The FDA recently dismissed a petition to add a new black-box label to the popular blood thinner Plavix. The implications of this decision remain to be seen in the long run.
Plavix, known generically as clopidogrel, is a blood thinner co-created by the Bristol-Myers Squibb and Sanofi-Aventis corporations. It has retained profits of $6 billion annually and has been prescribed to millions of patients recovering from a heart attack or suffering from heart disease risk.
In 2013, a petition by a citizens group called for an update to the black box labeling of the product. They claimed that there was a risk of extreme bleeding in people who had arterial stents implanted and took Plavix for more than a year. While this information was included in the guidelines of use, as well as a reminder to doctors to review cases individually, many people were concerned that most people did not read the guidelines and therefore needed an extra reminder.
In an unusual turn of events, the FDA rejected the request and threw out the claim. Typically the FDA has been shown to attempt to appease petitions of this nature to some degree if they feel they cannot give the people what they request, but they have declined the change and offered no alternative solution. The FDA did note in the course of its investigation that there was no precedent for individuals to take Plavix for over a year with heart stents and this may have been a factor in their denial.
Another factor in the FDA’s denial was a 2016 study by the American Heart Association that noted that Plavix did increase bleeding while also drastically lowering chances of heart disease and heart attack. According to a letter from late December of last year, Jante Woodcock, Research Director at the Center for Drug Evaluation stated that: “An unqualified statement advising physicians that continuation of clopidogrel for longer than 12 months following percutaneous insertion of a [stent] is of ‘questionable additional benefit’ in a boxed warning — or indeed in any section of labeling — and would be inconsistent with available data.”
Woodcock went on to describe that she and the Center for Drug Research felt that the information in the drug guidelines was adequate for their purposes.
What this rejection has meant for the rest of the country may include the de-legitimizing of lawsuits against Plavix nationwide. A New Jersey federal court is handling multiple cases claiming that these bleeding risks violate Plavix’s claim of being safe and effective have seen a number of dismissals, though no data exists currently on how many cases remain open.
These results are not ideal for the consumer. There are many reasons that an individual may not read the guidelines for their medication and not all of them involve laziness or lack of initiative. This series of events demonstrates that the FDA may not require pharmaceutical companies to display on all surfaces what some consumer would rightly consider is vital information. To that end, it becomes critical that everyone read not only the labels but the guidelines for any medication you may be taking to ensure total awareness of the risks and requirements of a particular medication diet.