FDA Restricts Use of Codeine and Tramadol for Children and Breastfeeding Mothers
The FDA issued a restriction April 20, 2017, on the use of codeine and tramadol in children and in breastfeeding mothers. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. The FDA also recommended caution in youths older than 12. The action is a broader one than a 2013 restriction of use of codeine in children after tonsillectomy.
"These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children," according to the statement released by the FDA.
"Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. We are also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants," according to the statement.
As a result of this restriction, the FDA required several changes to the labels of all prescription medicines containing codeine or tramadol.
These new actions further limit the use of these medicines beyond the FDA's 2013 restriction of codeine use in children younger than 18 years to treat pain after tonsillectomy and/or removal of adenoids.
To that restriction, the FDA is now adding:
* The agency's strongest warning, a contraindication, to the drug labels of codeine and tramadol alerting that, in children younger than 12 years, codeine should not be used to treat pain or cough and tramadol should not be used to treat pain.
* A new contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
* A new warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
* A strengthened warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These reactions in infants can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
Source: http://www.fda.gov/Drugs/DrugSafety
HHS Funds State Grants Toward Opioid Addiction
Health and Human Services (HHS) Secretary Tom Price, MD, announced in an April 19, 2017, press release that his agency will provide $485 million in grants to help states combat opioid addiction. The money will be administered by the Substance Abuse and Mental Health Services Administration (SAMHSA). States and territories were awarded funds based on rates of overdose deaths and unmet need for opioid addiction treatment, according to a press release from HHS.
In the release, Price said this would be the first of 2 rounds of grants. For the second round, he said, he would seek data and input from experts to develop policies and funding allocations that are "clinically sound" and effective.
According to the release, HHS has prioritized 5 specific strategies to fight the opioid epidemic: strengthening public health surveillance; advancing the practice of pain management; improving access to treatment and recovery services; targeting availability and distribution of overdose-reversing drugs; and supporting "cutting-edge" research.
The funding will be issued to all 50 states, the District of Columbia, 4 US territories and the free associated states of Palau and Micronesia.
"These grants aim to increase access to treatment, reduce unmet need and reduce overdose-related deaths," Price said in the press release. "I understand the urgency of this funding; however, I also want to ensure the resources and policies are properly aligned with and remain responsive to this evolving epidemic. Therefore, while I am releasing the funding for the first year immediately, my intention for the second year is to develop funding allocations and policies that are the most clinically sound, effective and efficient. To that end, in the coming weeks and months, I will seek your assistance to identify best practices, lessons learned, and key strategies that produce measureable results."
Source: https://www.hhs.gov/about/news/2017/04/19/trump-administration-awards-grants-sta.