Bristol-Myers Squibb has been hit with a lawsuit alleging that the anti-psychotic drug Abilify has been linked to a 7-fold increased risk of type-2 diabetes in children. The drug-maker is accused of failing to adequately warn doctors and patients about this risk.
Abilify Diabetes Lawsuit
August 2014 — A young woman has filed an Abilify Diabetes Lawsuit (PDF) after she developed substantial weight-gain that caused her to be diagnosed with type-2 diabetes.
The lawsuit accuses drug-makers Bristol-Myers Squibb. and Otsuka American Pharmaceutical Inc. of failing to warn that children are nearly 10-times as likely to develop adult-onset diabetes after taking high doses Abilify.
The plaintiff, Cheyenne Beth Confer, was just 15 when she was prescribed Abilify “off-label” to treat depression. Six months later, she had gained 30 pounds and was diagnosed with diabetes.
According to her attorneys, Bristol-Myers Squibb has ignored years of research linking anti-psychotic drugs with an increased risk of diabetes — especially in children, who are more sensitive to the drugs’ effects. The risk increases with higher doses. Lawyers say that drug-makers have known about the risk since at least 2005, but failed to update the label.
The lawsuit was filed in New York and it is believed to be the first case of its kind.
What is the problem?
Diabetes is a well-known side effect of anti-psychotic medications in adults, but few studies have investigated the risk in children. This is concerning, because childhood diabetes and prescriptions for anti-psychotics in children have both increased substantially over the last few decades. In many cases, children are prescribed powerful drugs for “off-label” uses like ADHD and disruptive behavior disorders.
Because drug-induced metabolic changes can persist over time, they may not be fully reversible when the drug is discontinued. The long-term health complications can be profound.
Epidemiological data suggests that children on anti-psychotics are 3-times as likely to develop diabetes, but children on Abilify may have an even higher risk. The side effect is often apparent during the first year after starting the drug.
Type-2 Diabetes
Type-2 diabetes is a chronic metabolic condition that occurs when cells become resistant to insulin, a digestive hormone that tells cells to absorb sugar from the bloodstream. People with diabetes have problem controlling blood-sugar levels.
Treatment for type-2 diabetes usually involves a combination of lifestyle changes and medications. Patients must maintain a healthy weight, exercise routinely, and adhere to a strict diet. Many patients also must take medications like metformin or supplemental insulin to control blood-sugar.
Complications
Without treatment, type-2 diabetes can worsen. It also increases the risk of complications, such as:
- Neuropathy (nerve pain)
- Edema (swelling due to fluid retention)
- Cataracts and other eye problems
- Foot infections
- Skin complications
- Stroke
- Kidney disease (nephropathy)
- High blood pressure
- Heart disease
- And more