Building a Body of Knowledge About Abilify from Scientific Studies

THE FDA pharmaceutical Studies (Animal Trials/studies for the drug’s safety) Show Organ Damage and Abilify Withdrawal and Even Drug Related Deaths

Animal studies  (Pharmacology Review Reports published in 7 parts ) were done by Bristol Myers Squibb (known as sponsor) and the FDA to determine Abilify’s safety.  Several animals died. There is conclusive proof that multiple organs including kidneys and adrenal glands and liver were damaged by the drug, yet this information is not disclosed in the consumer safety sheets that accompany the drug.  The FDA animal studies are in the pharmacology review and there are 7 parts. Of particular note: The Executive Summary of Part 2, and p.67 in Part 3.

According to the studies/trials,  Abilify impacts pituitary and mammary glands, it produced dark dislocation of the adrenal glands, it caused estrus cycle irregularities and a decreased fetal weight at higher doses.  Baby monkeys were born dependent. It inhibited GI transit in mice, caused a decrease weight in ovaries and uterus, impacted the kidneys, liver and spleen and caused an increase in body weight in the various animal tests.  It also repeatedly caused convulsions and its anesthesia properties were noted.

The studies were conclusive:     there is a dependence developed and that there is a withdrawal.  This is not a high chasing or drug seeking dependence but rather the body develops a need for the drug and misses it when it is gone.  

The FDA studies show there is a withdrawal, yet further study on withdrawal was not done and this is negligent, given the drugs long half-life.  The studies only tested abrupt cessation for which causality was established but did not test tapering off.

The FDA documents show that animals died during the trials – due to both directly and indirectly to the drugs active/main ingredient and its mechanism.   Animals had seizures, stooped over posture, suffered withdrawal- and addiction was transferred through the placenta to babies.

The studies also indicate that the drug is a form of anesthesia.  

The animal studies by themselves do not succinctly or readily summarize the drug damage and you have to read the studies completely to see the dangers.

The original FDA animal studies (Pharmacology Reviews) can be found at these links:

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify_pharmr_P1.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify_pharmr_P2.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify_pharmr_P3.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify_pharmr_P4.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify_pharmr_P5.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify_pharmr_P6.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify_pharmr_P7.pdf

Additional studies can be found through the FDA.