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Fda avandia july 2010

Common Questions and Answers about Fda avandia july 2010

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Avatar n tn She is gaining weight, has trouble breathing, and has been experiencing some chest pains lately (Dr. gave nitro). She is on avandia and I would like to know if this could be the cause of her recent decline in health?
Avatar m tn Daily visits to selected websites, subscriptions to selected scientific and medical podcast as well as my monthly magazines such as Nature, Scientific American, Physics Today, Science Magazine and Science Readers. respirate just convinced me to add the FDA website into my dailies. What is good with technology these days is that you can be very selective regarding the kind of information you want to get and newspapers make me angry for some reasons that are totally personal.
1236243 tn?1277680851 See this link for FDA issued warnings on Actos and Avandia http://diabetes.niddk.nih.gov/dm/pubs/medicines_ez/insert_J.aspx Kinda makes you wonder if it's time to leave the sinking ship.
Avatar m tn Also, Avandia is the other drug that falls into this classification. The FDA warns not to use Avandia for first time users, in fact, the FDA severely restricts its use. You can read about the different oral diabetes medication classifications and drugs that fall into each class here. http://tinyurl.com/type2-diabetes-drug-classes Always ask your doctor why he/she is Rx a drug vs others on the market.
29837 tn?1414534648 They are going to use a “rolling NDA” (New Drug Application) submission to the FDA starting the quarter of July of this year. Another very interesting thing he told me is that they are doing a small Phase 2 study combining Telaprevir with VX-222, without the awful Interferon and Ribavirin. Keep your fingers crossed on that one... So, I will report as he reports to me.
Avatar f tn In addition she maintained 30 minutes of aerobic exercise 5-7 days a week most weeks since diagnosis. In July, 2010, despite compliance to treatment, she was not improving as we expected and we began to be concerned about her ability to start school and extracurricular activities. She started midodrine in July, 2010 beginning with 2.5 mg dose three times a day progressing to 7.5 mg three times a day until early August.
1594263 tn?1297221575 Should be ready and FDA approved in June or July.....you will be fine until then. No drinking and no smoking. Eat a well balanced fat free diet. Don't despair....we're with you !
Avatar m tn I use Actos, but for some reason my fingers typed Avandia. Our FDA went through the same review on Avandia recently, and reluctantly left it on the shelf; however, it is used only when patients are found refractory to other, similar drugs, I believe. FlGuy, although I was down to 185 pounds at one point during treatment, I’m currently the lankiest 6’ 0” 250 pounder you’ve ever seen :o). I’ve always led an active lifestyle, so I don’t fit the sedentary profile of typical DM II patients.
2053416 tn?1330411192 Actos belongs in class of diabetes medications called thiazolidinediones. In this class are Avandia and a combination drug Avandamet [Avandia and Metformin]. Rezulin is in this class but not much known about it.
Avatar m tn did they give you MRI metal, Gadolinium metal? fda gov blackbox warning? no mention of metal? see mri side effects, willis law firm, ignore him, he won't take case unless NSF diagnosis by skin doc, but you can have retained metal that dechelates or is retained if told to take iron, zinc , copper, etc, read rsna org, auntminnie com and fiercebiotech com sites, see fda gov and nyas org, free registration, Fourth Annual NSF conference, e briefing 13 Sept 2010.
Avatar n tn Also go on the websites of the manufactures, sometimes they have coupons for a % off your bill. When I joint the avandia program I got a couple months free avandia, plus they send coupons at times. Also ask your md for samples. I use to work at a doctors office and we got enough samples to open a pharmacy. Another thing, if your job offers a flexible spending account, I find that is nice as well. it reduces your taxes and you can contribute up to 3000 a year to them. good luck.
Avatar f tn I know that it still hasnt been approved byy the FDA but I read that if added to the combo therapy, it can make the chances go up for a SVR....
585414 tn?1288941302 Update. The medication was FDA approved recently and will be available next year. http://www.medscape.com/viewarticle/731619 " FDA Approves Once-Daily Lurasidone for Schizophrenia Yael Waknine October 29, 2010 — The US Food and Drug Administration (FDA) has approved the atypical antipsychotic lurasidone (Latuda tablets; Sunovion Pharmaceuticals Inc) for the once-daily treatment of patients with schizophrenia...
Avatar n tn the opportunity to submit comments to FDA hearing FDA-2010-N-0107 on expanding early-access to DAA drugs is about to close. The hearing docket now includes a full transcript of the hearing held on April 30 and a number of interesting comments by drug manufacturers and advocacy groups. However only a couple of patient comments have been submitted.
29837 tn?1414534648 s the difference. A Standard Approval (by the FDA) means that the maximum amount of time the FDA can take in approving a new drug is 10 months. A Priority Approval means the FDA has to either approve or not approve a new drug within a maximum amount of time no greater than 6 months. Vertex is submitting a Rolling NDA for Telaprevir. This means that if they file for it with the FDA this month, it can be approved by the end of this year and we could initially get the drug in January, 2011.
Avatar f tn Yes, i was put on Avandia for Type 2 abt 5 years ago. Since then my #'s have improved with diet and exercise to the point that a new Dr. said she saw no reason for me to be on Avandia and i have since stopped useing it. It was never vy high, around 159 or so when it was diagnosed. If i am not careful of my diet it can jump up to the 130's to 140's. Am also on diovan for HBP which is usually under good control with the 1 med.
179856 tn?1333547362 Vertex was granted Fast Track designation by the FDA for telaprevir in 2005. In mid-2010, as part of the Fast Track designation, Vertex began to submit completed sections of the NDA for review by the FDA on a rolling basis rather than wait until every section of the application was complete" I hope this is the start of something grand! Someone had posted the timeline for FDA approval but I don't remember it. Hope it is soon....
5558609 tn?1369861434 It all started in July 2010, we had gone on vacation and I gained about 10lbs. I didn't think much of it at first since I have always had a struggle to evacuate my bowels while I am traveling. I started to have the heaviest periods to the point that I had to wear adult diapers! I was 31 years old and had always had regular menstrual cycles and this scared me. Every month for the next 6 months my weight steadily increased 10 more pounds.
Avatar f tn Can I take Evening Primrose and Femara together? I'm also taking Avandia. Any thoughts would be great!
29837 tn?1414534648 As a footnote, I've tried the IND application through my doctor, but Vertex refused. I would bet my liver that it was because of the potential lawsuit that could arise if the victim who was given this drug (Telaprivir) happened to die before the FDA approved it. Vertex, along with other pharmaceutical companies are reluctant to release new drugs before FDA approval. I cold be wrong, but logic dictates that this is the protocol. At any rate, below is the answer from the FDA to me...