NCHR Testimony at the FDA on the Use of Abilify for Treating Irritability in Children with Autism

We are particularly concerned about Abilify because of its well established serious side effects of tardive dyskinesia, tremor, muscle stiffness, and sudden cardiac death.  Other risks include nausea, insomnia, anxiety, weight gain, high blood sugar, and high cholesterol. Moreover, the impact on a child’s developing brain is unknown because we lack high-quality, long-term research. The longer-term results indicated no significant difference between Abilify and placebo at week 16 in reducing the symptoms of irritability in pediatric patients who had already maintained a response for  the first 12 weeks of Abilify treatment. Clearly the evidence for the effectiveness and safety of Abilify for children with autism and symptoms of irritability is insufficient to outweigh the risks, especially for girls and nonwhite children. We urge the FDA to revise the labeling to state that Abilify has not been proven effective in the long-term for this indication.

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NCHR Testimony at the FDA on Shingles Vaccine, Shingrix

An effective shingles vaccine is important for public health. As patients get older, they are more likely to develop long-term pain, or post-herpetic neuralgia (PHN), as a complication of shingles. This pain can be severe and chronic. There is no cure, and treatments do not reliably relieve pain for all patients. The only way to reduce the risk of developing shingles and PHN is to get vaccinated. We urge this Advisory Committee to recommend that the FDA require critical post-approval long-term studies to further evaluate the efficacy and safety of Shingrix. We also strongly recommend that the company conduct subgroup analyses to ensure that the vaccine is safe and effective for both women and men and also people of color.

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NCHR Testimony at the FDA about Pediatric Labeling for an Opioid

It is important for this panel and the FDA to make decisions about drug labeling based on good science and strong data. We concur with the 2016 Advisory Committee that because pediatric patients are vulnerable to drug use and addiction due to ongoing brain development; proper prescribing, patient selection, and education are crucial to optimize safety in this population. Results of Study 3031 do not provide sufficient evidence to inform health care providers about the safe use and proper dosing of Butrans in the management of pain for pediatric patients. We urge this Advisory Committee to advocate for pediatric patient safety and urge the FDA to require that the drug be appropriately evaluated before allowing information about Butrans to the pediatric section of the labeling.

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