San Diego, CA (PRWEB) June 05, 2013
Resource4thePeople announced today that its attorneys are offering free legal consultations to patients who used Victoza and other medications in newer classes of diabetes drugs and allegedly suffered severe pancreatic side effects.
The consultations are being offered in response to a large volume of inquiries from consumers over concerns raised about Victoza and the other medications in 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 Victoza 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.”
In its Drug Safety Communication the FDA said "These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. 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."
Along with liraglutide (Victoza), the FDA identified these drugs as exenatide (Byetta, Bydureon), 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.
The FDA recommends that Victoza 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.
In addition to the FDA's Safety Communication about concerns over pancreatic cancer, Victoza's web site also warns patients of a possible link to thyroid cancer:**
"In animal studies, Victoza® caused thyroid tumors—including thyroid cancer—in some rats and mice. It is not known whether Victoza® causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people, which may be fatal if not detected and treated early. Do not use Victoza® if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). While taking Victoza®, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer."
Victoza's manufacturer, Novo Nordisk Inc., filed a plan with the FDA to upgrade its warnings and precautions to health care professionals (HCPs) and consumers about the concerns about thyroid cancer and pancreatitis.
Included in this plan, which was updated in May, 2011, was a correspondence to primary care physicians:
"This letter is to remind you of important safety information about VICTOZA® (liraglutide [rDNA origin]) injection. This letter is being sent to you because a recent assessment of healthcare providers’ understanding of the serious risks of VICTOZA® showed that some primary care providers are not fully aware of the serious risks associated with the use of VICTOZA® .
VICTOZA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The Food and Drug Administration (FDA) has required Novo Nordisk to communicate the following risk information to potential prescribers. You should note the following potential serious risks of VICTOZA®:
- There is potential risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) associated with VICTOZA®
- VICTOZA® may increase the risk of acute pancreatitis
Because of these risks, VICTOZA® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Additional information about these risks is provided in the remainder of this letter."
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.