FDA Approves First Pill With Digital Tracking System

FDA approves the first pill that can alert your doctor when you swallow it

The first "digital pill" has been approved by the FDA and it includes a sensor that tracks a patient use of the medication Ablify.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

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).

Abilify MyCite is not approved for treating patients with dementia-related psychosis. This is picked up by a wearable patch-worn on the left rib cage and replaced after seven days-which then sends the information to a smartphone app that allows patients to track when they took their medication. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology.

Abilify MyCite does outline some precautions when using it though stating that the smart pill should be not used to track drug ingestion in real-time or during an emergency as detection could be delayed.

This technology might work better for different medications, like antibiotics where it's crucial that the patient finish the dose, or medication for elderly patients who might need help remembering to take their pills.

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers". Labeling information stresses that it has not been proven if tracking such information improves treatment regimens.

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. Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out. Skin irritation at the site of the MyCite patch placement may occur in some patients. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants.

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