Relatives of patients who overdosed on painkillers told federal regulators Thursday they want changes on the labels of narcotic painkillers, The Wall Street Journal reports. Pain patients concerned such action could limit their access to the medications spoke against the proposed changes.
They spoke at a Food and Drug Administration (FDA) hearing on the use of opioids in the treatment of chronic pain. The FDA said it wants to gather scientific evidence on issues including diagnosis and understanding of patient pain, understanding and adhering to the labels of pain-treating products, limiting opioid prescriptions and use, and abuse and misuse of opioid medicines.
The FDA is considering a petition by Physicians for Responsible Opioid Prescribing, a group of doctors and pain specialists, to include a recommended upper daily dose on the medications’ label, and to limit opioid treatment to 90 days, the article notes. The doctors’ group is also recommending that opioids be indicated for severe pain, not moderate pain, except in cancer patients.
Last month, a FDA advisory panel voted to strengthen restrictions on hydrocodone combination drugs, such as Vicodin. The panel recommended the FDA make the drugs more difficult to prescribe. If the FDA accepts the panel’s recommendation, it will be sent to the Department of Health and Human Services, which will make the final decision.
Read More »