Labeling limits use of Rx opioid cough and cold meds in children
The FDA announced it is requiring new safety labeling changes to limit the use of prescription opioid cough and cold medications containing codeine or hydrocodone in children younger than 18 years because the serious risks associated with these medications outweigh their potential benefits in this population.
The products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults age 18 years and older. Labeling is also being updated with additional safety information for adult use, including an expanded boxed warning, about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
In addition to limiting use in children, labeling for adult-only use of prescription opioid cough and cold medications that contain codeine or hydrocodone will now include updated safety information. The new labeling will provide safety warnings on these products consistent with the labeling of other opioid-containing drug products, including immediate-release opioid analgesics and extended-release and long-acting opioid analgesics. The FDA is taking these actions based on an extensive review of data and expert advice on pediatric use of opioid-containing cough and cold products.
Vancomycin oral solution approved for diarrhea
The FDA has approved vancomycin hydrochloride oral solution (Firvanq) for the treatment of diarrhea associated with Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. The oral solution is a product of CutisPharma.
Previously, pharmacists used CutisPharma's FIRST-Vancomycin Unit-of-Use Compounding Kit to compound vancomycin oral liquid. The availability of an FDA-approved vancomycin oral liquid treatment will effectively allow any pharmacy to stock this therapy and encourage third-party payer reimbursement, significantly improving accessibility and convenience for patients.
The most common adverse reactions include nausea, abdominal pain, and hypokalemia.
New recommendations for mumps vaccine
New recommendations have been issued by the CDC's Advisory Committee on Immunization Practices for mumps vaccinations.
Individuals who have previously received two doses of a mumps-containing vaccine should receive a third dose if they are identified by public health authorities as being part of a group at increased risk for acquiring mumps. The third dose is recommended to help improve protection of individuals in outbreak settings against mumps infection and mumps-related complications.
The recommendation was based on a review of evidence that showed a third dose of measles, mumps, and rubella (MMR) vaccine was safe and effective for preventing mumps.
Zika vaccine candidate fast tracked
The FDA has granted fast track designation to Takeda's investigational Zika virus vaccine, TAK-426, a purified, inactivated, alum-adjuvanted whole-vaccine candidate that is currently in a phase 1 clinical trial to evaluate safety and immunogenicity. There is currently no vaccine approved and available for Zika virus. Fast track designation facilitates the development, expedition, and review of drugs and vaccines for serious conditions and those that fill an unmet need. Takeda's Zika program is supported by federal funds.
There are 240 male and female individuals between the ages of 18 and 49 enrolled in the phase 1 trial of the Takeda Zika vaccine candidate, which is being conducted in the continental United States and U.S. territories. If initial data from the clinical trial are supportive, Takeda will work to progress into phase 2 development as soon as possible.