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`Copyright 1990 PR Newswire Association, Inc.
`PR Newswire
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`November 8, 1990, Thursday
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`SECTION: Washington Dateline
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`DISTRIBUTION: TO NATIONAL AND MEDICAL EDITORS
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`LENGTH: 327 words
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`HEADLINE: FDA ISSUES GHB WARNING
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`DATELINE: WASHINGTON, Nov. 8
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`BODY:
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` The Food and Drug Administration today warned consumers to discontinue use of
`an illegally marketed drug -- GHB or gamma hydroxybutyric acid -- that has been promoted
`as a "legal psychedelic" but has caused more than 30 people in California, Florida
`and Georgia to become ill with symptoms ranging from nausea and vomiting to severe
`respiratory problems, seizures and coma.
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`Health departments in those states have been working with the FDA to learn more
`about the GHB-linked illnesses. Thus far, the investigation has uncovered strong
`evidence linking GHB consumption to the illnesses.
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`Gamma hydroxybutyric acid, also called sodium oxybate and gamma hydroxybutyrate
`sodium, is a chemical that is being promoted for strength training, body building,
`weight loss and as a replacement for L-tryptophan, a food supplement that FDA ordered
`removed from the market last year after it was linked to a rare blood disorder.
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`GHB has been used in Europe as an anesthetic adjunct and it is being evaluated
`in FDA-approved clinical trials for the treatment of narcolepsy.
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`The FDA offered consumers the following medical advice:
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`-- Anyone taking GHB outside of physician-supervised clinical trials should stop
`immediately.
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`-- Anyone who has consumed GHB and is experiencing seizures, uncontrolled shaking,
`headache, unexplained drowsiness or other central nervous system disorders, nausea,
`vomiting or diarrhea should consult their physician immediately.
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`-- Physicians treating patients exhibiting these conditions should report these
`cases to their local poison control center.
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`According to the California health department, GHB is sold through mail order outlets,
`health food stores, body building gyms and fitness centers. It is marketed as powder
`or granules. CONTACT: Bill Grigg, 301-443-3285 or, after hours, 202-652-1864; or Donald
`McLearn, 301-443-4177 or, after hours, 301-926-6909, both of the Food and Drug
`Administration
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`LOAD-DATE: 110890 DC020
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`JAZZ EXHIBIT 2001
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00547
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