FDA Approves OTC Differin 0.1% Gel for acne

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zelman

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Is use during pregnancy not a real problem?
 

farmadiazepine

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To all the people who paid hundreds of dollars for prescription only Differen, here's to you.
 
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deleted723470

Is use during pregnancy not a real problem?
Per Lexicomp. "A case report described maternal use of adapalene 1 month prior to pregnancy and through 13 weeks gestation; cerebral and ocular malformations were reported in the exposed fetus which resulted in termination of pregnancy (Autret, 1997). In clinical trials, women of childbearing potential were required to have a negative pregnancy test prior to therapy."

Crazy I know, but better safe than sorry.
 

zelman

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Per Lexicomp. "A case report described maternal use of adapalene 1 month prior to pregnancy and through 13 weeks gestation; cerebral and ocular malformations were reported in the exposed fetus which resulted in termination of pregnancy (Autret, 1997). In clinical trials, women of childbearing potential were required to have a negative pregnancy test prior to therapy."

Crazy I know, but better safe than sorry.
Oh. I see it's category C. I thought all the topical retinoids were category X, but I guess that's just tazarotene.
 

ldiot

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I still wouldn't recommend category c to someone pregnant, especially an acne cream.
 
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I've been waiting to see this on shelves since FDA announced this way back in April...it's going to be a huge seller for those NJ Cougars & palliation of fine wrinkles (jokingly). But seriously, has anyone seen retailers carrying this yet?
 

radio frequency

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Most drugs are Cat C.
Oh. I see it's category C. I thought all the topical retinoids were category X, but I guess that's just tazarotene.

I still wouldn't recommend category c to someone pregnant, especially an acne cream.

Categories are gone, guys. The FDA has been trying to rid us of them since last year and replace them with good data in hopes we'll all look more closely at actual published risks and the potential patient benefits.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm

My hunch is this product packaging will have a pregnant person outline and an X through it, much like the packaging for the oral retinoids or ribavirin. Scratch that; I just looked at the FDA site and it looks like they aren't concerned about Differin in pregnancy (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510362.htm). Well...my other sources make me think this is definitely one I'll still avoid recommending to pregnant patients.
 
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zelman

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Categories are gone, guys. The FDA has been trying to rid us of them since last year and replace them with good data in hopes we'll all look more closely at actual published risks and the potential patient benefits.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm

My hunch is this product packaging will have a pregnant person outline and an X through it, much like the packaging for the oral retinoids. Scratch that; I just looked at the FDA site and it looks like they aren't concerned about Differin in pregnancy (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510362.htm). Well...my other sources make me think this is definitely one I'll still avoid recommending to pregnant patients.
Are they gone already? I thought that was still in process.
 

radio frequency

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Are they gone already? I thought that was still in process.
Gone officially for new drug applications since summer 2015, but they seem to still be lingering around in some old literature and apps for older medications.
 
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deleted723470

I've been waiting to see this on shelves since FDA announced this way back in April...it's going to be a huge seller for those NJ Cougars & palliation of fine wrinkles (jokingly). But seriously, has anyone seen retailers carrying this yet?

Are they gone already? I thought that was still in process.

Gone officially for new drug applications since summer 2015, but they seem to still be lingering around in some old literature and apps for older medications.

"Once the rule takes effect, it will require all new drugs to adhere to the new labeling requirements. In addition, it requires that all previous pregnancy risk categories be removed within 3 years."
 

RealRX

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Shouldn't topical retinoid be safe for pregnancy since they're not absorbed systemically???
 
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