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Baxter International Inc. informed the public on February 28, 2008 of a full-scale recall of Heparin, the company’s popular blood-thinning drug. Baxter International, Inc. initially held off on mounting a recall because of concerns over a shortage. During the past several weeks Heparin has been in the news after several patients reported experiencing allergic reactions to the drug.

In excess of 400 people have been stricken with adverse side effects thought to be related to Baxter-made Heparin, and four such patients have died. In mid-January, 2008, Baxter recalled nine lots of Heparin, disclosing for the first time that there had been scores of adverse reactions. The company said it hadn’t yet determined the source of the problem, but thought that whatever the difficulty was, it was limited to the nine lots of the product that Baxter was recalling.

Later, however, the company disclosed that it had determined the problems weren’t limited to the nine production lots it had recalled. But, it said, company officials and the FDA decided that because the number of Heparin producers is so limited, and because the product is so widely used nationwide in surgery as well as in kidney dialysis, Baxter would suspend production but wouldn’t recall Heparin on the shelves of hospitals, drug distributors and medical clinics.

However, on February 28, 2008, Baxter said, “the FDA has now concluded that that there is sufficient capacity on the part of other suppliers that Baxter’s recall will not jeopardize access to this drug.”

The FDA, Baxter said, has now “told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.”

Baxter said it is taking the “precautionary step” of recalling all remaining products on the market, even though the vast majority of the reports of adverse reactions have been associated with the multi-dose form of the product.

Safety officials announced a recall of approximately 24,000 cribs on February 28, 2008, and also alerted parents against putting their babies to bed with pillows and other soft bedding that could suffocate them.

The nearly 24,000 Indonesian-manufactured cribs were recalled because children were at risk of falling out of the. The cribs, imported by Munire Furniture Inc., have inappropriate brackets that don’t allow their mattresses to be fully lowered. As a result, a child inside the crib could crawl over the railing and fall.

The recall includes the company’s Majestic Curved Top, Majestic Flat Top, Essex, Brighton/Sussex and Captiva cribs with various model numbers. The cribs were sold at children’s specialty stores between November 2005 and November 2007. To date no injuries have been reported.

The Consumer Product Safety Commission (CPSC) is also concerned about what parents are placing inside their babies’ cribs. From 2002 to 2004, an estimated 241 children under age 5 died in incidents involving nursery products, the CPSC said. About 40% of the deaths involved cribs, with soft bedding cited as the leading contributing factor. Many of the children suffocated when lying face down on pillows or other bedding, the agency said.

“Less is more when you’re talking about the crib,” CPSC spokeswoman Julie Vallese said, adding that cribs should be free of adult pillows and blankets, stuffed animals and baby quilts.

To diminish risk of suffocation and sudden infant death syndrome, parents should place babies on their back in a crib that meets current safety standards, the agency said.

Among other incidents of death in cribs, babies became trapped when the mattress was ill fitting, CPSC said. Old, broken and modified cribs should not be used, and parents should never allow a gap larger than two fingers at any point between the sides of the crib and mattress, the agency advised.

The agency said there were 36 deaths over the same period relating to baby baths and bath seats. All occurred when caregivers left the baby unattended. In many instances, babies slipped out of bath seats, fell out of baby seats or tipped forward or sideways into the water.

At no time, even for a few seconds, should babies be left unattended in the tub, Vallese said. Deaths involving playpens also were high, with many resulting from the use of soft bedding. Although CPSC has in recent years issued many crib product recalls, Vallese said there were no related deaths during 2002 through 2004 that involved a recalled product or a product that eventually was recalled.

In 2006, the most recent year in which injury data was collected, CPSC counted about 66,400 emergency injuries linked with nursery products among children under age 5. Most of these were related to baby carriers and car seats, excluding motor vehicle accidents, followed by incidents involving cribs and mattresses.

The most common injuries in 2006 resulted from falls, and the head was the most frequently injured body part.

For more details on the crib recall, call 866-586-9639 or visit http://www.munirefurniture.com.

The FDA announced on Wednesday, February 27, 2008, that Biogen Idec Inc and Elan Corp Plc warned doctors of significant liver injuries experienced by some patients taking the multiple sclerosis drug Tysabri. Signs of liver damage took place in some patients as early as six days after their initial dose of Tysabri, the drug companies said in a letter to physicians companies co-market the drug, with Biogen taking the lead in the U.S.

The letter dated February 2008 reflects a label update approved by the FDA in January as part of an expanded clearance for the drug to treat the bowel disorder Crohn’s disease, an FDA spokeswoman said. Biogen estimates that less than one in 1,000 patients using Tysabri for either MS or Crohn’s disease suffered from serious liver injury according to post-marketing reports, Biogen spokeswoman Shannon Altimari said.

Approximately 21,000 patients were taking the drug as of the end of December, Altimari said. Tysabri had $129 million in fourth-quarter sales, and Biogen has forecast it to become a $2 billion-a-year blockbuster.

In some cases, liver problems occurred after the drug was stopped and then restarted, confirming the Tysabri link, the letter said. Severe liver injury may lead to death or the need for a transplant.

Tysabri has been haunted by safety concerns since it was approved.

Sales of the drug were suspended in 2005 amid three cases of a brain infection, known as known as Progressive Multifocal Leukoencephalopathy, or PML. The drug returned to the market in 2006 with limits after the FDA decided that MS patients were willing to accept the risks in light of possible benefits.

A copy of the companies’ joint letter has been posted at http://www.fda.gov/medwatch/safety/2008/Tysabri_dhcp_letter.pdf