Abilify Injuries

Synopsis of Prescription Drug Litigation

Abilify is an atypical antipsychotic and antidepressant used in the treatment of schizophrenia, bipolar disorder and clinical depression. It was approved by the US FDA for schizophrenia on November 15, 2002; for acute manic and mixed episodes associated with bipolar disorder on October 1, 2004; as an adjunct (additional) for major depressive disorder (MDD) on November 20, 2007; and to treat irritability in children with autism on November 20, 2009.

Aripripazole is associated with a number of serious and life-threatening adverse reactions that include: dangerous blood clots such as deep vein thrombosis (DVT) and pulmonary embolism, diabetes, Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia (TD). NMS is a potentially fatal syndrome involving muscle rigidity, an altered mental status and symptoms of cardiac instability (irregular blood pressure, heart rate and pulse). The FDA has become concerned about the possibility of a specific and potentially fatal heart rhythm irregularity called torsade de pointes. Tardive Dyskinesia (TD) is a central nervous system disorder characterized by involuntary movements of the limbs as well as twitching of the face and tongue. It can be a permanent and debilitating disease. Abilify can also cause cause the body to lose regulation of core body temperature known as malignant hyperthermia.

Abilify® (aripripazole): Manufactured by Bristol Myers, Squibb and developed and co-marketed with Otsuka America and approved by the FDA in November of 2002. Abilify is one of Bristol Myers, Squibb's strongest sellers. In 2009, it had a 22 percent increase over the previous year with sales of $2.8 billion annually. Since its approval, Abilify has gone through 11 labeling revisions and major black box warning additions.

Why is this medication prescribed?: Aripiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used alone or with other medications to treat episodes of mania or mixed episodes (symptoms of mania and depression that happen together) in adults, teenagers, and children 10 years of age and older with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Aripiprazole is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Aripiprazole is also used to treat children 6 to 17 years of age who have autistic disorder (a developmental problem that causes difficulty communicating and interacting with others). Aripiprazole may help control irritable behavior such as aggression, temper tantrums, and frequent mood changes in these children. Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

What you should know before taking Abilify:

Before taking aripiprazole,

• tell your doctor and pharmacist if you are allergic to aripiprazole, any other medications, or any of the ingredients in aripiprazole tablets, orally disintegrating tablets, or oral solution. Ask your doctor or pharmacist for a list of the ingredients..
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants (mood elevators); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); antihistamines; bupropion (Wellbutrin); carbamazepine (Tegretol); clarithromycin (Biaxin); fluoxetine (Prozac, Sarafem); HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); ipratropium (Atrovent); medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; nefazodone; paroxetine (Paxil, Pexeva); quinidine;rifampin (Rifadin, Rimactane); sedatives; sleeping pills; telithromycin (Ketek); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with aripiprazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you use or have ever used street drugs or have overused prescription medication and if you have or have ever had heart disease, heart failure, a heart attack, an irregular heartbeat, high or low blood pressure, a stroke, a ministroke, seizures, a low number of white blood cells,or any condition that makes it difficult for you to swallow. Tell your doctor if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking aripiprazole, call your doctor. Aripiprazole may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aripiprazole.
• you should know that aripiprazole may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking aripiprazole.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking aripiprazole or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking aripiprazole: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
• you should know that aripiprazole may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking aripiprazole. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that aripiprazole may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain phenylalanine. If you have diabetes, you should know that aripiprazole solution contains sugar.
• you should know that when aripiprazole is used to treat children, it should be used as part of a treatment program that may include counseling and special education. Be sure that your child follows all of his or her doctor's or therapist's instructions.

Black Box Warning:

Lawsuits: STATUS OF ABILIFY LITIGATION: There are currently hundreds of lawsuits involving Abilify throughout the U.S. With its documented high profile of serious adverse effects, aggressive marketing by the manufacturer and off label uses, litigation is furiously on the rise for Abilify.

When to call the Venardi Law Firm: The antipsychotic aripiprazole-sold under the brand name Abilify and less commonly as Aripiprex-might have caused you to suffer life-threatening side effects. The medication, prescribed to you by your doctor, was supposed to ease your depression, schizophrenia and bipolar disorder-not expose you to greater risk.

The manufacturer alone is at fault. Certainly, you're not to blame. And you shouldn't have to go through more trouble to be compensated for the harm you've already suffered. The Venardi Law Firm, an Abilify law group, knows this, and we want you to believe it. Because the drug manufacturer put its own profits before your well-being, now you need a sympathetic advocate who will represent only your interests-and who will make the process as painless as possible. If you have taken Abilify and been harmed, contact The Venardi Law Firm today for a free consultation.