Save the Date!
October 18, 2014
Seattle Conference Center
Eighth and Pike, Seattle, WA
AUDIENCE: Neurology, Pharmacy, Dermatology
ISSUE: FDA is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. FDA approved changes to the Onfi drug label and the patient Medication Guide to describe the risk of these serious skin reactions.
These skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment. However, the likelihood of skin reactions is greater during the first 8 weeks of treatment or when Onfi is stopped and then re-started. All cases of SJS and TEN in the FDA case series have resulted in hospitalization, one case resulted in blindness, and one case resulted in death. See the FDA Drug Safety Communication for a Data Summary and additional information.
The Onfi drug label has been revised to add information about the risk for serious skin reactions to the Warnings and Precautions section and to the Medication Guide.
BACKGROUND: Onfi is a benzodiazepine medication used in combination with other medicines to treat seizures associated with a severe form of epilepsy called Lennox-Gastaut Syndrome.
RECOMMENDATION: Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment or when re-introducing therapy. Health care professionals should discontinue use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related.
Patients taking Onfi should seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives. Patients should not stop taking Onfi without first talking to their health care professionals. Stopping Onfi suddenly can cause serious withdrawal problems, such as seizures that will not stop, hallucinations, shaking, nervousness, and stomach or muscle cramps.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the FDA Drug Safety Communication and prescribing information (label).
ISSUE: The U.S. Food and Drug Administration (FDA) is recommending that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to the labels of anticoagulant drugs known as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar products.
BACKGROUND: Serious adverse events continue to occur (see Data Summary). To address this safety concern, FDA worked with the manufacturer of Lovenox, Sanofi-Aventis, to further evaluate this risk and to update the Warnings and Precautions section of the Lovenox label with these additional timing recommendations. The labels for generic enoxaparin products will also be revised accordingly, as will those of other low molecular weight heparin-type products.
RECOMMENDATION: Health care professionals and institutions involved in performing spinal/epidural anesthesia or spinal punctures should determine, as part of a preprocedure checklist, whether a patient is receiving anticoagulants and identify the appropriate timing of enoxaparin dosing in relation to catheter placement or removal. To reduce the potential risk of bleeding, consider both the dose and the elimination half-life of the anticoagulant:
*For enoxaparin, placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses such as those used for prevention of deep vein thrombosis. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily).
*A post procedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter remova
*In all cases, a benefit-risk assessment should consider both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.
For Complete MedWatch Safety Alert including link to Drug Safety Communication please click here.