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Sleepy teen finds relief in narcolepsy diagnosis

For as long as Maeve Sheehy can remember, she’s had short spells of feeling like she was about to fall over. “It wasn’t like feeling faint, it was more like my knees would buckle underneath me,” says Maeve, now 16. “I would instinctually try to keep from falling by bracing myself.” Sometimes the bracing didn’t work and Maeve would topple over. If she was with friends, she’d pretend she had tripped, to cover it up. But she secretly worried something was wrong with her. When she tried to explain the falling feeling to her parents and doctors, she was told she was probably dehydrated. More mysterious symptoms As she entered middle school, Maeve started to have other symptoms. She felt exhausted all the time, despite regular naps. Sometimes, she was so tired in class that she couldn’t even hold her pen to take notes. “Her eyes also seemed droopy and she had slow speech,” says Maeve’s mom Kim. “We took her to the pediatrician and she was tested for thyroid problems, allergies and Lyme disease, but all the tests all came back negative.” Maeve shares her story in a TED Talk. Convinced something was not right, Maeve did what any computer-savvy teen might — she Googled her symptoms. The results surprised her. “I learned that the falling over feeling was a symptom of cataplexy, a loss of muscle control that’s associated with narcolepsy,” says Maeve. “I just didn&...
Source: Thrive, Children's Hospital Boston - Category: Pediatrics Authors: Tags: Our Patients’ Stories Center for Pediatric Sleep Disorders Dr. Eric Zhou Dr. Kiran Maski Narcolepsy Source Type: news

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Source: Journal of Sleep Research - Category: Neurology Authors: Tags: Regular Research Paper Source Type: research
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The FDA recently released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the minor changes that should be documented in an annual report. As the number of chemistry, manufacturing and controls (CMC) postapproval manufacture supplements continue to increase, the FDA decided to publish this guidance. Guidance This guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12. Specifically, the guidance describes chemistry, ...
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