Friday, November 28, 2008

FDA Acts to Reduce Risk of Salmonella Infections

FDA Acts to Reduce Risk of Salmonella Infections

What do 1,000 yellow-bellied sliders and Mississippi map turtles have to do with public health?

These turtles can make people very sick.

On March 3, 2008, Strictly Reptiles Inc., a wildlife dealer in Hollywood, Fla., sold 1,000 baby yellow-bellied sliders and Mississippi map turtles to a souvenir shop in Panama City, Fla. The sale violated a Food and Drug Administration (FDA) ban on small pet turtles designed to protect the public from the disease-causing bacteria Salmonella. Turtles often carry Salmonella on their outer skin and shell surfaces, and people can get Salmonella infection by coming in contact with turtles or their habitats.

On July 14, 2008, the U.S. District Court in Fort Lauderdale convicted and sentenced Strictly Reptiles for its role in illegally selling, and offering for sale, live undersized turtles. The Florida District of FDA's law enforcement arm, the Office of Criminal Investigations (OCI), and the U.S. Fish and Wildlife Service investigated the case leading to the conviction, with help from FDA's Center for Veterinary Medicine.

"The illegal sale of these pet turtles put one of our most vulnerable populations—children—at risk for becoming very sick," says Philip Walsky, assistant special agent in charge in FDA's OCI Headquarters office.

Salmonella Infection Can Cause IllnessAll reptiles (turtles, lizards, snakes) and amphibians (frogs, salamanders) are commonly contaminated with Salmonella. The bacteria do not make these animals sick, but they can make people ill and even be life-threatening to children, elderly people, and others with weakened immune systems.

Small pet turtles are of particular concern because children are more prone to handling the turtles without washing their hands afterwards, and even putting the turtles in their mouths.
In 1975, FDA banned the sale of small pet turtles—those with shells less than four inches long.

Infectious disease specialists estimate that banning small turtles prevents 100,000 Salmonella infections in children each year in the United States. The ban excludes small turtles when they are used for educational, exhibitional, or scientific purposes—not as pets.

Despite the ban, in recent years, several widespread outbreaks of Salmonella infection related to undersized turtles have been reported to the Centers for Disease Control and Prevention (CDC).

In 2007, two teenaged girls in South Carolina became very ill with bloody diarrhea, cramps, fever, and vomiting after they swam in an unchlorinated, in-ground pool where the family's pet turtles had also been allowed to swim. The same strain of Salmonella found in the teenaged girls was also found in 101 other people in 32 states who were reported ill between early May 2007 and mid-January 2008, according to CDC. When 80 of these people were questioned, 47 of them confirmed that they had been exposed to a turtle during the seven days before they got sick.

In February 2007, the tragic death of a four-week-old baby in Florida was linked to Salmonella from a small pet turtle.

The owner of Strictly Reptiles admitted to OCI agents that he intentionally did not ask customers their purpose for purchasing the turtles in order not to lose sales.

On March 3, 2008, Strictly Reptiles sold about 1,000 undersized turtles to a souvenir business for $2.75 to $3.00 each. The souvenir business, in turn, sold the undersized turtles for $14.99 each.

At sentencing, the court ordered a criminal fine of $5,000, the forfeiture of more than 6,300 turtles, and two years' probation that allows federal agents to inspect sales records of all Strictly Reptiles' live turtles.

The court further ordered Strictly Reptiles to obtain a signed document from every buyer of undersized turtles that indicates the buyer is aware of the legal restrictions placed on the sale, or holding for sale, of these turtles.

"FDA will vigorously pursue its mission of protecting the public from those who violate the law, flagrantly disregarding the risk to public health for the sake of their own profit," says Walsky.

Don't buy small turtles for pets or as gifts.
If your family is expecting a child, remove any pet turtle (or other reptile or amphibian) from the home before the infant arrives.
Keep turtles out of homes with children under five years old, elderly people, or others with weakened immune systems.
Do not allow turtles to roam freely through the house, especially in food preparation areas.
Do not clean turtle tanks or other supplies in the kitchen sink.
Use bleach to disinfect a tub or other place where turtle habitats are cleaned.
Always wash hands thoroughly with soap and water after touching a turtle, its food or housing, or anything else that comes in contact with a turtle or its habitat.
Be aware that Salmonella infection can be caused by contact with turtles in petting zoos, parks, child day care facilities, or other locations.
Watch for symptoms of Salmonella infection, such as diarrhea, stomach pain, nausea, vomiting, fever, and headache.
Call your doctor if you or your family have any of these symptoms.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products.

For More Information

FDA Law Enforcers Protect Consumers' Healthwww.fda.gov/consumer/updates/oci072307.html

Pet Turtles: Cute But Contaminated with Salmonellawww.fda.gov/consumer/updates/turtles012508.html

Reptiles and Salmonellawww.cdc.gov/Features/ReptilesSalmonella/

Thursday, November 27, 2008

Demands For Baby Formula Recall Mount

Demands For Baby Formula Recall Mount

FDA Changes Its Story On Melamine Contamination, But Insists Products Are Safe

Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer group and the Illinois attorney general demanding a Food and Drug Administration recall.

The FDA shunned those calls, but admitted it had released inaccurate information on what chemicals were found in which top selling products.

As worried parents called manufacturers looking for guidance about the presence of melamine and a key byproduct in U.S.-made formula, the FDA reiterated its position that the baby food is safe and parents should continue feeding it to their babies, contending the extremely low levels of contamination do not present a health danger.

Also, a spokesman for one major manufacturer criticized the FDA for its release of the inaccurate information.

"We're getting inundated by calls from moms confused about the situation," said Pete Paradossi, a spokesman for Mead Johnson, one of the three major manufacturers of U.S.-made formula involved in the problem detections.

Melamine is the industrial chemical found in Chinese infant formula - in far larger concentrations - that has been blamed for killing at least three babies and making at least 50,000 others ill.

The FDA and said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, whereas melamine was intentionally added to the Chinese products. U.S. Manufacturers say their products are safe.

"The levels that we are detecting are extremely low," said Dr. Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "They should not be changing the diet. If they've been feeding a particular product, they should continue to feed that product. That's in the best interest of the baby."

Part of the confusion Wednesday stemmed from the FDA's own statements.

While proclaiming that the very low concentrations detected of melamine and a similar
compound called cyanuric acid pose no health danger to infants, the FDA has maintained it is unable to identify any exposure level of melamine in infant formula "that does not raise public health concerns."

Further complicating the situation was inaccurate data that FDA released to The Associated Press, which was disclose the formulas' brand names in an investigative report Tuesday.

A spreadsheet the AP obtained from the FDA under a Freedom of Information Act request stated that Mead Johnson's infant formula powder, Enfamil LIPIL with Iron, contained traces of melamine.

On Wednesday, FDA spokeswoman Judy Leon said that spreadsheet contained an error - that the FDA had incorrectly switched the names of the Mead Johnson product with Nestle's Good Start Supreme Infant Formula with Iron. That meant, Leon said, that the Nestle's Good Start had melamine while Mead Johnson's Enfamil had traces of cyanuric acid.

The FDA said last month that the toxicity of cyanuric acid is under study, but that in the meantime it is "prudent" to assume that its potency is equal to that of melamine.

Problems with melamine-spiked formula surfaced this fall in China, where unscrupulous manufacturers intentionally dumped it into watered-down milk to falsely elevate protein levels.

The concentrations in China were as much as 2,500 parts per million - about 10,000 times greater than what the FDA found in the U.S.

The FDA said there have been no reports in the United States of human illness from melamine. The chemical, which legally can be used in product packaging and a solution to clean
manufacturing equipment, can bind with other chemicals in urine, potentially causing damaging stones in the kidney or bladder and, in extreme cases, kidney failure.

Mead Johnson spokesman Paradossi said he was frustrated that the FDA had provided inaccurate information for worldwide distribution by the AP. He said the FDA informed his company of the test results, as well as the inaccurate disclosures only Wednesday, during an emergency conference call the agency staged with major manufacturers and the industry's trade group. During a similar call Monday, the FDA told the industry about the upcoming AP investigative report.

Nestle did not returns calls seeking comment Wednesday.

At the same time, Illinois Attorney General Lisa Madigan called on the state's public health department and the FDA to recall both the Nestle and Mead Johnson products - and urged the companies to take that step regardless of what any government agency does.

Madigan also criticized the FDA's handling of its test results.

The [FDA] apparently withheld the results of its testing from the public for over three weeks, and then only disclosed the information in response to a [Freedom of Information Act] request by The Associated Press.

Illinois Attorney General Lisa Madigan"The agency apparently withheld the results of its testing from the public for over three weeks, and then only disclosed the information in response to a FOIA request by The Associated Press," she wrote in a letter to Michael Leavitt, the secretary of the U.S. Department of Health and Human Services, which oversees the FDA.

As for possible consideration of a recall, the FDA's Leon said: "The agency would only seek to remove a product on the basis of a risk, based on scientific evidence. That's not what we're talking about here."

Consumers Union said that the FDA's assurances are of small comfort to parents and caregivers.

"The FDA originally said there was no safe level for these contaminants in infant formula. So this formula is contaminated," said Jean Halloran, the group's director of Food Policy Initiatives. "It is very disturbing to us that no recall has been requested."

She urged the FDA "to immediately make public all of the results of its tests for melamine contamination in food," even those with levels below what would trigger agency action."

Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, also has called for recalls.

During a series of calls with formula manufacturers starting Monday - put together hurriedly, according to several participants, as the AP was preparing to publish its story - the FDA has told manufacturers it has taken 230 samples of various products, including pediatric supplements and ingredients used in infant formula. Leon said that 87 of those samples are of infant formula, and that 77 of those have been analyzed.

Under the corrected information she relayed Wednesday, the results were:

Nestle's Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample, with readings of 0.137 and 0.14 parts per million.

Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron had three positive tests for cyanuric acid, at an average of 0.247 parts per million.

Separately, a third major formula maker - Abbott Laboratories, whose brands include Similac - told AP that in-house tests had detected trace levels of melamine in its infant formula. Those levels were below what FDA found in the other formulas, an Abbott spokesman said, and below any nation's safety guidelines.

The three firms - Abbott Laboratories, Nestle and Mead Johnson - manufacture more than 90 percent of all infant formula produced in the United States.

Tuesday, November 25, 2008

Increased risk of serious skin reactions from phenytoin therapy

FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502.

This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais.

Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug.

Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.

A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided in the MedWatch safety alert.

Read the MedWatch safety summary, including links to the Information for Healthcare Professionals and FDA Drug Information pages, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Phenytoin

Sunday, November 23, 2008

IKEA to pay fine for 2006 candle recall

IKEA to pay fine for 2006 candle recall

The government says the home furnishing company IKEA has agreed to pay a $500,000 fine for being slow to report defective outdoor candles.

The company recalled 133,000 packages of the candles in the United States in May 2006. The step came after IKEA received at least 32 reports of problems worldwide, including 12 reports of injuries.

The Consumer Product Safety Commission says IKEA did not promptly report problems with these candles, as the law requires.

In the settlement agreement with the agency, IKEA North America Services denies it knowingly broke the law.

Tuesday, November 18, 2008

HHS Opens Offices of the Food and Drug Administration (FDA) in China

HHS Opens Offices of the Food and Drug Administration (FDA) in China

As part of an ongoing strategy to continually improve import safeguards to meet the changing demands of a global economy, the U.S. Department of Health and Human Services (HHS) is this week officially opening offices of its Food and Drug Administration (FDA) in Beijing, Guangzhou and Shangai in the People’s Republic of China. HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach, M.D. will travel to the three cities this week to meet with manufacturers and Chinese government officials to discuss policy and governance reforms aimed at improving the safety of food and other consumer products. They will also mark the opening of the three offices, and introduce some of the HHS/FDA officials who will work there.

“We’re opening up a new era, not just new offices,” Secretary Leavitt said. “By having a presence in other parts of the world, we can work more closely with manufacturers and other governments, better share best practices and further ensure that quality and safety are built into food and consumer products at the point of manufacture.”

“A permanent FDA presence in China will help us address the challenges presented by globalization,” Commissioner von Eschenbach said. “We look forward to working with the Chinese government and manufacturers to ensure that FDA standards for safety and manufacturing quality are met before products ship to the United States.”

HHS is working to have an FDA presence in five geographic regions: China, India, Europe, Latin America and the Middle East. Recent Secretarial announcements and visits have highlighted HHS/FDA activities in these areas. During a visit to the Middle East in October, Secretary Leavitt announced that the FDA’s Middle East office will be headquartered in Amman, Jordan.

In June, the Secretary and other HHS and FDA officials met with government and industry leaders from Central America and México at a summit on product safety in El Salvador to outline possible ways of working together more closely, including through a proposed memorandum of understanding.

In December 2007, the United States signed two Memoranda of Agreement on the safety of food, feed, drugs and medical devices with agencies of the Chinese government. The agreements, signed by Secretary Leavitt for the United States, contain a framework for closer collaboration between HHS/FDA and its Chinese counterpart agencies to help assure Chinese products under HHS/FDA jurisdiction that come to the United States will be safer. As a result, the transmission of information between the agencies of the two countries has especially improved, and they have worked more closely to address safety concerns.

Establishing a permanent HHS/FDA presence in China will greatly enhance the speed and effectiveness of regulatory cooperation and efforts to protect consumers in both countries. HHS/FDA officials will also assist the Chinese Government, as requested, in its ongoing efforts to improve its regulatory systems for exports to help assure product safety.

FDA has selected eight senior experienced FDA officials to work in its offices in China. The employees are inspectors and senior technical experts in foods, medicines and medical devices. The HHS/FDA office in Beijing will be located in the US Embassy. In Guangzhou, it will be located in the U.S. Consulate General, and in Shanghai it will be part of the U.S. consular mission there, but will be situated in the Shanghai Centre, a well-established business complex in the city where several other U.S. government agencies have staff.

For more information about HHS import safety initiatives, visit http://www.importsafety.gov/.

For more information about HHS global health efforts, visit www.globalhealth.gov.

Monday, November 17, 2008

Health Canada Reminds Canadians About the Risks of Eating Raw or Undercooked Shellfish

Health Canada Reminds Canadians About the Risks of Eating Raw or Undercooked Shellfish

Information Update2008-174

Health Canada is reminding Canadians that raw bivalve shellfish - such as oysters, clams, scallops, mussels and cockles - can carry bacteria, viruses and toxins that can cause foodborne illnesses if they are not stored, handled or prepared appropriately.

Canada's Food Guide to Healthy Eating recommends that Canadians eat at least two servings a week of fish and seafood. However, as with all foods, it is important to store, handle and prepare shellfish and seafood appropriately to help prevent illness. In particular, children, pregnant women, the elderly and people with weakened immune systems (including people with liver diseases) are more susceptible to foodborne illness and should avoid eating raw or undercooked shellfish.

Here are some steps you can take to prevent foodborne illness from these foods:
Buy bivalve shellfish and seafood from reputable sources, and keep them cold (below 4 °C).
A retailer selling raw shellfish should be able to show you a shellfish shipper's tag.
Only shellfish from approved sources with a shellfish shipper's tag should be eaten.
Refrigerate these foods immediately after purchase.
Do not put live shellfish in a closed container or into fresh water.
Cover the shells with a damp cloth and place on the lowest shelf of the refrigerator.
Store shucked shellfish in a closed container.
Raw shellfish can be kept refrigerated for a few days, depending on their freshness and quality, and can be stored in the freezer for 2-4 months.
Shucked oysters should be frozen if you do not eat them within two days.
Check the packaging on frozen seafood.
Make sure that the packaging is not torn or open and that there is minimal frost or ice crystal formation on the packaging.
Too much frost could mean that the seafood has been frozen for a long time or has been thawed and refrozen.
Place the frozen seafood in the freezer immediately after purchase until you are ready to use it. You should never defrost seafood at room temperature.
Thaw food in the refrigerator, in cold water, or in the microwave if you will be cooking it immediately.
If thawing in cold water, replace water every 30 minutes.
Keep raw bivalve shellfish separate from cooked foods and follow good hygiene practices: wash hands before preparing foods, wash hands after handling raw shellfish, and wash counters and utensils with soap and warm water after preparation.
Make sure your shellfish is fresh.
Fresh oysters, clams, scallops, mussels and cockles should close their shells when you tap them. Shucked oysters (usually sold in tubs) are not meant for raw consumption.
It is best to cook oysters, clams, scallops, mussels and cockles to minimize the chances of foodborne illnesses.

Guidelines for cooking shellfish are: Boil oysters, clams, scallops, mussels and cockles until the shells open, and then boil for an additional 3-5 minutes.
You should also boil or simmer shucked shellfish for at least 3 minutes or until the edges curl. Steam for 4-9 minutes and throw out those that did not open.
Fry for at least 3 minutes at 190 °C (375 F). Bake for at least 10 minutes at 230 °C (450 F).
If you wish to harvest bivalve shellfish yourself, make sure you do so in areas that are open for harvesting.
Contamination due to impurities or natural toxins from marine algae can occur at any time of the year, and cooking will NOT destroy these toxins.

Contact your nearest Department of Fisheries and Oceans office listed in the blue pages of your local telephone directory for information on areas currently open for bivalve shellfish harvesting.

You may also want to check with your local or provincial government about harvesting restrictions or consumption advice for shellfish not purchased from commercial establishments.

It is estimated that there are as many as 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.

Thursday, November 13, 2008

Feds Offer Car Recall News Electronically(Wonder where they got the Idea?)

Feds Offer Car Recall News Electronically

The National Highway Traffic Safety Administration (NHTSA) has unveiled a new initiative to notify vehicle owners electronically when their car is recalled. The recall alerts can be received via e-mail or RSS-feeds on personal computers, cell phones or PDA devices-automatically and free-of-charge. However, consumers must sign up to receive the notices.

According to NHTSA, there are about 600 vehicle recalls each year. Historically, one in four motorists ignore these recalls when they are announced.

"It is extremely important that people are aware of recalls and act quickly to get their vehicles repaired," Transportation Secretary Mary Secretary Peters said. "When it comes down to it, ignoring a recall means ignoring a safety defect that could put you and your family at risk."

Under the new alert system, consumers can elect to receive all vehicle recalls as they are made public, or personalize the alerts to specific vehicles.

David Kelly, acting administrator of NHTSA, noted that the vehicle recall notification system is an expansion of the agency's consumer safety communications program. Earlier this year, NHTSA also introduced automated recall alerts for child safety seats and tires.

"I urge everyone to visit the safercar.gov website and sign up for all three recall alert programs," Kelly said. "In these cases, information is not just power, it can save your life and the lives of your family and loved ones."

To start receiving NHTSA's recall alerts, go to www.safercar.gov and select the "Email recall notifications" option.

p.s. (TRI members know this is a day late and a dollar short!)

Let us know what YOU think!

Wednesday, November 12, 2008

Shop CPSC Toy Safety Tips Before Shopping for Holiday Gifts

Shop CPSC Toy Safety Tips Before Shopping for Holiday Gifts

The holidays are here and the U.S. Consumer Product Safety Commission (CPSC) has its list.

Parents and gift buyers are encouraged to check it twice. Today, CPSC issued its annual holiday safety messages, joined by U.S. Customs and Border Protection (CBP) and Safe Kids Worldwide, to remind parents to be diligent when making holiday shopping choices.

“CPSC, CBP and industry activity has been with one goal in mind, to keep the toys our children play with the safest in the world” said Acting Chairman Nancy Nord. “Vigorous inspection of toys, testing and law enforcement have made toys the safest this season.”

For 2007, the Commission has reports of 18 toy-related deaths and CPSC staff estimates that there were about 170,100 hospital emergency-room treated toy-related injuries to children under 15. Most of the deaths were associated with airway obstruction from small toys, drowning, or motor vehicle accidents during play. Most of the injuries were lacerations, contusion and abrasions; the head and face was the area most frequently affected.

The top 5 toy hazards:
Scooters and other Riding Toys – Riding toys, skateboards and in-line skates go fast and falls could be deadly. Helmets and safety gear should be worn at all times and be sized to fit.

Small Balls and other Toys with Small Parts – For children younger than age three, avoid toys with small parts, which can cause choking.

Balloons - Children under eight yrs. can choke or suffocate on un-inflated or broken balloons. Keep un-inflated balloons from children. Discard broken balloons at once.

Magnets – For children under age six, avoid building or play sets with small magnets. If magnets or pieces with magnets are swallowed, serious injuries and/or death can occur.

Chargers and Adapters – Charging batteries should be supervised by adults. Chargers and adapters can pose thermal burn hazards to children.

Once the gifts are open:
Immediately discard plastic wrappings on toys before they become dangerous play things.

Keep toys appropriate for older children away from younger siblings.

Pay attention to instructions and warnings on battery chargers. Some chargers lack any device to prevent overcharging.

With the increased popularity of second-hand stores and on-line vendors, gift-givers should be especially vigilant to prevent the sale or purchase of hazardous products that have been recalled, banned or do not meet current safety standards. Before placing products in the second-hand market, check its recall status at www.cpsc.gov. Buyers should make sure their gifts do not include any of the recalled toys or children's products on CPSC's web site.

Saturday, November 8, 2008

Bottled water contains disinfection byproducts, fertilizer residue, and pain medication

Bottled water contains disinfection byproducts, fertilizer residue, and pain medication

The bottled water industry promotes an image of purity, but comprehensive testing by the Environmental Working Group (EWG) reveals a surprising array of chemical contaminants in every bottled water brand analyzed, including toxic byproducts of chlorination in Walmart’s Sam’s Choice and Giant Supermarket's Acadia brands, at levels no different than routinely found in tap water.

Several Sam's Choice samples purchased in California exceeded legal limits for bottled water contaminants in that state. Cancer-causing contaminants in bottled water purchased in 5 states (North Carolina, California, Virginia, Delaware and Maryland) and the District of Columbia substantially exceeded the voluntary standards established by the bottled water industry.

Unlike tap water, where consumers are provided with test results every year, the bottled water industry does not disclose the results of any contaminant testing that it conducts. Instead, the industry hides behind the claim that bottled water is held to the same safety standards as tap water.

But with promotional campaigns saturated with images of mountain springs, and prices 1,900 times the price of tap water, consumers are clearly led to believe that they are buying a product that has been purified to a level beyond the water that comes out of the garden hose.

FULL STORY: http://www.ewg.org/reports/bottledwater

Friday, November 7, 2008

ThermoGenesis Corp. of Rancho Cordova reported a bigger fiscal first-quarter loss as it announced plans for a product recall.

ThermoGenesis Corp. of Rancho Cordova reported a bigger fiscal first-quarter loss as it announced plans for a product recall.

The company lost $2.7 million, or 5 cents per share in the quarter ended Sept. 30. That was 17 percent worse than the loss of $2.3 million, or 4 cents per share, in the company’s fiscal first quarter last year.

First-quarter revenue totaled $4.5 million, up 24 percent from $3.6 million in the same period of last year.

ThermoGenesis makes equipment and disposable bags for processing and storing stem cells from blood and adult bone marrow. Stem cells are used to treat cancers such as leukemia and lymphoma and blood diseases.

The first quarter financial results include a $520,000 cost resulting from a voluntary recall of disposable AutoXpress stem-cell processing bags. The bags contained small particles that could cause contamination of the stem-cell samples.


The company said it will submit a recall plan for U.S. Food and Drug Administration approval this week.


“The company believes that it has adequately accrued for the costs related to this plan, but the estimate may change depending on the discussions with the FDA,” the company said in a news release. “As part of the recall plan, the company will provide customers a blood filter to be used, as necessary, with any bag already processed.”

The company also experienced short-term delays in shipments of AXP devices dued to a “flawed supplier component” and because the company filled nearly its entire bag set backlog during the prior quarter, according to the news release.

The company ended the quarter with $22.3 million in cash and short term investments.
The company expects overall fiscal 2009 revenue growth of 10 to 20 percent, a downgrade from prior guidance of 30 to 35 percent.

The company has revised its strategy for its Vantus Inc. veterinary subsidiary. It will now focus on the company’s Res-Q system for bone marrow processing and concentrating platelets from peripheral blood.

Thursday, November 6, 2008

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

“This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body.

Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.

To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

Tuesday, November 4, 2008

September 2008 posting includes 36 drug products with safety labeling changes to the following

The September 2008 posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2008/sep08_quickview.htm

The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2008/sep08.htm

In September 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Aceon (perindopril erbumine) Tablets
Proair HFA (albuterol sulfate) Inhalation Aerosol
EpiPen (epinephrine) Auto-Injector 0.3 mg & EpiPen JR (epinephrine) Auto-Injector 0.15 mg
Erbitux (cetuximab) Solution for Intravenous Use
Exubera (insulin human [rDNA origin]) Inhalation Powder
Gleevec (imatinib mesylate) Tablets
Heparin Sodium Injection, USP [Preservative Free]
Heparin Sodium Injection, USP [Preserved with Parabens]
Nasacort AQ (triamcinolone acetonide) Nasal Spray
Noroxin (norfloxacin) Tablets
Photofrin (porfimer sodium) Injection
Reyataz (atazanavir sulfate) Capsules
Rituxan (rituximab) Injection for Intravenous Use
Tarceva (erlotinib) Tablets
Uroxatral (alfuzosin HCl extended-release tablets)

Monday, November 3, 2008

Pregnant women advised to limit caffeine consumption

Pregnant women advised to limit caffeine consumption

The Agency has today issued new advice on caffeine consumption during pregnancy. This follows the results of new FSA-funded research carried out by the Universities of Leeds and Leicester.

‘Everyone wants the best for their baby. Limiting daily caffeine intake is one way which you can ensure your baby has the best start in life.’

Pregnant women are advised to limit their daily caffeine intake to 200mg a day – roughly two mugs of coffee a day. This is because too much caffeine might result in a baby having a lower birth weight than it should, which can increase the risk of some health conditions in later life.

There is also some evidence which suggests that high levels of caffeine can result in spontaneous miscarriage. Caffeine is found in coffee, tea, chocolate, some soft drinks, and certain medicines.

The Agency had previously recommended a maximum daily intake of 300mg. However, the new research, published by the British Medical Journal today, suggests a limit of 200mg per day will help to reduce this low risk even further.

Professor Janet Cade, from the University of Leeds, said: 'Everyone wants the best for their baby. Limiting daily caffeine intake is one way which you can ensure your baby has the best start in life.'

Pregnant women who have been following the previous advice, and limiting consumption to below 300mg a day, should not be concerned. Not only is the risk likely to be very low, but the research also showed that the average daily caffeine intake during pregnancy was already below 200mg, so many pregnant women will not be affected by this change in advice. Those currently consuming more than this 200mg a day are advised to simply reduce their caffeine consumption to less than 200mg a day for the remainder of their pregnancy.

Andrew Wadge, Chief Scientist at the FSA, said: 'This new advice doesn’t mean that pregnant women have to cut out caffeine completely, simply that they should be careful and make sure they don't have too much. We would emphasise that the risks are likely to be very small and believe our new advice, which is based on new research and has been considered by leading independent scientists, is sensible and proportionate.'

These findings and the results of other studies were considered by independent experts of the FSA's Committee on Toxicity, who advised a change in the FSA's advice on daily caffeine intake for pregnant women.