Adenoscan FDA Alerts
The FDA Alerts below may be specifically about Adenoscan or relate to a group or class of drugs which include Adenoscan.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Adenoscan
Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death
[Posted 11/20/2013]
ISSUE: The FDA is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine). FDA has approved changes to the drug labels to reflect these serious events and updated recommendations for use of these agents. At this time, data limitations prevent FDA from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan.
The Warnings & Precautions section of the Lexiscan and Adenoscan labels previously contained information about the possible risk of heart attack and death with use of these drugs. However, recent reports of serious adverse events in the FDA Adverse Event Reporting System (FAERS) database and the medical literature prompted approval changes to the drug labels to include updated recommendations for use.
BACKGROUND: Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Lexiscan and Adenoscan help identify coronary artery disease. They do this by dilating the arteries of the heart and increasing blood flow to help identify blocks or obstructions in the heart’s arteries. Lexiscan and Adenoscan cause blood to flow preferentially to the healthier, unblocked or unobstructed arteries, which can reduce blood flow in the obstructed artery. In some cases, this reduced blood flow can lead to a heart attack, which can be fatal.
RECOMMENDATIONS: Screen all nuclear stress test candidates for their suitability to receive Lexiscan or Adenoscan. Avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan or Adenoscan.
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: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[11/20/2013 -Drug Safety Communication - FDA]
Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems
Reports Received on Adenosine and Amiodarone Products
[UPDATED 05/06/2011] FDA recommends that, to reduce the potential risks to patients, healthcare professionals and risk managers stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or pre-filled plastic syringes, if possible. The use of needleless pre-filled glass syringes in emergency situations should be avoided.
Refer to the May 2011 FDA Drug Safety Communication, featuring photos, a list of affected adenosine and amiodarone products, and IV access systems known to be incompatible with adenosine and amiodarone pre-filled glass syringes.
[Posted 11/17/2010]
ISSUE: FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, often when attempting to connect to some pin activated needleless IV access systems. Adenosine is a cardiac drug that is administered when a patient has a rapid or irregular heart rhythm in an attempt to return their heart rhythm to normal. Adenosine must be injected rapidly into the blood stream in emergency situations and this failure could delay treatment.
In some cases where an attempt is made to connect to pin activated needleless IV access systems, the syringe may cause the pin to break thus clogging the syringe, or damaging the IV tubing and/or the needleless connector and requiring reestablishment of a new intravenous access. These failures can cause a delay in administration of the medication, which could potentially result in serious harm to patients.
BACKGROUND: Adenosine pre-filled glass syringes are marketed by Teva, Sagent, Baxter, and Wockhardt. FDA has also received reports of problems related to certain pre-filled needleless glass syringes containing the cardiac drug amiodarone. See the FDA letter for a list of affected adenosine and amiodarone products.
RECOMMENDATION: Healthcare professionals, risk managers, and staff who purchase, stock, or administer emergency crash cart medications, operating room medications, emergency drug boxes, or types of emergency drug caches should be alerted to this incompatibility problem and potential for damage or blockage of the IV line and delay in administering the medication. Healthcare organizations currently using glass prefilled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes as a back up measure.
FDA has expanded the scope of its review to include all currently marketed pre-filled needleless glass syringes intended for use with needleless intravenous access systems, where delay in administration could potentially result in a life threatening event. FDA is working with manufacturers to correct the problem and identify additional mitigation strategies.
Healthcare professionals and healthcare organization managers are encouraged to report adverse events or problems experienced with the use of needleless pre-filled glass syringes to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. FDA is interested in receiving information on the type, manufacturer and NDC numbers of the prefilled syringes and type and manufacturer of needleless IV access devices. FDA is especially interested in any description of the nature of the syringe failure, any adverse patient outcomes, and any mitigation strategies that have been identified or implemented by users of these products.
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[05/06/2011 - Drug Safety Communication - FDA]
[11/17/2010 - Letter to Stakeholders - FDA]
