Human Drug Imports, FDA

U.S. Food and Drug Administration

FDA protects public health by promoting supply chain integrity working to ensure medicines imported to the U.S. comply with applicable legal and regulatory requirements. Imported drugs must meet FDA’s standards for quality, safety and effectiveness. For example, medicines from outside the legitimate U.S. drug supply chain do not have the same assurance of safety, effectiveness and quality as drugs subject to FDA oversight.

FDA reviews shipments of imported drugs to determine whether they are admissible into the U.S. An imported drug may be refused entry if, for example, it appears to be:

  • Adulterated – Federal law requires manufacturers to comply with quality manufacturing regulations. A drug may be adulterated if, for example, it was not manufactured in compliance with these quality manufacturing requirements.
  • Misbranded – Appropriate label information is an important aspect of marketing a drug because it gives patients the information they need to take medications correctly. A drug label must comply with FDA regulations. A drug may be misbranded if, for example, its label is false or misleading, it lacks FDA-required information, or otherwise does not follow FDA’s label rules. Manufacturers also must register and list their drugs with FDA. A drug may be misbranded if a manufacturer has not complied with these requirements. A drug may also be misbranded if it is a prescription drug offered for sale without a prescription.
  • Unapproved – Drugs must be proven to be safe and effective for use before companies can market them in the U.S. A drug that lacks the required FDA-approval is considered to be unapproved.

FDA examines and analyzes samples of imported drugs to ensure they comply with applicable standards and/or label requirements. See the human drug imports flyer for more information.

Import information

Safe Importation Action Plan

The safe importation action plan describes steps HHS and FDA will take to allow the safe importation of certain prescription drugs originally intended for foreign markets. The action plan describes two pathways to provide safe, lower cost drugs to consumers. FDA has published a draft guidance and a Notice of Proposed Rulemaking outlining two pathways to allow importation of certain prescription drugs to the U.S.

Personal importation policy (PIP)

In most circumstances, it is illegal for individuals to import drugs into the U.S. for personal use because the medicine has often not been approved by FDA for use in the U.S. FDA’s personal importation policy provides guidance regarding situations where patients might be able, in limited circumstances, to import an unapproved drug for personal use.

Pre-launch activities importation requests (PLAIR)

FDA grants pre-launch activities importation requests (PLAIR) in certain circumstances to allow product sponsors anticipating approval of a drug application to import unapproved finished drug products in order to prepare for market launch. See the following documents for additional information on PLAIR.

www.fda.gov

User Reviews for Efudex

The following information is NOT intended to endorse any particular medication. While these reviews might be helpful, they are not a substitute for the expertise, skill, knowledge and judgement of healthcare practitioners.

Condition Avg. Ratings Reviews Compare
Basal Cell Carcinoma
11 reviews 2 medications Summary of Efudex reviews 7.2 70 reviews

Reviews may be moderated or edited before publication to correct grammar and spelling or to remove inappropriate language and content. Reviews that appear to be created by parties with a vested interest in the medication will not be published. As reviews and ratings are subjective and self-reported, this information should not be used as the basis for any statistical analysis or scientific studies.

Reviews for Efudex

For Basal Cell Carcinoma «I’m 69 and using Efudex for the second time. Just as in 2008, I have been recommended for 21 days of Efudex cream, 2 applications per day, followed by 21 days of twice a day applications of Desonide 0.05%. I am applying the cream broadly on my forehead back to my receded hairline, my sideburn area and my nose. After the first week most areas turned blotchy red and grew increasingly sore and itchy. I have experienced mild stomach upset and my face feels hot. It started to effect my ability to sleep around day 16. Almost packed it in on day 19 but read these posts and decided to persevere for 3 more days. It worked very well back in 2008 and I’m looking forward to the ordeal ending and getting similarly good results.»

  • What this helpful?
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0 · Report

For Actinic Keratosis «I spent years in the sun scuba diving and hiking in Mexico and Arizona. For years I’ve constantly had to use lip balm because my lips were so dry. I tried many products and they never worked. My lips would crack and peel all the time. Just recently I got diagnosed with Actinic Chelitis. I have been prescribed a Effudex 5% once a day for 3 to 4 weeks. I am at Week 2 and experiencing severe, almost unbearable, burning pain because of deep sores with massive amounts of oozing and crusting and now bleeding, tightness and severe dryness. I will try to endure another week but I think I would rather surgery any day than this.»

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2 · Report

For Actinic Keratosis «I used Flouroplex about 15 years ago on my chest and face, they were both a mess for 5-6 weeks, but the treatment is worth is. I started seeing the same damage on my chest and face and my DR prescribed Efudex 5%. It works the same and when I spread it on the chest little red spots started showing, then more and more. I look like my chest has the measles. Some are large spots that swell and ooze. It is very itchy with prickly pain, now in the third week, hard to sleep. I’m going to stop at the weeks end for a full 4 weeks. I also treated some specific spots on the side of my face but it just got very red, turned blackish, I stopped that at 3 weeks and it is healing nicely with the help of vaseline. I have not had any side effects with vomiting or headaches as others have reported. Once my chest starts healing I’m going to try some additional spots on my face. It is not pleasant but what chemo treatment would be? The alternative is surgery.»

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6 · Report

For Actinic Keratosis «Was told to use efudex 5% 2x’s/day for 2 or 3 weeks, but pain would not let me do that. Used it for only 4 days and had a serious reaction to it. Had raised redness over 3/4 of my face, like welts. Had stinging and pain at 4 days & Dr. said that 4 days was enough. Unusually fast reaction. Now I want to see how long it will take to get back to normal. Today is day 5. My sister & bro in law have also used it with good results.»

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5 · Report

For Actinic Keratosis «I am on Efudex for a few spots of actinic keratosis on my face. I am on day 15 and was prescribed to stay on it for 21 days . My face is raw, swollen , and monstrous looking I feel like it’s super glued. I’m gonna do my best to stick it out for the next six days. Like many others, my doctor did not tell me about the intense pain and scary look. However my father-in-law was on the cream a few years ago so I knew what I was in for. I also went through photo light therapy 12 years ago where that result was immediate, threw up on the way home from the pain. Efudux has the same pain , just a long drawn out process to get there.»

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9 · Report

For Basal Cell Carcinoma «Face was covered in about 7 areas after years of sun damage from working in the sun, used Efudex for 15 days applied 2 times a day till the 40mgs tube ran out , week 2 the pain was not nice but honestly go thought it it is worth it , Like having a face lift looking 10 years younger . Believe me it is truth . Using it on my arms now just started For any one going though a course, it really is impressive cream»

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23 · Report

For Keratosis «Dermatologist prescribed efudex for keratosis 1 week on and 3 weeks off x 4 to treat my face but said not to apply on chin. After a few days freckles appeared and by day 7 today my skin feels quite irritated, itchy and a slight sting — especially the sides of my nose. One spot above my eyebrow has bled slightly last night and tonight after washing my face. My dermatologist said I could continue to wear foundation but to wait 15 mins after applying cream.»

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10 · Report

For Actinic Keratosis «I am grateful for Efudex, although the treatment is quite difficult, because it is effective, comprehensive and empowering! Skin cancer surgeries are another kind of difficult I hope to avoid! I’ve used Efudex three times on my face. the first two weeks are the easiest, the second two are more challenging. Plan to stay at home week 4 and the first week of healing. If you are using around your mouth, it will be hard to comfortably eat and drink. Eat soft foods and use a straw. With supervision, my doctor directed me to use Efudex on my lips, which was the most challenging of all applications! Because lips are a more sensitive area, I only needed to apply for 7-10 days. I made it to 8 and could do no more. No doubt Efudex is challenging to use, but it beats multiple surgeries where hunks of your face are removed! I plan to use in the future where issues emerge. because the “bad” cancer causing cells will keep appearing. And, now I can do something when they do!»

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22 · Report

For Actinic Keratosis «I was prescribed Efudex for basal carcinoma on my leg. Used twice a day for 3 weeks. Excellent result. Now 6 weeks on and just left with red area which I assume will fade with time. I was also told to treat AK on my face, used cream once a day for 4 weeks (stopped 3 days short). As with other comments made, I was not informed by the dr that I would look absolutely monstrous. Immediate reddening of the entire face, followed by scabbing. Still at the scabbing stage. I could get a part in a horror movie. The cream seemed to migrate towards my eyes where I had not applied it. Would I have used Efudix if I had known what I would look like — probably wouldn’t have had the courage as people stare when I am out and about. Determined to continue with my life as normal. Think it’s better than it turning into cancer at a later stage. I await the results with bated breath, although I think this may be many months away.»

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18 · Report

For Skin Cancer «Two weeks after efudex and my skin looked incredible — soft and everyone asked if I got a peel! 1 day later day 15 there was burn abrasions, raised cuts and I went to my scheduled two week check in with dr and she said it’s “working Beautifully” and continue for two more weeks. During week 3 I had small “cuts” all over my face where I applied cream 2x a day. Small scabby cuts also appeared on my scalp, chest even though I didn’t apply the medication there. The dr said that was strange, but I read in the leaflet it’s plausible. Horrible taste in mouth and sick to my stomach within 20 min of applying still. I’m in horrible pain, look awful and two more weeks to go. Had SCC with two Mohs surgery then reconstruction of Nose and head earlier last year. I’m 47 years old and grew up in cal sun. Hope this prevents future SSC»

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20 · Report

For Actinic Keratosis «I am using efudex and the spots were getting raised and crusty as expected but then it got damp in the shower and came off with a bit of bleeding. It has settled down now . But I was worried if this has set back the process. I would appreciate your comments.»

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14 · Report

For Actinic Keratosis «I had a very tiny split on the side of my nose that wouldn’t heal. It was BCC. It was surgically removed. One of the most horrible experiences, emotionally. I used Efudex a year ago for a spot that appeared on my chest. It worked well, although painful and itchy. I am now using it on my forehead, nose and upper lip area. I was shocked at how many spots appeared! Extremely painful when touched, but otherwise just a little itchy on occasion. I am grateful for all the comments here. it gives me courage to keep going. Week 2. «

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19 · Report

For Basal Cell Carcinoma «Have found using efudux apply only every 3 or 4 th day seems reaction not so bad and it will do the job in same amount of time .. works for me»

  • What this helpful?
  • Yes
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18 · Report

For Basal Cell Carcinoma «I was prescribed this cream to treat BCC on my nose. I had a red spot with suspected basal cell carcinoma. My dermatologist wanted me to treat my entire nose, to get any spots that hadn’t emerged yet. I put on twice daily for two weeks. It took about a week for anything to happen, but then the spot turned red. Soon my entire nose turned pink. At day 14 my nose was red, with purple areas, blisters, and depressions. I had to put Vaseline on it to tolerate the pain. It felt like someone had burned my face with a hot iron. The skin was pulled taught and I was afraid of scarring. It has been 8 weeks after the application stopped. It is still a little pink. Unfortunately it did not get my spot, it is not superficial enough. The cream redness lasts longer for me than I anticipated. It was an 8 week process for me and still have a pink nose. hope it isn’t permanent.»

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26 · Report

For Actinic Keratosis «Was prescribed Efudix by the NHS to treat incorrectly diagnosed psoriasis (they thought it was Actinic Keratosis because I have AC on arms/hands from growing up in a hot country) on my ankle. Used the cream for 6 weeks roughly in 2018 and stopped using the cream after the 6 weeks. Developed a case of Discoid Eczema which originated from the psoriasis spot and I’ve had now for a year. Have to apply Epimax cream twice a day to contain the eczema which is incredibly/unbearably itchy and causes red welts to appear on my legs below and on the knees. If you have a choice I would not use Efudix.»

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10 · Report

For Keratosis «Efudex was extremely painful. It affects cancer spots. Well I guess that is all over because my entire body was inflamed.»

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15 · Report

For Keratosis «Put it on the obvious parts of my face that I thought needed to be treated, found that the Efudix somehow seeped to cover much more of my face, had lots of redness followed by crusty scabbing, had to stop treatment after just short of 3 weeks as my eye were in agony with stinging gritty feeling, even though I didn’t put any anywhere near my eyes — wonder if gets into sinus system and makes its way there.»

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40 · Report

For Actinic Keratosis «Had to stop using Efudix on my face after 2 weeks and 2 days because of pain, dizziness, and mouth sores. My face was a fright, bright red all over as the cream seemed to creep» when used . One week later the rash has settled and the pain has subsided but I fear it will be weeks before I return to my normal look. I have dry flakey scabs on my face where scabs were not evident before Efudix. I regret using this cream on my face. My chest looks like I have been blasted with both barrels of a shotgun. Red welts everywhere as I dressed the whole area with Efudix as advised by DR. Not really painful but starting to itch. I am 3 weeks into this area, I feel I could stop now but will give it a few more days. The jury is still out. «

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25 · Report

For Actinic Keratosis «I am a 60 year old with very fair skin and blue eyes who grew up at the beach. I was regularly burned to a blister stage every year. I had many keratosis burned off from age 30 to 50. Finally advised to use Efudex. I have completed treatments on my face 5 times now over the course of these 10 years. I have an unusually mild reaction each time. In fact, I have to use it for 40 days to get the full benefit. So, you never know how your own skin will react. The dermatologists have been amazed at the length of time it takes me to get a reaction. But for the chest area, the reaction is incredibly painful, red, and fast. Maybe the constant freezing of those places on my face helped more than I know? In any case, Maybe it could be recommended to try a small area before using on the entire face. The end results are very good and I would not let fear keep you from trying this.»

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50 · Report

For Keratosis «Been using Efudex for 3 weeks now applying it nightly on a small spot on the left cheek, the area of skin been scaly now really red and has spread to double the size , I have stopped applying it as the soreness has gone and will wait a month to see if it clears , the treatment gave me a funny taste , dicky tummy and terrible itching on my back for ten mins after a bath or shower , scored 5 at the moment because my cheek looks a mess with the redness but hope it will clear over the coming weeks , applying sudacrem hope it helps !»

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23 · Report

For Actinic Keratosis «Used for 4 weeks to treat what physician thought might be an AK (Actinic Keratosis) — a very tiny dry scaly spot above my upper lip. Efudex was easy to use, not painful, just a gnarly scab that took weeks to fall off. Once gone, the skin was smooth but red. Red spot was 3X larger than the AK being treated (now the size of a pencil eraser). Hoping the redness will heal in time. Finished treatment two months ago but the smooth red splotch remains. It looks far worse than the tiny dry spot I had before I began treatment. Regret using Efudex»

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24 · Report

For Actinic Keratosis «Growing up at the Jersey Shore and summers spent at Fl Beaches, I fell in love with the warmth of the sun, and a healthy tan. At 55, the sun made my chest bubble up, and my legs reverse tan. It is no surprise that I had actinic keratosis multiplying fast. I was prescribed Efudex 5% for my chest, neck and face. I had no idea it was topical Chemo. What? I googled everything Efudux, bought Aveeno, vanicreme, Aquaphor, asked for anxiety med for my mounting fears and took a personal leave from work. Its Day 13, saw Dr., I’m done. I did look beat up. In the afternoon insane itching.. tap tap. Many more dead lesions, surface and crust up. I’m using cortizone, and aquaphor on the corners and for lesions around my lips. I will be doing this for years to come peeling back the many layers of damage. It has not been as bad as it was for others. It’s uncomfortable yet tolerable, and much better than the alternative. The knife or Cancer. Oddly, I feel healthier and fortunate to be given this chance.»

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45 · Report

For Keratosis «Treatment with efudex on both arms for keratosis, caused damage, had bad reaction creating auto-immunity situation; still being treated by dermatologist after 12 months. Itching unbearable on arms, bleeding after scratching and left with watery mess. Relief from ice-packs help and then moisturising. Treatment from Prednisolone, Cyclosporin lasts for a few weeks and then I break out again. Been around this way 6 times now! Efudex: seek all the info you can before treatment.»

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31 · Report

For Basal Cell Carcinoma «I’ve had surgery for basal cell over the years and had an area near my nose. I used efudex as directed. Sure, it looked horrible after treatment it was a bit lumpy like it was scarred. I thought it didn’t work. The area, came back totally cancer free and the lumpy look went away. You would never know it was treated. Well worth it. I’m currently using it on my cheek and hoping for the same result. «

  • What this helpful?
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43 · Report

For Skin Cancer «Used Efudex on my whole face 10 years ago. I think it was for 4 weeks. Week 2 the redness turned into lesions on my whole face , especially my left side (drivers side). Hurt like hell. I play poker sometimes at a casino. I didn’t have to look at me so my appearance wasn’t my problem. After the lesions healed my face was as smooth as a baby’s butt. A couple of the players were surprised I was still alive because I looked like I had full blown aids. I recommend it as I had no idea my face was such a mess. It is an ordeal. Using it on my ear now. started 6 weeks ago and in the last few days. Fingers crossed. Not pleasant but hopefully I can avoid surgery and plastic surgery .»

www.drugs.com

User Reviews & Ratings — Premarin vaginal

Read user comments about the side effects, benefits, and effectiveness of Premarin vaginal.

« Premarin vaginal Information

Overall User Ratings

Current Rating: 0

Current Rating: 0

Current Rating: 0

User Reviews

Reviewer: 55-64 Female (Patient)

Current Rating: 1

Current Rating: 1

Current Rating: 1

Comment:
Read about the horrific treatment to the pregnant mares and their slaughtered babies before using and the 1 billion dollars that Pfizer profits from their abuse

Comment:
Read about the horrific treatment to the pregnant mares and their slaughtered babies before using and the 1 billion dollars that Pfizer profits from their abuse
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1 person found this review helpful.
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Reviewer: Axxiefox, 55-64 on Treatment for 10 years or more (Patient)

Current Rating: 2

Current Rating: 2

Current Rating: 1

Comment:
It driving me bananas one day Im fine the next day im ok and by the third day I want to cry. Im not sure if this going yo help me sexually. I havent had sex in such a long time. Its not pleasant because you deal with pain. Another thing, I just read about the mares and the suffering these poor things go through.Im going to ask my doctor to give me something different. I dont need a mare to suffer . Show Full Comment

Comment:
It driving me bananas one day Im fine the next day im ok and by the third day I want to cry. Im not sure if this going yo help me sexually. I havent had sex in such a long time. Its not pleasant because you deal with pain. Another thing, I just read about the mares and the suffering these poor things go through.Im going to ask my doctor to give me something different. I dont need a mare to suffer like Im suffering, ill see something different.
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0 people found this review helpful.
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Reviewer: Dominique , 55-64 on Treatment for 1 to 6 months (Patient)

Current Rating: 2

Current Rating: 2

Current Rating: 2

Comment:
I used Premarin for 3 months and when I learned of the horrible torture mares go through in Premarin farms I stopped immediately. To my surprise, I realised I did not really need it and could live very well without it. No bad side effects either . and I feel so good not being a part of the Premarin customers.

Comment:
I used Premarin for 3 months and when I learned of the horrible torture mares go through in Premarin farms I stopped immediately. To my surprise, I realised I did not really need it and could live very well without it. No bad side effects either . and I feel so good not being a part of the Premarin customers.
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4 people found this review helpful.
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Reviewer: Holly, 45-54 Female on Treatment for less than 1 month (Patient)

Current Rating: 2

Current Rating: 5

Current Rating: 1

Comment:
I just started this because of the painfull intercourse,haven’t had sex yet as I’ve only been on it for 4 days, husband is out of town for 5 days a week so I hope I can tell a difference. My pharmacist did find a coupon for me and I only have to pay 15.00 for 2 mo.

Comment:
I just started this because of the painfull intercourse,haven’t had sex yet as I’ve only been on it for 4 days, husband is out of town for 5 days a week so I hope I can tell a difference. My pharmacist did find a coupon for me and I only have to pay 15.00 for 2 mo.
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0 people found this review helpful.
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Reviewer: 45-54 on Treatment for less than 1 month (Patient)

Current Rating: 3

Current Rating: 3

Current Rating: 3

Comment:
After just one week of taking 1g per night my water retention increased. Therefore I’m reducing my weekly dose in an effort to obtain the best combination of less water retention and improved vaginal dryness. I’m not happy with this price. I’ll be looking for a compound pharmacy competitor.

Comment:
After just one week of taking 1g per night my water retention increased. Therefore I’m reducing my weekly dose in an effort to obtain the best combination of less water retention and improved vaginal dryness. I’m not happy with this price. I’ll be looking for a compound pharmacy competitor.
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5 people found this review helpful.
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