Devices Claimed To Improve Safety Are Dangerous

Main Category: Medical Devices / Diagnostics
Also Included In: Public Health;  Sleep / Sleep Disorders / Insomnia
Article Date: 22 Nov 2012 – 0:00 PST

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Portable bed rails marketed to “make any bed safer” actually increase the risk of injury and death, according to an article in Biomedical Safety & Standards (BS&S). A newsletter for medical device safety professionals, BS&S is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

More Drug Shortages in Fungal Meningitis Aftermath

ampule and syringe

Nov. 2, 2012 — Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.

Ameridose — the sister firm of the NECC, the compounding pharmacy whose tainted products are at the heart of the outbreak — has shut down, and at the FDA’s urging recalled the more than 2,000 products it sold nationwide. The FDA yesterday admitted that these actions will worsen the ongoing shortage of six important drugs hospitals need to help critically ill patients.

FDA Finds Mold, Germs at Compounding Pharmacy

Contaminated Steroid Shots From Pharmacy Have Killed 25


Oct. 26, 2012 — “Greenish black foreign matter” in supposedly sterile drug vials. Germs growing in steroid vials supposedly tested for sterility. Mold growing in the “clean room” where drug vials were filled.

These are just some of the observations made during an FDA inspection of New England Compounding Center (NECC). The Massachusetts compounding pharmacy’s products appear to be the source of the ongoing fungal meningitis outbreak.

As of today, there have been 331 cases of fungal meningitis and seven joint infections caused by tainted steroids made by NECC. So far, 25 people have died.

Epilepsy Drug Fycompa Approved by FDA

WebMD Health News

ct scan of human brain

Oct. 24, 2012 — Fycompa (perampanel) has received FDA approval for the treatment of partial onset seizures among epilepsy patients aged 12 and older.

The new drug is the first of a new class of epilepsy medications and joins the ranks of other medications available to the estimated 2 million Americans with epilepsy. More than one-third of people with epilepsy experience seizures despite taking currently available treatments, according to the CDC.

New Warnings in Fungal Meningitis Outbreak


Oct. 15, 2012 — More patients — not just those who got steroid shots — will be getting calls from their doctors warning them they might have a dangerous fungal infection.

The FDA now suspects fungal contamination is possible in all of the supposedly sterile products made by the New England Compounding Pharmacy (NECC) on or after May 21, 2012. People who got shots of any of these medicines — particularly those given during eye treatments or heart surgery — are at risk.

Covidien Announces FDA 510(k) Clearance And CE Mark For Nellcor™ Bedside Respiratory Patient Monitoring System

Main Category: Medical Devices / Diagnostics
Article Date: 07 Oct 2012 – 0:00 PDT

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Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, has announced U.S. Food and Drug Administration 510(k) clearance and European Economic Area (EEA) CE Mark approval for the Covidien Nellcor™ Bedside Respiratory Patient Monitoring system.

Teva’s High-Dose Generic Wellbutrin XLWithdrawn

High-Dose Generic Wellbutrin XL Withdrawn

Oct. 5, 2012 — The FDA has withdrawn its approval of Teva Pharmaceutical’s Budeprion XL 300-mg tablets, a generic version of GSK’s Wellbutrin XL extended-relief antidepressant.

The FDA action comes five years after patients complained of headaches and returning depression after switching from brand-name Wellbutrin XL to Teva’s generic version. The Teva generic was approved in December 2006.

In 2009, the FDA wrongly assured patients that the Teva generic worked just as well as the name brand. But it wasn’t until 2010 that the FDA finally decided to test the full-dose version of the drug. Those tests, completed just weeks ago, found that instead of proper extended release, Teva’s drug dumped too much active ingredient too soon and failed to maintain effective drug levels.

What Are Cosmeceuticals?

By Ayren Jackson-Cannady
WebMD Feature

Cosmeceuticals are the marriage of cosmetics and pharmaceuticals. Think: antioxidant plus lipstick or retinol plus face serum.

“Cosmeceuticals will contain active ingredients that are known to be beneficial to humans in some way,” says Marie Jhin, MD, a dermatologist in San Francisco. “For example, vitamin C is a known antioxidant and when this is added to a lotion or cream the product is considered a cosmeceutical.” 

If you read a product’s label and see things like botanical and marine extracts, vitamins, or peptides, it probably could be considered a cosmeceutical.

Humira Approved for Ulcerative Colitis Treatment

Sept. 28, 2012 — The FDA has approved Abbott’s Humira for the treatment of moderate to severe ulcerative colitis.

Humira (adalimumab) now is approved for both forms of inflammatory bowel disease (IBD): ulcerative colitis and Crohn’s disease.

It was already approved to treat Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, and ankylosing spondylitis.

For ulcerative colitis, Humira is approved when other drugs to suppress immune responses haven’t worked.

“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” says Donna Griebel, MD, director of the FDA’s gastroenterology division. “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”