" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
RINSE THOROUGHLY AFTER EACH USE. Patients should be closely monitored and use should be immediately discontinued at the first sign of any of the symptoms described below.
Rapid absorption of hexachlorophene may occur with resultant toxic blood levels when preparations containing hexachlorophene are applied to skin lesions such as ichthyosis congenita, the dermatitis of Letterer-Siwe's syndrome, or other generalized dermatological conditions. Application to burns has also produced neurotoxicity and death.
pHisoHex SHOULD BE DISCONTINUED PROMPTLY IF SIGNS OR SYMPTOMS OF CEREBRAL IRRITABILITY OCCUR.
Infants, especially premature infants or those with dermatoses, are particularly susceptible to hexachlorophene absorption. Systemic toxicity may be manifested by signs of stimulation (irritation) of the central nervous system, sometimes with convulsions.
Infants have developed dermatitis, irritability, generalized clonic muscular contractions and decerebrate rigidity following application of a 6 percent hexachlorophene powder. Examination of brainstems of those infants revealed vacuolization like that which can be produced in newborn experimental animals following repeated topical application of 3 percent hexachlorophene. Moreover, a study of histologic sections of premature infants who died of unrelated causes has shown a positive correlation between hexachlorophene baths and lesions in white matter of brains.
Avoid accidental contact of pHisoHex with the eyes.
If contact occurs, promptly rinse thoroughly with water. To assist in the detection of ocular irritation, applications to the head and periorbital skin areas should be performed only in responsive patients with unanesthetized eyes.
pHisoHex is intended for external use only. If swallowed, pHisoHex is harmful, especially to infants and children. pHisoHex should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity Studies In Animals
Hexachlorophene was tested in one experiment in rats by oral administration; it had no carcinogenic effect.
No case reports or epidemiological studies were available.
Impairment Of Fertility
Embryotoxicity And Teratogenicity
Placental transfer of hexachlorophene has been demonstrated in rats.
Hexachlorophene is embryotoxic and produces some teratogenic effects.
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Hexachlorophene should be used during pregnancy only if the potential benefit justifies potential risk to the fetus.
Hexachlorophene has been shown to be teratogenic and embryotoxic in rats when given by mouth or instilled into the vagina in large doses.
Administration of 500 mg/kg diet or 20 to 30 mg/kg bw/day by gavage to rats caused some malformations (angulated ribs, cleft palate, micro- and anophthalmia) and reduction in litter size. Placental transfer and excretion in milk of hexachlorophene has been demonstrated in rats.
In another study, doses of up to 50 mg/kg diet failed to produce any effects in 3 generations of rats. Hexachlorophene did not interfere with reproduction in hamsters.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hexachlo- rophene, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
pHisoHex must not be used for bathing infants (see WARNINGS). Infants may absorb the active compound in pHisoHex more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions. For premature infants: see WARNINGS.
Clinical studies of pHisoHex did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, use in elderly patients should be cautious, reflecting the greater frequency of dermatological disease, peripheral circulatory disease, and decreased propensity for wound healing in this group. In addition, use in elderly patients should take into account any decreased hepatic, renal, or cardiac function, as well as any concomitant disease or other drug therapy.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/15/2016
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