Watson Pharmaceuticals, Inc. announced Tuesday that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the U.S. is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 145287A, have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between April 2, 2009 and May 20, 2009. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall. A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No serious injuries have been reported in connection with the recalled lot. However, exposure to...
Since 2007, the FDA has been discussing and debating the development of Risk Evaluation and Mitigation Strategies (REMS) for opioid medications . The purpose of these REMS is to make access to opioid drugs more difficult for drug abusers while still giving chronic pain patients the ability to fill their prescriptions without undue problems. Of course, that is more easily said than done. Needless to say, since the idea of REMS was first announced, chronic pain patients have been concerned about how the REMS would affect their ability to get the pain medications they need. Many have already run into problems with doctors who are no longer willing to prescribe opioids and pharmacists who refuse to fill their prescriptions for various reasons. It's a reasonable assumption that additional restrictions would only make getting their medications more difficult. Although this first set of approved REMS for a class of drugs will not apply to most chronic patients, it...
Generic Name: FENTANYL SPRAY - NASAL Pronounced: (FEN-ta-nil) Fentanyl Citrate Nasl Precautions
Before taking fentanyl, tell your doctor or pharmacist if
you are allergic to it; or if you have any other allergies. This product may
contain inactive ingredients, which can cause allergic reactions or other
problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or
pharmacist your medical history, especially of:
brain disorders (such as head injury, tumor,
breathing problems (such as asthma, sleep apnea, chronic
obstructive pulmonary disease-COPD)
mental/mood disorders (such as confusion,
personal or family history of regular use/abuse of
stomach/intestinal problems (such as blockage, constipation,
diarrhea due to infection, paralytic ileus)
difficulty urinating (such as due to enlarged
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