Medical Articles - FDA Alerts
Safety Alert: Voluntary Recall and Supply Reduction
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk; Including the following products:
- Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
- Opana (oxymorphone hydrochloride) CII
- Oxymorphone hydrochloride Tablets CII
- PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
- PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
- ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
- ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
- MORPHINE SULFATE Extended-Release Tablets CII
- ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
AUDIENCE: Pharmacy, Consumers
ISSUE: FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product.
BACKGROUND: Opiates are potent medications used to alleviate pain and are available only by prescription. Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009; all three were detected by pharmacists. Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.
RECOMMENDATION: FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same.
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.fda.gov/MedWatch/report.htm
- 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
[01/09/2012 - Visual Guide - Endo]
Related to this recall, Endo Pharmaceuticals, Inc., announced that a temporary shut-down of Novartis Consumer Health Inc.'s Lincoln, Neb., manufacturing facility was required, where some of Endo’s products are also packaged. The company says pharmacies may experience a short-term shortage of certain opioid analgesics.
FDA MedWatch - Celexa (citalopram hydrobromide)
Date: Aug, Wed 24 2011 09:52 -0400 (EDT)
Subject: FDA MedWatch - Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses
Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses
AUDIENCE: Psychiatry, Cardiology
ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.
Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.
BACKGROUND: Celexa (citalopram hydrobromide) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients.
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:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm
Date: Aug, Wed 24 2011 09:52 -0400 (EDT)
Subject: FDA MedWatch - Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses
Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses
AUDIENCE: Psychiatry, Cardiology
ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.
Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.
BACKGROUND: Celexa (citalopram hydrobromide) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients.
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.fda.gov/MedWatch/report.htm
- 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
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm
FDA NEWS RELEASE - Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate..
6/27/2011
Butalbital
Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled.
See the FDA website by clicking above for more information.
6/27/2011
Butalbital
Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled.
See the FDA website by clicking above for more information.
FDA NEWS RELEASE - ENDOCET - OXYCODONE / ACETAMINOPHEN TABLETS RECALL
6/27/11
ENDOCET - OXYCODONE / ACETAMINOPHEN TABLETS RECALL
Some bottles contain different strength tablets. Click on the link above for more information from the FDA.
6/27/11
ENDOCET - OXYCODONE / ACETAMINOPHEN TABLETS RECALL
Some bottles contain different strength tablets. Click on the link above for more information from the FDA.
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