Here's the latest headline from the Associated Press: Drug safety experts urge FDA to make drug safety info more accessible to patients.
Here's the opening paragraph to their story: Did you know that Lunesta will help you fall asleep just 15 minutes faster? Or that a higher dose of the osteoporosis drug Zometa could damage a cancer patent's kidneys and raise their risk of death?
Only by wading through the FDA's 403-page internal review of Lunesta do the details emerge: patients fell asleep 15 minutes faster and slept 37 minutes longer, on average.
In a scathing editorial in this week's New England Journal of Medicine, drug safety experts Drs. Lisa Schwartz and Steven Woloshin claim much of what the Food and Drug Administration knows about a drug's safety and effectiveness is not included on the label. Remember, the use of the term "label" in this context is not the label on the prescription vial, but the official labeling, a.k.a. the package inert.
The title of the Editorial is: Lost in Transmission — FDA Drug Information That Never Reaches Clinicians. It can be accessed at: http://healthcarereform.nejm.org/?p=2126&query=home
To read the "spin" on this article check out the full AP story:
Hmm... as someone that has had trouble both getting to sleep and staying asleep, I have to disagree with the author's dismissal of Lunesta's efficacy. I've never taken that medication, but problems with insomnia don't always boil down to just sleep time and etc.
ReplyDeleteOne big problem with insomnia is that it takes away functional waking time. Yeah you might stay up longer, but that doesn't mean you're thinking longer. Often 30 minutes more of sleep can mean 1 hour more of clearheadedness during the day.
Here, a medication that lets you fall asleep 15 minutes sooner, stay asleep 37 minutes longer, and spend 9 minutes less time awake in the middle of the sleep cycle sounds pretty decent to me.
First of all, that grants about 25 minutes extra time to the day that's not wasted in failed sleep. That's time that could be used to cook a meal, or read a book, or spend time with family, etc.
And like I said before, that 37 more minutes of sleep could translate into twice as much functional waking time. Over the course of a week, those benefits add up.
I'm wondering when AstraZeneca is going to commission a study to add an indication for induction and maintanance of sleep to the package insert for Dipirivan.
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