Morphine Sulfate Recall- Voluntarily Recall by Ethex Corp

ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall. The voluntary single-lot recall is due to a report that a tablet with as much as double the appropriate thickness was identified and the possibility therefore that there may be other similar oversized tablets that may have been commercially released in the affected lot. Such tablets may contain as much as twice the labeled level of active morphine ingredient. The product is a white oval tablet with “60″ on one side, and “E” on the reverse.

No report of unexpected side effects or injury has been received. However, opioids such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness. As such, they may be less likely to be able to determine that a tablet is overweight or oversized than an unimpaired individual.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation previously initiated the recall notification to wholesalers and retailers who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact the number above regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Remicade, Enbrel, Humira and Cimzia- FDA Warning – Tumor Necrosis Factor Blockers & Cancer

The FDA released an advance Communication regarding an Ongoing Safety Review to inform health care professionals that the Agency is looking into a potential connection between the use of Tumor Necrosis Factor (TNF) blockers and the maturation of lymphoma and other cancers in children and young adults. FDA is investigating around 30 reports. The reports were presented to the FDA’s Adverse Event Reporting System during a ten-year period, starting in 1998 through April 29, 2008.

These reports identify cancer occurring in children and young adults who started taking TNF blockers (and other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), while they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn’s disease or other diseases. Around 1/2 of the cancers were lymphomas, including  Hodgkin’s and non-Hodgkin’s lymphoma.

Long-term studies are required to render conclusive replies about whether TNF blockers increase the happening of cancers in children since cancers could take a long time to arise and may not be observed in short-term studies. Until the evaluation is finished, healthcare providers, parents, and caregivers should be mindful of the conceivable risk of lymphoma and other cancers in children and young adults when choosing how to better treat these patients.