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The consumer watchdog group Public Citizen is raising questions about the effectiveness and possible side effects of Onglyza, a relatively new diabetes drug.
In their monthly newsletter, Worst Pills Best Pills, Public Citizen warned that consumers should wait seven years, until 2016, before they use Onglyza (saxagliptin) so that more information is available about the risks and benefits.
Even though it was only released in 2009, Onglyza side effects have already drawn the FDA’s interest. The agency has asked the manufacturer, Bristol-Myers Squibb, to conduct postmarketing studies and is concerned about the drug’s heart risks, liver toxicity, and potentially severe skin reactions.
Onglyza was approved for the treatment of the symptoms of type-2 diabetes. It belongs to a new class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.
The first DPP-4 inhibitor, Januvia, is on Public Citizen’s “Do Not Use” list. Another DPP-4 inhibitor, Galvus, has been approved in Europe but was denied U.S. approval by the FDA due to concerns about liver toxicity and extreme allergic reactions, including Stevens-Johnson Syndrome.
In 2009, the FDA issued a warning that Januvia side effects could be linked to pancreatitis. At least 88 Janumet or Januvia pancreatitis reports were received by the FDA between October 2006 and February 2009, leading the agency to recommend that doctors monitor their patients carefully for signs of pancreatitis after starting treatment or increasing dosage. In addition, since the drugs have not been studied among individuals with a history of pancreatitis, they should be used with caution and appropriate monitoring for these patients.
Beyond the potential Onglyza health risks identified by the FDA, Public Citizen also raised several other issues of concern for this drug and others like it. Public Citizen points out that Onglyza is only for improving blood sugar control in adults with type 2 diabetes and that some consumers and doctors mistakenly think that means that the drug will reduce the chances of heart attack and stroke, which are the major concerns for diabetes patients. However, Onglyza and similar drugs are only meant to address diabetes symptoms, like frequent urination and thirst. No type 2 diabetes drug currently on the market is allowed to say that it can reduce the chances of heart attack or stroke.
Public Citizen also notes that new drugs are not required to be better than older drugs currently on the market, but many consumers mistakenly think that because the drug is newer that it must be more effective. All that is required is that the drug must be statistically better than a placebo. In two Onglyza randomized, controlled trials, the pill managed to reduce the blood sugar indicator hemoglobin A1c by between 0.3 and 0.5 percent.
To address the FDA’s concerns over potential side effects, Bristol-Myers Squibb will first have to conduct a clinical trial to assess Onglyza’s cardiovascular risks. Heart problems were a key issue in the recent restrictions placed on the sale of another diabetes drug, GlaxoSmithKline’s Avandia.
In September, the FDA stopped just short of an Avandia recall amid growing concerns about an increased risk of heart attacks and other cardiovascular side effects of Avandia. Instead, severe restrictions have been placed on Avandia’s use and availability.