2006P-0007 Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
FDA Comment Number : EC2
Submitter : Dr. Richard Harris Date & Time: 04/28/2006 04:04:18
Organization : Dr. Richard Harris
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a Pain Management specialist with Board Certification in Anesthesiology, Pain, Hospice and Palliative Care. I see no benefit to bringing this product to the market. The mixing of narcotics with other substances seldom brings forth any clinical benefit, while increasing the probability of toxic side effects from tylenol, etc. A practitioner treating pain with an opiod should do so with a pure opiod product and add adjuvants as indicated by the patients clinical condition. Having a fixed amount of added tylenol only increases the risk that in a pain crisis situation the patient will be susceptible to tylenol overdose either on an acute basis or chronic use basis. With recent literature questioning the suitability of large doses of tylenol to be used in a chronic treatment modality, the approval of this product would be a step backwards and without clinical justification. If treatment is to be acute in nature, the patient could take the oral oxycodone solution followed by an acetaminophen solution without difficulty should there be clinical grounds for doing so. I would advise that this product not be brought to market for the above noted reasons.