drugs and fda

For the last 20 years, the standard treatment for hepatitis C has involved a grueling one-year regimen of pills and injections. These two antiviral drugs, known as ribavirin and interferon-alpha, cause flu-like side effects including nausea, diarrhea and muscle achiness. The introduction of new drugs from Merck and Vertex Pharmaceuticals in 2011 helped shorten the treatment period and boost cure rates as high as 75 percent.

its best to get to the root of the problem and not mask them with drugs and suppliments...

If you are "sliding into stage 3" it is not a "life and death" situation. I am at stage 4, a fairly new father, and still performing on stage.

The way the study was done to test the safety and effectiveness of the drugs is by adding salmeterol or the combination to the present treatment the asthmatic was on. Thus some of the people were using ONLY salmeterol and ventolin. Because of this study we found out that there is a danger from only using long-acting bronchodialators. Think of what happens in the lungs during a flare-up, you get bronchospasms as well as inflammation.

I am very concerned from going to not taking any medication to starting them on March 25th. This past weekend my feet and teeth were in so much pain I took 3 Norco and 6 tremendous.

stated letters sent to healthcare professionals by the FDA and PriCara, the maker of the 2 medications and a division of Ortho-McNeil-Janssen Pharmaceuticals. The letters, 1 for each medication, noted that tramadol, an opioid, can intensify the effects of other opioids as well as alcohol and illicit drugs that depress the central nervous system. The letters also warned that people with addiction disorders may seek out tramadol and cited the risk of criminal diversion.

That's pretty standard of the FDA, they do this all the time (in other words, it's not earth shattering). Law requires any claims at cures (or more precisely 'treatment') be backed up by clinical trials, FDA clinical trials to be precise. That is why nobody can say any drug, supplement, etc, is a treatment or cure without first completing a multi-million dollar FDA clinical trial that will last for 10 to 20 years.

As you may know, I'm relentless in my effort to get the PI's out ASAP. Today I got not one but two calls from the FDA, so apparently my persistence is paying off. They are going to do whatever the pharmaceutical companies suggest, especially since there are no other alternative drugs except Interferon and Ribavirin.

//www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-serious-immune-system-reaction-seizure-and-mental-health This is probably what is going on. I was taking lamotrigine for at least 5 years. Now I have serious lung problems reducing the oxygen my body gets.

For sure Will and that's not counting rescue drugs. In this country we have PCP coverage, HMO and other various and assorted versions of health coverage. Once a drug is approved by the FDA I don't think the insurance companies can deny the drug but we don't know what stipulations they will put on actually approving the drug for use in conjunction with interferon and ribavirin.

Hi Chuck Welcome to the community. I wouldn't be surprised if everyone here who treated with Sovaldi Olysio did not have some trouble working with their insurance companies. There is a questionnaire I have heard that ment had to have their doctors fill out about their medical condition I guess my doctor did too but for me it was all behind the scenes I call my drug insurance provider and bugged a few people some faxes were exchanged and voila I had the meds.

I am assuming here they mean us with GT 1 who as of now would be doing a year with the present drugs. This is all good news and its great to see soemthing in the paper about Hepatitis c.

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.

I don't think anybody knows for sure but certainly it's going to be supply and demand and they will tightly control it and make sure it's very expensive - after all they have paid all the money out to get the patents. Interferon and ribavirin is not experimental yet even with the Berg Study AND Sanchez Tapias Study and Dr.

why when everything we take can cause seizures strokes death are they s worried? I think there's some intense viaing for position and political lobbying for new blod buidersaid to safer...and the FDA doesn't seem to care if you get winded just passing gas in the bathroom.... Is it the cheap drugs that get this scrutiny or the expensive ones?

They have a physician assigned to every drug. Go to their site and look up the drug history. You can call them on the phone and ask for the FDA physician assigned to the drug, but be aware they have little time and expect you to be familiar with the material they have on that drug approval. It is better to e-mail them.

HAS ANYONE STARTED ON THE NEW DRUGS THAT WERE APPROVED BY THE FDA IN THE MONTH OF MAY?

Priority Review status can apply both to drugs that are used to treat serious diseases and to drugs for less serious illnesses. The FDA goal for reviewing a drug with Priority Review status is six months. The distinction between priority and standard review times is that additional FDA attention and resources will be directed to drugs that have the potential to provide significant advances in treatment.

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