PMID- 17854353
OWN - NLM
STAT- MEDLINE
DCOM- 20080407
LR  - 20131121
IS  - 0007-0963 (Print)
IS  - 0007-0963 (Linking)
VI  - 157
IP  - 5
DP  - 2007 Nov
TI  - The safety of tacrolimus ointment for the treatment of atopic dermatitis: a 
      review.
PG  - 861-73
AB  - Tacrolimus ointment is a topical calcineurin inhibitor (TCI) that was developed 
      specifically for the treatment of atopic dermatitis (AD). It is one of the most 
      extensively tested dermatological products, with more than 19 000 patients 
      (including approximately 7600 children) having participated in the tacrolimus 
      ointment clinical development programme. Recent regulatory reviews have focused 
      on the potential risk of malignancy with TCIs, based on their mode of action and 
      the effects of systemic tacrolimus when given to transplant recipients. Studies 
      have shown, however, that the systemic absorption of tacrolimus when applied 
      topically is very low, with blood concentrations being below the level of 
      quantification in most patients. Moreover, TCIs are not associated with a 
      decrease in immunocompetence in the skin and there is no increase in the 
      incidence of infections with long-term treatment. More than 5.4 million 
      prescriptions for tacrolimus ointment have been issued worldwide, with no 
      evidence of an increased risk of malignancy in adults or children compared with 
      the general population. Similarly, epidemiological studies have failed to 
      demonstrate an increased incidence of skin cancer in patients using TCIs. The 
      most common adverse events (AEs) that occur with tacrolimus ointment treatment 
      are transient application-site reactions, such as burning or pruritus. These 
      complications are related to disease severity, and decrease in frequency over 
      time as AD improves. The incidence of nonapplication-site AEs does not increase 
      with long-term treatment, and most such events occurring in clinical trials were 
      considered to be unrelated to therapy. Although it is important that clinicians 
      are aware of the recent changes in product labelling, extensive clinical trials 
      continue to show that tacrolimus ointment is well tolerated, and is generally an 
      effective therapy for suitable patients with AD.
FAU - Rustin, M H A
AU  - Rustin MH
AD  - Department of Dermatology, Royal Free Hospital, Pond Street, London NW3 2QG, UK. 
      malcomrustin@btinternet.com
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20070913
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Dermatologic Agents)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Ointments)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Administration, Topical
MH  - Dermatitis, Atopic/*drug therapy
MH  - Dermatologic Agents/adverse effects
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects
MH  - Ointments
MH  - Skin Neoplasms/chemically induced
MH  - Tacrolimus/*adverse effects
MH  - Treatment Outcome
RF  - 77
EDAT- 2007/09/15 09:00
MHDA- 2008/04/09 09:00
CRDT- 2007/09/15 09:00
PHST- 2007/09/15 09:00 [pubmed]
PHST- 2008/04/09 09:00 [medline]
PHST- 2007/09/15 09:00 [entrez]
AID - BJD8177 [pii]
AID - 10.1111/j.1365-2133.2007.08177.x [doi]
PST - ppublish
SO  - Br J Dermatol. 2007 Nov;157(5):861-73. doi: 10.1111/j.1365-2133.2007.08177.x. 
      Epub 2007 Sep 13.