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Is Retin A safe? Increased Risk of Death Amoung Retin A Users!

 

The recent study by Weinstock published in the reputable Archives of Dermatology was very disturbing.   See the abstract below and my blog that is coming on www.skinguru.com.
The study showed that elderly men with a history of smoking had a greater death rate when on tretinoin then when not on tretinoin.  (Tretinoin is Retin A or Renova)
What does this mean?  We are not sure.  Many dermatologists are saying not to worry.  I feel that if you are a smoker- you should worry.  This study just published so I am waiting to hear more from those who conducted the study.
 
It is important to realize that this is the first sign of a risk to using tretinion after decades of use of this product, so this study may be meaningless. However, it is prudent to take this advice…. If you use tretinion, retinol, adapalene, tazarotene or take Vitamin A or beta carotene supplements, please do not smoke. Smoking is known to age your skin prematurely and to cause lung disease and heart disease. 
 Lets discuss.  I will keep you posted on this imporatnt development.
Here is the abstract of the study:
 
Topical Tretinoin Therapy and All-Cause Mortality
Martin A. Weinstock, MD, PhD; Stephen F. Bingham, PhD; Robert A. Lew, PhD; Russell Hall, MD;
David Eilers, MD; Robert Kirsner, MD, PhD; Mark Naylor, MD; James Kalivas, MD; Gary Cole, MD;
Kimberly Marcolivio, MEd; Joseph Collins, ScD; John J. DiGiovanna, MD; Julia E. Vertrees, PharmD;
for the Veterans Affairs Topical Tretinoin Chemoprevention (VATTC) Trial Group
Objective: To evaluate the relation of topical tretinoin,
a commonly used retinoid cream, with all-cause mortality
in the Veterans Affairs Topical Tretinoin Chemoprevention
Trial (VATTC). The planned outcome of this trial
was risk of keratinocyte carcinoma, and systemic administration
of certain retinoid compounds has been shown
to reduce risk of this cancer but has also been associated
with increased mortality risk among smokers.
Design: The VATTC Trial was a blinded randomized chemoprevention
trial, with 2- to 6-year follow-up. Oversight
was provided by multiple independent committees.
Setting: US Department of Veterans Affairs medical centers.
Patients:Atotal of 1131 veterans were randomized. Their
mean age was 71 years. Patients with a very high estimated
short-term risk of death were excluded.
Interventions: Application of tretinoin, 0.1%, or vehicle
control cream twice daily to the face and ears.
Main Outcome Measures: Death, which was not contemplated
as an end point in the original study design.
Results: The interventionwas terminated 6months early
because of an excessive number of deaths in the tretinointreated
group. Post hoc analysis of this difference revealed
minor imbalances in age, comorbidity, and smoking
status, all of which were important predictors of death.
After adjusting for these imbalances, the difference in mortality
between the randomized groups remained statistically
significant.
Conclusions: We observed an association of topical
tretinoin therapy with death, but we do not infer a
causal association that current evidence suggests is
unlikely.
Trial Registration: clinicaltrials.gov Identifier:
NCT00007631
Arch Dermatol. 2009;145(1):18-24

 

7 Responses to “Is Retin A safe? Increased Risk of Death Amoung Retin A Users!”

  1. Robert Kirsner Says:

    Leslie,

    The data showed that even after controlling for smoking there was an increased risk of death. You might wish to correct that in your comments. Agree as do the other authors - likely just a chance occurrence.

    All the best,

    Rob

  2. Dr. Leslie Baumann Says:

    Dr. Kirsner- so you are saying that the risk is higher even if you do not smoke and that you think that this was a chance occurence in the trial and you are not concerned. That is what several derms are saying as well. My thoughts:The product has been on the market for decades and patterns of complications have not been noticed before so this may be an errant finding. I felt that people need to know about this anyway. Thanks for your input. I know that you were one of the investigators on the trial.

  3. Sarah Anne Says:

    Thank you so much for your article. I was wondering if there is any concern with using glycolic peels and smoking? or using glycolic creams/alpha hydroxy creams and smoking?

  4. Dr. Leslie Baumann Says:

    No risk with glycolic peels and smoking. We really do not know why they saw increased death in this study. It may be an errant finding or there may be something to it. Its not the exfoliation effect that glycolic has. Its more likely due to the effects that retinoids have on hormone receptors.

  5. Sarah Anne Says:

    Thank you. What about gylcolic creams and alpha hydroxy creams (such as Gyltone products)and smoking?

  6. Sarah Anne Says:

    Sorry for all the questions. What about other creams that contain retinol besides Retin-A? any risk with those or is it just Retin-A? Thanks.

  7. Dr. Leslie Baumann Says:

    The study just looked at high strength 0.1% tretinoin. It did not look at retinol so I feel it is still safe.