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PC SPECS again. . . .and more

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Folks,

This health warning was just released. Note that PC SPECS was found

to contain DES, ethenil estradiol and indomethacin. The estradiol and

DES may explain the gynomastia that was reported in several men.

 

 

 

HEALTH WARNING NO.  02-31

DATE:   June 5, 2002

FOR RELEASE:    IMMEDIATE

 

CONTACT:   Ken August or Lea Brooks    (916) 657-3064    

http://www.dhs.ca.gov

 

STATE HEALTH DIRECTOR WARNS CONSUMERS ABOUT HERBAL SUPPLEMENTS THAT

COULD CAUSE SERIOUS HEALTH EFFECTS

 

SACRAMENTO - " Consumers should immediately stop using the herbal dietary

supplements Arthrin, HepaStat, Neutralis, OA Plus, Osporo, Poena and RA

SPES because they contain undeclared prescription drug ingredients that

could cause serious health effects if not taken under medical

supervision, " State Health Director Diana M. Bontá, R.N., Dr.P.H., said

today.

 

BotanicLab, the Brea-based manufacturer of the products, issued a letter

to its customers advising them to immediately stop using the products

and destroy any stock. The company closed its operations June 1.

 

Laboratory analysis of the products by the California Department of

Health Services (CDHS) found that the products contain the following

drug ingredients, which are available only by prescription:

 

Arthrin -- Alprazolam, Indomethacin.

HepaStat --Indomethacin.

Neutralis --Indomethacin.

OA Plus -- Alprazolam, indomethacin.

Osporo--Diethylstilbesterol (DES).

Poena -- Indomethacin.

RA Spes -- Alprazolam, indomethacin.

 

" Consumers should stop using these products and seek medical advice,

especially if they currently are using any other prescribed medication, "

Bontá said. " State, federal and private laboratory testing of the

BotanicLab products has shown wide variation in the types and quantities

of undeclared prescription drugs present in BotanicLab’s products.

 

" Consumers are encouraged to consult with their health care provider

whenever they take dietary supplements, including herbal products.

Dietary supplements can alter the effectiveness of prescription drugs

and produce harmful effects in people suffering from serious diseases.

Dietary supplements should not be used to treat serious diseases. "

 

Alprazolam, which may be habit-forming, exacerbates the effects of

alcohol and other central nervous system depressants. DES and ethinyl

estradiol are estrogens and can affect fertility, cause cardiovascular

problems and have been associated with an increased risk of cancer.

Indomethacin can cause ulcers or gastrointestinal bleeding, nausea,

vomiting, headache, depression and fatigue.

 

In January, BotanicLab voluntarily recalled the herbal dietary

supplement SPES because it contained alprazolam. In February, the

company voluntarily recalled PC SPES because it contained warfarin, a

blood-thinner that is available only by prescription. Later testing of

PC SPES found that it also contained DES, ethinyl estradiol and

indomethacin. CDHS' Food and Drug Branch is continuing to investigate

these products and can be reached at 1-800-495-3232 for more

information. Information about CDHS' actions regarding SPES and PC SPES

also is available at http://www.dhs.ca.gov/.

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