Saturday, December 18, 2010

FDA Saturday

Yesterday on the blog was this FDA Warning : DO NOT EAT Sally Jackson Cheese Due to Risk of Escherichia coli O157:H7 .

All Sally Jackson cheeses on the market should be avoided because the products were processed under conditions that create a significant risk of contamination, and because Sally Jackson cheeses have been identified as one possible source of several cases of Escherichia coli (E. coli) O157:H7 infections
Continue Reading........

Johnson & Johnson Fines and Recalls
Candymaker behind Rolaids recall

Johnson & Johnson spokesman Marc Boston confirmed to CNNMoney Friday that Mooresville, N.C.-based Best Sweet is the contract manufactuer of various softchew Rolaids medicines recalled after consumer complaints of foreign materials.

J&J's confirmation about Best Sweet followed a letter sent to the FDA on Friday by Rep. Darrell Issa, the Republican ranking member on the Committee on Oversight and Government Reform, which is investigating McNeil's string of recalls this year of non-prescription drugs including Tylenol, Motrin and Benadryl.
Continue Reading.....

Recalls, Citations and Fines for Johnson & Johnson This Week

Reuters reported on December 15 that a report of a FDA inspection from October to December this year of the company’s Fort Washington, PA plant that has been closed since April for manufacturing problems, revealed that J&J failed to adequately handle consumer complaints, lack of proper record keeping and failure to investigate product quality discrepancies.
According to an ABC News story today, a Pennsylvania court has ordered Johnson & Johnson to pay $52 million in damages and penalties for deceptive trade practices. The court found that J&J falsely reported drug prices to manipulate a drug pricing benchmark used by state agencies to calculate drug reimbursements, resulting in great expense to Medicaid and PACE prescription drug program for seniors.
Continue Reading.....

Knowing that the readers of this blog are computer users you may have purchased one of these lamps to use at your home "computer station".

—About 1,600 desk and table lamps from wholesaler CDX Group Inc., of Brooklyn, N.Y. The Consumer Product Safety Commission says the lamps have substandard electrical wiring, connections and plugs that pose a fire and shock risk to consumers. No injuries have been reported. The lamps were sold at CDX Group's showroom, New Chens Discount, Concordia Trading Inc. and Grace Mini Market in Brooklyn, N.Y. and Dollar King in Lexington, Ky. from April 2010 through July 2010. Consumers can contact the company at 877-253-4599 for more information.

See website for all the pictures of the lamps and product numbers

FDA begins process of revoking Avastin approval for breast cancer
FDA notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.
FDA is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.
FDA recommends that oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.
Patients currently receiving Avastin for breast cancer should speak with their oncologists about whether to continue their treatment or explore other treatment options.
Continue reading

Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms Injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in pediatric and adult patients. Continue reading........

Please share copies of this printer-friendly PDF (799 KB)

December 15, 2010 -
FDA: Tainted products marketed as dietary supplements potentially dangerous

On Dec. 15, 2010, the Food and Drug Administration (FDA) took new steps aimed at keeping consumers safe from harmful products that are marketed as dietary supplements and that contain undeclared or deceptively labeled ingredients.
FDA has found that these products are often promoted for weight loss, sexual enhancement, and bodybuilding.
The new steps FDA has taken include:
A letter from Commissioner of Food and Drugs Margaret A. Hamburg to the dietary supplement industry emphasizing its legal obligation and responsibilities to prevent tainted products from reaching the U.S. market.

A new rapid public notification system7 (RSS Feed) on its website to more quickly warn consumers about these products.
A mechanism for industry to alert FDA about potentially tainted products and about the firms that make

View slide show dietary supplements and that contain undeclared or deceptively labeled ingredients

Keeping Children and Grandchildren Safe
For Immediate Release: Dec. 14, 2010Media Inquiries: Shelly Burgess, 301-796-4651,
Consumer Inquiries: 888-INFO-FDA
FDA says Tessalon liquid cough capsules pose risk for young children Medication has candy-like appearance; should be kept in child-proof containers

The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.
Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug’s candy-like appearance – a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established.

“Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, R.Ph., director of FDA’s Division of Medication Error Prevention and Analysis. “The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”
A review of the FDA’s Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five of the cases resulted in death in children ages 2 years and younger. Overdose with benzonatate in children younger than 2 years has been reported following accidental ingestion of only one or two benzonatate capsules.

Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion.
The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion resulting in overdose and death in children younger than 10.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of benzonatate to the FDA's MedWatch Adverse Event Reporting program at or by calling 800-332-1088. For more information:
Tessalon Drug Safety Communication
Render Date('Thursday, December 16, 2010 8:33 AM EST
Dec 16, 2010 8:33 AM EST
if (PLATFORM.Event Man) PLATFORM.EventMan.triggerEvent('WNStoryRelatedBoxdone');
WASHINGTON (AP) - It's the end of the traditional crib that has cradled millions of babies for generations. The government outlawed drop-side cribs on Wednesday after the deaths of more than 30 infants and toddlers in the past decade and millions of recalls.

It was a unanimous vote by the Consumer Product Safety Commission to ban the manufacture, sale and resale of the cribs, which have a side rail that moves up and down, allowing parents to more easily lift their child from the crib. The new standard requiring cribs to have fixed sides would take effect in June. The move by CPSC would also prohibit hotels and childcare centers from using drop-sides, though those facilities would have a year to purchase new cribs.
Around for decades, drop-side cribs have come under scrutiny in recent years because of malfunctioning hardware, sometimes cheaper plastics, or assembly problems that can lead to the drop-side rail partially detaching from the crib. When that happens, it can create a dangerous "V"-like gap between the mattress and side rail where a baby can get caught and suffocate or strangle.

CPSC Chairman Inez Tenenbaum hailed the new standard for cribs as one of the strongest in the world. "I believe these new standards will markedly reduce crib-related hazards and help to ensure that young children sleep more safely in their cribs," Tenenbaum said after the vote. In all, drop-side cribs have been blamed in the deaths of at least 32 infants and toddlers since 2000 and are suspected in another 14 infant fatalities.

No comments:

Post a Comment