2002 Safety Alert - SPES, PC SPES |
NUMBER: 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 BotanicLabs 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/.
HTML by JLW