Vapotherm ISSUES URGENT NATIONWIDE RECALL OF All Vapotherm® 2000i Respiratory Gas Humidification Devices
FOR IMMEDIATE RELEASE — Stevensville, MD — January 24, 2006 — Vapotherm, Inc., Stevensville, Maryland, is initiating a nationwide recall of all Vapotherm 2000i Respiratory Gas Humidification devices. Some of these devices have been found to contain the Ralstonia species of bacteria. Ralstonia, as with any gram negative organism, may cause infection, sepsis and in most severe cases be life threatening.
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Drug Label Update Hydrea Droxia
Hydrea (hydroxyurea capsules)
Droxia (hydroxyurea capsules)
Audience: Pharmacists and Oncological healthcare professionals
[Posted 01/26/2006] Bristol-Myers Squibb notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information to describe cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, in patients with myeloproliferative disorders during therapy with hydroxyurea, most often reported in patients with a history of or currently receiving interferon therapy. The PRECAUTIONS and DOSING AND ADMINISTRATION sections have been revised to provide updated information on the safe handling of these products.
The proposed changes are highlighted in the following “Dear Healthcare Provider” letters issued January 2006 by Bristol-Myers Squibb; specific wording of these additions and revisions to the labeling is pending FDA review and approval.
State Health Department Issues Warning on Juice Harvest Assorted Juices
FOR IMMEDIATE RELEASE — Sacramento, CA — January 20, 2006 — Consumers should not drink Evolution, Harvest or Trader Joe’s brand assorted juices manufactured by Juice Harvest Corp. of San Bernardino because the products were not fully pasteurized and may contain harmful bacteria that pose a health risk, State Public Health Officer Dr. Mark Horton announced today. The containers list the following code dates: “1-12, 1-14, 1-17, 1-20 or 1-23.” No illnesses associated with these products have been reported.
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Drug Safety Information Ketek Telithromycin
Ketek (telithromycin)
Audience: Infectious Disease, Hepatology and other healthcare professionals
[Posted 01/20/2006] Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases were also reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. As a part of this, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.
FTC Releases Top 10 Consumer Fraud Complaint Categories
Identity Theft Again Leads the List
The Federal Trade Commission today released its annual report detailing consumer complaints about fraud and identity theft in 2005. Complaints about identity theft topped the list, accounting for 255,000 of more than 686,000 complaints filed with the agency in 2005. The complaints, filed online or at a toll-free number, are shared via a secure database with more than 1,400 federal, state, and local law enforcement agencies, and law enforcement and consumer protection agencies in Canada and Australia.
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The Truth about Cell Phones and the Do Not Call Registry
The Federal Trade Commission today reiterated that despite the claims made in e-mails circulating on the Internet, consumers should not be concerned that their cell phone numbers will be released to telemarketers in the near future, and that it is not necessary to register cell phone numbers on the National Do Not Call (DNC) Registry to be protected from most telemarketing calls to cell phones.
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FDA Approves Updated Labeling for Two Eczema Drugs, Elidel and Protopic
The Food and Drug Administration (FDA) today announced the approval of updated labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.
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FDA Statement on Fraudulent, Unapproved Influenza-Related Products
The U.S. Food and Drug Administration (FDA) considers the sale of unlicensed or unapproved influenza -related products as a potentially significant threat to the public health and is taking measures to protect consumers from fraudulent products that claim to prevent or treat seasonal or avian (bird) influenza in people.
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Steve & Barry’s University Recalls Children’s Outerwear with Drawstring
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Children’s Upper Outerwear with Drawstrings
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Fire Hazard with Oscillating Heater Sold in Wal-Mart Prompts Recall
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Maxi-Heat(tm) Dream Tower Heater
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