FDA

Understanding the Confusion Around Drug Names

Drugs and their names are just confusing. When they are being developed they are given many different names. Despite their names the drugs (or treatments) are the same. Names are just names nothing more. For laymen, drugs having multiple names for the same drug is confusing. So, why are there so many different names for [...]

By | 2017-10-19T10:45:56+00:00 December 15th, 2016|Advanced Prostate Cancer, Drugs & Treatments, FDA, Uncategorized|0 Comments

The House Passes The 21st Century Cures Act – On To The Senate

Last Wednesday the House passed with a vote of 392 to 26, a medical innovation bill known as the 21st Century Cures Act, aimed at curing diseases, with the measure securing bipartisan support after months of negotiations. The bill’s goals are to speed up the Food and Drug Administration’s approval of new drugs while also investing [...]

Caution – The FDA Has Limited The Usage of Nizoral (ketoconazole)

Nizoral (ketoconazole, keto) is an older drug that has been used as a part of hormone therapy (ADT) for many years.  Keto, which is an inexpensive anti-fungal drug had been used for many years as an inhibitor of adrenal androgen synthesis as is abiriterone (Zytiga). Ztiga has been shown to be more effective, however, it [...]

U.S. Congress Passes Omnibus Funding with Significant Increases for Medical Research

We have some good news, the United States Congress has passed the Omnibus spending package.  The package will fund the U.S. Government through fiscal 2016.  We should take note that this bill includes a $2 billion increase for the National Institute of Health (NIH), a 5% increase for the National Cancer Institute (NCI) and the [...]

US Government Begins to Crack Down on Clinical Trials Reporting

Yes, it is true, many clinical trial results are not published, especially negative results. This is even true for FDA approved drugs and treatments! Failing to publish, or actually hiding negative results and harmful side effects that occur in clinical trials is too common and jeopardizes each and everyone of us, including survivors of advanced [...]

Nationwide Recall of Gabapentin for the Treatment of Hot Flashes Resulting from Hormone Therapy (ADT)

The drug Gabapentin is occasionally prescribed to help control hot flashes resulting from hormone deprivation therapy (ADT). Today, Aurobindo Pharma USA, Inc. issued a voluntary nationwide recall of their Northstar Labeled Gabapentin Capsules, USP 300 mg 100 count bottle. The recall was issued on complaints about empty capsules in prescriptions received by patients. There is [...]

We Need to Report Serious Adverse Events or Serious Drug Side Effects to the FDA – How You Can Make a Report

The Food and Drug Administration (FDA) is charged with protecting the general health and well being of Americans with medicines and certain treatment equipment. Sometimes these medications or treatment equipment fail, don't work as indicated or cause serious, life threatening side effects. Reporting these events is important so the FDA can track and monitor these [...]

The Well Reviewed Guide to Advanced Prostate Cancer (A Survivor Perspective) Has Been Updated and is Now Available for a free Download

Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and [...]

FDA Approves Movanik for Opioid Induced Constipation in Non-Cancerous Patients – Does It Also Have A Role in Cancer Survivors?

As prostate cancer progresses so does the pain we will suffer. In the normal course we will also progress on to different drugs to help control the pain. Opioids are one of the most common of these drugs prescribed to help control pain. As with all drugs opioids have many side effects. One of the [...]

Application for the FDA Approval of Xtandi in the Pre-Chemo State Has Finally been Submitted

The good news is that finally Astellas and Medivation have  submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. As of today XTANDI is currently only approved for [...]