Louisville Personal Injury Lawyer - Defective Drugs

Trasylol Linked to Thousands of Deaths(2)

Jennifer Moore — Sat, 23 Feb 2008 10:50:57 GMT

60 Minutes recently reported that the drug, Trasylol, may be linked to the death of thousands of patients. Trasylol had been on the market for 14 years and was made by Bayer. Estimates show that worldwide over four and a half million people have been given the drug -- about a third of them were Americans. Trasylol was given in the operating room to control bleeding. Bayer aggressively marketed the drug and Trasylol was being used in about 1/3 of all cardiac bypass operations. Trasylol is now off the market, but can still be used in special cases during surgery.

Two studies confirmed that Trasylol causes an increased risk of death and kidney damage compared to alternative medicines or taking no medicine at all. The stories were published in the New England Journal of Medicine.

One study showed elevated risks of kidney damage, including dialysis, heart attack and stroke. According to the 60 minutes report, the delay in taking the drug, Trasylol, off the market may have cost 22,000 lives. The physician behind the study, Dr. Dennis Mangano, estimates that as many as 1,000 people per month died as a result of the use of Trayslol during coronary bypass surgery from the publication of his article in January, 2006 until the drug's withdrawal in November of 2007.

Trasylol is an antifibrinolytic agent used during cardiac surgery to reduce the risk of blood transfusions. However, two alternatives exist, which are substantially less expensive than Trasylol. According to the two most recent articles and Dr. Mangano's study, these alternatives are equally effective in reducing the risk of needing blood transfusions due to blood loss and present none of the health risks associated with Trasylol.

...there had been concern about the drug as far back as the early 1980's. It was then, in Bayer's hometown, that Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol. He told Bayer, but he was surprised by the drug company's reaction.
"I felt that Bayer wasn't interested to examine these side effects," Fischer says.
Soon, the same side effects were being seen in humans in America.
"The most common problem we saw was renal failure. That is, that kidneys did not function properly after surgery," says the Missouri Baptist Medical Center's Dr. Nicholas Kouchoukos, one of this country's top heart surgeons.
In 1992, he conducted a small study, not funded by Bayer, in which Trasylol was given to 20 patients.
"Thirteen of these patients had problems with kidney function after the procedure," Kouchoukos says.

Originally posted at InjuryBoard by Jennifer Moore

Braun Recalls Lot "SFR" Flush Saline Syringes

Courtney Mills — Mon, 17 Sep 2007 14:53:40 GMT

Braun Medical has issued a recall of all normal saline flush syringes with lot numbers ending in "SFR". There have been a heightened number of customer complaints of particulate matter in Braun's saline solution, which has prompted the recall.

Patients may not develop any signs of injury until receiving multiple exposures to tainted saline, but multiple exposures pose a risk of severe injury. Damage to organs such as the kidneys, brain, heart, and lungs could all result from repeated exposure to silicone-tainted saline, therefore Braun urges that patients attend to the recall.

According to the FDA firm press release, the visible particulate matter contained in the "SFR" lot syringes has been identified as medical grade silicone. Silicone, although biocompatible, as injected poses a health risk. The recall concerns saline 3mL in 12mL syringes, designated by product code 513584, and normal saline 10mL in 12mL syringes, designated by product code 513587.

For more information on this subject matter please refer to Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Courtney Mills

Laxative causes kidney problems?

Jennifer Moore — Mon, 20 Aug 2007 00:46:09 GMT

Fleet Phospho-soda is an over-the-counter laxative that is commonly used to flush patients' bowels prior to colonoscopies. In 2006, the FDA reported that it had documented at least 21 cases of kidney failure associated with use of this laxative and its generic equivalent. Several lawsuits have been filed alleging that the laxative has caused serious kidney problems and, in some cases, death. More than 50 lawsuits have been filed against the manufacturer, C.B. Fleet Company of Lynchburg, Virginia. Some individuals who took the laxative suffered from kidney failure and had to go on dialysis or receive a transplant.

While Phospho-soda been on the market more than 100 years, and the Food and Drug Administration lists it as safe when used as a single-dose laxative, in the early 1990s the company began promoting a double-dose regimen for people about to undergo colonoscopies and surgical procedures, according to the lawyers' group.
The FDA has not certified the double-dose regimen. In fact, the FDA issued an alert to doctors and patients in May 2006 warning that it had documented 21 cases of kidney failure associated with the use of oral sodium phosphate solutions such as Phospho-soda and its generic competitors.
...
Fleet's Web site urges patients using Phospho-soda for bowel preparation to review the FDA's information statement, follow their doctors' instructions and drink at least 72 ounces of clear liquids to replace the fluids they will lose.

If you have experienced kidney problems after taking Phospho-soda, you should seek medical treatment. You should also seek the advice of a lawyer.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Jennifer Moore

Should Avandia Still Be Available?

Jennifer Moore — Wed, 01 Aug 2007 09:26:24 GMT

FDA panel decided on Monday to leave Avandia on the market. Consumers with Type II diabetes can continue to purchase the drug, Avandia, despite recent study showing increased risk of heart attack. At the same time, the FDA panel recognized that the drug, Avandia, has been linked to increased heart attacks among patients. Some panelists recommend a black box warning to be printed on the drug label. However, one heart attack due to a drug is too many. Further studies should be conducted and a thorough investigation into the risks of Avandia must be pursued.

About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Jennifer Moore

Avandia Lawsuit Filed

Jennifer Moore — Tue, 03 Jul 2007 23:02:20 GMT

A wrongful death lawsuit was recently filed against GlaxoSmithKline, the maker of Avandia, alleging that it withheld information from the public on the negative side effects of the drug. Avandia is a drug prescribed for Type II diabetes. A study published in the June 2007 issue of the New England Journal of Medicine links taking Avandia to a significant increase in the risk of heart attack.

The lawsuit was filed on behalf of the estate of an individual who died of a heart attack and alleges that the fact he took Avandia for over two years increased his risk of heart attack.

The lawsuit accuses the company of withholding from physicians, patients and the public information it had on adverse side effects.
"At least by September 2005, Glaxo was in possession of evidence that could reasonably be expected to diminish the sales of its second largest selling drug," the lawsuit adds. The information was not made public.
"During the following year of concealment, Glaxo pressed its sales of Avandia to a distribution of approximately 13 million prescriptions in the Unites States," the document notes.
"With a month's supply of Rosiglitazone costing between $90 and $200, Glaxo was able to rack up sales of $2.2 billion in 2006," it adds. Knowing by way of 42 different studies of patients using the drug that its product "was unreasonably dangerous ... Glaxo continued to expand sales."

Consumers should monitor closely defective drugs, such as Vioxx and now Avandia, and speak to their doctor immediately if taking the drug.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Jennifer Moore

Dangerous Toothpaste Recall Extended to Fake Colgate

Shannon Weidemann — Sat, 16 Jun 2007 22:32:09 GMT

Colgate has announced that five ounce tubes of toothpaste sold in four states is fake and may contain a dangerous ingredient. The recalled toothpaste was sold in discount stores and may say "made in South Africa." The manufacturer used diethylene glycol to sweeten the toothpaste. The harmful ingredient may cause kidney or liver damage.

Colgate-Palmolive issued a press release early Thursday saying the tubes are counterfeit.
The company said it does not use, nor has it ever used, diethylene glycol as an ingredient in Colgate toothpaste anywhere in the world.
"Colgate does not import toothpaste into the United States from South Africa," said the statement from Colgate-Palmolive. "In addition, the counterfeit packages examined so far have several misspellings including: `isclinically,' `SOUTH AFRLCA' and `South African Dental Assoxiation.

The FDA has issued a warning to be on the lookout for toothpaste made in China that may also contain diethylene glycol. Consumers should stop using the toothpaste and return it to the store for a refund.

Originally posted at InjuryBoard by Shannon Weidemann

Avandia Study Worries Diabetics

Shannon Weidemann — Thu, 24 May 2007 16:27:10 GMT

Avandia is a popular diabetes drug used to control the disease. A recent study in the New England Journal of Medicine has many that are taking the drug worried. The study found an increased risk of heart attack and death for those on the medication.

The suggestion of a greater heart risk is especially troubling, though, because two-thirds of diabetics die of heart problems. More than 6 million people worldwide have taken Avandia since it came on the market in 1999 to treat Type 2, the most common form of diabetes and the one linked with obesity.
The Gonda Diabetes Center at the University of California, Los Angeles has answered at least 10 calls and individual doctors have received scores of e-mails from patients.

It is highly recommended that you speak with your doctor before you stop taking Avandia. The FDA has not announced a product recall pending further studies.

Originally posted at InjuryBoard by Shannon Weidemann