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First Digital Pill to Track Patient Medication


Pennsylvania defective medical device lawyers help victims of experimental medical pursuits.The Food and Drug Administration has approved a digital pill capable of tracking whether patients are taking their medication. The pill, which will become available to patients in 2018, includes a minute digital sensor that records when patients take the drug. Currently, the approval is strictly for Abilify MyCite, a medication approved for schizophrenia or bipolar treatment or as an additional drug for patients in treatment for depression. However, Abilify has been the subject of numerous lawsuits, leaving some wondering if the pills could become defective medical devices.

Ingestible Sensors

The sensor sends a message to a wearable patch, which then transmits the information to a mobile app on the patient’s smartphone. The sensor contains silicon, copper and magnesium—all of which are found in foods—and works by sending signals once it encounters stomach fluids. Patients must wear a patch that picks up the signals on the rib cage, and the patch requires weekly replacement.

Other medications with ingestible sensors are sure to follow. Patients not taking their medications, or not taking them in a timely manner, is a major issue in the healthcare field. Insurance companies may provide incentives for the use of such medication tracking devices.

Patient Permission

Patients may allow their doctors, caregivers and/or family members access to their ingestion information via a web-based portal. Up to four people may receive this permission from the patient, which requires a consent form. The patient can also block someone previously granted permission by using a smartphone app.

The FDA notes that Abilify MyCite should not be used to “track drug ingestion in ‘real-time’ or during an emergency because detection may be delayed or may not occur.”

Abilify Lawsuits

Ironically, Abilify, the medication chosen for this first-ever tracking system, has been the subject of numerous lawsuits. Abilify has been linked to compulsive behaviors including:

  • Gambling
  • Eating
  • Spending
  • Shoplifting
  • Hypersexuality

The drug is linked to other side effects, some of which are now included in a warning label on the medication’s box. These side effects include:

  • Suicidal thoughts
  • Insomnia
  • Panic attacks
  • Mania
  • Mood swings
  • Aggression and violence
  • Death in patients suffering from dementia.

Researchers have documented other side effects reported by patients but not included in the FDA’s medication guide. These include:

  • Sexual dysfunction
  • Seizures
  • Cognitive impairment

Other side effects documented by the FDA include headache, constipation, nausea, vomiting, anxiety, restlessness and dizziness.

Abilify Background

Abilify, also known as aripiprazole, is marketed by Bristol Myers Squibb and the Otsuka Pharmaceutical Company. Bristol Myers Squibb settled charges of illegal marketing brought by the federal government in 2007 for $515 million. The company did not admit wrongdoing. Allegedly, Bristol Myers Squibb marketed the drug to nursing homes, even though Abilify is not approved for patients with dementia.

Pennsylvania Defective Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Help Victims of Experimental Medical Pursuits

If you or a loved one has been harmed by a defective medical device, contact a Pennsylvania defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. For a free consultation, call 800-369-0899 or 215-569-4000 or contact us online. We serve clients throughout the Philadelphia area and New Jersey including Philadelphia CountyChester County, and Delaware County.