A weight loss dietary supplement is being recalled by the Food and Drug Administration after an FDA analysis found the supplements contain the presence of undeclared drug ingredients, including a suspected cancer-causing agent. The recalled supplement is made by GMP Herbal Products and is marketed under the name Pai You Guo.
Pai You Guo was found to contain sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss (Meridia); and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA warning stated that the agency has not approved the Pai You Guo products as a drug, therefore safety and effectiveness of this product is unknown.
Pai You Guo is either sold in a box of 30 capsules or a bag of 10 g powder. The affected products were sold and distributed nationwide via the Internet.
While no illnesses or injuries have been reported to the company to date in connection with this product, the FDA advises consumers that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Some commonly known side effects of Meridia (sibutramine hydrocholoride monohydrate) are:
Pai You Guo was found to contain sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss (Meridia); and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA warning stated that the agency has not approved the Pai You Guo products as a drug, therefore safety and effectiveness of this product is unknown.
Pai You Guo is either sold in a box of 30 capsules or a bag of 10 g powder. The affected products were sold and distributed nationwide via the Internet.
While no illnesses or injuries have been reported to the company to date in connection with this product, the FDA advises consumers that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Some commonly known side effects of Meridia (sibutramine hydrocholoride monohydrate) are:
headache
change in appetite
constipation
heartburn
dry mouth
weakness
back pain
nervousness
difficulty falling asleep or staying asleep
runny nose
flu-like symptoms
flushing
painful menstrual periods
Some uncommon but dangerous side effects are:change in appetite
constipation
heartburn
dry mouth
weakness
back pain
nervousness
difficulty falling asleep or staying asleep
runny nose
flu-like symptoms
flushing
painful menstrual periods
fast or pounding heartbeat
chest pain
shortness of breath
nausea
stomach pain
vomiting
extreme excitement
restlessness
anxiety
depression
dizziness
lightheadedness
fainting
confusion
uncoordinated or abnormal movement
muscle stiffness
shaking hands that you cannot control
seizures
shivering
excessive sweating
fever
sore throat
large pupils (black area in center of eyes)
change in vision
eye pain
hives
skin rash
itching
difficulty speaking, breathing, or swallowing
hoarseness
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
unusual bleeding or bruising
Since commonly used TCM agents are not consistently and properly measured during dispensation, it is not uncommon for people to experience the more hazardous side effects when taking these medications, sometimes at great risk to themselves.
chest pain
shortness of breath
nausea
stomach pain
vomiting
extreme excitement
restlessness
anxiety
depression
dizziness
lightheadedness
fainting
confusion
uncoordinated or abnormal movement
muscle stiffness
shaking hands that you cannot control
seizures
shivering
excessive sweating
fever
sore throat
large pupils (black area in center of eyes)
change in vision
eye pain
hives
skin rash
itching
difficulty speaking, breathing, or swallowing
hoarseness
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
unusual bleeding or bruising
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