IA#66-35 --- 2/11/87
BACKGROUND:
Dallas district has reported that some clinics in Nuevo Laredo, Mexico are
engaged in the business of selling potentially dangerous combinations of
otherwise possibly useful drug products to U.S. citizens for weight loss.
According to newspaper accounts, the diet regimen consists of several drugs
including diuretics, laxatives, thyroid hormones, depressants and
antihistamines. The primary drug associated with the diet regimen is called
Redotex, manufactured by Medix, a Mexican pharmaceutical company. According
to the Mexican Diccionario de Especialidades Farmaceuticas (Mexican equivalent
to PDR) each capsule of Redotex consists of the following:
English Translation (Spanish)
o Tri-iodothyronine (Triyodotironina) 75 mcg. - A hormone used to increase
the metabolic rate of tissues.
o Norpseudoephedrine (Clorhidrato de D-Norseudoefedrina) 50 mg. - An
amphetamine like drug.
o Atropine sulfate (Sulfato de Atropina) 0.36 mg. - Used as a respiratory
and circulatory stimulant.
o Aloin (Aloina) 16.2 mg. - Laxative.
o Diazepam (Diacepam) 8 mg. - A depressant (Valium).
Other drugs associated or used in conjunction with Redotex include:
1) Ponderex 40 - (Clorhidrato de Fenfluramina) 40 mg. Manufactured by A.H.
Robbins de Mexico
2) Moduretic - Manufactured by Merck Sharp and Dome de Mexico.
3) Asenlix (Clorhidrato de Clobenzorex) 30 mg. - Manufactured by Grupo
Russellsa - Mexican Pharmaceutical Co.
4) Ionamin-(Complijo de Resina de Fentermina) (equivalente a 30 mg. de
fenil-ter-butiliamina) 142 mg., manufactured by Pennwalt Labs de Mexico.
5) Fluddro - Furosemide
The products normally given to patients consist of Redotex and product number
1 and number 2 listed above. Products 3 and 4 listed above have been reported
to be substituted for Redotex in some instances. Newspaper accounts have also
reported the occassional use of product 5.
A health hazard evaluation by CDB of the product Redotex has revealed that the
use of Redotex poses a health hazard, especially when taken without adequate
medical supervision. The irrational combination of these thyroid, diurectic,
stimulant and tranquilizer drugs may cause serious and potentially fatal
adverse reactions. These would include alteration of metabolic rate,
increased heart rate, lowering or increasing of blood pressure, loss of body
electrolytes by diuretic action, as well as confusion and hallucinatory states.
GUIDANCE:
Automatically detain all entries, including those encountered by U.S. Customs
during routine examination of personal baggage, of Redotex; and the other diet
drugs mentioned above if encountered in combination with Redotex and charge:
"The article(s) are violative within the meaning of 801(a) (3) in that it
appears to be a new drug without an approved New Drug Application (NDA)
pursuant to section 505; and it is misbranded under Section 502."
Alert your local Customs of FDA's interest in these products, however,
emphasize to Customs that FDA's interest regarding examination of personal
baggage is limited only to routine examination.
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