive.
ella is contraindicated in women with known or suspected pregnancy and is not recommended for use in women who are breast-feeding. ella is manufactured by Laboratoire HRA Pharma and will be distributed by Watson Pharma.