San Diego, CA (PRWEB) May 10, 2013
Resource4thePeople announced today that its attorneys are offering free legal consultations to patients who used a certain class of diabetes drug including Januvia and allegedly suffered severe pancreatic side effects.
The consultations are being offered in response to a large volume of inquiries from consumers over the Food and Drug Administration’s Drug Safety Communication* March 14, 2013.
In that communication the FDA said that it is investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs such as Januvia for type 2 diabetes.
“There are a significant number of Americans who treat their diabetes with these medications and the FDA announcement generated a large number of inquiries from patients who have asked about their legal options in cases in which they allegedly suffered these serious side effects,” said Resource4thePeople.
“As a result, our national legal network is now offering free legal consultations in which consumers may determine their eligibility to file a claim or lawsuit and seek compensation for the medical expenses, pain and suffering and other costs that may have been incurred.”
The FDA said in the Drug Safety Communication that the findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.
The FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.
The FDA identified these drugs as exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).
Resource4thePeople notes that there may be legal time limits involved in such actions and is requesting consumers to make contact as soon as possible in order to preserve all legal options available.
Januvia was originally approved by the FDA in 2006 as a daily pill to control blood sugar in patients with type-2 diabetes control blood sugar.
Since then the FDA directed Januvia’s manufacturer to update its Warnings and Precautions labels with the following information that was included in the FDA’s October, 2012 Prescribing Information:**
- “There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA.”
- “There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter.”
- “There is an increased risk of hypoglycemia when JANUVIA is added to an insulin secretagogue (e.g., sulfonylurea) or insulin therapy. Consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.”
- “There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with JANUVIA such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly stop JANUVIA, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes.”
The FDA recommends that Januvia and other incretin mimetic medications be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
But, in its Safety Communication announcement,* the FDA reiterated a previous public warning “about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of incretin mimetic drugs exenatide and sitagliptin.”
Agency officials also said in the communication that a recently published study that examined insurance records also found the use of exenatide or sitagliptin could double the risk of developing acute pancreatitis.
Resource4thePeople also is recommending that consumers update themselves through media reports about the side effects that allegedly can be caused by the use of this class of medications.
One was recently posted by Bloomberg News about the research study and concerns about the safety of Byetta as voiced by the FDA earlier and by physicians:***
“Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the FDA said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta.
“The agency issued a similar alert for Januvia in 2009. An analysis of insurance records published last month in the journal JAMA Internal Medicine showed such drugs may double a user’s risk of pancreatitis. That hasn’t stopped these medicines from becoming multibillion-dollar drugs.”
The FDA in its Drug Safety Communication said it will communicate its final conclusions and recommendations when its review is complete or when the agency has additional information to report.