Who are we?

We are in no way affiliated with or connected to the FDA, drug companies, consumer advocate groups, or law firms. We are a group of professionals with many years of experience evaluating safety data of researched and approved drugs. We do not believe that all drugs are bad. In fact, we believe that many drugs can save lives or provide a better quality of life.

Consumers and professionals must evaluate the information provided by us with great caution. Patients are greatly encouraged to consult their physician. We welcome users of ADRES to submit comments, questions, or concerns to us. We also require users of ADRES to agree to our Terms Of Use.

Why bad drugs make it to the market

Reviewers at the FDA do their best to remove extremely harmful drugs from the market but in many cases regulations and laws can interfere with this process. The reality is that some harmful drugs have been approved. This is a result of several factors. For drug approval, pharmaceutical companies are required to conduct a few clinical trials which may include two double blind, placebo controlled trials. One criteria for approval is that the drug must demonstrate an "acceptable" risk/benefit ratio. The entire clinical development program may include as few as a couple of thousands of patients. With so few patients in clinical trials, many adverse events are not detected simply because not enough people have taken the drug. Some adverse events cannot be detected unless or until 10,000 patients or more have used the drug. Even more problematic is the fact that drugs are approved without long term use. Therefore, adverse event data is limited when using the drug for weeks or months. The FDA is faced with the decision to approve drugs based on relatively short clinical trials with limited patients' data. MEDWATCH is an important tool to help monitor drugs post-approval. Despite the fact that the information comes from uncontrolled trials, the cumulative evidence can lead to important discoveries about drug safety that have resulted in either pulling a drug off the market or adding a black box warning or other cautions to the label.

To make a compelling case about a drugs safety profile, one must look at several factors which include among others: the frequency of certain events in comparison to other drugs, timing of the adverse reaction relative to taking the drug, other drugs taken concurrently, dose and frequency, and patient demographics. Most or all information can be found in our database. You may want to review the case study by publiccitizen.org of fluroquinolones that was used to petition the FDA to add a black box warning for tendon rupture.