Abilify (Aripiprazole): Lawsuit Settlement – Serious Side Effects – NOT FDA Approved in Children and Seniors

43 States have received millions of dollars in settlements from Bristol-Myers Squibb for the questionable marketing and pricing of certain prescription drugs for the poor.

Bristol-Meyers Squibb and its former subsidiary, Apothecon Inc., agreed in September to pay a total of $499 million, according to a spokeswoman for the company. The payments to the individual states, like Georgia’s Medicaid program went out in July 2008.

“The allegations were that these companies not only engaged in a pattern of kickbacks and false reporting to drive up both the sales and prices for its drugs, they also encouraged health care providers to prescribe a potent drug to both children and seniors for uses that had not been approved by the FDA,” Georgia Attorney General Thurbert Baker said in a prepared statement. “The drive to make certain that the bottom-line meets Wall Street expectations can never justify defrauding the taxpayers or putting our most vulnerable citizens at risk.”

Bristol-Myers Squibb and Apothecon were accused of reporting inflated prices to get higher reimbursements from government health care programs and of paying doctors, health care providers and pharmacies to push their products.

One medication at the center of the complaints was Abilify, an antipsychotic drug prescribed for children and for dementia-related psychosis. The federal Food and Drug Administration had not approved Abilify for those uses.

The drug company also was accused of misreproting prices for Serzone, an antidepressant, so consequently rebates to Medicaid were less.

Federal law requires pharmaceutical companies give their lowest prices to Medicaid programs and that was the basis of complaints that led to the settlement.

A spokeswoman for the company, when asked for comment Tuesday, referred to a statement released in September when the matter was resolved. “Bristol-Myers is pleased to have resolved these matters from the past and is proud of its commitment to conduct business with the highest standards of integrity in its mission to extend and enhance human life.”

Source: “The Atlanta Journal-Constitution, Published on 07/15/08″

Below you will find additional state settlements:

Alabama – Not Participating

Alaska – Not Participating

Arizona – ?

Arkansas $1.3 million

California – $23 million

Connecticut – $1.9 million

Delaware – $1.1 million

District of Columbia – $923, 685.85

Florida $21.5 million

Georgia $12.1 million

Hawaii – ?

Idaho $1.7 million

Illinois $10 million

Indiana – $2.2 million

Iowa – $1.9 million

Kansas $3 million

Kentucky – $3 million

Louisiana -$9.6 million

Maine – $829,862

Maryland – $2.3 million

Massachusetts – $9.2 million

Michigan -$10,990,484

Minnesota – $2.35 million

Mississippi – Not Participating

Missouri $11 million

Montana – $295,091.26

Nebraska $3.2 million

Nevada – ?

New Hampshire $1.2 million

New Jersey – ?

New Mexico – $1.3 million

New York $40 million

North Carolina $14.8

North Dakota – $194,873.36

New York City $7.5 million

Ohio $6.5 million

Oklahoma – $1.37 million

Oregon – $3 million

Pennsylvania – Not Participating

Rhode Island – ?

South Carolina – Not Participating

South Dakota – $700,000

Tennessee – $3.5 million

Texas $15.7 million

Utah – $2 million

Vermont $218,963

Virginia – $7.1 million

Washington – $6.8 million

West Virginia – ?

Wisconsin – Not Participating

Wyoming – $554,320

If your state is not listed above you may go to http://naaq.org/attorneys_general.php and ask for the Media Relations person and request a press release for the Bristol-Myers settlement amount for your state or check back for updates.

Below you will find some of the “new” information about the devastating side effect of ABILIFY® found on their website. The question is – why would our government allow such dangerous drugs to be on the market?

If you wish to stop taking any antidepressant or antipsychotic medication it has been my experience that doctors and psychiatrist tend to give out additional medication to address any side effects, thus drugging you more and adding additional side effects. If you really wish to stop taking such drugs demand it from your doctor. Since these drugs often have withdrawal symptoms which are often just as bad as the drug side effect itself, you should not stop taking the medication cold (abruptly). For alternative help in stopping or tapering off such medications visit http://www.theroadback.org/workbook.htm. On the left-hand side of the page you will find a free online book entitled, “How to Get Off Psychiatric Drugs Safely”.

IMPORTANT SAFETY INFORMATION ON SERIOUS ABILIFY® (Aripiprazole) SIDE EFFECTS:

Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with atypical antipsychotic medicines, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING). Antidepressants 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. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient’s healthcare professional right away, especially if they are sever or occur suddenly. ABILFY is not approved for us in pediatric patients with depression (see Boxed WARNING).”

“Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue.

Serious side effects can occur with any antipsychotic medicine, including ABILIFY. Tell your healthcare professional right away if you have any condition or side effects, including the following:

• An increased risk of stroke and ministroke has been reported in clinical studies of elderly patients with dementia-related psychosis

• Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), (a life-threatening neurological disorder most often caused by an adverse reaction to neuroleptic or antipsychotic drugs) a rare but serious side effect which could be fatal

• Abnormal or uncontrollable movements. These may be signs of a serious condition called tardive dyskinesia (TD), which may be permanent”. (Per other sources, this is a permanent condition.)

• “Diabetes, risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it. Ask your healthcare professional about the need to monitor your blood sugar level before and during treatment.

Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY.

Medicines like ABILIFY can effect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you.

Since medicines like ABILIFY can impact your body’s ability to reduce body temperature, you should avoid overheating and dehydration.

If you have suicidal thoughts, you should tell your healthcare professional right away.

Medicines like ABILIFY have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.

Tell your healthcare professional if you have a history of seizures, or are pregnant or intent to become pregnant, and about all prescription and non-prescription medicines you are taking or plan to take.

Most common side effects (greater than 10%) from all clinical trials involving adults or pediatrics include:

ADULTS: Nausea, vomiting, consitipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety and insomia.

PEDIATRICS: (10-17 years): Uncontrolled movements, headache, sleepiness and nausea.

While taking ABILIFY, avoid:

• Drinking alcohol

• Breast-feeding an infant

It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasm or contraction which may be signs of a condition called dystonia.

For patients who must limit their sugar intake, ABILIFY Oral Solution contains sugar.

For patients with phenylketonuria or PKU, ABILIFY^® DISCMELT^TM (aripiprazole) contains phenylalanine.”

Source: http://www.abilify.com/abilify/home/index.jsp?BV_UseBVCookie=Yes

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