A Big Letdown?
updated 05/12/2003 AT 01:00 AM EDT
•originally published 05/12/2003 AT 01:00 AM EDT
Horror turned to relief when he realized that both he and his wife, Kelly—who worked nearby and was pregnant with their daughter Caitlin, now 14 months old—had escaped unharmed. But the ordeal left him with nightmares, disrupted sleep and anxiety attacks—symptoms he'd never experienced before 9/11. Those troubles eased in January 2002, after a doctor diagnosed him with post-traumatic stress disorder and prescribed Paxil, among the world's bestselling antidepressants. After six months he was feeling better and decided to quit the drug cold. He says he lasted two days before debilitating symptoms—nausea, severe fatigue and paresthesia, a sensation of electric "zaps" shooting through his body—forced him back onto Paxil. "I wasn't warned," says Magnotta. "That makes me angry."
Now the Dover, N.J., insurance executive is channeling his rage: Magnotta has joined more than 500 other plaintiffs across the country who are charging Paxil's maker, GlaxoSmith-Kline, with misleading consumers—and their doctors—by concealing the drug's allegedly addictive qualities. Their lawsuits demand that Glaxo pay for lost wages and medical bills but chiefly seek to force the company to alter advertisements and prescription inserts billing the drug as "non-habit-forming."
Much is at stake for the London-based Glaxo: Last year alone, Paxil yielded sales approaching $3 billion. Spokeswoman Mary Anne Rhyne points out that package inserts have included warnings since 1994. "They say discontinuation symptoms occur in some patients," she says, including dizziness, anxiety, nausea and unspecified "sensory disturbances." Rhyne adds that Glaxo avoids the word "withdrawal" by design: "Withdrawal tends to imply addiction. There's no reliable scientific evidence that Paxil leads to addiction."
Therein lies the dispute. "It's very much a semantics fight between us, the drug company and the experts over the meaning of 'addiction,' " says Los Angeles attorney Karen Barth, who is leading efforts to unite plaintiffs in a national class-action suit against Glaxo. Prescription inserts, she adds, are too vaguely worded even for many physicians and "fall far short of an adequate warning."
Glaxo received a boost, however, when the FDA recently ruled that Paxil was not habit-forming—according to the agency's definition, which labels medications addictive only when they cause "drug-seeking behavior, often with the user escalating the dose for psychological or physical gratification." Most experts agree. "It would be a great disservice to call Paxil addictive," says Dr. Stephen Stahl, chairman of the Neuroscience Institute at the University of California at San Diego, a world-renowned authority on the effects of drugs. "Addiction is where you have craving if you stop a drug and euphoria if you take it. That's not what an antidepressant is."
Not all psychiatrists share that view. "Patients trying to get off Paxil call themselves addicted, because in plain English, that's how they feel," says Dr. Joe Glenmullen, author of The Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil and Other Antidepressants. "It's like having the rug pulled from under their brain cells." Like Prozac and Zoloft, the drug relieves depression by ensuring the free flow of serotonin, a chemical that transmits crucial information between brain cells. But Paxil leaves the body far more quickly than its cousins, which can make quitting that much harder, especially for people particularly sensitive to serotonin fluctuations. "Skip a dose," says Dr. Peter Breggin, author of The Antidepressant Fact Book, "and you could get symptoms the same day."
Or the next day, as plaintiff Katherine Keith claims. Prescribed Paxil for menopausal symptoms in 1997, she, like Magnotta, felt well enough to stop cold turkey. "I thought my head was going to blow off," says Keith, 45, a divorced mother of two who works as a massage therapist in North Hollywood, Calif. "I was vomiting nonstop, had diarrhea. I had the zaps so bad I was crying uncontrollably." Twice, Keith says, she stuck a pistol in her mouth—and had to argue herself out of pulling the trigger.
Keith went back on Paxil, but with her doctor's help she weaned herself by March 2001. And that is the one point on which all parties agree: If you're on Paxil, do not stop short. "The key factor is that the dosage needs to be lowered very, very slowly," says Dr. Stuart Shipko, a Pasadena psychiatrist and expert witness in the lawsuit against Paxil. "Patients often do get sick this way, but they shouldn't despair. Eventually they can stop taking the drug entirely."
Chris Magnotta has done precisely that—with help from a physician who shepherded him through the four-month ordeal. He hopes the lawsuits will smooth the way for future patients. "I want a clear warning of the side effects," Magnotta says. "Nobody should have to go through this."
Ron Arias in Los Angeles and Debbie Seaman in Dover