FDA Warns Abilify Linked to Poor Impulse Control

The U.S. Food and Drug Administration (FDA) has recently issued a warning about the drug Abilify. Abilify, which is also known as Abilify Maintena, Astrida, and manufactured in generic form, is typically used as an anti-psychotic medication.  According to the FDA, there have been reports of adverse events (side effects) linking the drug to various compulsive or uncontrollable urges to engage in certain high risk behavior including gambling, binge eating, shopping, and sex.

Xarelto injuryThese instances of impulsive behavior have been linked to taking the drug, and have been seen to stop once the drug is stopped. But there is no telling how much damage could be done during the time a patient is suffering from these uncontrollable urges as described by the FDA.As our Boston Abilify injury lawyers can explain, Abilify is classified as an atypical anti-psychotic medication. It is commonly prescribed to treat those who have been diagnosed with schizophrenia (with our without paranoid delusions), and bipolar disorder.  However, while these are the main on-label uses for the drug, it has also been prescribed for a broader array of mental heath conditions including the following:

  • Major Depressive Disorder (MDD)
  • Disorders resulting in a facial or other tic
  • Certain conditions associated with autism

Even in cases where it is not a drug used for primary treatment, it is being used as what is known an add-on treatment. So we are dealing with a much higher number of patients than only those who suffer from schizophrenia and bipolar disorder. Bipolar disorder is the same condition formerly known as manic depression.

Manufacture of  a Dangerous Drug Lawsuit In Boston 

As we have seen with various other drugs such as Xarelto, Pradaxa, and Eliquis, some drugs are simply manufactured in a defective manner. Often there was not enough safety testing before drugs were marketed as being relatively safe. Many actually turn out to pose a serious risk.  One way in which a drug can be defective is because it was simply manufactured in a defective or dangerous manner. This can be the result of not enough safety testing, and a push by the finance and marketing departments of a major drug company to get their products on the market before they are proven to be safe.  While it is true the FDA requires pre-market safety testing on human research subjects, the FDA is often only looking at information supplied by the drug companies.  If the drug company is in control of the study process, there are a lot of ways results will not reach the FDA. The drug companies also have a very strong lobbying operation so they are able to help craft federal regulations that are advantageous to manufacturers.

Failure to Warn of a Known Danger Claims In Boston 

In addition to a claim of manufacture of a dangerous drug, some drugs will function as they were intended, but doctors and patients are not given a complete picture of all of the associated risks of a particular drug, so there was no way a patient could give his or her informed consent.  If a drug company knew or should have known of a serious risk, but did not inform the FDA, doctors, or patients via direct patient marketing of these known dangers, and a patient is injured as a result of one of these dangerous side effects, plaintiffs may have a case based upon failure to warn of a known danger.

It should be noted a drug company cannot choose not to do a certain type of safety testing out of fear it will get a result that may harm the profitability of a particular drug and then try to use this lack of knowledge as a defense to liability. When a defendant chooses to remain ignorant of a potential risk, this knowledge will be imputed to the defendant, as a company had known and failed to adequately warn doctors and patients.  This is because the law deals with a defendant who knew or should have known of a potentially dangerous side effect. When you choose not to know something, this will fall under the category of something you should have known.

These cases can present some very complex legal issues so you should only speak with an experienced attorney who has handled many dangerous drugs lawsuits in the past. It is also important to understand these cases are often filed as a class action lawsuit involving multidistrict litigation (MDL).  This means a case that has already been filed by other plaintiffs may affect  the potential recovery in your case since federal courts do not like to litigate the same issues over and over again.  For this reason, if you or a family member has been injured by taking Abilify, you should speak with an experienced attorney as soon as possible to see if you have a valid claim.  These large lawsuits often have local steering committees and your attorney can explain the process to you and what you must do to pursue your valid claim.

You should not worry about not being able to afford an experienced attorney, since these cases are handled on a contingency fee basis. This means your attorney will have you enter into a written contingency fee agreement and you will not have to pay any legal fees unless you are successful in obtaining a settlement, or you receive an award from a jury following a verdict in your favor. While there is no guarantee of success, having an experienced Boston products liability attorney in your corner fighting for your right to full and appropriate financial recovery can certainly increase the likelihood of a successful outcome.   You should also know the initial consultation should be completely free so there is no risk in speaking with an experienced attorney about the merits of your case.

If you are the victim of Massachusetts product liability, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

FDA Drug Safety Communication: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada), May 3, 2018, US. FDA

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