Drug Injury Watch

Aranesp Associated With Increased Risk For Stroke In Patients With Diabetes And Chronic Kidney Disease

2009-11-06T16:35:00-05:00

TREAT Study Revealed, Also, That This Amgen Anemia Drug Was No Better Than Placebo In Reducing Deaths Or Cardiovascular Problems

(Posted by Tom Lamb at DrugInjuryWatch.com)

The anemia drug Aranesp (darbepoetin alfa) might cause an increased risk for stroke in patients with diabetes and chronic kidney disease, according to the results from the Trial to Reduce Cardiovascular Events with Aransep Treatment (TREAT), a new study that was published in the October 30, 2009 edition of the New England Journal of Medicine (NEJM) and presented recently at the annual meeting of the American Society of Nephrology.

As background, patients with type 2 diabetes and kidney disease often become anemic. In turn, heart and kidney problems can be accelerated by anemia. Accordingly, doctors have long prescribed Aranesp and other erythropoiesis-stimulating agent (ESA) drugs based on the belief that treating the anemia would improve patient’s prognosis.

In an October 31, 2009 Boston Globe article, "Researchers question anemia drug benefits", reporter Elizabeth Cooney provides a good summary of the unexpected results from this TREAT study and the implications of those results:

The study, led by Boston researchers, is the first trial to compare this class of anemia drugs with a placebo in the ability to prevent death and serious complications - even though the drugs have been in use for decades.

"The risks of the therapy were bigger than we thought, namely stroke, and the benefits were less than we thought, in quality of life," said Dr. Marc Pfeffer, a cardiologist at Brigham and Women’s Hospital who led an international group studying Aranesp, which raises red blood cell levels....

The study confirmed that patients taking Aranesp required fewer blood transfusions and suffered less fatigue, but other hoped-for outcomes were not seen.

Dr. Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice said the findings reinforce a crucial message in medicine.

"This current study is an important reminder of how important it is not to assume the treatments work, but to prove them," said Woloshin, who was not involved in the study. Aranesp, made by California-based Amgen, was approved by the Food and Drug Administration in 2001 for use in kidney patients, but a similar drug also made by Amgen has been prescribed for 20 years.

The NEJM article about this TREAT study concerning Aranesp, "A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease", was accompanied by an editorial, "Treatment of Anemia in Chronic Kidney Disease — Strategies Based on Evidence", from Philip A. Marsden, M.D.

Amgen, the drug company that makes Aranesp, issued a press release about the TREAT study results, "Large Study of Anemia Treatment in Chronic Kidney Disease Patients Not on Dialysis Published in the New England Journal of Medicine Failed to Meet Primary Efficacy Endpoints", which includes this statement:

Amgen has shared this information with global regulatory authorities and anticipates that the TREAT results will be included in labeling once discussions are complete.

We will be watching for this revised package insert, or label, for Aranesp which may or may not be announced by means of a so-called "Dear Doctor" letter.

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

Diabetes Drug Byetta Linked To Kidney Problems And Cases Of Renal Failure

2009-11-03T17:35:00-05:00

October 2009 Byetta Label Change Follows Earlier Alert From U.K. About Kidney-Related Side Effects

(Posted by Tom Lamb at DrugInjuryWatch.com)

In March 2009 the Drug Safety Update Newsletter alerted us about reports of kidney-related side effects associated with the use of the diabetes drug Byetta (exenatide) from the U.K.

About eight months later, in early November 2009, the FDA informed doctors and other healthcare providers in the U.S. that it had approved revisions to the Byetta package insert, or label, so that it will now include information about numerous post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

This move seemingly was prompted by reports of 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency) in patients using Byetta that were received by the FDA from April 2005 through October 2008.

From the Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta) issued by the FDA on November 2, 2009, and the Data Summary part of that document in particular, we get these details:

FDA has completed a review of 78 cases of altered kidney function reported in patients with diabetes using Byetta. The cases were reported to FDA’s Adverse Event Reporting System (AERS) between April 28, 2005 and October 29, 2008. Sixty-two of the cases were classified as acute renal failure and 16 cases were classified as renal insufficiency. Cases of acute renal failure or insufficiency occurred as soon as 3 days and up to 2 years after initiation of Byetta. The patient ages ranged from 23 to 83 years, with an average age of 60 years.

The majority of patients, 74/78 (95%), had at least one contributory risk factor for altered kidney function, such as cardiac insufficiency, hypertension, pancreatitis, rhabdomyolysis, and urinary tract infection, as well as concomitant medications such as antiretrovirals, antihypertensives, diuretics, and non-steroidal anti-inflammatory drugs (NSAIDs)....

Hospitalization was required in 71 of 78 (91%) patients and there were 4 deaths reported in the cases reviewed. Eighteen patients required dialysis and two patients required kidney transplantation after initiation of Byetta. Of those patients who required dialysis, six had no prior history of altered kidney function, two had a prior history of altered kidney function, and the remaining 10 patients reported no information regarding prior renal history.

Byetta was discontinued in 63 of 78 (80%) patients, with 39 (50%) patients reporting improved signs and symptoms after discontinuation of the drug. One patient experienced recurrent altered kidney function after re-initiation of Byetta....

Due to the serious potential consequences of altered kidney function and temporal relationship between the development of renal effects and initiation of Byetta, FDA has approved revisions to the drug label for Byetta to describe this risk.

For the drug-company perspective concerning this Byetta label change about kidney-related side effects, we direct you to the October 2009 "Dear Doctor" letter from Amylin Pharmaceuticals Inc. and Eli Lilly and Co. which includes, as an enclosure, the "BYETTA® (exenatide) injection Full Prescribing Information (October 2009)".

We will continue to monitor and report about this emerging drug safety issue involving the diabetes medication Byetta.

P.S. On November 2, 2009 Amylin Pharmaceuticals, Inc., and Eli Lilly and Company issued their joint statement in response to the FDA on BYETTA® (exenatide) injection. (11/4/09)

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

FDA Should Make Drug Efficacy And Safety Information More Accessible To Patients

2009-10-27T16:40:00-04:00

Package Inserts Prepared By Drug Companies Which Exagerrate Benefits And Downplay Risks Need To Be Addressed

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the October 21, 2009 edition of The New England Journal of Medicine (NEJM) there is a Perspective piece, “Lost in Transmission — FDA Drug Information That Never Reaches Clinicians”, by Lisa M. Schwartz, M.D., and Steven Woloshin, M.D., that will ring true with most patients who have used prescription drugs.

From that NEJM editorial, two of the primary points raised by the authors are:

“Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.”

[A]lthough the US “federal stimulus package included $1.1 billion to support comparative-effectiveness research” no money has been allocated to “disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs.”

Reporter Matthew Perrone does a good job of breaking down this NEJM editorial piece for us in his October 21 AP news article, "Drug safety experts urge FDA to make drug safety info more accessible to patients", published by the Chicago Tribune. He starts by sharing part of his discussion with Dr. Lisa Schwartz:

"The take home point is that just because a drug is approved doesn't mean it works very well," said Schwartz, in an interview with the Associated Press. "You really need to know more to see whether it's worth the cost."

He then focuses on the the fact the FDA-approved label for a prescription medication often comes up short as regards the drug's efficacy, or benefits:

In the case of Sepracor Inc.'s blockbuster sleeping pill Lunesta, it's virtually impossible to tell how well the drug works based on the labeling, which only indicates that it worked better than placebo, or a dummy pill.

Only by wading through the FDA's 403-page internal review of Lunesta do the details emerge: patients fell asleep 15 minutes faster and slept 37 minutes longer, on average.

"Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness," the authors state.

Despite that lackluster finding, the drug has grown into a $600 million-a-year drug for Sepracor, helped by the company's advertisements featuring a green Lunesta moth.

Next, Perrone's October 21 AP article shows how important safety information may not only be missing from a drug's package insert but, furthermore, how the FDA makes this critical information hard to find and hard to understand:

The authors [Schwartz and Woloshin] point to the example of Novartis' Zometa, which was approved in 2001 to prevent skeletal fractures in cancer patients with brittle bones. The drug was approved in both 4-mg and 8-mg doses, despite FDA findings of increased kidney damage and death with the higher dose.

FDA went back and added language about kidney toxicity in 2008, but the information about death rates is still missing from the label.

While FDA reviews are posted online, they are often hundreds of pages long and written in extremely dense medical language.

In closing, Perrone reports that a spokesman for the FDA declined his invitation to comment or be interviewed for his article about the points raised by Dr. Schwartz and Dr. Woloshin in their October 2009 NEJM editorial piece.

Here, we welcome your Comments about the adequacy of drug labels as concerns the disclosure of balanced and comprehensive information about the benefits versus risks of prescription medications.

P.S. Here is a clarification issued by the AP regarding the October 21, 2009 Matthew Perrone article referenced in this post:

Correction: FDA drug label story

October 27, 2009

WASHINGTON (AP) — In an Oct. 21 story about drug labels, The Associated Press erroneously described the Novartis drug Zometa. Zometa was approved in 2001 to treat excessive calcium levels, not to treat a form of osteoporosis in cancer patients. Also, the drug was approved only in a 4 milligram dose, not in both 4 milligram and 8 milligram doses. A corrected version of the story appears below.

(10/28/09)

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

Yasmin And Yaz Birth Control Pills Are Under Scrutiny By Drug Regulators In Europe

2009-10-22T17:26:07-04:00

Bayer Confirms To German Newspaper There Are 129 Yasmin / Yaz Lawsuits In U.S. As Of Mid-October 2009

(Posted by Tom Lamb at DrugInjuryWatch.com)

From an October 21, 2009 article, "Bayer under pressure as birth control pills linked to blood clots", published by the German newspaper Deutsche Welle, we learn that the popular birth control pills Yasmin and Yaz have come under scrutiny in Europe as well as in the United States.

As reported here previously, Swissmedic is analyzing the safety of Yaz and other drospirenone-containing contraceptives following the death of 21-year old woman in Switzerland who died while using Yaz.

The October 21 Deutsche Welle article starts by pointing to two recent studies published in the BMJ medical journal which found birth control pills containing drospirenone and has almost twice as likely to cause blood clots when compared to older oral contraceptives containing the progestin levonorgestrel.

From there, this German newspaper article about Yasmin and Yaz goes on to focus on what is going on in Germany as regards these Bayer birth control pills:

In Germany, 25-year old Felicitas Rohrer collapsed in July with three thromboses in her lung. Since 2001, seven women in Germany have died while taking a contraceptive from the Yasmin family.

In total, 130 cases of adverse drug reaction have been reported to Germany's Federal Institute for Drugs and Medical Devices. However, not all of them are related to thrombosis, Ulrich Hagemann, head of the institute's department of drug safety, told Deutsche Welle....

Bayer said that it is known that the risk for venous thromboembolism, or blood clots in the veins, can be increased when starting the pill. Earlier studies funded by Bayer concluded that the drospirenone-containing pills held no higher risk than older, so-called second-generation pills.

But "arznei telegram," an independent publication for doctors and pharmacists, said the studies were not valid due to "massive method-related deficiencies."

Next, this October 21 Deutche Welle article focused on what the German drug oversight agency has to say about Yasmin and Yaz:

Ulrich Hagemann from the Federal Institute for Drugs and Medical Devices said 20 out of 100,000 women who take an oral contraceptive from the second-generation, which were developed in the 1970s, develop thromoembolic symptoms. For the newer, third-generation pills - and also for contraceptives containing the hormone drospirenone, like Yasmin - women face a risk twice as high, with 35 to 40 women out of 100,000 experiencing thromboembolic effects each year....

"There is a need from my point of view to change the text" in the product information that accompanies the pills, said Hagemann.

Also of interest is what a Bayer spokesperson had to say to this German paper about the Yasmin and Yaz lawsuits filed in the United States:

Bayer, who earns 1.2 billion euros ($1.8 billion) from the worldwide sales of the Yasmin line, confirmed to Deutsche Welle that it currently faces 129 lawsuits in the United States, brought by women who say they've developed health problems after taking Yaz or Yasmin.

"Bayer is still in the process of gathering information on these cases, and the complaints we have received so far pertained to side effects that are warned about in our approved labeling and the labeling for other oral contraceptives," said spokesperson Friederike Lorenzen. "Bayer will defend itself vigorously against these lawsuits."

Going back to Switzerland, it is expected that the results of the safety analysis concerning Yasmin and Yaz side effects reports will become available sometime later this month.

As they say, stay tuned for more about this emerging drug safety issue.

For a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and Ocella, see our Focus Page on YAZ / Yasmin / Ocella.

P.S. According to an October 22, 2009 Swiss news article about the Swissmedic analysis, the agency's (rather ambivalent) conclusion is: "Birth control pills containing the active ingredient drospirenone carry the same health risks as similar contraceptives on the market."

You can translate and read the Swissmedic Announcement, "Venöse Thromboembolien unter Antibabypillen: Swissmedic informiert über Abklärungen und erinnert an die Vorsichtsmassnahmen", to see if you think this Swiss news article accurately characterizes the agency's conclusion. (10/23/09)

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

First Zometa-ONJ Personal Injury Lawsuit Against Novartis Goes To Jury This Week

2009-10-20T11:26:42-04:00

Montana Woman's Case Is First To Trial; More Than 500 Other Jaw Side Effect Cases Filed In Federal MDL And New Jersey Courts

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Missoula woman awarded $3.2M in lawsuit against maker of bone-strengthening drug Zometa" (10/22/09)

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Let us set the stage, medically, by starting with an article, "Osteoporosis treatments and adverse events", which was published in the April 30, 2009 edition of Current Opinion in Rheumatology. It concerns the class of drugs known as bisphosphonates, with Fosamax, Boniva, and Actonel being the more popular brand names for the pills that are prescribed for the prevention and treatment of osteoporosis. In relevant part:

... relatively little is known about their long-term safety. Recent case reports cite a range of potential adverse events. We review data regarding atrial fibrillation, bone pain, osteonecrosis of the jaw (ONJ), atypical fractures, and osteosarcoma....

Zometa is in the bisphosphonate class of drugs, also, but it is primarily used by patients with cancer and it is administered intravenously. Despite those differences, Zometa has been associated with the same set of serious side effects listed above.

Peggy L. Stevens is a Montana woman who allegedly developed osteonecrosis of the jaw (ONJ) due to her use of Zometa and, in turn, sued the drug's maker, Novartis Pharmaceuticals Corp., for failure to warn adequately about that particular side effect. This Zometa lawsuit, according to an October 19, 2009 article published by the Missoulian newspaper, "went to trial on Oct. 13 in Missoula District Court and closing arguments will likely begin on [October 20, 2009]."

In more detail, from this October 19 article, "Verdict in Missoula woman's lawsuit against drugmaker could have national significance", by Missoulian reporter Tristan Scott:

Stevens, who has lymphoma, developed severe dental and jaw-related problems after taking Zometa, a bone-strengthening medication manufactured by Novartis. Her attorneys say the company knew patients taking Zometa were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures, like root canals or tooth extractions.

Doctors in Missoula administered Zometa to Stevens intravenously for about three years before she had a tooth pulled and developed the disease. Its symptoms include pain, loosening of teeth, exposed bone and infection.

"Instead of disclosing concerns about this relationship [between dental work and the jaw disorder] in a timely fashion, Novartis focused on obscuring the causal relationship, delaying disclosure and controlling the public relations fallout that would occur from the disclosure," attorneys wrote in a pre-trial brief....

On a national level, Novartis faces lawsuits from approximately 550 plaintiffs whose cases have been consolidated in a Tennessee federal court and a New Jersey state court. The first of those cases is slated for trial in March 2010.

We will be watching the Missoulian for their continuing coverage of this first Zometa trial, and will report the result of this Montana Zometa case as well as future significant developments concerning the Zometa litigation.

As some of you may have heard, the first Fosamax trial in the federal court Fosamax MDL involved Shirley Boles, a woman who used Fosamax from 1997 to 2006 and eventually developed osteonecrosis of the jaw (ONJ). The trial of her lawsuit concluded with the judge essentially declaring a "draw" after determining that the jury was unable to reach a verdict, as explained in September 11, 2009 Reuters article, "Merck lawsuit over Fosamax ends in mistrial".

The next Fosamax MDL trial is scheduled to start on January 5, 2010, followed by another case which will go to trial on April 19, 2010. Sometime after those trials, it is expected that the Boles Fosamax case will be scheduled for a second trial in an attempt to get a jury verdict.

Of course, we will continue to monitor the Fosamax litigation, also.

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

FDA’s Sentinel Initiative Project: An Overview, Progress To Date, And Next Steps

2009-10-15T16:50:28-04:00

Presentation Made At September 17, 2009 FDA Drug Safety Oversight Board Meeting

(Posted by Tom Lamb at DrugInjuryWatch.com)

At the September 17, 2009 meeting of the FDA Drug Safety Oversight Board (DSB), members heard presentations and discussed four topics:

An update on the Sentinel Initiative;
The DSB path forward in 2009 and beyond;
The CDER Center Director’s conversation with the DSB; and,
A one-year follow-up on issues presented to the DSB.

We were most interested in the update on the FDA's Sentinel Initiative project for monitoring medical product safety, which we last reported on in March 2009.

From the Public Summary for the September 17, 2009 DSB meeting we get the following information about the Sentinel Initiative update:

The Scientific Lead on FDA’s Sentinel Initiative presented an overview, progress to date, and next steps in FDA’s Sentinel Initiative. The goal of the Sentinel Initiative is to develop an active electronic safety monitoring system to strengthen FDA's ability to monitor the postmarket performance of medical products. The Sentinel Initiative’s intent is to augment, not replace, existing safety monitoring systems, and to enable FDA to access existing automated healthcare data by partnering with healthcare insurance providers, academic institutions, federal and state government agencies, healthcare providers, and other owners of various electronic health records.

The Board discussed the following advantages of the Sentinel Initiative:

1. Identifying and evaluating safety issues in near real time

2. Expanding FDA’s capacity for evaluating safety issues

3. Improving access to information on subgroups and special patient populations

4. Improving precision of risk estimates because of expanded numbers of patient available for study

5. Actively surveying and identifying an increased risk of common medical product-related adverse events that health care providers may not suspect are related to medical products

As for the make up of the Drug Safety Oversight Board, at the present time it consists of representative from three FDA Centers (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health) and six Federal Partners (the Agency for Health Care Research and Quality, Centers for Disease Control and Prevention, Department of Defense, Indian Health Service, National Institutes of Health, and Department of Veterans Affairs).

We will continue to monitor developments related this FDA Sentinel Initiative project.

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

A Review Of Recent Research On Issue Of Whether Januvia Can Cause Pancreatitis

2009-10-12T17:07:00-04:00

Is Pancreatitis A Januvia Side Effect Or Is There An Increased Risk Of This Medical Condition Among Type 2 Diabetics Across All Treatments

(Posted by Tom Lamb at DrugInjuryWatch.com)

A few weeks back we reported that the FDA wants Merck to change the package insert, or label, for the diabetes drug Januvia (sitagliptin) so as to show an increased warning about the risk of developing pancreatitis.

Since then we have found some reports about relatively recent research about this issue of whether or not there is, in fact, any link between Januvia and pancreatitis.

We start with the early online publication of "Beneficial Endocrine but adverse Exocrine effects of Sitagliptin in the HIP rat model of Type 2 Diabetes, interactions with Metformin" in the medical journal Diabetes back in late April 2009.

From a press release which was issued by UCLA in connection that online publication, "Popular diabetes treatment could trigger pancreatitis, pancreatic cancer", we get these points:

[R]esearchers from the Larry L. Hillblom Islet Research Center at UCLA found that sitagliptin, sold in pill form as Januvia, caused abnormalities in the pancreas that are recognized as risk factors for pancreatitis and, with time, pancreatic cancer in humans.

Sitagliptin [i.e., Januvia] is a member of a new class of drugs that enhance the actions of the gut hormone known as glucagon-like peptide 1 (GLP-1), which has been shown to be effective in lowering blood sugar in people with Type 2 diabetes.

The UCLA study suggests that there may indeed be a link between drugs that enhance the actions of GLP-1 and pancreatitis — by increasing the rate of formation of cells that line the pancreatic ducts.

Moving on, we turn next to an October 1, 2009 article, "EASD: No Extra Risk of Acute Pancreatitis Seen with Exenatide", published online by MedPage Today. While this article is principally about a presentation on a large study concerning the diabetes drug Byetta (exenatide), it contains some discussion that is relevant to the Januvia - pancreatitis issue.

To start, the underlying study is "Incidence of acute pancreatitis in exenatide initiators compared to other antidiabetic drug initiators: a retrospective, cohort study", by Gary Bloomgren, of Amylin Pharmaceuticals, et al, which can be found in the medical journal Diabetologia (2009; 52: S9).

From the October 1 MedPage Today article we set these items for thought:

Two years ago, after reports of 30 cases of acute pancreatitis in patients taking exenatide, the FDA forced Amylin and its marketing partner, Eli Lilly, to add a caution to the drug's prescribing information. [See: "FDA Alerts Doctors About Diabetes Drug Byetta And Acute Pancreatitis Reports"]

The issue of acute pancreatitis and drugs acting on the glucagon-like peptide-1 pathway gained new prominence last week when the FDA requested a caution on the drug sitagliptin (Januvia), after 88 cases were reported to the agency.

However, the agency never determined that [Byetta] actually caused these effects, or that the incidence was any greater than might be expected in a diabetic population.

Bloomgren cited one recent study that found the risk of acute pancreatitis among type 2 diabetics is about three times that of nondiabetic individuals, across all treatments.

Exenatide [i.e., Byetta] is a synthetic GLP-1 mimic, while sitagliptin [i.e., Januvia] inhibits the dipeptidyl dipeptidase-4 (DPP-4) enzyme that degrades GLP-1, thereby making the peptide more available.

Another DPP-4 inhibitor was reported here to have no association with acute pancreatitis in a review of controlled clinical trial data involving nearly 12,000 patients.

The drug was vildagliptin, marketed in Europe as Galvus but not available in the U.S.

As you can see, the findings from these two recent medical studies about the diabetes drugs Januvia and Byetta are mixed as regards the issue of whether Januvia causes an increased risk of pancreatitis.

We welcome any and all feedback or guidance as regards this emerging drug safety issue concerning Januvia. Please participate in the conversation by submitting a Comment, below.

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

Waiting For The Results From Swissmedic Safety Analysis Of Yaz And Other Drospirenone-Containing Contraceptives

2009-10-09T15:27:00-04:00

Prompted By Investigation Into Death Of Young Woman Who Died While Using Yaz; Results Of Analysis Expected In Late October 2009

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late September 2009 we learned that the Swiss drug safety oversight regulator, Swissmedic, was investigating a possible link between the use of Yaz and a fatal pulmonary embolism (PE) suffered by a young woman in Switzerland earlier that month.

From the September 25, 2009 Reuters article, "Bayer contraceptive probed over possible death link":

Swiss medical authority Swissmedic said on Friday it was investigating suspicions of a possible link between the death of a woman from a blood clot 10 months after she was prescribed Bayer's low-dose oral contraceptive, Yaz....

Nine deaths in Switzerland since 1990 have been connected with oral contraceptives, according to Swissmedic. The authority said it began investigating all birth control pills after a 16-year-old was disabled by a lung embolism in May after taking Yaz.

Bayer launched Yaz last year in Europe, two years after it began selling it in the United States.

The drug company confirmed that the Swissmedic agency and an investigative judge are looking into the case of this young woman in a statement posted on Bayer AG's Swiss health unit's German language web site on September 25, 2009.

That same day, Swissmedic also posted a statement about the unexpected death of this young woman while using on Yaz on its German language web site.

As part of its investigation into the circumstances of this young woman who died while using Yaz in Switzerland during September 2009, the Swiss regulators will do an analysis regarding the overall safety of drospirenone-containing contraceptives, i.e., Yaz, Yasmin, and Ocella.

In particular, according to the September 25, 2009 Swissmedic statement, the agency will consider two recent studies which suggested that Yaz may have a higher risk of blood-clot complications than older birth control pills.

Those two articles, which were published August 13, 2009 by the medical journal BMJ, are:

"The venous thrombotic risk of oral contraceptives, effects of estrogen dose and progestogen type: results of the MEGA case-control study"; and,

"Hormonal contraception and risk of venous thromboembolism: National follow-up study".

Lastly, the September 2009 Swissmedic statement concerning this possible Yaz-related death due to pulmonary embolism (PE) said that the results of its Yaz safety analysis is expected in late October 2009.

We will be watching for news of the Swissmedic findings about Yaz and will report it as soon as possible here at Drug Injury Watch.

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

FDA Transparency Task Force Will Hold Its Second Public Meeting On November 3, 2009

2009-10-06T16:23:32-04:00

Emerging Safety Issues Concerning FDA-Regulated Products Is One Issue For Discussion Listed in October 2009 Federal Register Notice

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the Federal Register for October 5, 2009 the FDA gave notice about a second public meeting to discuss issues related to transparency at the agency to be held in Washington, DC on November 3, 2009.

As you may recall, in the June 3, 2009 Federal Register the FDA first announced it would begin to set up a new Transparency Task Force within the agency whose purpose is to recommend ways by which there could be more timely disclosure about FDA regulatory and safety decisions. In that same notice the FDA informed us about the scheduling of a first public meeting intended to solicit recommendations on how the FDA can make more available, useful, and understandable information on its activities and decisions. That first Transparency Task Force public meeting was convened on June 24, 2009.

Returning to the October 5, 2009 Federal Register notice -- Food and Drug Administration
Transparency Task Force; Public Meeting; Request for Comments -- in summary the FDA has requested comment on early communication about emerging safety issues concerning FDA-regulated products, disclosure of information and product applications that are abandoned or withdrawn by the applicant before approval, and communication of agency decisions about pending product applications. Comments are due by November 6, 2009.

In more detail, from the October 2009 FDA notice:

The second public meeting will be conducted as a series of three moderated discussion groups covering these three topics. The specific topic for each discussion will be presented in the form of a case study. Only one discussion group will be held at a time. Following each moderated discussion, Task Force members may ask questions of the participants in each discussion group. Others in attendance at the public meeting then will have an opportunity to comment on the issues discussed during the public comment period that will occur after each discussion group. At least 7 days in advance of the meeting, the initial scenarios of the case studies for each of the three topics will be made available on the Internet. The initial scenarios will be placed on file in the public docket (docket number found in brackets in the heading of this document), which is available at http://www.regulations.gov. The initial scenarios will also be available on FDA’s Web site at http://www.fda.gov/transparency along with the agenda for this meeting. The complete case studies will be available in the same locations after the public meeting....

As for the three general issues for discussion listed in the October 2009 FDA notice in the Federal Register, the first one, titled "Emerging Safety Issues Concerning FDA-Regulated Products", is of the most interest to us.

We will continue to monitor developments concerning the relatively new FDA Transparency Task Force, including reports about this second public meeting and notices of any additional public meetings in the future.

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

October 2009: Yasmin And Yaz Multidistrict Litigation (MDL) Transfer Order For Injury And Death Cases Filed In Federal Court

2009-10-01T15:47:13-04:00

MDL No. 2100 -- IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation -- Assigned To Southern District of Illinois

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Our Focus Page on YAZ / Yasmin / Ocella has a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and Ocella.

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UPDATE: Visit the YAZ, Yasmin, and Ocella Information page at our Drug Injury Law web site for more recent developments regarding personal injury and wrongful death lawsuits that involve YAZ, Yasmin, and Ocella.
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On October 1, 2009 the United States Judicial Panel on Multidistrict Litigation (JPML) filed its Transfer Order which serves to consolidate all Yaz and Yasmin personal injury and wrongful death cases filed in federal court in a U.S. Code Section 1407 Multidistrict Litigation, or MDL.

MDL No. 2100 was assigned to the Southern District of Southern Illinois according to this October 1 Transfer Order, with U.S. District Court Judge David R. Herndon presiding over these Yaz and Yasmin cases for "coordinated or consolidated pretrial proceedings".

In relevant part, from the JPML Yasmin and Yaz Transfer Order for MDL No. 2100:

On the basis of the papers filed and hearing session held, we find that these 32 actions involve common questions of fact, and that centralization under Section 1407 in the Southern District of Illinois will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All actions share factual questions relating to at least one of the drospirenone-containing oral contraceptives Yaz and Yasmin, which are manufactured by Bayer. Plaintiffs in the products liability actions challenge the safety of those oral contraceptives and bring claims for personal injuries or wrongful death stemming from use of the drugs....

Yaz and Yasmin, as well as the generic Ocella, have been associated with various serious side effects, including deep vein thrombosis (DVT), pulmonary embolism (PE), and ischemic stroke (CVA).

The official name given to MDL No. 2100 is IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation.

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