Suicidal Behavior in Antiepileptic Drug Patients – FDA

The FDA announced today that is has completed review of reports of suicidal behavior from its clinical studies of 11 drugs used to treat epilepsy, psychiatric disorders and other conditions. In the Agencies investigation patients using the following antiepileptic drugs had twice the risk of suicidal behavior than those taking placebo:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

The FDA further alerted healthcare professionals to closely monitor their patients using any antiepileptic drugs for behavioral changes that could result in suicidal thoughts, actions, behaviors or depression. The FDA expects that label changes to these drugs will occur in a broad based manner.

If you have lost a loved one to suicide due to use any of the antiepileptic drugs listed and would like to learn your legal rights, please contact us 1-888-775-3779. Our law firm is presently investigating claims involving antiepileptic drugs and suicide.

NuCel Eye Drop Recall and Eye Wash Products. Recall

January 31, 2008

The FDA announced a recall to consumers and healthcare professionals about NuCel Labs voluntarily Eye Drop Recall and Eye Wash Products. This is a nationwide recall due to testing which indicated potential bacteria and particulate matter making the products non-sterile. Use of the products poses an unacceptable risk of eye infections and in rare cases blindness or loss of vision.

There are presently no reported injuries and consumers are asked to discontinue use and immediately return the product to NuCel Lab. If you or a loved has been injured from using these products please seek immediate medical attention. Our law firm is presently investigating injuries and eye infections from the use of this product.

Contact us today for a free confidential case review.

Zetia – Vytorin Draw FDA Scrutiny

January 22 2008 – Merck/Schering-Plough announced the pulling of all TV advertisements for the drugs Zetia and Vytorin. Zetia alone is a Merck/Scherin anti-cholesterol drug and Vytorin is a drug that contains both Zetia and Zocor(simvastation).

Reports by consumers of severe and potentially life threatening side effects appear to be growing related to rhabdomyolysisa, a rare a possibly fatal disease involving destruction of skeletal muscle, as well as serious liver related injuries and damage, thrombocytopenia, hepatitis and pancreatitis.

If you or a loved one has been injured or has suffered serious side effects of Vytorin or Zetia, visit www.resource4thepeople.com

Ketek Side Effects Federal Investigation

A congressional subcommittee wants to subpoena criminal investigators at the Food and Drug Administration about their own probe concerning the antibiotic Ketek, which has been linked to liver failure.

For months, subcommittee leaders have alleged that the FDA approved Ketek even though the agency knew the large safety study it required before approval was fraught with data problems. A vote on issuing the subpoenas is scheduled for Tuesday.

Ketek was approved in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. After receiving reports of liver failure in patients treated with the drugs, the FDA last February issued a black box warning — its sternest — and restricted use to patients with pneumonia.

Ketek, metabolized by the liver, is an orally-taken medication. Typically, it is prescribed in adult (over 18) patients who have lung and/or sinus infections that have been caused by bacteria rather than a virus. mlive

For more information about Ketek and Ketek side effects visit www.resource4thepeople.com or call us 24 hours a day/ 7 days a week at 1-866-242-0905

Nursing Home Abuse – Ohio Nurse Accused of Rape

SANDUSKY, Ohio — John Riems would leave Christmas cards on car windshields and barely wave to neighbors. The exceptionally private night-side nurse and his wife seldom had visitors to their tidy mobile home near Lake Erie. His co-workers said he had a temper and would swear at patients.

Officials say Riems had far more concerning behavior: the 49-year-old is accused of raping, nursing home abuse and assaulting a paralyzed patient.; the victim list could reach 100 if investigators believe what Riems claims.

Fire Star – Dura Star Balloon Catheters Recall

The FDA along with Cordis Corporation have issued a Class I recall of All Fire Star and Dura Star balloon catheters.

The defective medical device lots recalled are13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart.

Products manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star™ RX was distributed in the U.S. on August 29, 2007 and Fire Star™ RX was distributed in the U.S. on August 31, 2007.

The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.

Consumers with questions may contact Cordis, Inc. at 1-786-313-2000

For Legal Questions and assistance call 1-866-242-0905 or visit the Fire Star Recall section.

Thomas Toymakers to Pay 30 Million Dollars Settlement

The maker of “Thomas & Friends Wooden Railway” toys has agreed to pay $30 million to settle a nationwide class-action lawsuit by thousands of families who purchased lead-tainted products, a plaintiffs’ attorney said Wednesday.Under the deal, Oak Brook-based RC2 Brands will offer cash refunds or replacement toys, plus what the company calls a bonus toy; it also promises to implement new quality controls, said Jay Edelson, a plaintiffs’ attorney in the case.

“We believe this really is the first step toward cleaning up the problem of lead paint in toys,” the Chicago attorney said. “It will put a lot of pressure on other companies to step up and act morally. We hope this becomes a problem of the past.”

The lawsuit was filed in the Circuit Court of Cook County last year, and the court gave the settlement preliminary approval on Tuesday. The judge is expected to give final approval at a hearing set for May 6, Edelson said.

This is the latest string in Toy Recalls and Defective Products recently in the US and Abroad.

Here is a short list from the recall and Consumers can also contact RC2 at (866) 725-4407 between 8 a.m. and 5 p.m. CT Monday through Friday or visit the firm’s Website at http://recalls.rc2.com

The front of the packaging has the logo “Thomas & Friends Wooden Railway” in the upper left-hand corner.

A tracking code may be located on the bottom of some of the products. Toys marked with codes containing “WJ” and “AZ” are not included in the recall.

The All-Black Cargo Car, included only in the Brendam Fishing Dock Set, is labeled “CARGO CAR” and has either no tracking code or one of the following codes on its undersides: 26833i, 28233i, 23243i00, 24643i00, 25343i00, 27443i00, 32043i00, 34743i00, 01553i00, 04553i00, 13353i00, 14753i00, 15453i00, 18353i00.

The toad vehicle with brake lever is labeled “TOAD” and has the tracking code 16560W000 on its underside. The Olive Green Sodor Cargo Box says “SODOR” on the side. The box was included only in the Deluxe Cranky the Crane Set.

The All-Green Maple Tree Top and Green Signal Base accessories were included only in Conductor’s Figure 8 Sets.

Cargo cars sold in other sets are not included in the recall.

If you believe that you have been adversely affected by a toy recall you can visit www.resource4thepeople.com for more information and legal help.

FDA Warns Stryker Howmedica Osteonics on Hip Implant

January 16, 2008

Stryker Howmedica Osteonics manufactures femoral hip components that are used for surgical implants.

The FDA has warned Stryker to fix the hip implant problems: In a letter to Stryker Federal Regulators wrote:

“Your firm has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence,” the letter states.

The FDA said it was aware that the company has received patient complaints starting January 2005 on many existing problems. Reported problems include improper fitting of hip implants that has caused bone fractures. Patients were also known to have complained about pain, difficulty walking and “squeaky” joins, and some have even had pieces of the implant parts break off.

If you have been hurt, injured or have experienced any problems with a Stryker Hip Implant, contact us today for a free case evaluation. www.resource4thepeople.com

1-866-242-0905

Catalytic Converter Theft Warning

This holiday season has seen an explosion in thefts of expensive, platinum-laced catalytic converters from parked cars, and authorities report that high-clearance sport utility vehicles are the targets of choice for thieves.

With a common socket wrench and 90 seconds, they leave drivers stuck with cars that sound like Harley-Davidson motorcycles, and facing repair bills topping $1,000.

“It’s an epidemic. It’s everywhere,” said Lt. Bob Turnbull of the El Segundo Police Department.

Thefts of catalytic converters have been logged in the last month in Los Angeles, Pasadena, the Bay Area and Sacramento. Arrests have been reported from Seattle to Virginia, near Pittsburgh, in the Maryland suburbs of Washington, D.C., and in Tennessee, where the Highway Patrol busted a thief cutting converters from cars impounded in one of its own lots.

“We’ve had them all over the place; we’ve had them in broad daylight in a Vons parking lot,” said Det. Jason Knickerbocker of the Manhattan Beach Police Department. “Most of them are at night. A lot of times, we never find the victim.”

The prize is a catalytic converter, a device used to reduce emissions. Platinum is more valuable than gold, and the contents of a typical converter are worth $40 to $50 to scrap-metal dealers.

Some thieves use saws, but the preferred weapon in Southern California is a ratchet with a 14-millimeter socket. The thief crawls under the car and unfastens the bolts holding the converter, a process that accomplished crooks can complete in 90 seconds.

Read the full article at the LA Times…..

Asbestos fine possible for University

Winona State University faces a proposed fine of $24,500 for seven serious workplace safety violations related to asbestos removal from dormitories and other campus locations this year.

The university repaired or replaced insulation without taking the necessary precautions to protect workers from asbestos, according to the complaint from the state Occupational Safety and Health Division.

James Honerman, an OSHA spokesman, said he could not provide any details about the citations, which the university received last month, because Winona State has contested the allegations and the matter has not been resolved.

What is Asbestos ?

How does asbestos cause Mesothelioma ?

Cristeen Custer, assistant vice president of marketing and communications at Winona State, said the university is cooperating with OSHA. “We take it seriously, and we do believe that we’ll come to a very positive result with our discussions with OSHA,” she said.

When asked whether students may have been exposed to asbestos during any of the repair work, Custer said: “Obviously student safety is of critical importance to us and we would never jeopardize or take liberties with student or worker health. If there was a concern we would have alerted students.”

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