Out Of Control: Enough Warning?Sep 6, 2002 | CBSNEWS.COM Dawn Branson’s experience with Adderall was tragic, a psychotic reaction to the drug, she says, that caused the terrible car accident in which her only child, Nathaniel, was killed.
“The guilt that I have for ever having taken that medication in the first place, that to me, right now, is my biggest cross,” she tells 48 Hours Correspondent Susan Spencer.
What made matters even worse, she says, was finding out from her mother that there had been a similar incident a year earlier.
“I read, ‘Man acquitted of murder, sues drug company.’ And I thought , ‘Oh my God, could this be Adderall?’” says Marge Frushon, Branson’s mother.
The newspaper article she was reading described how in January 1999, 27-year-old Ryan Ehlis of Grand Forks, N.D., took a shotgun and killed his 5-week-old daughter. He then turned the gun on himself. Ten days before, he had started taking Adderall.
“I had no inkling or ability to say ‘What’s the matter with me?’ or ‘This doesn’t make any sense.’ That was not there at all," Ehlis says.
He was charged with murder. Although he later admitted taking much more Adderall than prescribed, the two doctors who evaluated him at the time both concluded that he was not criminally responsible because he was suffering a substance-induced mental illness.
“I don’t look back at that and say, ‘I did that.’ It’s like that was a totally different person,” Ehlis says. “That is somebody who is completely insane.”
Both Branson, who was also cleared of any criminal responsibility for her child’s death, and Ehlis say they were completely unaware that psychosis was even a possible side effect of Adderall.
The package insert, considered adequate by the Food and Drug Administration, lists psychotic episodes as a side effect, followed by the word “rare” in parenthesis. The insert is one inch wide and two feet long. But that insert goes to the treating physician and the pharmacy, generally not to patients. Ehlis and Branson say their doctors didn't tell them psychotic episodes could be a side effect. And both of them are suing Shire Pharmaceuticals, the makers of Adderall, to force the company to beef up its warnings, to highlight potential problems.
“The doctor didn’t tell me about that and I didn’t get that with the printout with the prescription,” Ehlis says of the package insert.
Dr. Alex Michaels, medical director of Shire Pharmaceuticals, says the chances of a psychotic reaction are three in a million. “When we look at the overall picture of benefit and risk associated with it, these are very, very infrequent events,” he says.
In legal proceedings since last November, Shire now says even if Adderall caused psychosis in Branson and Ehlis, its warnings were adequate. And they say it is the doctors' decision how to advise the patient.
Still, Branson and her parents are convinced that Adderall cost them Nathaniel's life.
“The gift of a child is the greatest blessing that we could have on this earth,” Branson says, “and I was entitled to that gift.” She and her family are determined that their experience never be repeated.
“I don’t want to have see another father have to tell his daughter that her little boy is dead,” her father says. “I don’t want anybody else to have to do that”