With a greater-than-accustomed dose of medicine in her system soon after taking her pill, a patient like Jillian Bealer might experience more of bupropion's recognized side effects, including irritability, headaches and insomnia. In the second half of her 24-hour pill cycle, she may feel the effects of a lower-than-accustomed dose, including depressed mood.
Cooperman adds that the different dissolution rates of the two products could have safety implications, since patients who take too high a dose of bupropion are at increased risk of having a seizure.
In December, Dr. Robert Temple of the FDA's Center for Drug Evaluation and Research confirmed that in the lab and in volunteers, the two products differed significantly in their dissolution rate. But that difference was within allowable limits set by regulators. By the time both pills had dissolved, he said, they had released equal levels of Wellbutrin's active ingredient into the bloodstreams of subjects.
The agency thought the allowed variations in the rate at which the medicine was absorbed by patients "wouldn't make any difference," Temple told Southern California public radio station KPCC-FM (89.3).
--
Back to brand names
Jillian Bealer thinks it made the difference between functioning effectively and dragging herself through a holiday season she usually loves. When she shelled out $150 to refill her prescription with Wellbutrin XL, Bealer said, she regained her good humor within a week and a half. She now pays a $45 co-payment instead of $15 for a generic refill. But she said she'll never go back.
The FDA, she said, will probably dismiss stories like hers as flukes. With so much company, Bealer thinks that would be a mistake. "This many people," she said, "could not be wrong."
--
melissa.healy@latimes.com
