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Fda gleevec warning letter

Common Questions and Answers about Fda gleevec warning letter

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Avatar m tn Here is an FDA warning. They are unapproved in the US. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm210825.
Avatar m tn m saying here is true, take a look at the warning letter the FDA sent to Diamond Food, Inc. back in February concerning the health claims the company had been making about its walnuts. Diamond Food, Inc., a large producer of nuts and nut products, had put some information on its website about the health benefits of walnuts (which are rich in omega-3 fatty acids).
Avatar m tn Hi, I don't know the answer -- but since both CML and Gleevec toxicity produce anemia because of marrow suppression, maybe it's not possible to tell the difference. E.g., both would show a low reticulocyte count. This full text paper on anemia from Gleevec https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.23879 shows that other signs such as red blood cell size can vary, so that doesn't seem to help. Sorry.
Avatar m tn FDA Hepatitis Update - Important information about alcohol prep pads packaged with Pegasys and certain other injection products Genentech has issued the following Dear Healthcare Professional letter for users of Pegasys and certain other other injection products: IMPORTANT DRUG WARNING IMPORTANT SAFETY INFORMATION REGARDING ALCOHOL PREP PADS MANUFACTURED BY TRIAD CO-PACKAGED WITH GENENTECH PRODUCTS (Fuzeon® (enfuvirtide); Boniva® Injection (ibandronate sodium); Pegasys® (pegylated interfer
Avatar n tn Is it possible that after taking gleevec for only two weeks WBC droped from 36.7 to 7? All other blood counts are also came back to normal range. Could doctor make mistake in diagnosis of CML? Maybe I should get seg second opinion?
Avatar n tn I was diagnosed with CML and given Gleevec 400 ml. After taking gleevec for 2 weeks doctor took additional blood test. My WBC dropped from 36.5 to 7.1 and all other blood counts came down to normal range. I'm wondering if gleevec could give such fast hematological response or I was possibly misdiagnosed originally. I don't and didn't have any symptoms, my spleen and liver weren't enlarged, no enlarged lymph. Should I get second opinion asap? Please, help me.
Avatar n tn After two weeks on 400mlg gleevec my WBC droped from 36.5 to 7.1. My doctor told to come for additional test in two weeks. Now my WBC is 1.3 and absolute neutrophils count is 0.04. I was told to stay home on antibiotics. How long it may take for my counts to clime back to safe range. And of course, I'm off gleevec right now. Does it seem that dose of 400mlg is too high for me.
Avatar n tn WARNING use the same post you started with if you start a new one again it will be reported
612876 tn?1355514495 The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval. “Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.
Avatar n tn Am on Gleevec 400mg, now having problems with blisters on the palm. What can I do about it?
Avatar n tn In response to these findings, the FDA issued an advisory warning about the possible risk of death, but allowed the drug to remain on the market. In August 2005, Health Canada allowed Adderall to re-enter the market because the agency was unable to prove (within that six-month period) that Adderall was more dangerous than other ADHD medications. While Adderall continues to be sold, there are serious risks associated with this popular medication.
Avatar f tn I was diagnosed last year and was immediatley put on gleevec 400mg/day.At my last consult my metabolic stats had risen,hence blood tests to determine if the gleevec is no longer working.I am still in firstphase and wonder what my options are if the gleevec is no longer an option.Amin pretty good form,just very tired and a lot of bone pain.
Avatar f tn Unapproved HIV Test Kits May Face Legal Challenge A consumer warning posted jointly by the FDA and the Federal Trade Commission cautions that HIV test kits that have not been approved for distribution may give inaccurate results. The statement goes on to say that the agencies may take action to halt the sale of kits that aren't up to par. The FDA has conducted several investigations of the reliability and accuracy of unapproved HIV home test kits since 1996.
Avatar m tn I have CML and was treated with Gleevec for 4 years and achieved remission. I have for the past several months been experiencing sudden onset of weakness which last for hours, to days. My blood pressure which has remained under control for several years with atenolol has been running 145/105 and higher for the past three to four months. I have a feeling of fullness in my stomach, and I have sporatic episodes of mild coughing, this occurs maybe once a week.
Avatar m tn it includes some of the following Cipro,Ciproxin,Ciprobay,Ciproproxine,Ciflox and Livaquin, Two other medications in this group have been taken off the market by the FDA some time ago for the nasty reactions they had. There are a lot of other antibiotics that don't have these nasty side affects and are safe to use, although when taking to many antibiotics your stystem could become immune to them and when you have an infection they don't do much good.