Wednesday, November 18, 2015

the drug war page 326 november 2012 White pill: Creative CropAdvertisement - Continue Reading BelowMichelle David never pictured herself as a nurse. She was squeamish about needles and couldn't stand the sight of blood. When she learned, in 2005, that she was pregnant with a second child, she was a dancer for the NBA's Philadelphia 76ers. She loved the job and hoped to return to it. But by the time her son, Lyam, turned one, David had left her dancing career behind and enrolled in nursing school. As a new student, she was already familiar with some of the medical procedures being taught—such as how to insert a nasogastric feeding tube: She'd learned them to care for Lyam.
More From ELLEAt six weeks, Lyam was barely eating. One night, his breathing became severely labored. David rushed him to Philadelphia's St. Christopher's Hospital for Children, where doctors told her he was going into cardiac arrest. He'd been born with holes in his heart and would need two open-heart surgeries immediately. Before the first could be scheduled, Lyam started vomiting blood, and his organs began to shut down. Unable to breathe on his own, he was placed on a ventilator for four months. When he was finally stable, he underwent both of the surgeries in less than a month.
"After the second, it was bad, ­because he had drainage tubes," David, 31, told me. "It was just—he looked so bad. I wasn't prepared for that." David had been matter-of-fact, even upbeat, as she'd described her son's medical history, but she now was overcome by emotion. "I'm sorry," she said, covering her face with her hand. Tears rolled down her cheeks. "It just really stinks that he's going to have to go through it again." David was referring to the open-heart surgery that Lyam will need within the next three years to fix yet another anomaly—all of which were caused by the boy's in utero exposure to the ­selective serotonin reuptake inhibitor (SSRI) Paxil, a Philadelphia jury ruled in October 2009.
David's doctor had prescribed Paxil for the mild anxiety she suffered after the death of a close friend. When she became pregnant a year later, she asked both him and her ob-gyn about the drug. Neither doctor was concerned, which isn't surprising: Paxil was one of the most-prescribed antidepressants at the time, and a number of psychiatrists were delivering nationwide talks for their fellow physicians endorsing the safety and efficacy of the drug during pregnancy.
But in December 2005, two months after Lyam was born, the FDA asked Paxil's manufacturer, GlaxoSmithKline, to change the drug's pregnancy-use classification from Category C ("animal reproduction studies have shown an adverse effect on the fetus, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks") to Category D ("positive evidence of human fetal risk"). The move came following the early results of two studies showing that women who took paroxetine (Paxil's generic name) during the first trimester were one and a half to two times more likely to have a baby with a heart defect—in most cases, atrial or ventricular septal defects like Lyam's. The FDA issued a public health advisory to doctors and clinics about Paxil and the danger of congenital heart defects.
The jury that ruled in David's favor also found that GlaxoSmithKline had "negligently failed to warn" her doctor about the increased risk of such problems and awarded David $2.5 million in compensation. It was the first and only SSRI case to ever reach verdict, though Glaxo has since settled more than $1 billion worth of claims out of court. David's attorney, Sean Tracey, says that there are many more cases pending against Paxil and other SSRI makers—this summer alone, 19 suits were filed against Zoloft—or awaiting settlement.
Tracey first learned about Paxil-related birth defects in 2006, when another lawyer walked into his office with a client named Lisa Collins, whose son, Chase, was born with part of his heart missing. Like David, Collins did not suffer from major depression or anxiety; she was prescribed Paxil for occasional claustrophobia. When Collins became pregnant, her family doctor assured her that it was "perfectly safe" to continue taking the drug. But just two weeks after he was delivered, Chase needed open-heart surgery. The strokes he suffered after the procedure left him with brain damage. GlaxoSmithKline reached a confidential settlement with Collins in 2008.
Despite cases like Lyam's and Chase's, the debate about the use of SSRIs during pregnancy is far from over. And the number of pregnant women taking SSRIs is as high as it's ever been.
Given the number of things women are told to avoid during pregnancy—alcohol, aspirin, unpasteurized cheese, and sushi, to name just a few—it may seem surprising that antidepressants aren't verboten too. But in recent years, doctors have become as concerned about the impact of depression on the mother and child as they are about the harm SSRIs might do to the fetus. An estimated 3 percent of pregnant women suffer from major depression, giving them a lifetime suicide risk 20 times higher than average. "The women I see say, 'Nothing gets me excited. I don't want to go out of the house, I can't get my stuff done at work, my boss has noticed,' " offers Kara Driscoll, MD, a psychiatrist at Northwestern Memorial Hospital in Chicago who specializes in treating depressed expectant mothers. "You can have a severe episode of depression without being suicidal. It's just the symptoms are really quite profound." (Those symptoms include lethargy, an inability to focus, feeling hopeless or guilt-ridden, eating or sleeping too much or not enough, and crying often.)
Advertisement - Continue Reading Below

No comments:

Post a Comment