San Diego, CA (PRWEB) April 17, 2013
Resource4thePeople announced today that its attorneys are offering free legal consultations to patients who used a certain type of diabetes drug including Byetta and allegedly suffered severe side effects of the pancreas.
The consultations are being offered in response to a large volume of inquiries from consumers over the Food and Drug Administration’s announcement* that it is investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs such as Byetta for type 2 diabetes.
An FDA spokesman said 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).
“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, out 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.”
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.
Byetta was originally approved by the FDA and released onto the market in 2005, with its primary function being to help patients with diabetes manage their condition.
It is applied by injection and it and the other incretin mimetics, according to the FDA, mimic the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal.
The agency said the medications are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
In its 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.”
An agency officials also said 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.
The official said that the Warnings and Precautions section of the drug labels and the patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis.
Resource4thePeople also is providing consumers some of the cautionary analysis about Byetta and its sister drugs. Here are some of the warnings and precautions taken from the agency’s web site:**
What is the most important information I should know about BYETTA?
Serious side effects can happen in people who take BYETTA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death.
Before taking BYETTA, tell your healthcare provider if you have had:
These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking BYETTA.
While taking BYETTA:
Call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. These may be symptoms of pancreatitis.
Resource4thePeople also is recommending that consumers update themselves on media reports about the side effects, such as one recently posted by Bloomberg News about the research study and concerns about the safety of the medication 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.”