Drug Lawsuit news

Calcium Gluconate Injection Recall

FOR IMMEDIATE RELEASE - July 18, 2011 - American Regent is conducting a voluntary nationwide recall to the user and consumer level of the following product:

Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package,
Lot # 1006, Expiration Date: January 2013, NDC # 0517-3900-25

PLEASE NOTE: This voluntary nationwide recall, initiated on July 18, 2011 to the user and consumer level is for lot # 1006 only. No other sizes or lots of Calcium Gluconate Injection, USP, are subject to this voluntary recall.

This voluntary recall was initiated because some of the vials of this lot may contain silicone particles. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if this lot of product is administered to patients.

Calcium gluconate is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. It is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage.

Calcium gluconate has also been employed to decrease capillary permeability in allergic conditions, non-thrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs. In hyperkalemia, calcium gluconate may aid in antagonizing the cardiac toxicity provided the patient is not receiving digitalis therapy.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Calcium Gluconate Injection, USP, 10%, Lot # 1006 for patient care, and should immediately quarantine any product for return to American Regent, Inc.

Please Note: Calcium Gluconate Injection, USP, 10% is a supersaturated solution and is prone to precipitation. Other lots and sizes may contain a precipitate that should dissolve upon warming. The Product Package Insert contains directions on dissolving this precipitate should it occur. However, the injection must be clear at the time of use. As stated in the Package Insert: “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

http://www.fda.gov/Safety/Recalls/ucm263531.htm

Mercedes-Benz G-Wagon LAPV 6.X

via www.uncrate.com

Based on the company's rugged G-Class SUV, the Mercedes-Benz G-Wagon LAPV 6.X is an armored patrol vehicle as fit for the battlefield as it is for the forest. Features include a diesel engine, a payload capacity of 1.3 tons, a full steel body, a mine deflector plate, an individual tire inflation system, and a number of advanced tactical military technologies from EADS.

Merck, Schering defend handling of Vytorin study

NEW YORK, Jan 25 (Reuters) - Merck & Co and Schering-Plough Corp on Friday defended their handling of a study of their shared cholesterol drug Vytorin amid criticism they lagged in releasing the study's results.

The mixed results of the "Enhance" trial, released Jan. 14, showed Vytorin failed to prevent buildup of fatty plaque in the carotid artery better than a widely used generic drug.

"While the Enhance trial was time consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial," Thomas Koestler, president of the Schering-Plough Research Institute, said in a statement.

Vytorin's manufacturers, Merck and Schering-Plough, announced that while the drug reduced levels of LDL, or bad cholesterol, in a group of 750 patients, the medication, which has been on the market since 2004, had little effect on the buildup of plaque in the arteries, a harbinger of heart attack and stroke.

Merck Pays $4.85 Billion for Vioxx Settlement

NEW YORK (Reuters) - Merck & Co has agreed to pay $4.85 billion to settle claims that its painkiller Vioxx caused heart attacks and strokes in thousands of users, the drugmaker said on Friday.                                                 

The agreement covers lawsuits filed against the company in U.S. courts, resolving a major legal battle that has dogged the drugmaker since it pulled Vioxx off the market three years ago.

Merck recalled the popular painkiller, which had $2.5 billion in annual sales, in September 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

In the settlement, reached with representatives of plaintiffs in federal and state courts, Merck did not admit Vioxx caused patient injury and did not admit fault.

Avandia - increased risk of heart failure

The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial is a six year study that has been on-going since 2003. But due to the meta-analysis study that concluded recently that rosiglitazone (Avandia) may cause heart attacks and fatal cardiovascular conditions, the researchers for the RECORD trial decided to publish some results in the middle of the trial.

The researchers concluded,

"Our interim findings from this ongoing study were inconclusive regarding the effect of rosiglitazone on the overall risk of hospitalization or death from cardiovascular causes. There was no evidence of any increase in death from either cardiovascular causes or all causes. Rosiglitazone was associated with an increased risk of heart failure. The data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction."

Rosiglitazone does have a side effect of increased risk of heart failure, which appears as a "black box" warning from the FDA, on the medication. Although the data wasn't strong enough to prove that rosiglitazone does cause an increase in risk of heart attacks, it does seem to support the FDA warning of increased heart failure risk.

Reuters reports that two advisory separate panels of the FDA are scheduled to study the issue of Avandia's safety at a series of meetings starting July 30. The endocrine and metabolic drugs committee and the drug safety and risk management committee will meet simultaneously, an FDA agency notice said.

The advisory panel will discuss the cardiovascular risks of the class known as thiazolidinediones, "with a focus on rosiglitazone," said an FDA statement. Rosiglitazone is the generic name of Avandia.

Lexapro, Zoloft, Paxil & Prozac Warnings

Expectant women and those trying to become pregnant should avoid taking antidepressants because of a risk of birth defects, a group of U.S. obstetricians suggested Thursday.

The American College of Obstetricians issued the warning, which is published as an opinion in the December issue of the journal Obstetrics & Gynecology.

The obstetricians said exposure to selective serotonin re-uptake inhibitors or SSRIs, a class of antidepressants that includes Prozac, Zoloft, Lexapro and Paxil, during the later stages of pregnancy has been linked with short-term complications in newborns.

But the group acknowledged that reproductive-age women face a higher risk for depressive disorders. Accordingly, the college suggested that doctors should decide on a case-by-case basis if women should continue to take the antidepressants.

Prempro Drug Trial In Second Day of Deliberations

No verdict after a second full day of jury deliberations Wednesday in a Benton woman’s lawsuit alleging that Wyeth Pharmaceuticals’ hormone drugs caused her breast cancer.

U. S. District Judge Bill Wilson Jr. ordered jurors to return at 9 a. m. today to the federal courts building in Little Rock to resume deliberations.

Jurors are asked do decide if the hormone drugs Premarin and Prempro were safely made and adequately labeled at the time Linda Reeves took them from 1992 to 2000 to prevent osteoporosis and alleviate vaginal dryness.

Reeves’ case is the first of several bellwether cases across the country to go to a jury. There are roughly 5,000 similar cases pending against Wyeth across the country.

Eli Lily Sued over Zyprexa

A West Baton Rouge Parish woman has filed a federal lawsuit against Eli Lilly and Co., claiming her son developed diabetes after taking the drug Zyprexa for three months in 2003.

Catherine Harrison’s lawsuit, filed Tuesday in U.S. District Court in Baton Rouge, says her son developed severe stomach and bowel problems and diabetes.

The lawsuit also claims the child has suffered extreme pain and will have substantial medical bills all his life. It also contends Eli Lilly did not give proper warning that the drug could have severe side effects.

Continue reading "Eli Lily Sued over Zyprexa"

Prempro Trial Getting Under Way

Merck has been the drugmaker in the news the past couple of months. It's fighting off thousands of Vioxx lawsuits one by one. But another company is set to steal that unwelcome spotlight. Wyeth is defending about 4,500 suits over its hormone replacement, Prempro. Six million menopausal women in this country have taken it. But the drug has been linked to breast cancer. Jury selection in the first case to go to trial began in late August.

Merck Loses Vioxx Lawsuit

New Orleans jury ruled against Merck in the latest trial related to the pain reliever Vioxx. The jury ruled that Merck failed to warn doctors about the medical risks associated with the drug. The jury also ruled a that a patient who had a heart attack after taking the drug is entitled to 50 million dollars of compensatory damages.

The panel has not decided on punitive damages in the case. Merck pulled Vioxx off the market in 2004 after a study found the drug increased the risk of heart attacks and strokes.