Anyone has experiences with Tacrolimus eyedrops?

[syclone]

Hi all
A couple of months ago I was so thrilled about getting blood serum eyedrops, a week ago I visited the doctor and instead of serumdrops I got tacrolimus eyedrops. I had absolutely no clue about this stuff, and today as I got the first bottle, I decided to browse some web.

I found out: Sucampo has has been doing some stuff with tacrolimus drops but the company freezed the development.

http://www.sucampo.com/article_59.shtml

Well, the text there doesn`t seem to be too promising but I`ll give it a try...
unless someone here tells me that ones eyes have been disappearing after the use

It says on the label:
Tacrolimus. (Prograf, Fujisawa)
Ricini oleum.
(0,1 mg/ml)

[neil0502]

Admittedly, my vision is pretty weak this morning, but the word "CANCER" seems to come up a lot when taking a brief look at this product and--more precisely--its component ingredient, "protopic." Despite the fact that these warnings concern the topical OINTMENT, I didn't see anything to indicate that the active ingredients differ. If somebody else DOES, please correct me.

To ME (everybody's tolerance for risk is different), trading dry eye for skin cancer or lymphoma isn't a really attractive proposition.

A small number of patients who used tacrolimus ointment or another similar medication developed skin cancer or lymphoma (cancer in a part of the immune system). There is not enough information available to tell whether tacrolimus ointment caused these patients to develop cancer. Studies of transplant patients and laboratory animals and an understanding of the way tacrolimus works suggest that there is a possibility that people who use tacrolimus ointment have a greater risk of developing cancer. More study is needed to understand this risk.Follow these directions carefully to decrease the possible risk that you will develop cancer during your treatment with tacrolimus ointment: Use tacrolimus ointment only when you have symptoms of eczema. Stop using tacrolimus ointment when your symptoms go away or when your doctor tells you that you should stop. Do not use tacrolimus ointment continuously for a long time.Call your doctor if you have used tacrolimus ointment for 6 weeks and your eczema symptoms have not improved, or if your symptoms get worse at any time during your treatment. A different medication may be needed.Call your doctor if your eczema symptoms come back after your treatment with tacrolimus ointment.Apply tacrolimus ointment only to skin that is affected by eczema. Use the smallest amount of ointment that is needed to control your symptoms.Do not use tacrolimus ointment to treat eczema in children who are younger than 2 years old.Do not use tacrolimus ointment 0.1% to treat eczema in children who are between 2 and 15 years old. Only tacrolimus ointment 0.03% may be used to treat children in this age group.Tell your doctor if you have or have ever had cancer, especially skin cancer, or any condition that affects your immune system. Ask your doctor if you are not sure if a condition that you have has affected your immune system. Tacrolimus may not be right for you.Protect your skin from real and artificial sunlight during your treatment with tacrolimus ointment. Do not use sun lamps or tanning beds, and do not undergo ultraviolet light therapy. Stay out of the sunlight as much as possible during your treatment, even when the medication is not on your skin. If you need to be outside in the sun, wear loose fitting clothing to protect the treated skin, and ask your doctor about other ways to protect your skin from the sun.Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tacrolimus and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.Talk to your doctor about the risks of using tacrolimus ointment.

http://www.nlm.nih.gov/medlineplus/d...r/a602020.html

[Lucy]

I can't read all the stuff in italics, (and I may not understand it) but reading Neil's take on it, no way.

We really are sitting ducks because we are so desperate. For me, I'm willing to try just about anything--and have. I have not yet tried "magical swamp water."

I need to remember, however, no matter how badly we feel with dry eyes--I will never die from dry eyes. I have yet to see anyone die from dry eyes. Even when we've had them for years, it may feel like we are dead sometimes :-), but we are NOT. Now, I gotta go shut my peepers. It's too bright out with all the newly fallen snow.

[neil0502]

I can't read all the stuff in italics,

Sorry 'bout that. Better?

[Scout]

A few years ago, Elidel (pimecrolimus) Cream and Protopic (tacrolimus) Ointment were developed and approved by the FDA for treatment of atopic dermatitis (eczema). They are topical immunosuppressant calcineurin inhibitors and were supposed to be the answer for people who had been using topical steroids for many years to control their symptoms. My daughter was prescribed Protopic when it first was on the market. Her dermatologist was concerned about how many years she had been using the steroid-based ointments. Luckily, she stopped using it fairly quickly because it didn’t work for her. Anecdotally, people using the “safer” ointment started showing signs of cancer, starting with children. It is now an FDA “black box” medication and is only to be prescribed after all other medications have been tried.

http://www.fda.gov/cder/drug/advisor...l_protopic.htm

FDA Public Health Advisory March 10, 2005
Elidel (pimecrolimus) Cream and Protopic (tacrolimus) Ointment

The FDA is issuing a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elidel (pimecrolimus) and Protopic (tacrolimus), products that are applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. It may take human studies of ten years or longer to determine if use of Elidel or Protopic is linked to cancer. In the meantime, this risk is uncertain and FDA advises that Elidel and Protopic should be used only as labeled, for patients who have failed treatment with other therapies.

The FDA recommends that healthcare providers, patients and caregivers consider the following:

*

Use Elidel and Protopic only as second-line agents for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.
*

Avoid use of Elidel and Protopic in children younger than 2 years of age. The effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream.
*

Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elidel and Protopic are unknown.
*

Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.
*

Use the minimum amount of Elidel or Protopic needed to control the patient’s symptoms. In animals, increasing the dose resulted in higher rates of cancer.

There are studies on PubMed that found tacrolimus eye drops to be effective for various forms of dry eye in humans and in canines, but most of the ones I could find were dated prior to 2005. Here is a press release from the company that was developing the tacrolimus eye drops in the U.S.


http://factsandcomparisons.com/News/...update&id=6776

Sucampo Suspends Tacrolimus Eye Drops Program


7/1/2005
Sucampo Pharmaceuticals, Inc. reports that it has voluntarily suspended its tacrolimus eye drops development program amid FDA safety concerns about Protopic, a different tacrolimus-based product (an ointment indicated for treating atopic dermatitis). Company officials stressed that patient safety is the primary concern and they will continue discussions with the FDA to determine the future of the dry eye syndrome treatment development program.

[Randal]

Looking at a few websites (Chem Industry and Fresh Patents), I see that ricini oleum is just another phrase for castor oil. That means that this is yet another eye drop that uses, of all things, castor oil as the vehicle for the active ingredient. (Others: Restatis, Refresh Endura, Refresh Dry Eye Therapy.)

This is starting to make me wonder if the "inactive" ingredient (which is what castor oil is listed as) is actually the active ingredient. On OptiBoard there are several posts by an optometrist who swears by the use of straight castor oil as eye drops for the treatment of dry eye. The particular pages are found here, here, and here .

What does everyone else think?

Randal

[syclone]

So I decided to stop putting that stuff into my eyes after one day. In deed dry eyes are better than even a fear of any cancer. Even if those drops helped, it wouldn`t help me at all because who would like to continue using them and at the same time be afraid of cancer.

Does that castor/ricin oil equal to petroleum products? Am I likely to get problems with meibomian glands in the long run?

[Randal]

Does that castor/ricin oil equal to petroleum products? Am I likely to get problems with meibomian glands in the long run?

No, castor oil is actually from the castor bean. I can't say for sure concerning your question about meibomian glands, but castor oil is, in some circles, used as a treatment for dry eye caused by problems with the lipid layer. You might want to see the links I posted in this thread a day or two ago.

Randal

[syclone]

Thanks, Randal
This article also relates to castor oil drops.
http://www.ophthalmologytimes.com/op...l.jsp?id=57630

I meant to ask if castor oil and petroleum products both mess up with your own oil production but the article above says the opposite. As there is no "commercial" version of castor oil drops (except refesh endura) maybe I should ask my doctor about these so some pharmacy could make them? Well, after he recommended tacrolimus eyedrops for me I don`t know what comes next...

[IanJ]

Hi all,

Just found this old thread after reading about tacrolimus on the web and how it makes the lacrimal glands to make more tears.

http://www.freepatentsonline.com/20040087612.html

Anyone know any more about this.......just wondered if tacrolimus eye drops are available yet (safe).

Ian.

[Rebecca Petris]

Anyone know any more about this.......just wondered if tacrolimus eye drops are available yet (safe).

No, and it's not in the pipeline for commercial development for ophthalmic use.

At least not human ophthalmic use. I seem to recall that several studies were done on use in dogs and it's possible they've had better luck with the safety studies in veterinary use than in human use.

[Tyilco]

I have chronic atopic conjunctivitis and severe dry eye and have used just about everything in its treatment. I found cyclosporin to be effective (Carboxymethyl cellulose solution-0.05% to 1.00%) but tacrolimus (0.03% by Leiter's Pharmacy Cal.) is probably the best drug I've used yet. It was terrible for the first two weeks and I almost stopped using it, but after that I was very happy with its performance.

[Tyilco]

Sorry for the second post but I thought you may like some details. I started using cyclosporin (0.05%) about 2.5 years ago. Originally it was made locally in a canola oil base and the results were very good. After about 6 months though I developed an intolerance and stopped using the drug. It was believed that the intolerance was towards the vegetable oil base.

I used nothing for a horrible couple of months and then tried restasis. I found restasis to be a truly terrible drug. I still shudder when I see the remaining ampules stashed away in the back of the medicine cabinet. I next tried a cyclosporin solution (0.05%, by Leiter's) made with carboxymethyl cellulose. This was also mostly successful, but I seemed to still have a couple of bad days out of every 30. Bad days seemed to coincide with getting to the end of the bottle. After 6 months the effectiveness seemed to die off (which seems to reflect a journal article I've read on the subject). This time however there didn't seem to be any intolerance.

I rested for about a month and then went onto tacrolimus. As previously mentioned the first two weeks were hard going then things leveled out. It's worth noting that I started about a month before spring (which is the hardest time of year for me) and had the best spring I can remember. Unlike the cyclosporin I had no bad stretches and it was effective enough to fend off spring (although spring this year was very mild and rainy, which generally helps). Now six months later it seems to be loosing its effectiveness, and I have decided to rest for a month if I can, although so far things are pretty miserable. I considered rotating back to cyclosporin but since the mechanism of action for these two drugs seem similar this may not be productive.

My current aim is to find a drug with a different mechanism for the milder months and then I can use tacrolimus for the harsher months. That way I rest the tacrolimus and maintain its effectiveness. Not sure if this is a wise plan but i guess that's a question for my Ophthalmologist next time I see her.