latest ‘fda drug bulletin’ briefs

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LATEST 'FDA DRUG BULLETIN' BRIE FS - Hexachlorophene : interim warning about use in pregnancy : Following a Swedish report on birth defects associated with topical useofhexachlorophane {see Inphorma No 153: p 2 (9 Sep 1978)J. the FDA is re-evaluating sa fety information on this widely used prescription antimicrobial. The Agency cannot draw definite conclusions without more information than the report provides, but as an interim precaulion, ' considers it prudent for surgeons. nurses, and other health car. personnel who 8'. or may become pregnant to. avoid hexachlorophene antibacterial scrubs'. -- New prescrilling prescribing directions for all or al phen ytoin products, because of n. ew evidence that dissolution and absorption rates differ for different dosage forms and for different brands of phenytoin sodium capsules. New labelling will advise doctors in general to patients on I dosage form and I manufacturer's product. When a capsu le change involves 'Dilantin' sodium capsules, doctors should chock patients' blood levels . The variations are not caused by faully man ufacturing. Generi c and brand name products from aU approved manufacturers should be equally satisfactory if doctors follow the new prescribing guidelines. The onl y brand of capsule at present recommended for once a day use is 'Dilantin KapseaJ'. Patients should not be staned on once a day therapy until they have been stabilised on divided doses. There seem to be 2 di stinct forms of phenytOin - fast release for tid or qid dos ing and slow rel ease for once a day dosing. The FDA and US Pharmacopoeia are working to establis h 2 different phenytoin standards for these. - A reminder that PUV A is still an investigational therapy for psoriasis: Although PUV A (psoraJen plus ultraviolet radiation) is an effective treatment for severe debilitating psor iasis, the FDA has not approved this treatment because of unanswered questions about the saf ety of its long term use. A complex situation is developing from wid es pread use of PUY A while it is still under investigation - both components are legally available. 'The Agency wants to remind doctors and patients that PUVA is still investigational as a therapy for psoriasis .' Its tND status allows it to be used only for patients with psoriasis on at least 30% of their bodies or seve re involvement of palms or soles. It should be given only by doctors with special expertise in photocbemotherapy and patients should be fully informed of the known benefits and risks. The Dermatology Advisory Co mmittee plans a meeting in Cktober to review the drug's status. FDA Oro, BuUetin 8: 26 (Aug·Sep 19 78) INPHARMA 23fd September. 1978 p4

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Page 1: LATEST ‘FDA DRUG BULLETIN’ BRIEFS

LATEST 'FDA DRUG BULLETIN' BRIEFS

- Hexachlorophene : interim warning about use in pregnancy: Following a Swedish report on birth defects associated with topical useofhexachlorophane {see Inphorma No 153: p 2 (9 Sep 1978)J. the FDA is re-evaluating safety information on this widely used prescription antimicrobial. The Agency cannot draw definite conclusions without more information than the report provides, but as an interim precaulion, 'considers it prudent for surgeons. nurses, and other health car. personnel who 8'. or may become pregnant to. avoid hexachlorophene antibacterial scrubs'.

- -New prescrilling ClireCtions·fcir-ph·.nytoin-(diph.nylhyd8ntoin~1'he-FDA-plans"tonquire-important"changcs-in

prescribing directions for all oral phenytoin products, because of n.ew evidence that dissolution and absorption rates differ for different dosage forms and for different brands of phenytoin sodium capsules. New labelling will advise doctors in general to k~p patients on I dosage form and I manufacturer's product. When a capsule change involves 'Dilantin' sodium capsules, doctors should chock patients' blood levels. The variations are not caused by faully manufacturing. Generic and brand name products from aU approved manufacturers should be equally satisfactory if doctors follow the new prescribing guidelines. The only brand of capsule at present recommended for once a day use is 'Dilantin KapseaJ'. Patients should not be staned on once a day therapy until they have been stabilised on divided doses. There seem to be 2 distinct forms of phenytOin - fast release for tid or qid dosing and slow release for once a day dosing. The FDA and US Pharmacopoeia are working to establish 2 different phenytoin standards for these.

- A reminder that PUV A is still an investigational therapy for psoriasis: Although PUV A (psoraJen plus ultraviolet radiation) is an effective treatment for severe debilitating psoriasis, the FDA has not approved this treatment because of unanswered questions about the safety of its long term use. A complex situation is developing from widespread use of PUY A while it is still under investigation - both components are legally available. 'The Agency wants to remind doctors and patients that PUVA is still investigational as a therapy for psoriasis .' Its tND status allows it to be used only for patients with psoriasis on at least 30% of their bodies or severe involvement of palms or soles. It should be given only by doctors with special expertise in photocbemotherapy and patients should be fully informed of the known benefits and risks. The Dermatology Advisory Committee plans a meeting in Cktober to review the drug's status. FDA Oro, BuUetin 8: 26 (Aug·Sep 1978)

INPHARMA 23fd September. 1978 p4