WASHINGTON—Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.
Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department's top drug expenditures and the No. 5 best-selling drug in the nation.
In White's case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day — more than double the maximum dose recommended for schizophrenia patients.
A short time later, White died in his sleep.
"He was told if he had trouble sleeping he could take another (Seroquel) pill," said his father, Stan White, a retired high school principal.
An investigation by the Veterans Affairs Department concluded that White died from a rare drug interaction. He was also taking an antidepressant and an anti-anxiety pill, as well as a painkiller for which he did not have a prescription. Inspectors concluded he received the "standard of care" for his condition.
It's unclear how many soldiers have died while taking Seroquel, or if the drug definitely contributed to the deaths. White has confirmed at least a half-dozen deaths among soldiers on Seroquel, and he believes there may be many others.
Spending for Seroquel by the government's military medical systems has increased more than sevenfold since the start of the war in Afghanistan in 2001, according to documents obtained by The Associated Press under the Freedom of Information Act. That by far outpaces the growth in personnel who have gone through the system in that time.
Seroquel is approved to treat schizophrenia, bipolar disorder and depression, but it has not been endorsed by the Food and Drug Administration as a treatment for insomnia. However, psychiatrists are permitted to prescribe approved drugs for other uses in a common practice known as "off-label" prescribing.
But the drug's potential side effects, including diabetes, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits. While on Seroquel, White gained 40 pounds and experienced slurred speech, disorientation and tremors — all known side effects.
Last year, researchers at Vanderbilt University published a study suggesting a new risk: sudden heart failure.
The study in the January 2009 edition of the New England Journal of Medicine found that there were three cardiac deaths per year for every 1,000 patients taking anti-psychotic drugs like Seroquel. Seroquel's unique sedative effect sets it apart from others in its class as the top choice for treating insomnia and anxiety.
AstraZeneca PLC, maker of the drug, said it is reviewing the study. The FDA is conducting its own review, citing the limited scope of the Vanderbilt study.
According to the Veterans Affairs Department, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD.
Marine Cpl. Chad Oligschlaeger, 21, was being treated for PTSD when he died in his sleep at Camp Pendleton, Calif., in May 2008. Oligschlaeger was taking six types of medication, including Seroquel, to deal with anxiety and nightmares that followed two tours of duty in Iraq.
The military medical examiner attributed the death to "multiple drug toxicity," indicating that Oligschlaeger, too, died from a drug interaction. Because of the complex reactions between various drugs, medical examiners do not attribute such deaths to any one medication.
After consulting with physicians, parents Eric and Julie Oligschlaeger now believe their son died of sudden cardiac arrest caused by Seroquel.
"Right now, I'm so angry, and I believe someone needs to be held accountable," said Julie Oligschlaeger, of Austin, Texas. "The protocol absolutely has to change."