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This case study discusses the positive impact of drug labeling changes on safety, with a focus on the importance of clear patient communication and the system's response to risks and benefits. The supportive role of a "Dear Patient Letter" in conveying safety profile changes with prescription refills is emphasized, illustrating the importance of proper communication in healthcare.
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22 Q Now, did any -- did any of the -- in light 1 of the cross-examination you had, has your opinion 2 regarding the labeling of the drug changed in any way 3 in terms of its adequacy and warning of risks and 4 benefits? 5 A Not in the slightest. To me, it's a 6 success story. It doesn't always work that well, but 7 it was a signal, the signal was followed up on, the 8 signal was confirmed, the label was changed, the 9 recommendations were made to the doctors. 10 Unfortunately, doctors didn't change their 11 practice as much as they could have. David Graham 12 has confirmed that. Alternative drugs came out and 13 so the drug became obsolete and was removed from the 14 market. Everything worked right. It's the way the 15system should work, and to me, this is a model case.
“Dear Patient Letter” • Clear statement of change in safety profile included with prescription refill • Highlighted for easy identification • Indication of newly approved status
