The FDA warns that prescription viscous lidocaine is not safe for teething infants and young children and has harmed some, and repeats its advice against benzocaine products such as Orajel for children under 2 because of rare, sometimes fatal methemoglobinemia.
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Government
Updates from the FDA, CDC and other agencies.
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Government
Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain
FDA is requiring a Boxed Warning on prescription oral viscous lidocaine 2% after reviewing 22 reports of serious harm, including deaths, in children aged 5 months to 3.5 years. It says the solution should not treat teething pain and points to chilled teething rings instead.
Government
Topical Acne Products Can Cause Dangerous Side Effects
The FDA warns that over-the-counter acne products containing benzoyl peroxide or salicylic acid can cause rare but serious, potentially life-threatening allergic reactions. Current labels list only milder irritation, and the agency has issued a Drug Safety Communication.
Government
Blood Pressure Monitoring Kiosks Aren't for Everyone
The FDA cautions that blood pressure cuffs on public kiosks do not fit everyone: a cuff that is too small gives an artificially high reading, and one too large may not work or may read low. Clinics keep cuffs in several sizes for that reason, says FDA engineer Luke Herbertson.
Government
FDA Updates for Health Professionals Received on June 18, 2014
An FDA bulletin for health professionals warning against the weight-loss product La Jiao Shou Shen, found to contain sibutramine and phenolphthalein, and against Thorne Research's Captomer supplements, which list the prescription chelator DMSA, plus a Class I device recall.
Government
FDA Updates for Health Professionals
An FDA bulletin for health professionals rounds up June 2014 items, including Alexion's voluntary recall of certain Soliris lots over visible particulates and a critical shortage of Sterrad Cyclesure 24 biological indicators, which hospitals are told to reserve for the most urgent cases.
Government
FDA’s Read the Label Youth Outreach Campaign Empowers ‘Tweens’ to Make Healthy Food Choices
The FDA expanded its “Read the Label” campaign, which teaches 9- to 13-year-olds to use the Nutrition Facts Label, adding for the first time an after-school component: a guide and activities for leaders of schools, summer camps, scout troops and community groups.
Government
FDA to require warnings on sunlamp products
FDA reclassified sunlamp products and their UV lamps from low to moderate risk and will require a black-box warning that they should not be used by anyone under 18. Manufacturers must now obtain 510(k) clearance before marketing the devices.
Government
Protecting Your Vision: Facts and Fiction
An FDA quiz for Healthy Vision month: decorative contact lenses are regulated medical devices that cannot legally be sold without a prescription, laser pointers and laser toys can cause permanent eye damage, and carrots help eyesight, as do other dark-colored fruits and vegetables.
Government
FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse
FDA proposed two orders that would reclassify surgical mesh for transvaginal repair of pelvic organ prolapse from a moderate-risk to a high-risk device, requiring manufacturers to file premarket approval applications with clinical data on safety and effectiveness.
Government
CDC looks back at 2013 health challenges, ahead to 2014 health worries
CDC's year-end release names 2013 accomplishments including the Tips tobacco campaign, an Advanced Molecular Detection pilot, Million Hearts and PEPFAR, and flags five 2014 threats: antibiotic resistance, slow HPV vaccine uptake, prescription opiate addiction and emerging infections.
Government
Order Your Free 2013 Consumer Action Handbook
A notice that the free 2013 Consumer Action Handbook, covering banking, housing, privacy and current scams and carrying a consumer assistance directory and a sample complaint letter, can be ordered in English or Spanish or downloaded.
Government
Is Your Mobile Bill a Cram Sandwich?
The FTC charged Wise Media with enrolling customers in text message subscription plans without consent, its first mobile cramming case. Consumers can spot crammed charges by reading the itemized bill monthly, asking carriers about third-party blocking and guarding their number.
Government
Affordable Care Act Provisions: What you need to know!
An IRS notice inviting federal, state and local government employers and payroll and benefits staff to a 60-minute phone forum on April 30, 2013 covering W-2 reporting of employer-sponsored health coverage and the Additional Medicare Tax.
Government
Drug Information Update - FDA Statement on Fungal Meningitis Outbreak
FDA advised providers on October 4 to stop using all New England Compounding Center products, and NECC recalled everything on October 6. A possible meningitis case tied to NECC's triamcinolone acetonide and two Aspergillus infections after its cardioplegic solution are under review.
Government
FDA/CDC Statements on Fungal Meningitis Outbreak
The FDA said it observed fungal contamination in a sealed vial of preservative-free methylprednisolone acetate from the New England Compounding Center, the steroid linked to meningitis in epidural injection patients. It advised against using any NECC product.
Government
How Vaccine Policy & Law Threatens Parental Rights in America
Mercola recommends The Greater Good, an award-winning documentary following families whose lives changed after vaccination and arguing for a calmer, more scientific vaccine debate. Barbara Loe Fisher says centrist positions get labeled anti-vaccine when the aim is safer policy.
Government
FDA encourages antibacterial drug development
The FDA formed an internal Antibacterial Drug Development Task Force to guide new antibiotic development under the GAIN provisions of FDASIA. Approvals have fallen since the 1980s, and more than 70% of bacteria causing hospital infections resist a common drug.
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