Soriano's wife, Sonette Marras is in a medically induced coma at The Queen's Medical Center. The 48-year old Maui woman is suffering from liver failure.

"She was healthy as a horse," says her son, Ronden Smith-Marras. He says she just wanted to lose weight. So this summer, she started taking OxyElite Pro, a diet supplement. After several weeks, Smith-Marras says his mother got violently ill.

"Nausea, vomiting, she would eat, then throw up," says Smith-Marras. His mother was flown to Oahu.

Michael Sorianoの妻Sonette Marrasは、Queen's Medical Centerで、医療行為から生じた昏睡状態に陥っている。48歳のマウイ在住のSonette Marrasは肝機能障害を起こしている。

「母は非常に頑健だった。母は減量したがっていた。」と息子Ronden Smith-Marrasは述べた。それで今夏に、彼女はダイエットサプリOxyElite Proを服用し始めた。数週間後に彼の母は重い病気になった。「吐気、嘔吐、母は食べては、もどした。」彼の母は、オアフ島に運ばれた。

[Lynn Kawano: "Woman who took diet pills dies of liver failure" (2013/10/03) on HawaiiNewsNow]
この記事掲載(2013/10/03)の翌日、Sonette Marrasは死亡した。
Sonette Marras' son tells Hawaii News Now that his mother died from liver failure Friday at The Queen's Medical Center
Sonette Marrasの息子がHawaii News Nowに、金曜日に母親が肝機能障害でQueen's Medical Centerで死亡したと告げた。

[Lynn Kawano: "Woman who took diet pills dies of liver failure" (2013/10/03 updated 2013/10/05) on HawaiiNewsNow]
このような症例はSonette Marrasだけではない。
The State Department of Health is investigating dozens of cases of people suffering from liver injuries after taking weight loss supplements. The cases range from acute hepatitis, to severe liver failure. At least one person has had a transplant and several others are on the waiting list.

OxyElite Pro isn't the only supplement that the patients took before getting sick. There is at least one other, but the Department of Health won't reveal the name of that supplement.

And it's unclear if an ingredient in the supplements is to blame or a combination of factors.

Another mystery, why the cases are only in Hawaii. Did Hawaii get a bad batch? These are all questions the health department and the FDA are looking into. The investigation could take weeks, even months and slowing things down, the government shutdown. The FDA is experiencing delays because of it.




[Lynn Kawano: "Woman who took diet pills dies of liver failure" (2013/10/03) on HawaiiNewsNow]

Hawaii News Now has learned that the number of cases of acute hepatitis linked to a weight loss supplement has tripled in the last week.

Officials with the State Department of Health say more cases were reported by concerned medical professionals after an alert went out statewide and nationwide last week.

There were 7 original cases but HNN sources say that number has gone up significantly since the weekend. They range from acute hepatitis to complete liver failure. At least one patient has already had a transplant, several more are on the list for a transplant and many more are being evaluated.

What's so shocking to the medical community is how quickly the patients' health declined. According to the State Epidemiologist Dr. Sarah Park, they were all healthy, adults who were trying to lose weight or gain muscle.



医学界に非常に衝撃的なのは、患者の健康があまりに急激に損なわれている点である。州疫学者Dr. Sarah Parkによれば、患者たちはすべて健康な成人で、減量あるいは筋肉増強しようとしていた。

[Lynn Kawano: "More cases of liver failure linked to diet supplement" (2013/09/27 updated 2013/10/04) on HawaiiNewsNow]

FDAが安全性についての根拠のないジメチルアミルアミンを含む製品に注意喚起 (HFNET訳)を出している。

OxyElite Proはこのアンフェタミン誘導体であるDMAAを含んでおり、取扱業者に対して在庫廃棄が命じられている。
In a victory for consumers, a Texas-based distributor of dietary supplements has destroyed its stock of two dietary supplements containing the stimulant dimethylamylamine (DMAA).

In addition, a major distributor of the products – GNC Inc. - agreed to destroy the supplements in its possession after the Food and Drug Administration (FDA) obtained seizure orders for GNC facilities in three states. GNC has already destroyed its DMAA products in two of the three states, and we expect the products in the third state to be destroyed this week.

The products – OxyElite Pro and Jack3D, distributed by USPlabs – had an estimated retail value of more than $8.5 million. Dietary supplements containing DMAA – an amphetamine derivative – are advertised as useful for losing weight, enhancing athletic performance and building muscle. Reports implicate DMAA in the narrowing of blood vessels and arteries, which can elevate blood pressure and lead to serious medical conditions, including heart attack, seizures, psychiatric disorders and even death. FDA has received reports of more than 100 illnesses associated with products containing DMAA, including six deaths.

A noteworthy aspect of this case is that FDA invoked its administrative detention authority to protect consumers. This authority was recently amended so that it can be used more easily.


さらに、これらの製品の主要な代理店であるGNC Incは、FDAが3州でのGNC施設についての廃棄命令を受けた後、在庫のサプリの廃棄に同意した。GNC Incは既に2州で、DMAA製品を廃棄しており、3つめの州での廃棄も今週中に行われると、FDAは期待している。

これらの製品OxyElite Pro及びJack3Dは、USP labsによって販売されており、小売の推定価値850万ドルである。アンフェタミン誘導体であるDMAAを含むダイエットサプリは、減量及び運動能力向上及び筋肉増強に効果があると宣伝されている。症例報告によれば、DMAAは、血管や動脈を収縮させることで、血圧上昇を起こし、心臓発作や突発的発作や精神疾患、さらには死亡を含む重篤な症状につながる可能性がある。FDAはDMAAを含む製品に関連した症例報告を100件以上受け取っており、6件の死亡症例も含まれている。

この事件の注目すべき側面は、 FDAが消費者保護のために行政強制権限を発動したことである。この権限は、発動しやすいように、最近、法改正がなされた。

[Daniel Fabricant, Ph.D.: "Dietary Supplements Containing Unsafe Food Additive Destroyed" (2013/07/30) on FDA Voice]

posted by Kumicit at 2013/10/05 19:51 | Comment(0) | TrackBack(0) | Others | このブログの読者になる | 更新情報をチェックする



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