Abstract
Coloring agents are frequently added to drugs, foods, and cosmetics. If approved by the FDA, these additives may be added or substituted without notifying physicians. A patient developed angioedema, wheezing, urticaria, and dizziness one hour after taking the first Premarin tablet from a new refill. She had previously tolerated Premarin daily for 7 months without any adverse reactions. The new tablets were noted to be a slightly different shade of maroon and subsequent investigation revealed that the dye formulation had been changed (FD and C red #3 and FD and C yellow #6 were changed to FD and C red #40 and D and C #27). Puncture skin testing with a suspended tablet from the new Premarin batch was positive but was negative to a different drug (dye-free). Premarin skin testing in two normal volunteers was negative. The patient has since tolerated transdermal estrogen without any adverse reactions. These findings suggest that an additive in the Premarin tablet, most likely one of the new dyes, and not the estrogen, was the cause of the anaphylaxis. Physicians need to be aware that inactive ingredients can be changed without warning and these new constituents may cause sudden and potentially very severe allergic reactions to previously tolerated medication.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 33-35 |
| Number of pages | 3 |
| Journal | Annals of Allergy |
| Volume | 72 |
| Issue number | 1 |
| State | Published - 1994 |
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ASJC Scopus subject areas
- Immunology and Allergy
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Anaphylaxis associated with a change in premarin dye formulation. / Caucino, J. A.; Armenaka, M.; Rosenstreich, David L.
In: Annals of Allergy, Vol. 72, No. 1, 1994, p. 33-35.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Anaphylaxis associated with a change in premarin dye formulation
AU - Caucino, J. A.
AU - Armenaka, M.
AU - Rosenstreich, David L.
PY - 1994
Y1 - 1994
N2 - Coloring agents are frequently added to drugs, foods, and cosmetics. If approved by the FDA, these additives may be added or substituted without notifying physicians. A patient developed angioedema, wheezing, urticaria, and dizziness one hour after taking the first Premarin tablet from a new refill. She had previously tolerated Premarin daily for 7 months without any adverse reactions. The new tablets were noted to be a slightly different shade of maroon and subsequent investigation revealed that the dye formulation had been changed (FD and C red #3 and FD and C yellow #6 were changed to FD and C red #40 and D and C #27). Puncture skin testing with a suspended tablet from the new Premarin batch was positive but was negative to a different drug (dye-free). Premarin skin testing in two normal volunteers was negative. The patient has since tolerated transdermal estrogen without any adverse reactions. These findings suggest that an additive in the Premarin tablet, most likely one of the new dyes, and not the estrogen, was the cause of the anaphylaxis. Physicians need to be aware that inactive ingredients can be changed without warning and these new constituents may cause sudden and potentially very severe allergic reactions to previously tolerated medication.
AB - Coloring agents are frequently added to drugs, foods, and cosmetics. If approved by the FDA, these additives may be added or substituted without notifying physicians. A patient developed angioedema, wheezing, urticaria, and dizziness one hour after taking the first Premarin tablet from a new refill. She had previously tolerated Premarin daily for 7 months without any adverse reactions. The new tablets were noted to be a slightly different shade of maroon and subsequent investigation revealed that the dye formulation had been changed (FD and C red #3 and FD and C yellow #6 were changed to FD and C red #40 and D and C #27). Puncture skin testing with a suspended tablet from the new Premarin batch was positive but was negative to a different drug (dye-free). Premarin skin testing in two normal volunteers was negative. The patient has since tolerated transdermal estrogen without any adverse reactions. These findings suggest that an additive in the Premarin tablet, most likely one of the new dyes, and not the estrogen, was the cause of the anaphylaxis. Physicians need to be aware that inactive ingredients can be changed without warning and these new constituents may cause sudden and potentially very severe allergic reactions to previously tolerated medication.
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M3 - Article
VL - 72
SP - 33
EP - 35
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
SN - 1081-1206
IS - 1
ER -