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Ercan Zorlu

İnfliximab (Remicade),Enbrel,Humira ÖLÜM SAÇIYOR.FDA RAPORLU
YAZININ ASLI....
Information for Healthcare Professionals
Cimzia (certolizumab pegol), Enbrel (etanercept),
Humira (adalimumab), and Remicade (infliximab) BAŞLIĞI İLE..
http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm
ADRESİN DE VERİLMİŞ...

KISACA....

MEDSCAPE MEDİCALNEWS SİTESİNDEDE YAYINLADIĞI
YAZI ÜZERE....

Alıntı:

Medscape Alerts
Patient Deaths Spark Stronger Warnings for TNF Blockers

Yael Waknine
INFORMATİON FROM INDUSTRY
Assess clinically focused product information on Medscape.
Click Here for Product Infosites – Information from Industry.

September 4, 2008 — Makers of tumor necrosis factor (TNF)-blocking agents are being ordered to strengthen warnings regarding the risk for histoplasmosis and other invasive fungal infections, the US Food and Drug Administration announced today in a news release.
"Since the initial approval of the 4 TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections," FDA officials said. "However, based on reports reviewed by FDA, healthcare professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment."
The agency has received 240 reports of histoplasmosis in patients receiving infliximab (Remicade, Centocor, Inc: 207 cases), etanercept (Enbrel, Immunex Corp: 17 cases), and adalimumab (Humira, Abbott Laboratories, Inc: 16 cases); 1 case occurred during treatment with certolizumab pegol (Cimzia, UCB, Inc), which was approved earlier this year. The majority of histoplasmosis reports came from Histoplasma capsulatum–endemic areas in the Ohio and Mississippi River Valleys.
Missed diagnoses in 21 patients led to treatment delays and 12 deaths, the FDA said, noting that fatal cases of coccidioidomycosis and blastomycosis have also been reported.
Healthcare professionals are advised to closely monitor patients for signs and symptoms of potential fungal infection both during and after treatment with anti-TNF drugs. Patients who develop fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates on X-ray, or serious systemic illness (including shock) should undergo a complete diagnostic workup.
A high index of suspicion should be maintained for invasive fungal infections in symptomatic patients who live or travel in areas where mycoses are endemic, according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting program. If possible, the decision to initiate empiric antifungal therapy should be made in conjunction with an infectious diseases specialist.
An infectious disease consultation is also recommended when determining the duration of antifungal therapy and whether anti-TNF therapy should be resumed on recovery, particularly for patients who reside in regions of endemic mycoses.
TNF blockers are immunosuppressive agents approved to treat 1 or more immune system diseases, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis.
Adverse events related to use of anti-TNF agents should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

KISA ÖZETLEMESİ...
Kullanımda olan, 4 çeşit TNF blokörü ,yan etkilerinin çokluğu nedeniyle, uzun zamandır FDA nın takibindeydi.
İnfliximab (Remicade, Centocor, Inc: 207 vaka), etanercept (Enbrel, Immunex Corp: 17 vaka), ve adalimumab (Humira, Abbott Laboratories, Inc: 16 vaka) ve certolizumab pegol (Cimzia, UCB, Inc)ile ilgili bir vaka olmak üzere toplam 270 vaka ,bu yıl ,FDA ya ulaşmış.Çoğunluğu histoplasmosis ( Histoplasma capsulatum) denen, mantar enfeksiyonu, hastalığına yakalanan vakalarmış.Bu vakaların 21 vakası, geç tespit edilebilmiş ve 12 si de ölmüş.
Bu nedenle bu tür ilaçları kullanan hastaların, mantar enfeksiyonları yönünden, ilaç öncesi ve devamında çok sıkı takip edilmesi gerekiyor.
BİZLER NELERE DİKKAT ETMELİ VE DR LARIMIZI UYARMALIYIZ.....
Ateş ,halsizlik,kilo kaybı,öksürük,nefes darlığı,yakından izlenmeli,
akciğer filimleri gerektikçe yenilenmeli ve takip edilmelidir.
En ufak şüphede enfeksiyon hastalıkları uzmanı bir hekimle ,
sonuçlar değerlendirilmelidir.
_________________
"Low Dose Naltrexone (LDN) may well be the most important therapeutic breakthrough in over fifty years. It provides a new, safe and inexpensive method of medical treatment by mobilizing the natural defenses of one's own immune system.
........... " — David Gluck, MD
ÇEVİRİSİ.:...............
"Düşük Doz naltrekson (LDN) de en önemli tedavi atılım elli yıl içinde olabilir. Bu kişinin kendi bağışıklık sisteminin doğal savunma seferber ederek tıbbi tedavi, güvenli ve ucuz yeni bir yöntem sağlar.LDN önemli sağlık maliyetlerini azaltır ve hastalıkların geniş bir dizi tedavi artırır........

Naltroxene (LDN = Low Dose
Naltrexone)..(ETHYLEX -VIVITROL-NEMEKSİN=Muadili NALTREXONE)
OKUNUŞLARI:Naltrekson,Naltrexone,Naltreksone
http://www.barsakforum.com/naltrexone-tedavisi-crohn-da-vt58.html?highlight=naltroxen