Is Relief Spelled Tacrolimus, Pimecrolimus or Something Along Those Lines?
It seems that every time something works, something goes wrong later. On November 16 2000, Fujisawa Healthcare announced that the United States Food and Drug Administration Dermatologic and Ophthalmic Advisory Committee had recommended their product Protopic (brand name for tacrolimus ointment) for approval to treat eczema since it was safe and effective. Within three months, Protopic was on the market and a new era had dawned in which something other than corticosteroids was available for treating this miserable skin condition.
Back when I first covered the Protopic story, the medication had only been around for a little over one year. At that time, I warned my readers:
“However, suppose we take a quick look at all the neat little side effects that can accompany use of this substitute for steroids while keeping in mind that it also modifies the immune system. This comes directly from Fujisawa’s instructions for patients:
‘The most common side effects of PROTOPIC are stinging, soreness, a burning feeling, or itching of the skin treated with PROTOPIC. These side effects are usually mild to moderate, are most common during the first few days of treatment, and typically lessen if your skin heals. Less common side effects include acne, swollen or infected hair follicles, headache, increased sensitivity of the skin to hot or cold temperatures, or flu-like symptoms [common cold and congestion (stuffy nose)]. Some people may get skin tingling, upset stomach, herpes zoster (chicken pox or shingles), or muscle pain. While you are using PROTOPIC, drinking alcohol may cause the skin or face to become flushed or red and feel hot. Call your doctor if side effects continue or become a problem.’
Ouch, that sounds quite a bit like Protopic not only causes problems locally where you apply it, but also penetrates the skin and, reminiscent of the steroids, can alter our immunity leaving us susceptible to things like chicken pox, shingles or even cancer.
It’s only been around now for a little over one year. What can we expect to occur in the next 10, 20 or more years? Oh well, at least it’s not a steroid.
And now, we come to another news release that appeared in Reuters Health on March 7, 2002. The occasion was the 58th Annual Meeting of the American Academy of Allergy, Asthma, and Immunology. The presenter was Dr. Lawrence Eichenfeld, of the University of California at San Diego. His topic involved another nonsteroidal topical immunodilator capable of inhibiting the production of those now well documented stimulators of inflammation, activated T cells and other effector cells which produce inflammatory cytokines. There was, however, a very familiar ring to the name of this new product since it’s called pimecrolimus, which sounds an awful lot like it must be related to tacrolimus. Both are, of course, immunomodulators, and pimecrolimus works by inhibiting calcineurin, which is required for producing those cytokines. I don’t mean to imply that pimecrolimus will also be capable of producing lots of side effects. After all, we’re only into the initial phases of trying out this new drug on humans. So for now, suppose we put aside all those paranoid suspicions of future disaster and look at the bright side.
Dr. Eichenfeld’s group separated patients with mild to severe atopic dermatitis into infants, children, and adults. Patients were allowed to use emollients if their skins were too dry, but the criteria for success was how often they were forced to use mid-potency topical steroids whenever their rashes flared up. The study compared pimecrolimus in an ointment vehicle to the vehicle by itself. Patients were chosen to get one or the other at random. To say the least, the results were quite impressive. All three groups responded pretty much the same and almost twice as many patients using pimecrolimus, as compared to the control vehicle, were able to go for 6 months without needing any steroids for flares. This held up almost as well after 12 months. Furthermore, the control groups had more secondary infections and skin reactions in spite of the immune modulating effect of the drug.
So, do we have a panacea or is this just another temporary expedient? Only time will tell. In the meanwhile, any among you who suffer from this nasty condition, anyone caring for a sufferer, or any physician treating it may soon have another weapon in their arsenal. Just step lightly and keep your eyes open.”
I’d like to report .I kept my eyes open for you. Here are two samples of what I found:
Tacrolimus (marketed as Protopic Ointment) Information
The Food and Drug Administration (FDA) has approved updated labeling on January 19, 2006 for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The new labeling includes a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling). The Medication Guide is to be distributed with each prescription to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.
Protopic Cream and Skin Cancer
Protopic (tacrolimus) was approved by the FDA in December 2004 for use in the treatment of eczema. It should be used only on areas of skin that have the reash, and should not be allowed to contact normal skin.
In March, 2005 the FDA warned doctors and patients about the increased risk of cancer from using the substance. Nineteen cases of related cancer had been reported and two died. Some were diagnosed with cancer within as little as 21 days.
It’s believed that Protopic causes skin cancers and lymphoma by suppressing the immune system. It’s also associated with leukemia, Hodgkins and non-Hodgkins lymphoma in children, as well as squamous cell carcinoma and breast cancer.
Lawyers began getting into the act by stating that the manufacturers of Protopic have from the outset been marketing the drug without adequate cancer warnings despite their knowledge of the lymphoma risks, and that their PDR references and product inserts for physicians did not contain this type of cancer risk information. They warned users with potential for legal action to file sooner than later, if you have been diagnosed with some form of lymphoma (including Non-Hodgkin’s and Hodgkin’s Disease), leukemia or skin cancer because you may have a case against the manufacturers of Protopic or Elidel.
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