Archive for March, 2008

Salmonella Tainted Water in Colorado Won’t be Safe for Weeks

 

The city of Alamosa, Colorado began flushing its water system with chlorine today in an attempt to eradicate the salmonella bacteria that has left more than 200 people sick. Unfortunately, it could be weeks before the Alamosa’s salmonella tainted water is safe to use. More than 200 residents of the small Colorado town have come down with symptoms of Salmonella poisoning, and health officials in the state still do not know what caused the contamination of the city’s water supply.While the city is flushing the system, the water will be unsafe to use even if it is boiled, due to the high amount of chlorine that is being used.

The Los Angeles Times reports that the salmonella scare has taken a toll on the town of roughly 10,000 people. Bottled water is scarce, with most residents relying on public distribution centers. Businesses have closed, and restaurants are empty. (more…)

Endoscopy Center of Southern Nevada Docs May be Subpoenaed

The city of Las Vegas will subpoena the doctors who own the  Endoscopy Center of Southern Nevada  to testify at a hearing that will determine if the clinic keeps its business license.  The April 7 hearing could mark the first time any of the clinic’s owners will speak publicly since a scandal over unsanitary practices employed by the Endoscopy Center of Southern Nevada first broke.  Those unsanitary practices could have exposed thousands of the clinic’s patients to hepatitis and HIV.

According to the Las Vegas Sun, Las Vegas officials in the process of subpoenaing the physicians who own the Endoscopy Center of Southern Nevada — majority owner Dr. Dipak Desai, Dr. Eladio Carrera, Dr. Clifford Carrol and Dr. Vishvinder Sharma.  According to the newspaper’s website, Desai has voluntarily agreed to stop practicing medicine during the Nevada State Board of Medical Examiners’ investigation of his conduct. The others may still be practicing at other affiliated clinics or in local hospital. (more…)

Long Island Mama Sbarro’s May Have Exposed Customers to Typhoid Fever

Patrons at a Long Island, New York Mama Sbarro’s restaurant have been advised to get tested for typhoid fever, after an employee there was diagnosed with the disease. Authorities from the Nassau County Department of Health identified the infected worker only as a New York City man who worked without symptoms on March 14 and 15 and had some symptoms on March 16.  The typhoid fever may have been passed to him from relatives visiting from overseas, authorities said, though they would not say from what country or when the relatives visited. The man was treated at a hospital and released last week and is now undergoing treatment with antibiotic drugs, authorities said; he will be monitored by the New York City Department of Health and Mental Hygiene for three months.

Typhoid fever, or Salmonella typhi, is a bacterial infection in the intestines contracted through eating food or drinking water contaminated by an infected person’s feces or urine, said Dr. Ken Steier, the patient safety officer at Nassau University Medical Center. Symptoms include fever, headache, constipation or diarrhea, rose-colored spots on the torso, and an enlarged spleen and liver and generally appear one to three weeks after exposure. Cases can be treated with specific antibiotics; the fatality rate for those who don’t get antibiotic treatment is about 20 percent, Steier said and less than one percent for those who do take antibiotics. Typhoid is rare in developed countries and there are about 400 cases of typhoid fever annually nationwide. Nassau County has seen between two and seven cases annually since 2003. About 75 percent of the time, the infected person contracted the disease while visiting a developing country, Steier said. (more…)

Heparin Supply Adequate, FDA Says

The Food & Drug Administration (FDA) says heparin supplies in the US are adequate, despite the fact that three companies have recalled heparin since January. The recalls came after heparin made by Baxter International was linked to hundreds of severe, allergy type reactions, and some deaths.

Baxter recalled 9 lots of its heparin in January, following reports of reactions. In February, Baxter expanded the recall to include all of its heparin and announced it was temporarily suspending sales of the drug. Reported reactions to Baxter heparin have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening. To date, Baxter heparin has been implicated in over 700 adverse reactions and possibly 19 deaths. (more…)

New Warnings Possible for Suprane, Colazal

Suprane and Colazal need more warnings regarding heart and lung problems that may occur when the drugs are used in children, according to documents posted on the Food & Drug Administration (FDA) website by agency staff. The FDA periodically reviews the safety of medicines recently approved for pediatric use, as required by the Best Pharmaceuticals for Children Act of 2002. According to the agency, outside experts on the agency’s Pediatric Advisory Committee will consider the recommend label changes for Suprane and Colazal on Tuesday.

Colazal was approved by the FDA in July 2000 for the treatment of mildly to moderately active ulcerative colitis. At approval, Colazal was the first oral new chemical entity approved in ten years and the first new therapy approved in seven years by the FDA for this indication. Colazal was one of Salix Pharmaceuticals Ltd.’s biggest selling drugs, but sales were hit hard in December because of the introduction of the introduction of generic competitors. The FDA staff has recommended that Colazal add new warnings on heart and lung risks to match those now carried by other drugs in the same class. (more…)

Another Heparin Recall, This Time From B. Braun

B. Braun is the latest company to recall heparin amid concerns that heparin ingredients imported from China were contaminated with a counterfeit ingredient. Concerns over the safety of the US heparin supply have been mounting since heparin sold by Baxter International was recalled earlier this year.  Baxter heparin has been linked to over 700 adverse reactions in the US, including 19 deaths.

On Friday, B. Braun Medical Inc of Irvine, California, announced a recall of 23 lots of its blood thinner after being notified by its supplier of a nationwide recall of Heparin Sodium USP because of the contamination issue. The company said it was was recalling the heparin lots as a precautionary measure, after Scientific Protein Laboratories said that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient it bought has a heparin-like contaminant. So far B. Braun Medical Inc. has not received any adverse event reports related to this issue. Scientific Protein Laboratories is the same company that provided the active ingredient for Baxter International’s heparin. (more…)

FDA Warns on Prezista

Prezista, has been linked to liver damage, prompting the Food & Drug Administration (FDA) to issue a warning on the HIV drug Friday.

According to the FDA, Prezista may be related to liver adverse events in 24 cases, including hepatic failure, hepatic necrosis, cirrhosis, hepatitis, jaundice and increased liver function tests. In all cases, patients were taking other drugs or had underlying medical conditions that may have contributed, the agency said. In nine of the 24 cases, the patient reported co-infection with hepatitis B or C. The FDA said that Johnson & Johnson’s Tibotec Therapeutics, the maker of Prezista, has sent a Dear Healthcare Professional letter to doctors, and the prescribing information and the package insert of Prezista have been changed to reflect the liver damage warning. (more…)

Salmonella Tainted Cantaloupes Sicken 50 in US and Canada

A warning regarding Salmonella tainted cantaloupes has been issued on two fronts. According to the US Food & Drug Administration (FDA) cantaloupes imported from Honduras have blamed for an outbreak of food poisoning that spans 16 states and several Canadian provinces. In addition, the Dole Fresh Fruit Company has recalled cantaloupes it purchased from a grower in Costa Rica because those cantaloupes have tested positive for Salmonella as well.

According to the Centers for Disease Control (CDC), Salmonella bacteria sicken 40,000 people every year. Although the true number could be much higher, because it is estimated that for every case of Salmonella poisoning reported, two others are unreported. Salmonella causes fever, abdominal pain, nausea, gas and bloody diarrhea. Symptoms appear within 36 hours of exposure, and usually last four to seven days. In very severe cases, Salmonella can lead to kidney failure and other complications. Salmonella can be particularly dangerous for children, the elderly and people with weakened immune systems. In rare cases, Salmonella can cause a disease called Reiter’s Syndrome, a difficult- to- treat condition that causes severe joint pain, irritation of the eyes, and painful urination. (more…)

UAB SA Recalls Neupro Patch, Warns of Shortage

Just weeks after warning that its Tussionex cough suppressant had been linked to accidental overdoses, UCB SA has issued a recall of its Neupro patch used in the treatment of Parkinson’s Disease. The company said that a manufacturing defect has prompted the Neupro recall, which is expected to cause a shortage of the medication in the United States.

According to a UCB press release, the company is recalling all Neupro patches in the United States, as well as some lots of the medication in Europe, after uncovering a “deviation from the approved product specification”. The company was not specific about the nature of the Neupro defects, but said they were “not one of product contamination or toxicity but rather one of possibly reduced clinical performance of some patches”. UCB did say that because of the recall, it expects supplies of Neupro to run out in the United States within the next few months. (more…)

SEC Could Move Against Bear Stearns Execs For Misleading Statements

The Securities and Exchange Commission (SEC) is considering an investigation of Bear Stearns over assurances some of its executives made about its solvency in the days before its collapse.

Bear Stearns was once one of the biggest investment banks on Wall Street before being acquired by JP Morgan Chase over the weekend in an effort to salvage the failing institution. Two of its hedge funds, heavily invested in subprime mortgages, folded in July. Bear’s investors became increasingly reluctant to do business with the company. Despite the company’s assurances that it had plenty of cash on hand to continue operations, it collapsed last Friday. (more…)