Despite testimony from the families of two Charleston veterans who died in their sleep while taking Seroquel, a Food and Drug Administration advisory panel recommended that the anti-psychotic drug labeled as a supplemental medication for depression.
CHARLESTON, W.Va. -- Despite testimony from the families of two Charleston veterans who died in their sleep while taking Seroquel, a Food and Drug Administration advisory panel recommended that the anti-psychotic drug labeled as a supplemental medication for depression.
Currently, Seroquel has FDA approval for treating schizophrenia and bipolar disorder. The potential market for Seroquel as a treatment for depression and anxiety, which affect a larger percentage of the population, represents a significant opportunity for drug maker AstraZeneca P.L.C.
The panel recommended that the agency approve Seroquel XR as a secondary treatment for patients who are not responding to other medications, said Stan White of Cross Lanes, who, with his wife Shirley, testified at the hearing in Washington, D.C.
The Whites' 23-year-old son, Andrew, a former Marine, died in his sleep in 2008 while taking Seroquel as part of his treatment for post traumatic stress disorder.
Janette Layne, whose husband, Eric, 29, also died in his sleep last year, testified that her husband - also an Iraq veteran suffering from PTSD - became lethargic, ate excessively, had tremors and slurred speech while taking Seroquel and Klonopin. He died after falling asleep on the couch. She was pregnant at the time with their second child, Jublilee, who accompanied her mother to the hearing.
Layne showed a video she took of her husband at Christmas 2007 slumped at a table and barely responsive to her questions. She said he didn't have any of these conditions before he took the medications.
"Janette's presentation was extremely upsetting. That video was heart-wrenching. It was me seeing Tom all over again on this medication," said Diane Vande Burgt of Charleston, whose husband quit taking Seroquel for his PTSD treatment. "The panel and audience was transfixed on that and you could see that many were very, very uncomfortable."
The Whites believe their son died from cardiac arrest caused by Seroquel. A Veterans Affairs investigation concluded his death was caused by "combined drug intoxication involving prescribed and non-prescribed medicines" and that it could not draw conclusions between the death and the medication regimens.
CHARLESTON, W.Va. -- Despite testimony from the families of two Charleston veterans who died in their sleep while taking Seroquel, a Food and Drug Administration advisory panel recommended that the anti-psychotic drug labeled as a supplemental medication for depression.
Currently, Seroquel has FDA approval for treating schizophrenia and bipolar disorder. The potential market for Seroquel as a treatment for depression and anxiety, which affect a larger percentage of the population, represents a significant opportunity for drug maker AstraZeneca P.L.C.
The panel recommended that the agency approve Seroquel XR as a secondary treatment for patients who are not responding to other medications, said Stan White of Cross Lanes, who, with his wife Shirley, testified at the hearing in Washington, D.C.
The Whites' 23-year-old son, Andrew, a former Marine, died in his sleep in 2008 while taking Seroquel as part of his treatment for post traumatic stress disorder.
Janette Layne, whose husband, Eric, 29, also died in his sleep last year, testified that her husband - also an Iraq veteran suffering from PTSD - became lethargic, ate excessively, had tremors and slurred speech while taking Seroquel and Klonopin. He died after falling asleep on the couch. She was pregnant at the time with their second child, Jublilee, who accompanied her mother to the hearing.
Layne showed a video she took of her husband at Christmas 2007 slumped at a table and barely responsive to her questions. She said he didn't have any of these conditions before he took the medications.
"Janette's presentation was extremely upsetting. That video was heart-wrenching. It was me seeing Tom all over again on this medication," said Diane Vande Burgt of Charleston, whose husband quit taking Seroquel for his PTSD treatment. "The panel and audience was transfixed on that and you could see that many were very, very uncomfortable."
The Whites believe their son died from cardiac arrest caused by Seroquel. A Veterans Affairs investigation concluded his death was caused by "combined drug intoxication involving prescribed and non-prescribed medicines" and that it could not draw conclusions between the death and the medication regimens.
About a dozen researchers and medical experts testified about a possible link between Seroquel and sudden cardiac death, diabetes, obesity and other health risks and said the drug trials weren't long enough to cover long-term risk, White said.
"They had their minds made up before we went in," White said. "The pharmaceutical groups are so powerful. You can't fight them."
The Charleston group and Dr. Fred Baughman of California presented a list of 40 military people whose deaths they say should be investigated. Many were healthy adults who died in their sleep or in their barracks while taking medication to treat PTSD.
AstraZeneca requested that Seroquel be approved as a first-line medication to treat depression and anxiety.
"They were asking for approval as a primary therapy, but they only got a secondary listing," White said. "I guess that's a small victory."
Reach Julie Robinson at jul...@wvgazette.com
or 304-348-1230.
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