While you’d think that a drug that has been approved by the Food and Drug Administration would be safe, it is important to note that an investigation on the approved drugs between the years of 2001 and 2010 has revealed that a third of them has had a safety event after they were released to the public. The team that has discovered this issue was comprised of Nicholas Downing, MD, and his colleagues that are part of the Department of Medicine, department belonging to the Brigham and Women’s Hospital.
They describe these post-market safety events as being situations that either result in the partial or complete withdrawal of the drug from the market, a warning placed on the box or a safety communication being issued by the FDA in regards to certain aspects of the drug. They have discovered that in approximately 220 therapeutics that were approved by the FD, three of them had been withdrawn, 61 had warnings on the boxes and about 59 had safety communications issued for them. More on the findings that the team had uncovered can be viewed in JAMA.
Nicholas Downing, the study’s lead, voiced that it’s assuring that the FDA is taking efforts in analyzing the drugs continuously after they had been released on the market, but the various warnings and withdrawals were initiated around four years after the initial approval. During this time, patients are vulnerable to the effects caused by the medication. Some of the drugs were withdrawn from the market in an overall period of 11 years.
The analysis showcases what is a clear amount of uncertainty in the benefits and risks of newly developed drugs during their approval period, and as such, it demonstrates that all those involved in the development process should be well documented in the usefulness of clinical information.