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FDA Requiring Label Changes for Amgen Anemia Drugs

The Food & Drug Administration (FDA) has required tough new warnings and restrictions for Aranesp, Epogen and Procrit. Yesterday’s announcement that the agency was requiring further label changes and restrictions is the first time the FDA has used authority granted to it in 2007 to force a drug maker to change a drug’s label.

In March, an FDA advisory panel recommended new restrictions for the drug. The FDA mandated label will say that the drugs shouldn’t be used in cancer patients receiving chemotherapy when a cure of their cancer is anticipated. The FDA also ordered inclusion of a statement that the drugs aren’t to be administered when hemoglobin levels are greater than or equal to 10 grams per deciliter. Language is being removed that seemed to imply that it was safe to continue treating patients until their hemoglobin rose to 12 grams per deciliter. (more…)

Breakthrough Reported in Salmonella Investigation

The Food & Drug Administration (FDA) has identified Salmonella Saintpaul on Mexican-grown serrano peppers, and has also traced the bacteria to contaminated irrigation water on a farm in Mexico. Laboratory testing by the FDA confirms that both a serrano sample and a sample of irrigation water collected by agency investigators on a farm in the state of Tamaulipas, Mexico—the farm’s business address is in Nuevo Leon, Mexico—contain Salmonella Saintpaul with the same genetic fingerprint as the bacterial strain causing the current outbreak in North America. This particular Salmonella Saintpaul fingerprint is normally seen in only 25 cases a year, said Ian Williams, chief of the Center for Disease Control and Prevention’s (CDC) Outbreak Net.

Spokesman Michael Herndon said that no one should eat raw serrano peppers from Mexico. Cooked or pickled peppers from cans or jars are not included in the warning. The FDA is also advising consumers to also avoid raw jalapeño peppers from Mexico, and any foods that contain them. (more…)

More Oil Leaking from Barge Involved in Mississippi River Oil Spill

The barge involved in the Mississippi River oil spill released more fuel oil yesterday, forcing closure of the river to traffic for about six hours. News of the new leak also heightened concerns over the safety of water supplies in nearby communities. According to the Coast Guard, yesterday’s oil leak was the result of a three-foot drop in the river’s level that allowed the barge to shift. Unfortunately, yesterday’s incident is not likely to be the last time the barge leaks toxic fuel into the river.

“These burps may happen again, ” Coast Guard Capt. Lincoln Stroh, who oversees the Port of New Orleans, told the Times-Picayune. “Only until we secure that barge and pump out or suck the fuel out of that barge will it stop.” (more…)

3 Deaths Linked to Baxter Heparin

Federal regulators have been able to tie tainted heparin sold by Baxter international to three deaths, out of 93 investigated by the Food & Drug Administration (FDA).

According to an article in The Chicago Tribune, the FDA said it completed its review of the death reports related to heparin that the agency received from Jan. 1 to March 31, when reports of heparin adverse reactions peaked. Of 10 reports of death from severe anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths, so the FDA could not determine if those patients received tainted heparin. (more…)

Barge Owner Denies Responsibility for Mississippi River Oil Spill

 

While it will pay to cleanup the Mississippi River oil spill, American Commercial Lines, the owner of the barge involved in the incident, says it is not to blame for the collision that led to the spill. Yesterday at a news conference, Paul Book, vice president of operations facilities for American Commercial Lines Inc., affirmed that his company would take responsibility for the cost of the oil spill cleanup. However, Book said American Commercial Lines was not responsible for the incident that caused the spill. “We were not the operator of the towing vessel nor the operator of the ship,” Brook said.

Separately, in a filing with the Securities and Exchange Commission, American Commercial Lines denied blame for the accident because its barge was controlled entirely by the Mel Oliver, a tugboat owned by DRD Towng of Harvey, Lousiana. In the filing, American Commercial Lines also confirmed it had been named in three class action lawsuits related to the oil spill. The company says it is seeking exoneration from the lawsuits, or limited liability. (more…)

Evidence Linking Mirapex to Compulsive Behavior Mounts

Evidence is growing that Mirapex and similar drugs used to treat Parkinson’s Disease cause compulsive behavior, including gambling addiction, in some patients. In June, results from the largest study ever to investigate the connection between compulsive behavior and dopamine agonists was presented at the at the International Congress of Parkinson’s Disease and Movement Disorders conference in Chicago. That study found that more than 13 percent of patients taking dopamine agonists, sold under brand names suffer from at least one of four serious behavioral addictions.

For years, people taking Mirapex and similar drugs have complained about problems with compulsive behavior. Most of those complaints involved people who had no history of compulsive behavior before they started dopamine agonist therapy, and most reported that the behavior stopped as soon as they quit using the drugs. Several small studies, including one published in 2005 by Mayo Clinic researchers, found a link between the drugs and compulsive behavior, especially gambling addiction. The drugs’ labeling also includes warnings about possible compulsive behavior. (more…)

More Revelations About Tugboat Company Involved in Mississippi River Oil Spill

The company that owned the tugboat involved in last week’s Mississippi River oil spill had a spotty safety record and failed an audit in May.

The barge responsible for the oil spill was being pushed by the tugboat the Mel Oliver, owned by DRD Towing out of Harvey, Louisiana. Last week, the US Coast Guard determined that no one on the Mel Oliver had the proper licensing for piloting a tugboat. The operator on the Mel Oliver at the time of the collision had only an apprentice mate’s license, and no one else on the barge had a license. To legally pilot a tugboat, an operator is required to have a master’s license. (more…)

Calls for Joint Implant Registry Renewed Following Zimmer Durom Hip Implant Debacle

Last week, Zimmer Holdings suspended sales of its defective Durom Cup hip implants, because of a high number of patient complaints. But if a national joint registry had been tracking complaints, Zimmer may have been forced to take the Durom cup off the market sooner.

Several countries, including Australia, Britain, Norway and Sweden, use joint registry databases to track the performance of artificial joint components, and they have proven invaluable in getting defective devices recalled quickly. If such a system were in use here, it could spare tens of thousands of patients from severe, painful injuries caused by defective implants like the Durom Cup. (more…)

Class Action Lawsuit Filed in Mississippi River Oil Spill

Two New Orleans residents have filed a class action lawsuit against the parties involved in last week’s Mississippi River oil spill. The lawsuit, filed Thursday in the U.S. District Court for the Eastern District of Louisiana, seeks to benefit all New Orleans residents adversely affected by last Wednesday’s oil spill. Under the Oil Pollution Act of 1990 (OPA), individuals and entities impacted by oil spills are entitled to compensation for property damage, loss of income and other damages from the parties responsible for the spill.

The Mississippi River oil spill class action lawsuit was filed by New Orleans residents Stephen Marshall Gabarick and Bernard Attridge. The plaintiffs are being represented by Louisiana attorneys Camilo K. Salas III and Daniel E. Becnel Jr., as well as Parker Waichman, LLP a law firm headquartered in Great Neck, N.Y (more…)

As Mississippi River Oil Spill Continues, Questions Raised Over Towing Company

Cleanup of last week’s Mississippi River oil spill continues, as a handful of ships have been allowed to make their way downriver. Meanwhile, more questions have been raised about the safety record of a Louisiana towing company that owned a tugboat involved in last Wednesday’s accident.

Almost 800 cleanup workers used containment booms, vacuum skimmers and other equipment over the weekend to scrub oil-coated riverbanks. Around 10 ships and barges have been stranded on the river due to the oil spill. According to the Times-Picayune, fifty vessels were allowed to move inside the spill zone Saturday, up from only four Friday. Two cleaning stations have been set up for ships leaving the spill zone, one at New Orleans and the other near the mouth of the river. As of Saturday afternoon, three ships had been allowed to pass into the Gulf of Mexico, and another was able to leave the zone’s northern end. Another 10 ships were cleared to leave the zone once they are cleaned. (more…)

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