In the wake of widespread reports of heart failures, liver damage, and other patient injuries and seemingly non-stop controversy surrounding the top-selling type-2 diabetes drug Avandia, the Food and Drug Administration now says that future diabetes drugs will face much tougher scrutiny.
Byetta, a drug commonly prescribed for the treatment of type 2 (adult onset) diabetes, has been linked to an increased risk of deadly pancreatic disease. Dozens of Byetta patients have suffered a painful injury called hemorrhagic pancreatitis, or inflammation of the pancreas, that resulted in death or serious injuries. The Food and Drug Administration has issued several public advisories about Byetta’s connection to pancreatic disease and warned users about the risk.
Seroquel, the antipsychotic drug made by AstraZeneca and widely used to treat schizophrenia and bipolar disorders, has been shown to increase the risk of developing diabetes and other blood sugar disorders. First approved by the Food and Drug Administration in 1997, Seroquel is among a newer class of medications called atypical antipsychotics, which are billed as being just as effective as older antipsychotics with fewer side effects. However, older antipsychotic drugs such as Haldol do not carry the same of side effects or complications as Seroquel.
While it is only FDA-approved for the treatment of schizophrenia and bipolar disorders, some physicians have prescribed Seroquel for unapproved, “off-label” uses, including the treatment of post-traumatic stress disorder, autism, and restless legs syndrome.
Seroquel and similar antipsychotics have been linked to an increased risk of blood sugar disorders and diabetes since 2003, when a study by the Department of Veterans Affairs at the University of Illinois was released. The report indicated that Seroquel, and similar drugs Risperdal and Zyprexa, had a higher risk of causing diabetes than older antipsychotic medications. The report also found that Seroquel was linked to cases of hyperglycemia and pancreatitis and in the deaths of elderly patients with dementia.
The American Diabetes Association, the American Psychiatric Association, the North American Association for the Study of Obesity, and the American Association of Clinical Endocrinologists have all warned that patients taking Seroquel should be closely monitored for signs of high blood sugar and diabetes.
In addition to diabetes and other blood-sugar disorders, a rare but potentially fatal side effect of Seroquel is neuroleptic malignant syndrome (NMS), a severe neurological disorder. NMS is marked by symptoms including very high fever, rigid muscles, shaking, confusion, sweating, changes in pulse, heart rate or blood pressure, and muscle pain and weakness.
Seroquel may also cause a condition called tardive dyskinesia (TD), which consists of uncontrollable movements of the face, tongue, or other parts of the body. TD may be permanent, and the risk of developing TD is thought to increase in patients taking Seroquel and similar antipsychotics.
Additionally, Seroquel has been blamed for causing dry mouth, sedation, drowsiness, dizziness, constipation, weakness, abdominal pain, sudden drop in blood pressure upon standing, sore throat, weight gain, sluggishness, high blood sugar, nasal congestion, abnormal liver tests, and upset stomach.
Avandia, the blockbuster type 2 diabetes drug taken by an estimated six million Americans, has been linked to an increased risk of heart attack and cardiovascular death. Avandia was approved in 1999 for the treatment of type 2, or adult onset, diabetes, which affects an estimated 18 to 20 million Americans and is a leading cause of coronary heart disease, blindness, kidney failure, and limb amputation.
Diabetes occurs when the body either does not produce enough insulin or is insensitive to insulin. Avandia belongs to the family of drugs called thiazolidinediones and has been shown to increase fluid retention in the body, which is a major factor in causing congestive heart failure and other diseases.
In May 2007, the U.S. Food and Drug Administration issued a public safety alert about the risk of heart attack and cardiovascular death associated with Avandia users. The New England Journal of Medicine had published a report showing that the drug resulted in a 43% increase in the risk of heart attack and a 64% increase in the risk of death from all cardiovascular causes in patients with existing cardiovascular disease.
In that published report, researchers followed the clinical trials of more than 15,000 Avandia patients and 12,000 in a control group not taking the drug. They found 86 heart attacks in the Avandia group compared to just 72 in the control group. The report also found a higher rate of death from heart disease among Avandia patients compared to those in the control group.
In 2006, the FDA ordered an update to Avandia’s product labeling to include warnings about the risk of heart failure and the potential for an increase in heart attacks and heart-related chest pain in patients. The advisory, a so-called “Black Box” warning which is the strongest such packaging warning issued by the FDA, cautioned patients with existing congestive heart failure about the dangers of taking Avandia.
