Abilify was first approved by the U.S. Food & Drug Administration (FDA) in November 2002 for the treatment of schizophrenia, and has since received additional approval to treat numerous other conditions, including certain bipolar disorder diagnoses.

However, according to an investigation that focused on the drug’s marketing, Bristol-Myers Squibb promoted Abilify for “off-label” indications not approved by the FDA, including pediatric use and for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease.

Investigators also found that the company made unsubstantiated claims about Abilify by downplaying its potential health risks and providing incentives to its sales staff for generating off-label prescriptions.

According to Abilify’s website, the drug “may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed.”

When atypical antipsychotics were first marketed in the 1990s, it was believed that they could be used as a long-term treatment for schizophrenia without posing the same risk of movement disorders, known as extrapyramidal symptoms (EPS), as first-generation antipsychotics.

However, Abilify has been linked to EPS, including akathisia (motor restlessness) and tardive dyskinesia, a condition that causes involuntary movements of the tongue, lips, face and extremities. The drug may also increase the risk of stroke in elderly patients, hyperglycemia and other severe conditions. Additionally, the FDA has required that labels of Abilify and other similar antipsychotics must carry a warning about compulsive behaviors such as gambling, sexual behavior, shopping and eating.

Per the agreement, Bristol-Myers Squibb is banned for a period of five years from:

  • Promoting Abilify for off-label use;
  • Rewarding healthcare providers with grants based on their prescribing habits;
  • Allowing non-scientifically trained personnel to offer opinions about, or to summarize off-label information;
  • Using medical education grants to promote Abilify, and
  • Providing samples of Abilify to healthcare providers whose clinical practices are inconsistent with Abilify’s approved uses.

The settlement also requires that Bristol-Myers Squibb:

  • Refrain from making unsubstantiated comparisons between Abilify and other medications;
  • Clearly present risk information concerning Abilify when promoting the drug;
  • Disclose payments to speakers and consultants associated with the marketing of Abilify;
  • Review and modify the call plans of personnel who promote Abilify to ensure that they market the drug for FDA-approved purposes only, and
  • Maintain records concerning unsolicited requests for off-label information about Abilify.

Sharing in the settlement are 43 states and the District of Columbia. The investigation was conducted by an executive committee of 10 states, which reviewed of thousands of documents as well as interviews with former Bristol-Myers Squibb personnel.

Source: The Consumerist

Posted by Ray Simon

Ray Simon is a veteran copywriter with more than a decade's worth of experience in the field. He studied journalism at Vanderbilt University, graduating Cum Laude in 2007. Ray currently specializes in writing content and news articles for independent publications.