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LAWSUITS NEWS & LEGAL INFORMATION

One Woman's Experience in a Wellbutrin / Norvir Drug Trial

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Austin, TXIn the small Canadian municipality of Lambton County, the Ontario Provincial Police earlier this month put out a call for the whereabouts of two bottles of antidepressants that had been stolen from a vehicle in Courtright, Ontario, close to the border with Michigan. One of those bottles contained Wellbutrin. Police would like to get that Wellbutrin back and save any unsuspecting person from potential Wellbutrin side effects.


Here's why: Ana Cantu, Commentary Editor for the Austin American-Statesman, wrote a compelling piece on 7/25/10 about her time as a participant in various drug trials in 2005 and 2006. Trial participants are paid volunteers who must abide by certain criteria to facilitate the testing of a drug. Cantu provided full disclosure, earning $4,800 for a month's work.

Cantu wanted to get the story on drug trials from the inside. So she signed up for a trial for the combination of Norvir—an AIDS drug—and Wellbutrin, an antidepressant. She noted in her personal blog at the time that she had heard that Wellbutrin, which she was given first, "gives you crazy dreams," although it is unclear if she herself suffered from any of those.

Cantu wrote that she was started on Wellbutrin initially, which was to be followed by the addition of Norvir six days later. She observed that she wasn't sleeping as much as usual, and she was having trouble eating while actively involved in the trial. She noted in her blog that to avoid becoming nauseated, the key was to not eat immediately after her dosings. Cantu also found that she was better if she ate no more than 50 percent of the food given to her. The less she had to eat, the better she felt—even though, she writes, she remained in a constant state of nausea for the duration of the trial.

It should be noted that any adverse reactions Cantu experienced would stem from the combination of Wellbutrin bupropion and Norvir, rather than any one drug alone.

Over the course of the month-long trial Cantu reports that she lost about 10 percent of her body weight. She could sleep no more than three hours each night.

She was reporting oral numbness and tingling in her extremities. A little more than three weeks into the trial, Cantu started experiencing random blackouts.

"All of a sudden, I couldn't see and lost the ability to balance," she writes. "If I hadn't been standing between two of my fellow subjects, who grabbed me and held me up, I would've slammed into the floor. I knew I hadn't fainted; I could still hear just fine, but all I heard was chaos as everyone around me freaked out. I dropped into the nearest chair and put my head between my legs while the study coordinator called the on-site paramedics. While the coordinator frantically called the staff doctor, a paramedic checked and re-checked me. I did fine as long as I wasn't on my feet for too long. The doctor cleared me to keep dosing.

"A few days after my first blackout episode, during a scheduled outpatient visit, one of the study coordinators said I had to be examined by the on-staff doctor. 'Why?' 'The sponsor is concerned about your side effects,' she said."

A little more than a month later, having lost weight and concerned about low levels of blood pressure that were surprisingly low even for her, Cantu was done with the trial. Checked by medical staff, she said she felt fine, "especially now that I'm off the drugs."

Wellbutrin, the antidepressant Cantu ingested along with one other drug, is associated with birth defects and other side effects. There have been reports of deepening depression while taking the medication.

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