URGENT: DRUG RECALL
DEMSER® – Frequently Asked Questions (FAQs)
URGENT: DRUG RECALL
February 17, 2010
Dear Healthcare Professional:
This is to inform you of a product recall involving:
DEMSER® (metyrosine) 250 mg are opaque, two-toned blue capsules coded MSD 690 on one side and DEMSER on the other. They are supplied in bottles of 100 under NDC 25010-305-15. The recalled lot is #9F661.
NO OTHER LOT NUMBERS ARE INVOLVED IN THIS RECALL.
DEMSER® lot #9F661 currently in the marketplace was recently found to be out of specifications on dissolution testing. The bioavailability of this lot currently in the marketplace may be lower than the bioavailability of previously marketed lots.
Effective immediately, Aton Pharma has suspended distribution of DEMSER® lot #9F661. Patients who are currently taking DEMSER® from lot #9F661 should be switched to an alternative therapy immediately. Aton Pharma is taking this action as part of an ongoing commitment to ensure patient safety. We will move ahead with production and distribution of a new lot that meets all specifications as soon as possible.
DEMSER® (metyrosine), is a medication provided by Aton Pharma that is employed in pre-surgical management of patients with pheochromocytoma (tumor of the adrenal glands that secretes excessive amounts of catecholamines such as adrenaline), among other uses (see full prescribing information).
Because DEMSER® is titrated in steps to produce the desired clinical effect with careful monitoring when used preoperatively, we believe the risk caused by a DEMSER® lot with lower than anticipated bioavailability if used throughout the preoperative treatment period is low. This would be true for all patient categories addressed in the DEMSER® label: e.g., patients with preexisting cardiac conditions, impaired hepatic or renal function, who are pregnant, nursing, pediatric and/or geriatric.
However, for patients using DEMSER® chronically (such as use as a component of non-surgical treatment of pheochromocytoma or other condition), a DEMSER® lot with lower than anticipated bioavailability could increase their risk: These patients would be initially titrated to the desired clinical effect most likely with careful medical monitoring. Once the maintenance dose is selected, the intensity of medical monitoring would most likely decrease. In these patients, the clinical effects of a DEMSER® lot with lower than usual bioavailability might not be detected and could be deleterious to the health of the patient.
This recall was voluntarily initiated by Aton Pharma and is being made with the knowledge of the Food and Drug Administration.
We deeply value the trust you have placed in Aton Pharma by prescribing our products, and apologize for any inconvenience this recall may have caused you.
Please contact the Aton Customer Service Department at (877) 286-6549 or medicalaffairs@atonrx.com if you would like more information or to discuss your questions and concerns.
Thank you.
Kevin Halloran
Vice President, Regulatory Affairs & Quality
Aton Pharma, Inc.
DEMSER® – Frequently Asked Questions (FAQs)
What is wrong with the product?
Dissolution testing was conducted on samples retained from the DEMSER® lot #9F661 currently in the market place. The samples were found not to dissolve as quickly as required in our specifications. It appears that the content of the capsule might in some cases be aggregated (clumped) instead of being a free flowing powder.
The implication of this finding in the clinical use of DEMSER® is unknown. It is conceivable however, that the bioavailability (the extent to which the medication can be used by the body) of the lot in the marketplace may be lower than the bioavailability of previously marketed lots.
Is the recalled product harmful?
The relationship between dissolution testing results and bioavailability of DEMSER® is unknown, the clinical implications are unknown, and the potential health consequences cannot be assessed with any reasonable certainty. It is conceivable that the bioavailability of the lot in question may range from normal to lower than expected with variability from capsule to capsule within the same bottle. It is also possible that the clumping of the powder in the capsule may be of no clinical consequence. There is no objective conclusion favoring one way or the other.
How soon will DEMSER® be available?
As a result of the recall, DEMSER® will be unavailable for several months.
What should I do?
If you are a patient, you should contact your medical professional immediately for alternative treatment and any additional information.
If you are a medical professional and have further inquiries, please call 1-877-ATON-549, option 1.
If you have questions regarding return of DEMSER® lot 9F661, please call 1-800-967-5952 (Inmar) for information.
