FDA To Strengthen Warnings On Diabetes Drug After 2 More Deaths
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Also Included In: Regulatory Affairs / Drug Approvals; Primary Care / General Practice; GastroIntestinal / Gastroenterology
Article Date: 19 Aug 2008 - 2:00 PDT
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Futher to an alert it issued in October 2007, the US Food and Drug Administration (FDA) is planning to strengthen the warnings on diabetes drug Byetta (exenatide) after receiving reports of another 6 patients having to be admitted to hospital, two of whom died, because they got hemorrhagic or necrotizing pancreatitis after taking the drug.
The four surviving patients are now recovering, said the FDA. They are no longer taking Byetta, a drug that is administered by injection for treating adults with type 2 diabetes. The FDA said it was working with the drug maker, Amylin Pharmaceuticals Inc, to strengthen warnings in the PRECAUTIONS section of the product label about the risks of acute hemorrhagic or necrotizing pancreatitis.
Symptoms of acute hemorrhagic or necrotizing pancreatitis include persistent and severe abdominal pain that can spread to the back and may or may not be accompanied by nausea and vomiting. It is usually confirmed by blood tests that show high levels amylase and/or lipase, and by taking radiation images.
The number of reports sent to the FDA of patients falling ill with acute pancreatitis after taking Byetta since the drug has been on the market now totals 36. Back in October 2007, the FDA published an alert about 30 post marketing reports of acute pancreatitis in patients taking Byetta, and issued new Information for Healthcare Professionals. The agency said at the time that "an association between Byetta and acute pancreatitis is suspected in some of these cases".
Doctors should tell any patients on Byetta to seek medical attention immediately if they feel any persistent severe and unexplained abdominal pain, with or without vomiting.
The FDA said if doctors suspect a patient on Byetta has pancreatitis, they should promptly stop taking it, and any other potentially suspect drugs.
Unfortunately the signs and symptoms of the less severe form of pancreatitis and the acute hemorrhagic or necrotizing pancreatitis associated with Byetta are difficult to distinguish. If suspected pancreatitis is confirmed, then the patient should start appropriate treatment and be monitored carefully until recovery and they should not be given Byetta again.
Also, doctors should consider other antidiabetic therapies for patients with a history of pancreatitis said the FDA.
The agency said it is not advising doctors to stop prescribing Byetta and will be posting further advice and alert updates as they get more information.
Any serious or adverse events linked to the use the drug should be reported to the FDA via its MedWatch program at http://www.fda.gov/medwatch/report/hcp.htm.
In its earlier alert, the FDA said that in 27 of the 30 reported cases of acute pancreatitis after taking Byetta, the patients had at least one other risk factor for the condition, including gallstones, severe hypertriglyceridemia (high level of blood fats), and alcohol use.
21 of the patients were admitted to hospital and there were no reports of hemorrhagic or necrotizing pancreatitis, but 5 of the patients experienced serious complications including dehydration and renal (kidney) failure, suspected ileus (non-mechanical intestinal obstruction), phlegmon (infected and inflamed soft connective tissue), and ascites (too much fluid in the abdominal cavity).
In 6 of the cases, the patients either started to get symptoms of pancreatitis or existing symptoms got worse shortly after their dose of Byetta went up from 5 to 10 micrograms twice a day.
In the reported cases, 22 of the 30 patients improved after they stopped taking Byetta. But when three of the patients who stopped taking the drug then started it again, the symptoms of acute pancreatitis came back, including nausea and vomiting in two cases. The third patient just had abdominal pain that went away when they stopped taking the drug for good.
Click here for FDA Information for Healthcare Professionals on Byetta.
Source: FDA.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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posted by Dan Abshear on 19 Aug 2008 at 4:35 amThe FDA’s Objective- A Much Needed Change?
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States in regards to what they consume, primarily. The one person who became the catalyst for the formation of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book. While the author intended with composing this book, “The Jungle”, to address and focus for the benefit of the readers the effects of capitalism, the issue regarding food safety is what ultimately captured the attention of everyone, including the president, so the FDA began during this time.
However, their purpose and function seems to have changed the past few decades, as the FDA appears to have decided to ensure the health of certain industries, and with the pharmaceutical industry, this is quite clear.
One example is the large amounts of money the industry gives the FDA for various reasons created recently- amounts so large that this accounts, according to some, for about half of the FDA’s total income, although it is by definition a governmental administration. An example of stated reason for receiving such funds is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and is now required to pay the FDA for faster approval of their pending medications after pharmaceutical companies submit a new drug application to the FDA.
Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs as demonstrated by their removal or the receival of a black box warning of such drugs. The lack of regulation and monitoring required by the FDA of such industries as the pharmaceutical one may be why there is this progressive safety concern of medications prescribed to many in the United States. In addition, perhaps, the FDA continues to validate what has been surmised through their known financial support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public.
Yet, the presumed collusion between these two organizations does in fact seem to continue to worsen. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales representatives to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval and presumed elation to possibly create harm to patients with this proposal due to the obvious uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional if not absurd, to say the least.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically and legally, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity that deviates from the product insert that illustrates the medication’s indications. In fact, it is a federal offense for such representatives to speak off-label about the drugs they promote, and more pharmaceutical companies are and have been penalized for this activity in the form of large settlements in the past as determined to some degree by the department of justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, rarely admit guilt as part of such settlement agreements, which include agreements where the corporation is not prosecuted. Off-Label activities are only some of the federal laws that have been frequently fractured in a progressive manner as well.
This off-label FDA protocol for drug representatives that has been described and proposed by our FDA is called, “Good Reprint Practices.” This would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials that aseptic and without bias, when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug representatives, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the medications involved in such trials- often by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol suggested by the FDA, yet possibly a protocol influenced by others. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration when they did suggest this ridiculous and frightening authorization.
Furthermore, this proposal is flawed in that most pharmaceutical representatives lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug representatives have little medical or clinical training in any objective way. So this seems to further complicate the idea of this off-label concept due to the ignorance of the representatives In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for representatives of the pharmaceutical industry to embellish statements to prescribers for their own benefit in regards to their promoted medications they present to them.
So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of any benefit to patient health. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.
However, there is freedom of speech, but in the amendment should certainly be restrictions in regards to public health, as speech should be accurate and objective when conducting dialogues with prescribers. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interest what I believe we as citizens demand, and should be enforced than it appears to be presently.
“Unlimited power is apt to corrupt the minds of those who possess it.” --- William Pitt
Dan Abshear (author’s note: what has been written was based on information and belief)
Unprotected Are Serious Problems For Human Beings
posted by MackLeo on 19 Aug 2008 at 8:13 pmWho, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part.This in itself lacks etiology for such discussions by drug representatives, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the medications involved in such trials- often by a third party.A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically and legally, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity that deviates from the product insert that illustrates the medication’s indications.
Mack
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