Dallas Accident Lawyer & Attorney : Fears Nachawati Law Firm : Personal Injury, Wrongful Death : Ft. Worth, San Antonio, Austin, Houston, Texas

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From CNBC News, A new report in the Journal of the American Medical Association is highly critical of drugmaker Merck and its handling of the painkiller Vioxx.

The JAMA article says Merck Merck & Co IncMRK
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[MRK 40.34 -0.88 (-2.13%) ] misrepresented apparent Vioxx-related deaths in studies to see if the drug worked on Alzheimer's Disease.

A review of the clinical trials, which came to light during the Vioxx litigation, shows a three-fold increase in the risk of death among the patients who got Vioxx, according to the peer-reviewed medical journal.

But in a press release, Merck says that after careful analysis there was no suggestion the deaths were caused by the drug and that the JAMA report's conclusions are "false, misleading, or lack context".

Merck voluntarily pulled Vioxx off the market in 2004 because of an increased heart risk. The company has since settled most of the resulting lawsuits for nearly $5 billion.

One of the two authors of the JAMA article was a paid expert witness for Vioxx plaintiffs.

www.cnbc.com/id/24133815/

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The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.

Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours (“extended-release”).

“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”

Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.

Highlights of the FDA’s recommendations to health care professionals include:

Tussionex should not be used (is contraindicated) in patients less than 6 years old. FDA has received reports of death in children less than 6 years of age who have been prescribed Tussionex.

Consult the prescribing information to determine the correct dose and dosing frequency of Tussionex. Tussionex is an extended-release formulation that should not be prescribed at an interval less than 12 hours.

Discuss with the patient the amount of and frequency of Tussionex to be given. Instruct patients not to take, and parents not to administer Tussionex more frequently than every 12 hours.
Highlights of the FDA’s recommendations to patients include:

One of the two ingredients in this long-acting cough product is hydrocodone, a narcotic. Too much hydrocodone can cause life-threatening breathing problems and death. Call your doctor right away if you have taken this medicine and have trouble breathing, slow heartbeat, severe sleepiness or cold, clammy skin.

For Tussionex, use a medicine syringe or other device designed to measure liquid medications. A household teaspoon or tablespoon should not be used because the spoons vary in size and you may receive too much or too little of the medicine. Ask your doctor or pharmacist if you are unsure how to measure the medicine.

If the cough is not controlled despite taking the prescribed dose at the recommended interval, talk to your doctor.
The manufacturer of Tussionex Pennkinetic Extended-Release Suspension (UCB Inc, Smyrna, Ga.) has agreed to update the labeling, including information that Tussionex should not be prescribed to or used in children less than 6 years of age, as well as the need for accurate dosing.

For more information and the full list of the FDA's recommendations, visit http://www.fda.gov/cder/drug/infopage/hydrocodone/default.htm

This alert does not impact short-acting cough products containing hydrocodone that can be given every 4 to 6 hours. However, the FDA is reviewing safety information on these other hydrocodone containing cough products and will provide updates as new information becomes available.

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The lives of 22,000 patients could have been saved if U.S. regulators had been quicker to remove a Bayer AG drug used to stem bleeding during open heart surgery, according to a medical researcher interviewed by CBS Television's 60 Minutes program.

The drug Trasylol was withdrawn in November at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients.

It had been given to as many as a third of all heart bypass patients in the United States at the height of its use over a period of many years, according to the report.

Dr. Dennis Mangano, the study's researcher, said during the program that 22,000 lives could have been saved if Trasylol had been taken off the market when he first published his study in January 2006, according to a CBS News report on its Web site ahead of a broadcast slated for next Sunday.

He said in the broadcast that Bayer failed to disclose to the FDA during an FDA advisory panel meeting in September 2006 -- at which Mangano's negative findings were discussed -- that the German drugmaker had conducted its own research which confirmed the same dangers established by his study.

The chairman of the FDA advisory panel, Dr. William Hiatt, told 60 Minutes he would have voted to remove Trasylol from the market had he been informed about Bayer's study, according to the CBS report.

Bayer spokeswoman Meredith Fischer said she could not comment about the broadcast until it is aired, including allegations that the drugmaker had failed to protect patients.

She said Bayer is facing a number of product-liability lawsuits filed by patients who had taken the medicine or their families, but said she not know how many lawsuits were filed.

Provided by Reuters.com

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The New England Journal of Medicine reports about the recent drug Trasylol.

September 30 is becoming a day of infamy for drug safety. On that date in 2004, Merck announced that rofecoxib (Vioxx) doubled the risk of myocardial infarction and stroke, and the company withdrew the drug from the market after 5 years of use in more than 20 million patients. On September 30, 2006, a front-page article in the New York Times reported that the Food and Drug Administration (FDA) had issued a warning that the antifibrinolytic drug aprotinin, widely used to reduce perioperative bleeding in patients undergoing cardiac surgery, could cause renal failure, congestive heart failure, stroke, and death.

Some experts had been concerned about aprotinin (Trasylol) ever since its approval in 1993.1 As Hiatt explains in his Perspective article in this issue of the Journal (pages 2171–2173), one of two epidemiologic studies reported early this year provided support for this concern. In an observational study involving 4374 patients who underwent coronary revascularization,2 Mangano et al. found that patients who were given aprotinin had an incidence of postoperative renal failure requiring dialysis that was more than twice that among patients who received different agents. Among patients undergoing uncomplicated coronary-artery surgery, those given aprotinin had a 55% increase in the incidence of myocardial infarction or heart failure and a 181% increase in the incidence of stroke or encephalopathy. The authors advised against further use of the drug, since safer, cheaper alternatives are available.

After the study was published, the FDA moved to convene an advisory committee to reassess the drug's safety and assembled the relevant data. The committee met on September 21, reviewed the available evidence, and concluded that there was no need for additional warnings on the drug's official labeling.

What put aprotinin on the front page on September 30, however, was the revelation that its manufacturer, Bayer, had hired a private contract research organization to perform its own large observational study of postoperative complications in patients given the drug. The analysis, completed in time for the FDA meeting, reached conclusions similar to those of Mangano et al. It, too, adjusted for a wide variety of clinical characteristics and showed that patients who received aprotinin had higher mortality rates and substantially more renal damage than those given other treatments. But neither Bayer nor its contractor had provided the report to the FDA or even acknowledged its existence before the meeting.

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The U.S. Food and Drug Administration (FDA) today approved revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved usage to specific situations. Trasylol is given to patients before heart surgery to reduce bleeding and the need for blood transfusions. Trasylol is marketed by Bayer Pharmaceuticals Corporation, Leverkusen, Germany.

"The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol and to ensure they understand the new warnings and use the product as directed by the label," said Steven Galson, M.D., MPH, Director of FDA's Center for Drug Evaluation and Research.

The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion in the setting of coronary bypass graft surgery (a procedure used to improve blood flow to the heart) when patients undergo cardiopulmonary bypass (a procedure that allows a machine to take over the heart's functions when it is stopped during surgery). The changes also include a warning that Trasylol increases the possible risk for kidney damage, and suggest ways to manage and reduce the patient's risk for hypersensitivity (exaggerated immune) reactions.

The labeling changes follow an FDA-conducted review of safety information that FDA became aware of after the product was introduced to the market. FDA began this safety review of Trasylol in January 2006. The review was triggered by the results of two published research studies. One study reported an increase in the possibility of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other drugs. The other study reported an increase in the possibility of kidney damage compared to other drugs, but did not show an increased risk of heart attack or stroke. On February 8, 2006, FDA issued a Public Health Advisory regarding these new findings with Trasylol. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, a Bayer worldwide safety review, and the FDA review of its own post-marketing database, and made recommendations for labeling changes. The labeling changes for Trasylol are based upon the recommendations of that advisory committee.

FDA announced on September 29, 2006, that Bayer informed the agency of an additional safety study on September 27, 2006. The preliminary results from that study suggest that in addition to serous kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes. The FDA review of this additional Trasylol safety information is continuing and it may result in other actions, including additional changes to the labeling. For additional information about Trasylol, see www.fda.gov/cder/drug/infopage/aprotinin/default.htm.

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The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.

"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."

Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.