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First “digital” pill approved by the FDA in circulation

The Food and Drug Administration announced on Tuesday they have approved the first digital pill in the United States to help health professionals ensure patients are taking their medication. This revolutionary, and uneasy, advancement in technology and medicine came as an interesting surprise. Abilify MyCite is a pill used to treat patients with mental disorders such as  schizophrenia, depression, and bi-polar disorders. The pill looks like any other normal pill, but it is engrained with a tiny ingestible sensor no bigger than a grain of sand.

Once ingested and mixed with acid in the stomach, Abilify MyCite activates an electrical signal. This signal is then transmitted to a patch that is worn by the patient on their left rib cage.  The information is then sent via bluetooth to a smartphone app, which can list the time the pill was taken, the dosage, and gives the patient the option to upload these results to a database where doctors can access the file.

Image courtesy of Proteus Digital Health

The sensor then passes through your body naturally, as the little chip is made of silicon, copper, and magnesium. The patch that will be worn on the body can last up to seven days and will continually record the data every time you take the pill. The patch is also able to track physical activity, steps taken, heart-rate, sleeping patterns and other data similar to a smart fitness tracker. This pill/patch combo does raise many concerns about patient privacy and the vulnerability of having our personal information available to others..

The patient has the power to upload the data, but can allow access to four other members, including family members or significant others. While this is a big step in digital health, there is also cause for concerns in terms of information sharing, especially considering the increase in data breaches and internet hacking.

Doctors must determine if the patient is capable and willing to use the pill/patch combo. Being an antidepressant, Abilify MyCite, does come with risks, including worsening suicidal thoughts and a list of side-effects determined during the clinical trial, including a possible skin irritation from the patch.

The pills are manufactured by Japanese pharmaceutical company, Otsuka, in collaboration with the producers of the sensors, Proteus Digital Health. Concerns have been raised that the FDA may have opened the door for other potential digital pills, but advocates says the technology will ensure medication is not wasted and that patents are actually taking their pills and getting the treatment they need.

Abilify was first approved by the FDA in 2012 and since then, the pill with an included sensor was in the works and Abilify MyCite was first approved for marketing in 2012 as well.

What are your thoughts on the first approved digital pill and does this reinforce the fact that Big Brother is always watching ? Comment below.