Is Nexium and Prilosec the New Avandia?
This week there were two major articles discussing the safety of AstraZeneca's Prilosec and Nexium, one in Forbes written by Matthew Harper, "Averting another Avandia" and on the Star-Ledger of New Jersey's Pharmalot.com written by Ed Silverman, " Will Nexium become the new Avandia"?
The articles were discussing the newly released public notice from the FDA on the "Early Communication About an Ongoing Safety Review Omeprazole (Prilosec) and Esomeprazole (Nexium)"
In the FDA public notice there is an alarming statement as to increased heart attacks and heart failure. An excerpt from the FDA public notice states "The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery."
However, on the other hand, Paul Seligman, an associate director in the FDA’s Center for Drug Evaluation and Research, tells reporters “It’s hard to know how this process will play out” and that “this is something of a moving target." This public notice was released to make the pubic aware the FDA is looking into this and will have results from more tests in about three months.
Should the public be alarmed? Is the FDA trying to prevent another Avandia? Time will tell.
On a positive note, it is good that the FDA released this public information rather than an independent source. The FDA communicated this new information in a somewhat timely manner. On May 29, 2007, AstraZeneca, the manufacturer of Prilosec and Nexium sent FDA their preliminary review of new data from two studies about the potential heart risks. Since that time, the FDA has been going over the data.
FDA "thank you" for making a bold step in sharing this information about Nexium and Prilosec to the public. We remain hopeful that you will honor your obligations to the public and find out if these two drugs are safe for the public or are they detrimental to increasing a patient's heart risks.
Let's all hope that Neium and Prilosec do not become the new Avandia.
Click Here to read more on Prilosec or Nexium from Forbes and from the Star-Ledger of New Jersey's Pharmalot.com.
