Warnings issued by the US Food and Drug Administration raised the concerns of eczema patients in Saudi Arabia, which 21% of the population suffers from due to the risks posed by two drugs used to treat the disease, and that they may cause skin cancer for their users, at a time when it imposed on the manufacturers to include a warning in a black box on packages The two medications. The authority’s move followed recommendations issued by a subordinate committee last year recommending that the drugs "Elidel" and "Protopic" should be used only after other treatments for eczema have failed.
Although the authority announced that it had received about 78 cases of cancer since last October, including skin cancer and lymph nodes in patients treated with the two medicines, Saudi consultants in dermatology in Riyadh described that what these two drugs are exposed to is nothing more than a war Drug companies, each with others, and that they are the two drugs, they pulled the rug from other medicines because it does not contain cortisone, which causes an increase in hair and a change in the shape of the skin and its thinning of the skin, and the appearance of capillaries on the skin due to the loss of its thickness.
Medical sources stated that the two medicines are present in the King Faisal Specialist Hospital and Research Center in Riyadh, and the National Guard hospitals, while the “Elidel” medicine is found in the hospitals of the Ministry of Health, the Armed Forces, the Internal Security Forces, and the private pharmacies. They have been in existence for nearly three years in the Saudi market, and there are no Such a warning is on medication packaging.
And in a phone call made by Al-Riyadh yesterday to Dr. Abdullah bin Muhammad Al-Issa, a consultant dermatologist and a member of the Saudi Society of Dermatology and Surgery, to take his opinion as a specialist in this aspect, where he said: The warning by the US Food and Drug Administration is not new, rather it is old, about a year ago. What was raised that the two drugs may cause cancer is only suspicion and scientific sources have not proven it, and therefore it has no logical support on the ground, and the cancers that appeared have no relationship to the cells on which the two drugs work, and patients are reassured of using it according to the directions and follow-up of the treating physician.
He pointed out that placing the warning label in a black box is applicable only in America, excluding other countries, for the US Food and Drug Administration to receive accusations of its failure to follow up on medicines, and to place warnings on medicines even with mere suspicion only.
Dr. Al-Issa added that the authority’s recommendations indicate that children under two years of age should not be treated for treatment, because its absorption of the drug is high from the skin, and the other recommendation is not to use it for a period of more than six weeks, and this is a preventive measure, that is, it is used intermittently, and these guidelines are followed in Countries in Europe and the Middle East, including Saudi Arabia, without the presence of the black box, stressing that the Europeans refused to place the warning due to the lack of clarity of rational justifications, in addition to the fact that the International Skin Organization also refused.
Dr. Al-Issa said that one-fifth of the Kingdom’s population suffers from eczema, about 21%, and the most prominent reason for this is genetics, and this percentage is very high compared to other rates that do not exceed 13%, and here patients are reassured with treatment, and I was in San Francisco, USA, to attend the World Conference For dermatological diseases, which was held on March 3-7, and there was reassurance from everyone, and an emphasis on not raising concerns. The US Food and Drug Administration had indicated in a statement the risks of two treatments used for "eczema" for skin cancer, and required manufacturers to include the "black box" warning sign in producer labels.
The department’s move followed the recommendations of one of its advisory committees last February to include warning labels in Elidel Crem and Protopic ointment.
The inclusion of a "black box" on prescription labels indicates an increased risk of side effects from the treatment.
In this context, a spokesperson for the US Food and Drug Administration said, “Warning of a potential danger, and the possibility of something happening in the long run, requires more research and studies.” And the deputy director of the Department of Dermatological and Dental Drugs Department, Dr. Stanka Kokesh, the department has received 78 cases of cancer, including melanoma and lymphoma, from among the users of the two products.
The department indicated earlier last year that in addition to the few incidence of cancer among children and adults, laboratory experiments showed a high incidence of cancer associated with the use of the two treatments among animals.
The Food and Drug Administration stated that although no conclusive answers were found about the safety of the two drugs in the long term, research conducted by manufacturers may take years.
It is estimated that about 10 million people use the "Eczema" treatments.
