With big money to be made, drugmakers have responded to the global rise in Type 2 diabetes with a host of new classes of treatments that work in different ways. And while that is generally a good thing, the full range of adverse effects of all of these new drugs can't be known until they have been on the market for awhile, and some will fare better than others, a new report states. The report from informatics firm AdverseEvents analyzes data on 11 of the newer drugs, and then comes to some conclusions about which are the safest and which may bear more watching. In the closely watched categories of GLP-1 receptor agonists and DPP-4 inhibitors, the best results were found for Bydureon, and the least favorable for Nesina. AdverseEvents reached those conclusions by first analyzing data from FDA's Adverse Event Reporting System (FAERS). It then looked at the number of suspect cases and figured up the percentages of those events that were life threatening, as well as those that resulted in hospitalizations, disabilities and death. From that it derived a score. The bottom line from the report is that both GLP-1 receptor agonists and DPP-4 inhibitors (especially sitagliptin) have elevated associations with pancreatitis and pancreatic cancer, but neither class appears to have strong links to presumed renal and hepatic complications. The report acknowledges that there has been conflicting studies on the associations to pancreatic cancer and pancreatitis. In fact, a report from the FDA and the European Medicines Agency in February said that suggestions that the drugs could cause pancreatic disease are "inconsistent with current data." AdverseEvents contends that of the three drugs evaluated in the GLP-1 receptor agonist class--Bydureon and Byetta from AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) and Victoza from Novo Nordisk ($NVO)--Bydureon appeared to be the safest. Other findings were that DPP-4 inhibitors, which include drugs like Janumet and Januvia from Merck ($MRK), Tradjenta from Boehringer Ingelheim and Eli Lilly ($LLY), and Nesina from Takeda, may be linked to more serious side effects than has generally been believed. It found that Nesina raised the most concern. It also said that the SLGT2 inhibitors are, as expected, associated with elevated urinary infection risks. It said they may also be linked to more serious events. Drugs in that class include Farxiga from AstraZeneca and Bristol-Myers Squibb and Invokana from Johnson & Johnson ($JNJ). It is not as if the FDA and other agencies are not keeping tabs on studies that suggest here-to-for unknown risks. The agency took its closer look at the heart risks of the GLP-1 agonists and DPP-4 inhibitors. And in February the agency announced it would evaluate the risks of AstraZeneca's diabetes drug Onglyza, one of the DPP-4 inhibitors for possible heart risks after a recent study suggested links. The FDA heightened its scrutiny of diabetes drugs and their heart safety after cardiovascular risks were associated with GlaxoSmithKline's ($GSK) Avandia, touching off a public controversy. That controversy also led the FDA to set a higher heart-safety bar for approving new diabetes drugs. Evidence of that was seen last year when it denied approval to Novo Nordisk's new diabetes treatment Tresiba, asking the Danish drugmaker for a new study of its cardiovascular safety. But given diabetes is a growing problem with growing financial potential for the drugs that can successfully treat it, more products will hitting the market and may need ongoing attention. Just yesterday, the FDA approved Tanzeum (albiglutide), a once weekly GLP-1 agonist from GSK. Eli Lilly's has its much-hyped dulaglutide, also a GLP-1 agonist, being considered now by the FDA. Read more: New report finds Bydureon safest of new class of diabetes drugs - FiercePharma http://www.fiercepharma.com/story/new-report-finds-bydureon-safest-new-class-diabetes-drugs/2014-04-16#ixzz2z6riKE58 Subscribe at FiercePharma
Ummm....can we delete these findings? That would really help! Go ahead, it doesn't matter if the FDA says not to. Thanks!
Risks and benefits.......if a provider prescribes a medication for you, you, as your own person, may choose to take that medication or not. Again, risks and benefits. You can't come back later and say....oh.....gee....I want some money now because I was "damaged".....Show us the proof that this medication, without a doubt, caused your cancer, and that the company KNEW this COULD happen, and withheld that information. Lets say there is a medication out there that could save your life, BUT.....for a small percent, , there are severe side-effects. My guess is most would still take it.
PROactive trial published in Lancet 2005. Hazard ratio of .84 versus standard of care for MACE composite endpoints of MI, Stroke, all cause mort (including those that died from cancer and heart failure). Plenty of meta-analysis show this as well but those are not quite rigorous enuff
FDA 2007 FDA's review of adverse event reports found cases of significant weight gain and edema — warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death.
Could you be more precise? Saying "FDA 2007" is rather broad and I for one would like to see the context of this reference. Regarding the reports about Nesina being the most dangerous T2D drug, please look into FiercePharma's reference: it is a group called AdverseEvents.com out of California (red flag, right there). If you check out its pristine Management group, it appears to be a bunch of hacks with degrees in Marketing and Poli Sci; not a team from whom I would seek medical info. I don't think the sky is falling yet, Chicken Little (and I'll bet you have a little chicken)
Ooooooooooh snap! I think you've been served! Did you really question a little chicken? Really? That's your idea of funny? Stop it!
