Here we go yet again

Here we go yet again

This past Friday the FDA issued a warning for DPP4 drugs as they may cause joint pain that can be severe and disabling, with some patients requiring hospitalization. This category includes the blockbuster Januvia from Merck (NYSE:MRK), Onglyza from AstraZeneca (NYSE:AZN) and Tradjenta from Lilly (NYSE:LLY).

According to the FDA, it identified 33 cases of severe arthralgia associated with the use of DPP-4 inhibitors from October 2006, when the first one was approved, to the end of 2013. The agency noted that in all cases, patients experienced “a substantial reduction in their prior level of activity,” with 10 patients hospitalized due to disabling joint pain. Further, the FDA stated that in 22 cases, symptoms emerged within one month of starting treatment with a DPP-4 inhibitor. The drug was suspected as a potential cause of the pain in 20 cases and was discontinued within a month after symptoms appeared, while in eight of the remaining 13 cases, a period of 44 days to one year elapsed between symptom onset and discontinuation of the drug. Further, symptoms were relieved in the majority of patients less than a month after discontinuation of DPP-4 inhibitor therapy.

Now if this sounds familiar it should as years ago the FDA also raised concerns over the increased incidence of bone fractures for patients taking TZD’s. Just as DPP4’s are widely used today so were TZD’s back when the bone fracture concerns came to light. Just as this issue over joint pain did not become evident until 7 years after the first DPP4 were approved by the FDA the same happened with TZD’s as the bone fracture issues  also became evident 7 years after these drugs were approved. TZD’s were eventually pulled from the market not for this risk rather concerns rather over possible cardiovascular risks, risks were also seem to be plaguing some but not all of the DPP4’s currently on the market.

Frankly Diabetic Investor is not surprised nor shocked by this news just as we weren’t when the news on TZD’s came out. The harsh reality is that not every risk associated with a diabetes drug will show up during the lengthy clinical trial process. That no matter how many studies are done that sometimes it takes years before a risk becomes evident. As much as we wish this wasn’t the case it is unfortunately the nature of the beast and does point to the additional risk faced by companies in this market. For as sure as day turns to night look for our friends the class action attorneys to use this warning as an excuse to begin trolling for victims. Next to football, class action lawsuits against big Pharma are America’s favorite sport.

Although there are some who foolishly believe that we can eliminate nearly every potential adverse event associated with diabetes drugs, the very nature of diabetes makes this impossible. Diabetes as everyone knows is a chronic disease state which has no cure. That even when patients are compliant with their therapy regimen complications can and do develop. Diabetes can be a very destructive disease leading to multiple serious complications. Complications that can take years to develop and are not easily identified early which would allow for constructive interventions.

The harsh reality is patients with diabetes must take their medications for a lifetime. That rarely does a physician remove medications until it’s obvious they aren’t working or new evidence comes to light regarding previously unknown adverse events. As we have noted physicians typically follow a treat to failure path, normally adding not subtracting additional drugs when the existing regimen isn’t working. This basically means that a drug like a DPP4 would not be removed from the patient’s daily regimen rather additional dugs would be added to this regimen. Simply put this increases the risk that joint pain will develop.

Given the nature of the FDA’s warning and the fact that issues go away after the drugs are discounted we don’t believe physicians will begin switching patients off DPP4’s or will they stop prescribing them. Yes it will add one more issue they must look for but it should not adversely impact sales of DPP4’s either.

About the only thing it does do is create yet another complicating factor when a patient asks what seems like a very simple question; “Is this drug safe?” As we’ve seen time and time again there are no simple questions or easy answers when it comes to diabetes drugs. This does not mean the FDA is unjustified in taking this action, this quite frankly is there job and the agency should not be scolded for doing their job.

Like it or not the facts are that there is no such thing as a completely “safe” diabetes drug. That like it or not every drug even those approved by the FDA and on the market for years can develop issues not seen when these drugs were going through the approval process. This is a risk every diabetes drug company is aware of. Unfortunately these companies must now deal with another risk they are also keenly aware of; class action lawsuits.

Here we go yet again.