Group asks for withdrawal of Victoza diabetes drug | Reuters

Group asks for withdrawal of Victoza diabetes drug | Reuters


"(Reuters) - Watchdog group Public Citizen urged U.S. regulators to withdraw approval of Novo Nordisk's diabetes drug Victoza, saying it increases the risk of serious health problems like thyroid cancer and kidney failure. Public Citizen said the drug was approved in 2010 against the advice of three reviewers from the U.S. Food and Drug Administration, according a petition filed to the FDA on Thursday."

Janumet, Byetta, and Januvia May Cause Pancreatitis & Pancreas Cancer

Persons Taking Diabetes Drugs Januvia, Byetta, and Janumet Should Be Aware of the Risk of Pancreatic Cancer and Consult Their Physician Regarding Potential Pancreas Cancer Risks by Texas Januvia Pancreatic Cancer Lawyer, Januvia Pancreatitis Lawyer, Janumet Pancreatic Cancer Lawyer and Januvia Pancreas Cancer Lawyer Jason S. Coomer

Pancreatic cancer is the fourth leading cause of cancer death for both men and women and is one of the most deadly of all types of cancer. This year approximately 45,000 Americans will be diagnosed with pancreatic cancer and about 38,000 will die from it.  Unfortunately, pancreatic cancer is difficult to diagnose, and the diagnosis is often made late in the course of the disease.  Early detection of pancreatic cancer is essential and will greatly improve a person's chances of surviving the disease. 

The diabetes drugs, Januvia, Byetta, and Janumet may cause an increased risk of pancreatic cancer that have taken the diabetes drugs. As such, people that have taken Januvia, Byetta, and Janumet should be aware of the potential danger and be especially aware of the following symptoms: stomach pain, weight loss, dark urine and clay-colored stools, back pain, and jaundice.  Those taking Januvia, Byetta, and Janumet should seek advice from a qualified medical professional as to if they have any signs of pancreatic cancer, if these diabetes drugs are safe for them, and what symptoms they should be aware of to detect any early onset of pancreatic cancer.

The Diabetes Drug Market is Over $40 Billion Each Year and Growing Rapidly Januvia and Janumet had Annual Sales of $4.7 Billion in 2011

More than 300 million people worldwide suffer from diabetes, including about 30 million Americans.  In 2010, the global prevalence of diabetes was estimated to have reached 285 million and predicted to reach 438 million in 2030. The corresponding figures for North America were 37.4 million in 2010 and 53.2 million by 2030 and in Europe 55.2 million in 2010 and 66.2 million in 2030.  The global market for products in the management of diabetes currently stands at $41 billion and is on pace to grow to over $114 billion by 2018. 

 

In 2011, Januvia annual sales rose 39%, to $3.3 billion, from $2.4 billion the year before and $1.9 in 2009. Januvia along with its sister drug Janumet (a combination of Januvia and metformin) has combined for sales of $4.7 billion for 2011.  Sales of Januvia and Merck’s Januvia (sitagliptin) is approved in all major markets and have outdone initial estimates for the drugs.  

Merck’s Januvia (sitagliptin) is approved in all major markets and is the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors.  It is approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Pharmas to Feel Lure of Deals in China

Pharmas to feel lure of deals BEIJING - China's drug market is primed for "explosive growth," making companies there attractive targets for drugmakers that will soon lose patents on their most popular treatments, according to KPMG LLP. Products worth more than $30 billion will lose patent cover this year, leading more drugmakers to look into buying or joining with companies in China, the world's third-biggest drug market, according to a KPMG report released on Wednesday.

Chinese Authorities are Suspending Sales of 13 Types of Capsules

Probe Launched into Pill Makers' Practices 

"Authorities are suspending sales of 13 types of capsules with reported chromium contamination and are checking the factories accused of producing them.The State Food and Drug Administration issued an urgent notice on Sunday to suspend sales until safety is tested.Police in Xinchang county, Zhejiang province, where China's largest capsule-manufacturing base in Ru'ao township is located, detained 22 people from four capsule factories on Monday, according to Xinhua News Agency.
Meanwhile, the administration and local authorities conducted inspections on 43 capsule factories in the county, closing those exposed by a China Central Television investigation to have made empty capsules using gelatin containing excessive chromium and selling them to pharmaceutical companies."
 

The Injectable Diabetes Drug Byetta May Cause Pancreatitis that May Lead to Pancreatic Cancer: Persons Taking Byetta Should Be Aware of Pancreatic Cancer Danger and Consult Their Physician Regarding Potential Pancreas Cancer Risks by Texas Byetta Pancreatic Cancer Lawyer, Byetta Pancreatitis Lawyer and Byetta Pancreas Cancer Lawyer Jason S. Coomer

The Injectable Diabetes Drug Byetta May Cause Pancreatitis that May Lead to Pancreatic Cancer: Persons Taking Byetta Should Be Aware of Pancreatic Cancer Danger and Consult Their Physician Regarding Potential Pancreas Cancer Risks by Texas Byetta Pancreatic Cancer Lawyer, Byetta Pancreatitis Lawyer and Byetta Pancreas Cancer Lawyer Jason S. Coomer

In November 2009, the FDA revised the prescribing information for Byetta to include information on reported cases of acute pancreatitis in patients using this drug.  This revision came after the FDA had received more than 30 reports of acute pancreatitis in Byetta users.  Based on these adverse reports, the FDA directed Amylin to conduct six post-marketing studies regarding acute pancreatitis associated with the use of Byetta, as well as to look at the risk of Byetta cancer, including thyroid cancer and pancreatic cancer. 

Pancreatic Cancer, Exocrine Pancreas Cancers (Pancreatic Adenocarcinoma) and Endocrine Pancreatic Cancers

Pancreatic cancer is the fourth leading cause of cancer death for both men and women and is one of the most deadly of all types of cancer. This year approximately 45,000 Americans will be diagnosed with pancreatic cancer and about 38,000 will probably die from it.

The most common kind of pancreatic cancer is pancreatic adenocarcinoma and includes about 90% of the cases of pancreatic cancer.  Pancreatic adenocarcinoma is a cancerous overgrowth of exocrine pancreatic cells and is unfortunately commonly undetected until it is too late for the patient.  Pancreatic adenocarcinoma because of late detection can often result a fatal diagnosis with very limited survival time. Other forms of exocrine pancreas cancer include: intraductal papillary mucinous neoplasm (IPMN), adenosquamous carcinomas, acinar cell carcinomas, mucinous cystadenocarcinomas, signet ring cell carcinomas, hepatoid carcinomas, colloid carcinomas, undifferentiated carcinomas, pancreatoblastomas, and undifferentiated carcinomas with osteoclast-like giant cells.

Unfortunately, pancreatic cancer is difficult to diagnose, and the diagnosis is often made late in the course of the disease.  Early detection of pancreatic cancer is essential and will greatly improve a person's chances of surviving the disease. As such, people that have taken Byetta, especially those with symptoms of weight loss, dark urine and clay-colored stools, back pain, and jaundice, should seek advice from a qualified medical professional as to if they may have pancreatic cancer and what symptoms they should be aware of to detect any early onset of pancreatic cancer.

Acute Pancreatitis, Hemorrhagic Pancreatitis, Necrotizing Pancreatitis 

Acute pancreatitis is a sudden inflammation of the pancreas that occurs over a short period of time. The pancreas is a digestive organ behind the stomach that secretes essential enzymes needed for the digestion of certain foods, including fats, carbohydrates and proteins. During an episode of acute hemorrhagic pancreatitis, several symptoms relating to digestion and abdomen may occur.  In severe cases, the person may experience confusion, difficulty breathing, or respiratory failure.  The person may also fall into a coma.

The severity of acute pancreatitis may range from mild abdominal discomfort to a severe, life-threatening illness. However, the majority of people with acute pancreatitis (more than 80%) recover completely after receiving the appropriate treatment.  In very severe cases, acute pancreatitis can result in bleeding into the gland, serious tissue damage, infection, and cyst formation. Severe pancreatitis can also create conditions which can harm other vital organs such as the heart, lungs, and kidneys.

The warning signs of pancreatitis include: 1) Upper abdominal pain that radiates into the back. Patients may describe this as a "boring sensation" that may be aggravated by eating, especially foods high in fat. 2) Swollen and tender abdomen 3) Nausea and vomiting 4) Fever  and 5) Increased heart rate.

Acute hemorrhagic pancreatitis is the sudden inflammation of the pancreas. This leads to death of pancreatic tissue and the formation of lesions, causing extensive bleeding. 

Necrotizing pancreatitis is a serious health condition where a person's pancreas is inflamed and bleeding. In Necrotizing Pancreatitis patients, there is inflammation and tissue death, with the pancreas destroying itself.  Whereas in Hemorrhagic Pancreatitis patients, the pancreas is bleeding.  Both are serious conditions and should be treated immediately.

Byetta Pancreatic Cancer Lawsuit Information, Byetta Pancreas Cancer Lawsuit Information, and Byetta Cancer Death Lawsuit Information

Byetta Pancreas Cancer Lawsuits and Byetta Pancreatic Cancer Lawsuits are in the process of being reviewed and filed as recent scientific evidence indicates that the injectable diabetes drug, Byetta (Exenatide), may cause an increased risk of pancreatitis, this side effect can and often does lead to the development of pancreatic cancer.  Pancreatic Cancer is an extremely deadly form of cancer.  Most people diagnosed with Pancreatic Cancer or Cancer of the Pancreas do not survive beyond the five years and many are given much less time as Pancreatic Cancer is hard to detect.  Early detection is the key to surviving pancreatic cancer.

Diabetics are more vulnerable to developing pancreatitis than those without the disease, recent studies indicate that taking Byetta can potentially increase the risk of pancreatitis. And, if pancreatitis becomes chronic, the inflammation of the pancreas will alter its normal structure and functions.  This can lead to pancreatic cancer. 

For more information on this topic, please feel free to go to the following web page: Byetta Pancreatic Cancer Lawsuit, Byetta Pancreas Cancer Lawsuit, and Byetta Cancer Death Lawsuit Information.

Increased Competition and Expansion in the Pharmaceutical Industry Creates Opportunity for Increased Corruption in Pharmaceutical Procement and Expands the Opportunity for Fraud in Pharmaceutical Drug Supply Chains that can create Dangerous Adulterated Drugs by International Adulterated Drug Whistleblower Lawyer and International Pharmaceutical Executive Whistleblower Reward Lawyer Jason S. Coomer

Increased Competition and Expansion in the Pharmaceutical Industry Creates Opportunity for Increased Corruption in Pharmaceutical Procement  and Expands the Opportunity for Fraud in Pharmaceutical Drug Supply Chains that can create Dangerous Adulterated Drugs by International Adulterated Drug Whistleblower Lawyer and International Pharmaceutical Executive Whistleblower Reward Lawyer Jason S. Coomer

Included in this globalization of the pharmaceutical industry is a shift in many international pharmaceutical manufacturing supply chains where raw material supplies for pharmaceuticals, medical supplies, and medical equipment that were traditionally from the United States and Europe are now produced in from China and India as well as other emerging countries.  This manufacturing shift create has created an environment where adulterated ingredients to pharmaceuticals, medical supplies, and medical devices may be used in the manufacturing of these products and can create dangerous and defective drugs, medical supplies, and medical devices being purchased by governments and given to patients. 

In the fiercely competitive medical device, medical supply, and pharmaceutical markets, there are strong economic incentives to search for the cheapest ingredients and methods to produce products.  Often these cheaper ingredients and manufacturing locations are in countries where standards and regulations are less stringent and corruption is more common.  When large corporations set up subsidiaries and joint venture partners in these countries, good manufacturing practices can often suffer, fraudulent actors can cut corners to reduce costs, and cheaper sometimes toxic materials can be added to the products.

Example of this scenario include the Baxter Heparin Recall in 2008 where Baxter, a US pharmaceutical firm which manufactures approximately 50% of the US heparin products, voluntarily recalled its heparin due to nearly 350 reported adverse events, including 19 deaths. In investigating this case, the USFDA revealed that the recalled heparin products contained a contaminated API. The tainted API, imported from Changzhou SPL China, contained a heparin-like contaminant that was structurally similar to heparin and not recognized in the solution until the FDA developed special testing for it. In March 2008, the FDA announced that they had identified the contaminant to be an altered form of an oversulfated chondroitin sulfate which is not a natural byproduct of the heparin manufacturing process. In April 2008, the US government held hearings and determined the cause to be non-sterile equipment, lack of following proper procedures, and lack of expertise.

Further, supply chains that are bigger and more complex present more opportunities for fraud.  As such, when a large corporation has a supply chain with several international subsidiaries and joint venture partners throughout the world, there are numerous opportunities along the supply chain for fraud to occur including supplier fraud, purchase order fraud, good manufacturing practices fraud, inventory fraud, documentation fraud, export fraud, import fraud, and other pharmaceutical fraud. 

International Whistleblowers along the pharmaceutical supply chain and other health care professionals are being offered large potential rewards to blow the whistle on adulterated pharmaceutical ingredients, adulterated medicine, adulterated drugs, contaminated medical supplies, and defective medical devices.  These whistleblower rewards can come from SEC Whistleblower Reward Lawsuits and traditional Qui Tam False Claims Act Whistleblower Reward Lawsuits.  For more information on these potential whistleblower rewards, feel free to go to the following web pages: International Adulterated Drug Supply Chain Whistleblower Reward Lawsuits and Drug Safety Fraud Qui Tam Adulterated Drug Whistleblower Reward Lawsuits.

Pradaxa Linked to Fatal Blood Loss, Internal Bleeding, and Hemorrhaging Deaths by Texas Pradaxa Fatal Blood Loss Lawyer, Pradaxa Hemorrhaging Death Lawyer, and Pradaxa Death Lawyer Jason S. Coomer

Pradaxa Linked to Fatal Blood Loss, Internal Bleeding, and Hemorrhaging Deaths by Texas Pradaxa Fatal Blood Loss Lawyer, Pradaxa Hemorrhaging Death Lawyer, and Pradaxa Death Lawyer Jason S. Coomer

 

Scientific evidence has recently confirmed that the the blood thinner, Pradaxa, may cause serious health problems including internal bleeding and hemorrhaging in certain populations of patients that may cause death.  Further, there are allegations that the drug manufacturer may have been aware of certain dangers of the drug's use, but did not warn the public in a timely manner of these health dangers.

Pradaxa Research May Lead to Pradaxa Internal Bleeding Lawsuits, Pradaxa Hemorrhaging Death Lawsuits, Pradaxa Internal Bleeding Death Lawsuits, and other Pradaxa Lawsuits

In September 2011, Pradaxa became the subject of an investigation in New Zealand after as many as five elderly Pradaxa patients reportedly died as a result of internal bleeding / hemorrhaging. Another 36 patients reportedly suffered bouts of serious internal bleeding / hemorrhaging. New Zealand media outlets reported that some families claimed the chain of events leading to their relatives' deaths began when they switched from warfarin to Pradaxa, and infections set in after their conditions had deteriorated to the point of hospital admission.

The New Zealand reports came weeks after regulators in Japan asked the maker of Pradaxa to notify doctors about potentially deadly bleeding / hemorrhaging in some Pradaxa patients. According to a letter sent to Boehringer Ingelheim by the country's health ministry, between March 14 and August11, 81 elderly patients taking Pradaxa suffered heavy bleeding / hemorrhaging, leading to five deaths. Japanese officials suggested that patients older than 70 may need a lower dose of Pradaxa. Bleeding / hemorrhaging is also a side effect of older blood thinners, such a warfarin. But warfarin bleeding can be treated with vitamin K. There is no antidote available for bleeding caused by Pradaxa and similar drugs, known as direct thrombin inhibitors. 

Please feel free to go to the following web page for more information on Pradaxa Internal Bleeding Death Lawsuit, Pradaxa Hemorrharing Death Lawsuit, and other Pradaxa Lawsuit Information.