Website with Adverse effects data

[Marlene]

I thought this would be a good site to share with everyone. It lists the reports filed with the FDA on adverse effect of med. So I looked up Exjade and was surprised to see so many. I didn't think Exjade had big market, hence the high cost.

So here's the link...when you put in a new drug, it will give you info on the drug and you can click on the FDA safety reports see them.

http://www.patientsville.com/medicat...de_effects.htm

Marlene

[Margie]

I read the FDA site about the negative side effects of Exjade. !!! I have read a lot about the side effects of Exjade, but can't seem to find any specific comments about how great it works in actually lowering iron levels in the body. My doctor says that he has not found it to lower the levels much, but to keep them from getting higher. Does anyone of this site have positive comments about how well Exjade actually works? Also, does anyone here know if iron overload in the body is distributed equally among the vulnerable organs, heart, liver, etc., or can more of it be disposited in one organ than another?

[Birgitta-A]

Hi Margie,
Here is an abstract from European Hematology Association June 2008 about the effects of Exjade:

"IRON CHELATION THERAPY WITH DEFERASIROX (EXJADE) REDUCES SERUM FERRITIN (SF) AND LABILE PLASMA IRON (LPI) IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS)
List, Alan, University of South Florida, Tampa, USA, Baer, M.R., Steensma, D. Raza, A. et al.
Background
Transfusion-dependent patients with MDS may benefit from iron chelation therapy to prevent the morbidity and mortality associated with iron overload. The once-daily oral agent, deferasirox, has demonstrated efficacy and tolerability in patients with MDS. Here we report 12-month data from the US03 trial in patients with MDS treated with deferasirox.

Aim
To evaluate the long-term efficacy and safety of deferasirox in patients with lower-risk MDS in study US03, an ongoing, Phase II, open-label, 3-year trial.

Methods
Patients enrolled had Low- or Int-1 IPSS risk MDS, transfusional iron overload (SF ≥1000 µg/L and >20 units RBC transfusions), and serum creatinine (SCr) ≤2-fold the upper limit of normal (ULN). Deferasirox was initially dosed at 20 mg/kg/day, and could be increased to 40 mg/kg/day based on tolerability and response. SF was monitored monthly; LPI, the reactive species of non-transferrin-bound iron, was assessed quarterly.

Baseline results
In 173 patients (102 men, 71 women) with a mean age of 70 years (range 21–90), IPSS risk groups were Low (46 patients; 27%), Int-1 (123; 71%) and other (four; 2%). Baseline parameters were: SF 3398 µg/L (863–36,280); LPI 0.4 µmol/L (0.0–3.6); mean lifetime transfusions prior to study 63; years of prior transfusions 3.5 (0–34). MDS therapy at study entry included: chemotherapy 22 patients; growth factors 46. Estimated creatinine clearance: normal (>80 mL/min) 77 patients; mild impairment (51–80 mL/min) 68; moderate impairment (30–50 mL/min) 25; severe impairment (<30 mL/min) two. Forty percent of patients had elevated LPI (≥0.5 µmol/L).

Efficacy
Fifty-three patients have reached the 12-month treatment milestone in this ongoing trial. Over 12 months, the mean dose was 21 mg/kg/day and mean transfusion rate was 4.1 units/month. Mean SF±SD (µg/L) values were: baseline 3398±3088; 3 months 3065±1743; 6 months 2775±1355; 9 months 2759±1562; 12 months 2603±1336 (Figure). Sustained suppression of mean LPI to the normal range was achieved after 3 months’ treatment.

Safety
Of 165 patients, 10 (6%) discontinued secondary to suspected adverse events (AEs), and seven (4%) serious AEs. There were 11 deaths (7%), all unrelated to deferasirox. Of 140 patients with normal baseline SCr, 35 (25%) increased >ULN (2.2 mg/dL max SCr). SCr increased >33% above baseline in 11 patients (8%) with abnormal SCr at baseline. Thrombocytopenia developed in 22 patients (13%) and neutropenia occurred in 52 (32%). Development of cytopenia was consistent with hematologic progression of MDS.

Summary/conclusions
Twelve months’ treatment with deferasirox in these patients with MDS and elevated SF decreased mean SF by 859±1548 μg/L and normalized trough LPI in all patients, indicating 24-hour sustained suppression. A high baseline SF may also have contributed to the elevation of SCr. Deferasirox was generally well tolerated. Recent reviews show a 30% increase in hazard ratio for every 500 µg/L increase in SF >1000 µg/L, and NCCN guidelines recommend considering iron chelation therapy in iron-overloaded patients with MDS. Ongoing assessments in this study will evaluate the effect of deferasirox treatment on cardiac, hepatic and endocrine function in these patients with MDS."

As I have written before doctors in Sweden don´t give Exjade to MDS patients because we don´t know much about the long term effects on bone marrow - I get Desferal 4 days with every transfusion.

As far as I understand iron first affects the liver. As long as the liver tests are OK the risks for damage on the heart, pancreas etc are lower.
Kind regards
Birgitta-A