Archive for July, 2008

Mississippi River Oil Spill Leaves Many Skeptical that Drinking Water is Safe

Even though they have been told city water is safe to drink, New Orleans residents aren’t buying it and are buying bottled water instead. following this week’s Mississippi River oil spill. One resident told The Times-Picayune that Mayor Ray Nagin’s recent statements that Algiers residents use city water in “moderation” had made some skeptical of claims that the supply is safe.

“The mayor’s saying, ‘Drink the water in moderation,’ so does that mean I’m going to get moderately sick?” said Ed Moise, an Algiers restaurant owner. “Or are my guests going to get moderately sick?” (more…)

Mississippi River Oil Spill Has Environmentalists Worried

The  Mississippi River oil spill is the worst New Orleans has seen in a decade, and concerns are growing about the impact the disaster will have on sensitive wildlife populations.   Two days after the spill, fumes from the fuel oil can still be smelled throughout New Orleans and up and down the river. Despite the acrid odor, health officials say the fumes pose no respiratory risks to residents.

As the oil slick continues to move downstream, there is a great deal of concern about its impact on the Delta National Wildlife Refuge. According to The New York Times, tens of thousands of feet of the plastic booms had already been put in place around the refuge. Thursday. If the oil flows through the main pass, or outlet, and on into the Gulf of Mexico, the effect will be limited; but if it seeps into the secondary passes, there is a more serious risk to the environment. (more…)

Zimmer Suspends Sales of Hip Implant Component Following Complaints

Zimmer Holdings is suspending sales of  the Durom cup hip implant component that some say is failing at high rates. Zimmer said it expected general need for early replacement of the device in patients to be low; however, Zimmer data and interviews with doctors suggest that hundreds of patients might need such procedures going forward.

As a result of halting sales, Zimmer said that it was also suspending United States premarketing trials of its system for resurfacing, the surgical process that is used in Europe with the Durom cup. That decision will put Zimmer further behind competitors that already have such products on the American market. (more…)

Vytorin Makers Go on Offensive

The makers of Vytorin have sent letters to doctors claiming that higher incidents of cancer among Vytorin users in a recent study was an “anomaly”. This latest Vytorin study – known as SEAS – was designed to investigate the effects of Vytorn in patients with aortic stenosis, partial blockage of the aortic valve in the heart. Left untreated, it can progress to death from heart failure or cardiac arrest.

In addition to failing to show that Vytorin did much to help patients with aortic stenosis avoid other heart problems, a safety analysis of SEAS found that Vytorin patients in the study had higher rates of cancer and cancer deaths. In the trial 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo. Researchers conducting the study said that while those numbers don’t prove a definitive cancer link, they were “statistically significant”, meaning the odds were less than 5 percent that they were the result of chance. (more…)

Pilot Involved in Mississippi River Spill Not Fully Licensed

The pilot of a tugboat pushing a barge that spilled thousands of gallons of toxic fuel oil into the Mississippi River near New Orleans did not have a proper license. The oil spill occurred early yesterday morning when a 600-foot tanker and the barge loaded with fuel collided. The barge split in half, spilling more than 419,000 gallons of tar-like oil into the river.

The barge’s owner, American Commercial Lines, immediately took responsibility for the oil spill. During a news conference in New Orleans, Coast Guard spokesman Stephen Lehmann said the tugboat operator pushing the barge had only an apprentice mate’s license, and no one else on the barge had a license. To pilot a tugboat, the operator should have had a master’s license, Lehmann said. The tug is operated by DRD Towing Co., LLC, of Harvey of Harvey, Louisiana. (more…)

Gardasil Declared Safe, Despite Side Effect Reports

Even with side effect reports nearing 10,000, the Food & Drug Administration (FDA) and Centers for Disease Control (CDC) are still standing by Gardasil. Earlier this month, the FDA and Merck announced that the prescribing information for Gardasil was being updated to include warnings about some of the more minor reactions seen after the vaccine, including joint and muscle pain, fatigue, physical weakness and general malaise. At the time, FDA spokeswoman Karen Riley told The Washington Times that the label updates have “nothing to do with” the serious cases that have been reported. She said the updates were made at Merck’s request and touch on possible “mild” symptoms.

As of June 30, 2008, there have been 9,749 Vaccine Adverse Event Reporting System (VAERS) reports of adverse events following Gardasil vaccination. Of these, 6 percent were deemed serious. The adverse event reports included 20 deaths, as well as reports of a rare neurological condition called Guillain-Barré Syndrome. (more…)

Birth Defect Risk Seen With Topamax

 

Topamax, a drug used to treat epilepsy and migraines, has been linked to birth defects, especially when used in combination with the drug valproate. Many epilepsy drugs carry an added risk for miscarriage and birth defects, but women with epilepsy often have no choice but to continue taking drugs like Topamax during pregnancy because epileptic seizures also put fetuses at risk. However, unlike many other epilepsy drugs, Topamax is taken by millions of women of child bearing age for migraines, which means much more of the population could be at risk for birth defects associated with the drug.

Since 2004, when the Food & Drug Administration (FDA) approved it for the treatment of migraines, Topamax has become one of the most widely prescribed drugs for the condition, which affects almost 30 million Americans. Women are three times more likely to suffer from migraines than men; women in their childbearing years are particularly vulnerable (more…)

Discovery of Tainted Jalapeno Sheds Light on Salmonella Mystery

The FDA has found a fresh jalapeno pepper tainted with Salmonella Saintpaul at a plant in Texas, prompting a new warning and a recall. Yesterday, the Food & Drug Administration (FDA) issued a recall of jalapeno peppers distributed by Agricola Zaragoza plant in Texas, the facility were the tainted pepper was discovered. The jalapeno pepper recall includes all those shipped from the plant since June 30. The jalapeno peppers being recalled were shipped in 35lb. plastic crates and in 50lb. bags with no brand name or label.

The FDA said no other produce currently in the plant has tested positive for salmonella, and was continuing to probe where the produce came from and went. The FDA has also not yet determined if the pepper became tainted at the plant, on the farm or somewhere in between. Officials from the FDA and CDC are on site in Mexico looking at farms and are studying the distribution center to see if the peppers could have been tainted during the handling and sorting process. (more…)

Another Study Raises Questions About Vytorin

The results of a new study indicate that Vytorin does not lessen the likelihood of heart attacks and other cardiac events in people  with aortic stenosis.  The  study – known as SEAS – also found that patients taking Vytorin were more likely to develop cancer.

SEAS is the second study to cast doubt on the effectiveness of Vytorin. The ENHANCE study, which was released on January 14, showed that Vytorin was ineffective in preventing clogged arteries, and might actually increase plaque in some users. When ENHANCE was vetted during the annual meeting of the American College of Cardiology in March, doctors there recommended that it be used only as a last resort. “Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz.

(more…)

American Red Cross Under Scrutiny

Despite facing a court order and millions of dollars in fines over the way it handles the blood supply, the American Red Cross is still not doing enough to make sure donated blood is safe.  Now, officials at the Food & Drug Administration (FDA) is threatening to initiate criminal charges if the Red Cross doesn’t get its act together.

The American Red Cross has been under a court order for the past 15 years to improve the way it handles the nation’s blood supply. Since 2003, the Red Cross has been fined more than $21 million for failing to do so. The Red Cross controls 43 percent of the country’s blood supply. According to FDA records, some of the safety lapses at the Red Cross that resulted in fines put patients in danger, and exposed them to diseases like hepatitis, malaria and syphilis. Despite repeated incidents, the FDA says the Red Cross has failed to investigate the results of its mistakes, so no one knows for sure if any of the incidents resulted in patient injuries. (more…)