FDA will add most serious safety warnings to bowel-clearing drugs after reports of kidney damage

On December 11, 2008, the Food and Drug Administration (FDA) said it is going to add the most serious safety warning available to bowel-clearing drugs used before colonoscopies. The warning comes after the agency received more than 20 reports of a serious form of kidney failure in patients taking the drugs.

The now boxed warning will apply to Salix Pharmaceuticals’ Visicol and OsmoPrep, prescription tablets that have been found to also cause lethargy, drowsiness and swelling.

Labels on the drugs, which are also known as oral phosphate products, warn patients older than 55 to use them with caution, especially those patients who suffer from dehydration and kidney disease. Patients who take other medications that affect the kidneys should also be cautious when taking Visicol or OsmoPrep.

Kidney damage in patients may occur within days or weeks of taking the medications, but other symptoms may not appear until much later.

In addition to the medications’ warnings, Salix Pharmaceuticals will distribute a medication guide warning about the drugs’ risks. Salix Pharmaceuticals must also conduct a follow-up study to determine which patients are most vulnerable to kidney damage.

The potential for kidney damage was first linked to Visicol and OsmoPrep in 2006, and a recent petition submitted to the FDA asked the agency to place a boxed warning on the drugs.

Source: “Bowel-clearing drugs to get sternest FDA label,” MSNBC.com, December 11, 2008.

Safety Commission investigating design of recreational vehicles after fatal accidents

Yamaha Motor’s Rhino center of probe

In November 2008, the United States Consumer Product Safety Commission announced it is investigating the design of recreational off-highway vehicles, such as Yamaha Motor Company’s Rhino, after reports of more than 30 fatal accidents.

The inquiry focuses on gaps in oversight of the products, which are larger than all-terrain vehicles (ATVs), seat two and have a protective roll cage. Current rules for conventional ATVs don’t apply to the recreational vehicles due to their designs, leaving the products unregulated. A seeming increase in deaths related to the vehicles led to the probe.

The Yamaha Rhino is at the center of the probe, with at least an estimated 30 consumer deaths. Other models include Polaris’ Razor, Honda Motor Company’s Big Red, Kawasaki Heavy Industries’s Mule, and Arctic Cat Inc.’s Prowler.

A California-based association for recreational off-highway vehicles is in the process of developing safety standards for review by early 2009. The commission intends to study how the vehicles are being used, how injuries are happening and how consumer behavior may cause injuries.

Source: Alan Ohnsman and Mary Jane Credeur, “US Agency reviews unregulated off-road vehicles after deaths,” Bloomberg.com, November 4, 2008.

Johnson & Johnson ordered to pay $13 million in fentanyl overdose lawsuit

Family of woman killed by defective painkiller patch granted compensation

On October 28, 2008, a jury ruled two Johnson & Johnson subsidiaries, Janssen Pharmaceutical Products and Alza, are responsible for the death of a 34-year-old woman who died from a painkiller overdose caused by a patch the companies manufactured. Johnson & Johnson was ordered to pay more than $13 million to the woman’s family.

The victim was an Army military policewoman who used Duragesic patches in combination with other painkillers after undergoing back surgery. Personal injury lawyers and family members of the deceased woman argued officials for Johnson & Johnson were aware of manufacturing defects in the company’s Duragesic patches, but sold the flawed devices anyway.

The product liability lawsuit was the third case over Duragesic patches to go to trial since 2006. Jurors have ruled against Johnson & Johnson in all three cases.

Duragesic patches were approved in 2000, but reports of adverse events related to the patches began occurring as early as 2001. The active ingredient in Duragesic patches is fentanyl, a drug under investigation by the U.S. Food and Drug Administration (FDA) due to reports of adverse respiratory events experienced by patients wearing the patch.

In July 2005, after a recall of Duragesic patches due to leaks, the United States Food and Drug Administration (FDA) began a probe of 120 fentanyl overdose deaths linked to Duragesic patches made by Johnson & Johnson and Mylan Laboratories Inc.

In an August 2008 U.S. Securities and Exchange Commission filing, Johnson & Johnson officials said Janssen, the distributor of the Duragesic patches, and Alza, the manufacturer, still face 60 product liability lawsuits over the patches.

Source: Jef Feeley, “J&J units must pay $13 million over pain-patch death, jury says,” Bloomberg.com, October 29, 2008.

Medical groups advise against using GlaxoSmithKline’s Avandia

Public Citizen petitions the FDA to ban the diabetes drug

In October 2008, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes announced that members of a medical panel unanimously advised against using GlaxoSmithKline’s controversial diabetes drug, Avandia. The Food and Drug Administration (FDA) also received a petition from consumer advocacy group Public Citizen asking the agency to ban the drug.

Avandia’s label already has a “black box” warning identifying 14 cases of liver failure caused by the drug, 12 of which resulted in liver-related deaths. Controversy surrounding the diabetes drug began in May 2007 when cardiologist Steve Nissen of the Cleveland Clinic published an article that found Avandia patients had a 43 percent higher chance of suffering a heart attack.

GlaxoSmithKline said it does not believe there is a connection between liver toxicity and Avandia. The FDA is reviewing Public Citizen’s petition. Officials from the agency have said there is a split within the agency over pulling Avandia off the market.

Avandia is a drug designed to help lower blood sugar in patients with Type 2 diabetes. It was approved by the FDA in 1999.

Source: Jennifer Corbett Dooren, “Leading medical groups advise against Avandia,” Wall Street Journal, October 31, 2008.

Firestone tires recalled due to insufficient tread base gauge

Continued use of recalled tires may lead to vibration, groove cracking

On October 29, 2008, Bridgestone Firestone North America Tire, LLC (BFNT) announced a recall of more than 160,000 imported tires because they were produced with insufficient tread base gauge. Consumers who continue to use recalled tires may notice tread separation or tread distortion, which could lead to a catastrophic injury from a car accident.

Included in the recall are 135,000 Firestone brand FR380 P235/75 R15 tires, imported into both the United States and Canada, and 27,000 LeMans Champion SE P235/75 R15 tires, imported into the United States.

The company said it has not received any reports of injuries related to the recalled Firestone tires. Consumers seeking information about identifying and inspecting tires may visit the company’s website.

Bridgestone Firestone North America Tire will notify owners of the recalled Firestone tires and will provide replacement tires. Owners may contact Bridgestone Firestone North America Tire at 1-800-465-1904, or may visit the company’s website.

For more information, consumers may also contact the National Highway Traffic Safety Administration’s Vehicle Safety Hotline at 1-888-327-4236, or visit SaferCar.gov.

Source: National Highway Traffic Safety Administration Campaign ID Number 08T026000, October 29, 2008.