Drug Injury Watch

FDA Wants Merck To Change Januvia Label With Increased Warning About Pancreatitis Risk

Is Januvia Similar To Byetta In Terms Of The So-Called Class Effect And Drug Injury Lawsuits Being Filed?

(Posted by Tom Lamb at DrugInjuryWatch.com)

On September 25, 2009 the FDA posted on its web site "Information for Healthcare Professionals - Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet)".

From the Background and Data Summary part of that document:

FDA has completed a review of 88 cases of acute pancreatitis in patients using sitagliptin or sitagliptin/metformin. The cases were reported to FDA’s Adverse Event Reporting System (AERS) between October 2006 and February 2009. Hospitalization was reported in 58/88 (66%) of the patients, 4 of whom were admitted to the intensive care unit (ICU). Two cases of hemorrhagic or necrotizing pancreatitis were identified in the review and both required an extended stay in the hospital with medical management in the ICU. The most common adverse events reported in the 88 cases were abdominal pain, nausea and vomiting.

Additionally, the analysis found that 19 of the 88 reported cases (21%) of pancreatitis occurred within 30 days of starting sitagliptin or sitagliptin/metformin.  Furthermore, 47 of the 88 cases (53%) resolved once sitagliptin was discontinued. It is important to note that 45 cases (51%) were associated with at least one other risk factor for developing pancreatitis, such as diabetes, obesity, high cholesterol and/or high triglycerides.

Based on the temporal relationship of initiating sitagliptin or sitagliptin/metformin and development of acute pancreatitis in the reviewed cases, FDA believes there may be an association between these events....

Also on September 25 Merck & Co., Inc. issued a statement saying its own analysis of the post-marketing adverse experience reports data did not confirm an excess risk for developing acute pancreatitis.  From this "Merck Statement About JANUVIA™ (sitagliptin) and JANUMET™ (sitagliptin/metformin)" document:

The safety profile of JANUVIA and JANUMET has been established through an extensive clinical development program.  In addition, in the nearly three years of marketed use, more than 18 million total prescriptions have been dispensed for sitagliptin worldwide.

In the September 25 edition of MedPage Today there appears an article, "Sitagliptin Label to Reflect Pancreatitis Risk", which suggests that the increased risk of developing acute pancreatitis may be a so-called "class effect" for some of the newer diabetes drugs such as Januvia and Byetta:

Acute pancreatitis is beginning to look like a class effect for the newer drugs against diabetes that act through the glucagon-like peptide-1 pathway.

Two years ago, the FDA demanded a similar label change for the incretin mimetic exenatide (Byetta), after 30 pancreatitis cases were reported. (See FDA Wants Pancreatitis Caution Added to Exenatide (Byetta) Label)

Both exenatide and sitagliptin act through receptors for GLP-1 -- exenatide is a synthetic mimic of the peptide, while sitagliptin inhibits the dipeptidyl peptidase-4 enzyme that degrades GLP-1 in vivo.

According to a September 25, 2009 Wall Street Journal Health Blog post, "Another Diabetes Drug is Linked to Pancreas Inflammation", by Jacob Goldstein:

This is the second time in just over a year that a popular, new-ish diabetes drug has been linked to pancreatitis — the previous case was Byetta, which is co-marketed by Amylin and Eli Lilly. In that instance, several deaths were reported....

Amylin and Lilly have been named as defendants in Byetta cases brought by 110 plaintiffs in cases primarily related to pancreatitis, Amylin said in its most recent quarterly report. Byetta sales fell slightly in the first half of this year, to $332.8 million from $336 million in the year-earlier period.

As we reported two years ago, the FDA first issued an alert to doctors informing them reports of acute pancreatitis in patients taking Byetta back in October 2007.

We will have to wait to see whether this increased warning about pancreatitis for Januvia results in any drug injury lawsuits being filed against Merck.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Case Report Of Bilateral Femur Fractures In Patient Using Fosamax

Medical Journal Article Points To Imbalance Between Bone Resorption And Bone Formation At Affected Bone

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the October 2009 edition of the Journal of Bone and Mineral Research we found an article which advances the epidemiology of bisphosphonate-related femur fractures.

This medical journal article, "Bilateral Fractures of the Femur Diaphysis in a Patient With Rheumatoid Arthritis on Long-Term Treatment With Alendronate: Clues to the Mechanism of Increased Bone Fragility", deals with a patient with rheumatoid arthritis and multiple risk factors for fractures who was treated with Fosamax (alendronate) for eight years and developed spontaneous bilateral subtrochanteric/diaphyseal fractures.

From the Abstract for this October 2009 article:

Bone biopsies obtained form the iliac crest and the femur showed decreased bone formation with histomorphometric evidence of markedly increased bone resorption at the femur. These results show for the first time that an imbalance between bone resorption and bone formation at the affected bone is associated with the occurrence of these atypical femur fractures.  The cause of this imbalance is currently unknown, and further studies of the epidemiology and pathogenesis of diaphyseal femur fractures are warranted.

As we have reported previously, atypical femur fractures have been reported in patients treated with Fosamax.

As the authors of the October 2009 case report article point out:

[A]lthough no causal relationship has been established between Fosamax and these femur fractures], excessive suppression of bone turnover and length of treatment with alendronate have been implicated in their pathogenesis.

We will continue to monitor this emerging drug safety issue involving Fosamax and femur fractures.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Asthma Drug Xolair Is Being Investigated By FDA For Possible Cardiac Problems

Serious Side Effects Include Heart Attacks, Abnormal Heart Rhythms, Heart Failure, And Various Conditions Caused By Blood Clots

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Xolair Is Associated With Higher Than Expected Reporting Of Arterial Thrombotic Events Such As Strokes And Cardiovascular Deaths"

UPDATE: "Xolair Asthma Drug Associated With Higher Rate Of Heart Attacks, Pulmonary Hypertension, Blood Clots Causing PEs And/Or DVTs, And Brain Blood Vessel Problems"

(12/29/14)

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By means of a July 16, 2009 MedWatch Email Alert we first learned about an ongoing FDA investigation of Xolair (omalizumab):

FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.  Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

In its "Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)" the FDA informs us that the EXCELS study is ongoing and final results are not expected until 2012.

Health Canada has followed the lead of the FDA, according to an August 13, 2009 report from CBC News, "Asthma drug probed for links to cardiac problems":

The safety of the asthma drug Xolair is under review to investigate a potential link to cardiovascular problems, Health Canada said Thursday.

The probe was triggered by interim findings in an ongoing U.S. study into the long-term safety of Xolair, known generically as omalizumab.

The early data point to a disproportionate increase in cardiovascular problems among people treated with Xolair compared with those who did not take the drug. The reported problems include heart attacks, abnormal heart rhythms, heart failure, fainting, mini-strokes and blood clots.

Xolair, which is made by Genentech and co-marketed by Novartis, was approved by the FDA in 2003.

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From a July 17, 2009 report from CNN, "FDA scrutinizing safety of asthma drug Xolair"", we get a comment and some context regarding this safety study of Xolair:

"We're not getting into numbers at this point because we're still in that evaluation stage," said Genentech spokeswoman Tara Cooper. "It's premature to really get into the details at this point."

The drug is used by 30,000 to 35,000 patients, representing less than one half of 1 percent of the eligible patient population, Cooper said. It is administered by injection every other week in a doctor's office. The estimated annual cost of the drug to the doctor -- before it gets marked up for the patient -- is about $19,000, Cooper said.

We will continue to monitor developments concerning the safety of Xolair, and we welcome any comments or information that you would like to submit concerning this issue.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Drug-Company Sponsored Ghostwriters Are Getting Busted By Some Medical Journals

Drug Industry Document Archive (DIDA) Adds Newly Released Wyeth Ghostwriting Documents In September 2009

(Posted by Tom Lamb at DrugInjuryWatch.com)

A September 18, 2009 article, "Medical Editors Push for Crackdown on Ghostwriting", published by The New York Times (NYT) provides a very good overview of how some big pharmaceutical companies have effectively turned scientific articles into marketing vehicles for their new drugs by means of industry-financed "ghostwriting".

From the beginning and ending parts of this September 2009 NYT article:

The scientific integrity of medical research has been clouded in recent years by articles that were drafted by drug company-sponsored ghostwriters and then passed off as the work of independent academic authors....

In January, editors at Blood, the journal of the American Society of Hematology, discovered that an unsolicited manuscript submitted by a prominent researcher involved significant contributions from a pharmaceutical company employee named in the acknowledgments — a major role in the manuscript that should have qualified the employee to be listed as an author of the paper. Further detective work quickly turned up two other ghostwritten manuscripts.

Editors decided to make their discoveries public in an editorial titled "'Ghostbusting' at Blood" in which they wrote that the journal would henceforth reject opinion pieces that had industry ties. [link to editorial added]

While the revelation about this practice of ghostwriting as concerns medical journal articles is news to most people, this practice is far from being a recent development.  Again drawing from the September 2009 article, written by NYT reporters Natasha Singer and Duff Wilson:

Allegations of ghostwriting first surfaced several years ago in the promotion of the diet drug combination fen-phen, which was taken off the market because of safety concerns in 1997, and the painkiller Vioxx, withdrawn in 2004. And last month, documents made public in litigation against the pharmaceutical giant Wyeth showed that the company had paid a medical writing firm to draft articles, published through 2005, favorable to its Premarin family of hormone drugs even as evidence mounted that certain hormone drugs could increase the risk of breast cancer.

Now the Wyeth ghostwriting documents that were "made public" last month -- i.e., unsealed by a Federal judge last month at the request of the Public Library of Science (PLoS) and The New York Times-- have been added to this Archive which has been created by the University of California at San Francisco (UCSF).

Here is an excerpt from an annoucement -- which we (thankfully) received from Kim Klausner, who is the Tobacco Digital Library Manager at University of California, San Francisco -- regarding the addition of these Wyeth ghostwriting documents to the DIDA:

As you are probably aware, the documents illustrate how Wyeth Pharmaceuticals contracted with DesignWrite, a medical communications company, to write articles for top-tier medical journals with the intention of bolstering the sales of the Premarin family of hormone replacement products.  After the articles were written, DesignWrite solicited prominent health professionals to appear as "authors."

The documents are full-text searchable and limited metadata, such as names of people and organizations mentioned, has been created for most documents to aid searching. The documents can be found by entering "ddu:2009*" without the quotation marks in the query box on DIDA’s home page (http://dida.library.ucsf.edu)

I have selected a few of the 1,120 documents that, taken together, show how the integrity of the scientific process was compromised.

A summary of DesignWrite’s work: a "comprehensive publication program for Premarin… [which] includes peer-reviewed journal articles, editorials, letters to the editor, sales training backgrounders, and critiques of the current literature, all designed to support the [company’s] marketing efforts."

An August 2000 contract between DesignWrite and Stephen Gutkin, President and founder of Rete Biomedical Communications, to write 8- to 10-page manuscript on "Can a Healthy Endothelium Influence the Cardiovascular Effects of HRT?"

A September 12 letter (page 4 of the document) to Gutkin paying him for completing the outline.

A DesignWrite document (page 2 of the document) from September 27 indicates that Professor Kwang Kon Koh has been approached to "author" the paper but "needs to be confirmed."

An October 13 letter (page 3 of document) from DesignWrite Medical Editor to Gutkin about revisions to the manuscript: "Anything that doesn’t bolster the main message that early intervention with estrogen in order to maintain a healthy endothelium in postmenopausal women can go."  The Editor accepts that the academic "author’s" "own additions will probably have to stay [in the article] no matter what."

A letter (page 2 of document) from DesignWrite to Gutkin asking for further revisions to the manuscript in January, 2001.

In April, Koh suggests in an email that DesignWrite staffer Karen Mittleman be listed as co-author of the paper.  (This document should be read from page 4 to page 1.)

The paper is published in the International Journal of Cardiology in 2003.  Mittleman’s "editorial assistance" is acknowledged.  Stephen Gutkin’s name is nowhere to be found.

As I reported last week, the Drug Industry Document Archive (DIDA) already contained over 1500 documents of various types before this addition of these Wyeth ghostwriting documents in September 2009.

We thank the good folks at DIDA for their efforts, and look forward to seeing more insightful documents about Big Pharma conduct added to this Archive in the future.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Some Of The Drospirenone (DRSP) Progestin Used In Yaz And Yasmin Pills May Have Been Of Bad Quality

August 2009 FDA Warning Letter Sent To Bayer Relates To Quality Control Problems Found In March 2009 At German Facility Where DRSP Was Made

(Posted by Tom Lamb at DrugInjuryWatch.com)

By means of a September 15, 2009 Associated Press (AP) news article, "FDA Warns Bayer Over German Manufacturing Plant", we first learned about a Warning Letter sent by the FDA back on August 5, 2009. 

The AP article suggests that this Warning Letter sent to Bayer by the FDA in early August 2009 was not made public until mid-September:

In a warning letter posted online [September 15, 2009], the Food and Drug Administration said its inspectors uncovered testing problems at [Bayer's] plant in Berghamen, Germany, during a March visit.

FDA inspectors said the company measured the quality of its drug ingredients based on an average of several samples, instead of reporting individual tests results.

Bayer shipped eight drug batches to the U.S. that were tested using the method, which the FDA does not accept.

The drug ingredients included drospirenone, which is used in the popular birth control pills Yaz and Yasmin. Those products were the company's top-selling pharmaceuticals last year, with global sales of $1.8 billion.

In this August 5, 2009 FDA Warning Letter to Bayer, the agency told the drug company that about eight batches of ingredients used in the drugs Yaz, Yasmin, and Angeliq "should not have been released for distribution".

Yaz and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and the new "fourth generation" progestin drospirenone (DRSP).  Yaz and Yasmin have been linked to blood clots and cardiovascular events as well as other serious side effects.  Some medical researchers have offered the theory that it is the DRSP component in Yaz and Yasmin that might cause some of these adverse reactions. 

Angeliq tablets (drospirenone/estradiol) are used as hormone therapy (HT) to relieve moderate to severe menopausal symptoms such as hot flashes and night sweats.

In more detail, this August 2009 Warning Letter was sent by FDA's Richard L. Friedman, M.S. -- the Director of the agency's Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research -- to Bayer's Dr. Franz-Josef Renneke -- who is the Site Manager for Bayer HealthCare - Bayer Schering Pharma AG at its manufacturing facility in Bergkamen, Germany.  The Warning Letter concerns certain batches of drospirenone (DRSP), ethinylestradiol (EE), and norethisterone acetate that were manufactured at this particular Bayer facility in Germany.

A response from Bayer about points raised in the FDA Warning Letter was due within thirty days of August 5, 2009, according to the letter.  To our knowledge, however, neither Bayer nor the FDA have made any such response letter publicly available as of September 16, 2009. 

We will report any future significant developments about the apparent quality control problem involving drospirenone to the extent that they call into question the safety of Yaz, Yasmin, and Angeliq.
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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

September 2009 Update On Paxil Lawsuits Alleging Birth Defects

Reports About Paxil Cases In Boston, Philadelphia, And Mississippi

(Posted by Tom Lamb at DrugInjuryWatch.com)

To set the stage we start back in December 2005, when the FDA issued a News Release titled "FDA Advising of Risk of Birth Defects with Paxil", from which we take this excerpt:

FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.

Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.

Since then, more than 600 lawsuits have been filed against Glaxo alleging its popular antidepressant drug Paxil causes birth defects.  The general theme of these Paxil lawsuits is Glaxo failed to warn about the risks of Paxil until forced to do so by the FDA in late 2005, as seen above.  Further, plaintiffs' lawyers assert that Glaxo documents show the drug company knew since 1980 that Paxil could raise the risk of birth defects.

From a September 11, 2009 Bloomberg article, "GlaxoSmithKline to Defend Paxil in Birth-Defect Case":

Animal studies didn’t show the drug was safe, company scientist John Baldwin wrote in a March 20, 1980, memo cited in court filings by [plaintiffs'] lawyers.

"There remains the possibility that this compound could be teratogenic at higher dose levels," he said. A teratogenic agent is one that causes malformations of an embryo or fetus.

"In the face of this warning from Baldwin, GSK chose not to perform any additional animal studies to explore the teratogenic effects of Paxil," the plaintiffs' lawyers wrote.

For our Paxil litigation September 2009 update we rely upon a second Bloomberg article, "Glaxo E-Mails Over Paxil Study Must Be Turned Over for Trial", by reporters Jef Feeley and Margaret Cronin Fisk, which was published on September 15, 2009.

First, we learn about a significant development in the Paxil litigation coming from the U.S. District Court, District of Massachusetts (Boston):

U.S. District Judge Nancy Gertner in Boston [on September 14, 2009] refused to block William Seale’s family from reviewing e-mails and other communications between Glaxo and Boston University researchers over Paxil’s birth-defect risks. The 1-year-old Seale, whose pregnant mother took the antidepressant, died in 2004 after three surgeries to address heart defects, according to court filings.

Seale’s family contends officials at London-based Glaxo, which funded the birth-defect research, sought to influence the study’s results to help protect the company from lawsuits, Gertner said in her ruling. The study was done at the university’s Slone Epidemiology Center.

“The plaintiffs are entitled to correspondence and documents between anyone at Slone and GSK about the study, its scope” and methodology, the judge concluded....

Gertner denied the family’s request to access the study’s raw data. The judge ordered Boston University researchers Allen Mitchell and Carol Louik to turn over other information about their contacts with the drugmaker.

Some of that information relates to communications Glaxo had with the researchers as they prepared to submit the study to the New England Journal of Medicine for publication, according to Gertner’s order. The study was published in 2007.

This ruling by Judge Gartner is related to the case Seale v. SmithKlineBeecham Corp., 07-cv-180-MPM, U.S. District Court, Northern District of Mississippi.

Coincidentally, on the day after this ruling was made in Boston, opening arguments were scheduled to begin in the first Paxil - birth defect case to go to trial: Kilker v. SmithKline Beecham Corp., 2007- 001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

From the September 15 Bloomberg article about this first Paxil trial:

Michelle David, Lyam [Kilker]’s mother, contends Glaxo officials knew Paxil posed an increased risk of birth defects to pregnant users and hid the information to pump up sales.

Lyam was born with two holes in his heart as a result of the drug, his mother said in court papers. The infant underwent multiple surgeries within six months of his birth, she added.

Lawyers for the company countered at a Sept. 3 pretrial hearing that there is no evidence David was taking Paxil at the time Lyam was conceived and that the company acted responsibly in testing Paxil and updating safety information.

We will be watching for news reports about this Paxil trial in Philadelphia and let you know the outcome.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Drug Industry Document Archive Has Over 1500 Documents Regarding Big Pharma Conduct

Includes Previously Secret Documents That Were Released During Lawsuits Against Merck & Co., Parke-Davis, Warner-Lambert, and Pfizer

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Drug Industry Document Archive (DIDA), created by the University of California at San Francisco (UCSF), contains over 1500 documents, many of which were previously secret and only made public as a result of lawsuits filed against pharmaceutical companies.

In more detail, the Drug Industry Document Archive (DIDA) includes:

• internal pharmaceutical company documents;
• correspondence between drug companies and physicians, researchers, various communications organizations, and educational institutions;
• regulatory and legal documents;
• court filings;
• depositions;
• expert reports; and, 
• internal University documents.

Most of these documents were made public as a result of lawsuits against the following pharmaceutical companies: Merck & Co.; Parke-Davis; Warner-Lambert; and, Pfizer.

At the DIDA site, under Document Sources, you can read about some of those drug company lawsuits, in particular:

United States of America ex rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert/Pfizer

Thomas Cona et. al. v. Merck & Co., Inc.

Humeston v. Merck & Co., Inc.

Estate of Brian Hermans et. al. v. Merck & Co., Inc.

Carol Ernst et. al. v. Merck & Co., Inc.

Neurontin Marketing and Sales Practices Litigation, MDL #1629

Abbott Laboratories Norvir Anti-Trust Litigation

In conclusion, this Drug Industry Document Archive from UCSF has various types of documents that will probably appeal to those individuals with an interest in public health, public policy, and/or the general activities of pharmaceutical companies.

(Hat tip to The Scout Report, September 11, 2009, Volume 15, Number 36 -- a publication of Internet Scout, which is sponsored by University of Wisconsin - Madison Libraries.)______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Public Surveys Indicate The Need For Reform In Drug Safety By Big Pharma And The FDA

Healthcare Providers And Patients Are Encouraged To Report Adverse Events Involving Approved Or Unapproved Indications As Well As Medication Errors

(Posted by Tom Lamb at DrugInjuryWatch.com)

In October 2006 Quintiles Inc., a leading CRO company, conducted a survey titled "Consumer Perceptions on Drug Safety" that consisted of 1726 US men and women aged 18 years and over.  As some may recall, at that time there was a heightened public awareness about drug safety issues in the U.S. due to the Vioxx recall and concerns about pediatric antidepressant use.

An article about this survey -- "Public perceptions of the pharmaceutical industry and drug safety: implications for the pharmacovigilance professional and the culture of safety." -- appeared in the January 1, 2009 edition of the Drug Safety medical journal.

From the Abstract from this article:

The survey results showed that the FDA, Congress and US pharmaceutical companies are perceived as having a notable amount of responsibility to ensure safety (by 75%, 41% and 70% of respondents, respectively). Additionally, 96% of the survey respondents indicated that they had some level of concern about adverse reactions to prescription drugs that are taken as directed. Seventy-six percent of the respondents were 'fairly' to 'extremely' concerned about adverse reactions, while approximately 42% of the survey respondents' opinions ranged from 'somewhat distrusting' to 'strongly distrusting' of the pharmaceutical companies that develop drugs. These findings are comparable to those in surveys conducted by the Kaiser Family Foundation in 2005 and PriceWaterhouseCoopers in 2007. These surveys suggest that about half the respondents believe there is both the need and desire for reform in drug safety by the pharmaceutical industry and the FDA.

This January 2009 article closes by encouraging all persons with personal knowledge about a serious adverse reaction involving a prescription drug to submit a MedWatch report to the FDA.

We second that call-to-action by the good folks at Quintiles.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Case Report Of Woman With Likely Byetta-Induced Acute Pancreatitis

August 2009 Medical Journal Article Presents Well-Documented Report Of Pancreatitis In Context Of Byetta Use

(Posted by Tom Lamb at DrugInjuryWatch.com)

In October 2007 the FDA announced that the agency had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes.

In August 2008 the FDA informed us that the agency had received reports about six cases of hemorrhagic pancreatitis or necrotizing pancreatitis since October 2007.

A year later, the August 24, 2009 edition of Endocrine Practice-- the official journal of the American College of Endocrinology (ACE) and the American Association of Clinical Endocrinologists (AACE) -- included a detailed case report about a woman who developed acute pancreatitis after using Byetta.  From the Abstract for "Exenatide Induced Acute Pancreatitis":

A 64 y.o. non alcoholic female with NIDDM presented with one month of epigastric pain beginning two days after starting exenatide. Serum lipase was 2700U/L (nl. 114-320) and amylase 131U/L (nl. 30-110). Liver tests, lipid profile and serum creatinine were normal. Abdominal computed tomography (CT) showed changes consistent with pancreatitis and absent gallbladder. Exenatide was discontinued. Conservative therapy resulted in rapid resolution of symptoms and normal lipase (151U/L) and CT of the pancreas 90 days later....  We believe this current report to be the most thoroughly documented example of likely exenatide induced pancreatitis with a Naranjo score of 7/9. Reinstitution of all medications except exenatide and glipizide did not reproduce symptoms, CT or lipase abnormalities, and implicates exenatide as the cause.

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The authors of this August 2009 medical journal article also critically reviewed previous reports of pancreatitis associated with Byetta injections:

The FDA has reported 36 cases of presumed pancreatitis associated with exenatide. However, none of the selection criteria were specified, 2/3 did not have CT and 90% had at least one other risk factor. The one published case report contained no description of the pancreas on abdominal CT, mention of alcohol use or normal values for lipase.

The Conclusion reached by the authors is simple but important:

CONCLUSION: In any diabetic patient with acute pancreatitis, exenatide use must be ruled out and if currently taken, discontinued.

If you are aware of any cases of drug-induced acute pancreatitis, hemorrhagic pancreatitis, or necrotizing pancreatitis possibly involving Byetta , please let us know by submitting a Comment, below, or you can send me a private email.