Louisville Personal Injury Lawyer - FDA & Prescription Drugs

Family Smoking Prevention and Tobacco Control Act

Karl Truman — Thu, 11 Jun 2009 18:00:28 GMT

On Monday this week, the Senate agreed to give the Food and Drug Administration authority to regulate cigarettes and tobacco products. The bill, entitled the Family Smoking Prevention and Tobacco Control Act, was passed by a 61-30 vote. Kentucky Senator, Mitch McConnell, among others who opposed the bill, are concerned how this new law will impact local tobacco farmers, and contend that it places additional burdens on the already overwhelmed FDA.

The AP reported:

Under this law, the FDA has the power to order removal of hazardous ingredients, restrict the marketing and distribution of cigarettes and smokeless tobacco, clamp down on sales to young people, require stronger warning labels and stop use of characterizations such as 'light' or 'low tar' that give people the impression of lower health risks.

The FDA plans to set up an office devoted solely to tobacco and cigarette regulation which is to be paid by a fee from tobacco companies.

The debate over FDA control over tobacco has been ongoing for over a decade. Opponents contend that regulation of the tobacco is necessary to set national standards to control the manufacturing of tobacco products and regulate the type and amount of ingredients used in these products. It’s estimated that over $400,000 people die each year from tobacco related illnesses. Philip Morris USA, the industry leader supports the new legislation.

USA Today reported Spokesman Bill Phelps, of Phillip Morris as stating that:

The company hopes it will be a "framework to pursue tobacco products that are less harmful than conventional cigarettes."

Greg Connolly of Harvard University's School of Public Health stated that he supports it but has "very, very serious concerns." He fears the FDA may do Philip Morris' bidding and focus on finding a "safer cigarette." Instead, he said, it should focus on reducing tobacco use.

"The critical issue," he said, "is what route the FDA will take."

Originally posted at InjuryBoard by Karl Truman

FDA Announces Re-Labeling of 20 Anti-Seizure Medications

Karl Truman — Thu, 07 May 2009 17:48:57 GMT

The FDA announced that 20 anti-seizure drugs are to have its warning lables revised due to the potential risk of an increase in suicidal tendencies. Anti-seizure drugs are commonly used to treat patients diagnosed with epilepsy, and to treat nerve-pain.

The official announcement on the FDA’s website stated that:

Manufacturers of anti-epileptic drugs (AEDs) or anti-convulsant drugs will update product labeling to include a warning about an increased risk of suicidal thoughts or actions and will develop a Medication Guide to help patients understand this risk. These changes affect all approved AEDs except those indicated only for short-term use.

The AP reported, "among the 20 anti-seizure medications to amend its labels are GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax and Pfizer's Lyrica."

The FDA sent letters to physicians indicating the specific language to be placed on the labels. It was further noted by the AP that the New York-based Pfizer said it "worked closely with the FDA to update the labeling for its antiepileptic medicines."

In January of 2008, the FDA announced its first alert of the health concerns associated with these anti-convulsants. In the 2008 report, the FDA reported its findings on an analysis conducted to determine the corrolation between aniti-seizure medications and the increase in suicidal tendencies.

An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving placebo (0.22 percent). This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidality than in the placebo groups.

With this in mind, the risk of an increase in suicidal tendencies is relatively low. Per the FDA's report, 2 people per every 1,000 taking anti-convulsants may experience this side effect.

The FDA advises that:

Patients who are currently taking antiepileptic medicines should not make any changes without first talking to their health care provider. Health care providers should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed for notable changes in behavior.

Originally posted at InjuryBoard by Karl Truman

Zyprexa Settlement. 1.42 Billion Dollars!

Karl Truman — Fri, 16 Jan 2009 12:00:23 GMT

A WSJ NEWS ROUNDUP
Eli Lilly & Co. agreed to pay $1.42 billion to settle a probe into alleged improper marketing of the antipsychotic drug Zyprexa, the Justice Department said Thursday.

The announcement and amount were expected, as Eli Lilly said in October it had set aside $1.42 billion for a potential settlement.

Zyprexa, which is approved to treat schizophrenia and bipolar disorder, has been Lilly's top-selling drug, garnering the company more than $37 billion in world-wide sales since its U.S. approval in 1996.

Bloomberg News/Landov
Zyprexa, an antipsychotic, isn't approved as a dementia treatment.
The Indianapolis-based company said it will pay $800 million to settle civil suits, including $438 million to the federal government and $362 million to states. It will pay $615 million to resolve the criminal probe and plead guilty to a misdemeanor violation for promoting Zyprexa as a dementia treatment.

The company didn't acknowledge any wrongdoing in the civil cases.

Federal prosecutors in Philadelphia have been investigating whether Lilly played down side effects of Zyprexa and promoted it for unapproved uses. The settlement removes the specter of a criminal indictment of Lilly, which could have threatened the company's lucrative business with Medicare and Medicaid.

The company has been resolving thousands of lawsuits as well as state investigations. In October, it agreed to pay $62 million to 32 states and the District of Columbia that had been probing consumer-protection claims.

Originally posted at InjuryBoard by Karl Truman

FDA Warns Consumers About Weight Loss Pills

Karl Truman — Tue, 13 Jan 2009 17:39:26 GMT

This is the time of year when many people are interested in weight loss. We have seen serious injuries in the past due to ingredients in weight-loss pills and supplements. The FDA has issued a warning to consumers not to purchase or consume 28 different products on the market for weight loss.

A complete list of the tainted weight-loss products can be found on the FDA web site www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html

Even products that claim to contain only "natural" or "herbal" ingredients can be harmful.

Information for consumers about weight loss products can be found at www.fda.gov/cder/consumerinfo/weight_loss_products.htm

Originally posted at InjuryBoard by Karl Truman

Dennis Quaid Testified Before Congress Regarding Injury to His Twins

Jennifer Moore — Thu, 15 May 2008 14:49:48 GMT

Yesterday, Dennis Quaid testified before Congress regarding the injuries his twins suffered due to the negligence of a prescription drug manufacturer. You can watch the video on our website, www.gminjurylaw.com.

In November, Quaid's 12-day-old twins, Thomas Boone and Zoe Grace, were undergoing intravenous antibiotic treatment for a staph infection at Los Angeles' Cedars-Sinai Hospital. According to standard procedure, nurses were supposed to clean the infants' IV lines with Hep-Lock, a drug containing a very small dose of the blood thinner heparin, to allow the lines to flow freely.

However, instead of the 10 units of heparin they were supposed to receive, the twins received 10,000 units, 1,000 times the prescribed amount. The babies survived, apparently with no permanent injury, Quaid told members of Congress, although no one knows whether they will show any long-term effects.

The actor grew emotional as he recalled a 41-hour ordeal in which his infants' blood was the consistency of water and their bodies bore bruises from internal bleeding.

"It made me feel that they had survived for a reason ... that maybe they were going to change the world in a little way," he said.

In researching the incident, Quaid told lawmakers he found that the bottles of 10-unit Hep-Lock and 10,000-unit heparin were "virtually indistinguishable." Both drugs are manufactured by Baxter Healthcare.

Originally posted at InjuryBoard by Jennifer Moore

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