"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA.
Applying technology directly into the medicines themselves is a more cutting-edge approach, but one that is clearly gaining traction, as evidenced by the FDA's approval of Abilify MyCite (aripiprazole tablets with sensor).
According to the FDA, the Abilify has been approved for the treatment of schizophrenia and bipolar disorder, as well as an add-on treatment for depression.
The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the US healthcare system an estimated $200 billion per year. Data from the patch sends the information to a mobile app, which can be monitored by patients, caregivers, and physicians via web portal.
Forgetfulness and cloudy thinking can be symptoms of the mental health conditions that Abilify is approved to treat, and patients with mental illness are known to struggle to take medication consistently.
As with similar antipsychotic drugs, Abilify MyCite's label will include a boxed warning that elderly people with dementia-related psychosis are at increased risk of death if they take this medication, the FDA said. In children, it warns of higher risks of suicidal behavior and thoughts. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.
Using Abilify MyCite to track drug use in real time or in the event of an emergency is not ideal, however, as there may be a delay or problem in the detection.
In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.
Prior to initial patient use of the product, the patient's health care professional should facilitate use of the drug, patch, and app to ensure the patient is capable and willing to use the system.
But patients in the 120 systolic blood pressure group had a higher rate of kidney injury or failure, as well as fainting. The AHA says the new guidelines are created to help people address the potentially deadly condition much earlier.
Eyewitnesses also said on Tuesday (Wednesday NZ time) that army tanks were seen about 20 kilometres west of the capital, Harare . In response the party's Youth League accused the military chief of subverting the constitution.
However, it also holds a backdoor which is capable of root access, even if the device has not been unlocked. The company recently admitted to collecting personal information of users without their permission.
Brinkley to disqualify herself from further involvement his case and allow a new judge to reconsider Mill's prison sentence. He was sentenced to another five months in prison in 2014 after he violated his probation by performing out of state.
Kardashian shared on Instagram that she was giving crystals as party favours, as well as fragrances from her new perfume line. Kim shared tons of videos and photos from her shower, which is unusual since fans would expect Kylie to do the same.
LeBron panned the camera next to a random guy sitting next to him who did not want to be any part of the NBA All-Star's video. LeBron James narrated most of the video, confirming it was his first time taking the subway in NY and second time overall.
The Corning Union Elementary School District said part of the shooting spree occurred at Rancho Tehama Elementary School . The gunfire began around 8 a.m.in the community of Rancho Tehama Reserve, about 130 miles north of Sacramento .
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