All Entries Tagged With: "FDA"
Consumers’ safety affected by unproven product labels, the FDA reports
The Food and Drug Administration (FDA) is warning consumers not to believe the claims of hand sanitizer and antiseptic products that promote MRSA prevention, and has since sent warning letters to four distribution companies about their unproven claims.
Warning letters were sent April 20 to four companies that either distribute or make hand sanitizing products that can be bought without a prescription over-the-counter, according to an FDA report:
Deborah Autor is the compliance director at FDA’s Center for Drug Evaluation and Research. She says in the FDA report that consumers are being misled if they buy these products in drug stores and think they will be protected from deadly infections such as MRSA.
Unproven product labels found by the FDA include:
- kills over 99.9% of MRSA
- helps prevent skin infections caused by MRSA and other germs
- is effective against a broad spectrum of pathogens, including MRSA
For more information and advice for consumers, check out the FDA report.
Medical device review process to be investigated by IOM
The Food and Drug Administration (FDA) has asked the Institute of Medicine (IOM) to review the current process for approving medical devices, reports the Wall Street Journal. The request comes after the FDA recently came under fire for rapidly approving certain devices. The current process allows device makers to market products without having those products undergo in depth trial testing. Devices can be cleared for marketing as long as they are similar to other devices already in existence. However, the current process is viewed by many as too quick, allowing devices that should not be cleared for use available for use.
The IOM expects its review, which will cost $1.3 million, will run through 2011. The medical device industry defended its practices. It has expected changes, however, since the Obama administration announced changes in leadership at the FDA earlier this year.
FDA investigates two patient deaths after heparin doses
The Food and Drug Administration (FDA) is investigating the deaths last weekend of two Delaware residents who died after being administered the anticoagulant drug heparin at Beebe Medical Center in Lewes, DE. The patients, a 71-year-old man and a 64-year-old woman, both reportedly suffered intracranial bleeding, along with a third patient who is being treated at Christiana Hospital in Newark, DE.
Two other patients initially believed to have fallen ill were not actually affected by heparin after undergoing additional tests, a hospital spokesperson said. The FDA does not believe the cases are part of a widespread problem. The agency is testing Baxter Healthcare Corp.’s heparin and its components.
Hospital officials don’t know whether the drugs were tainted or whether the deaths and illnesses were due to human error, Delaware Online reports. The drug was administered to the three patients by different hospital staff members.
Baxter recalled batches of heparin in 2008 after the FDA found it was contaminated with a chemical that caused allergic reactions and low blood pressure in patients who received high doses.
FDA issues warning about MRI burns
The Food and Drug Administration (FDA) issued a warning yesterday about the risk of burns to patients who wear transdermal patches. These are medicated patches most often associated with smokers who are trying to quit smoking. These patches have been catching fire during MRI scans because many of them contain a metal backing that’s not always visible to the wearer, or the person administering the scan.
While the FDA is compiling a list of those patches that could ignite during a scan, it has issued the following advice to healthcare workers:
- identify those patients who are wearing a patch before the patients have the MRI scan
- advise those patients about the procedures for removing and disposing of the patch before the MRI scan
- advise those patients about replacing the patch after the MRI scan
New budget calls for MD and RN loans to be repaid
Part of President Obama’s latest budget proposal includes money to repay the loans of nurses, doctors, and dentists, especially those who vow to work in medical sectors that are lacking the necessary numbers of workers. The Wall Street Journal Health Blog is reporting that in addition to repaying loans, part of the $330 million would go to building up nursing schools and nursing programs. The nation is currently suffering from a nursing and primary care physician shortage.
Other health-related concerns addressed in the budget proposal are cancer and autism research, as well as better oversight of the Food and Drug Administration. Check out the full budget proposal here.
Do you think adding loan payback incentives will drive more professionals in this country to consider becoming a nurse, doctor, or dentist?
New USP standards aim to prevent drug errors
The U.S. Pharmacopeial (USP) Convention today unveiled new standards for two widely used drugs–the blood thinner heparin and the sweetener glycerin–that have been involved in scores of patient deaths after the drugs were adulterated with toxic ingredients.
More than 200 patients worldwide reportedly died after batches of heparin with adulterated with over-sulfated chondroitin sulfate, which can be derived from the dietary supplement chondroitin and can mimic heparin’s blood-thinning properties. Glycerin is used in many drugs and consumer goods such as cough syrup and toothpaste; there have been numerous incidents in which diethylene glycol, a poisonous chemical used in antifreeze, was added either intentionally or accidentally as a cheap substitute for glycerin. The most recent incident occurred in Nigeria last year.
All manufacturers whose products are used in the U.S. must comply with these new standards, which are slated to become effective in May for glycerin and August for heparin (after a public comment period) and are enforceable by the Food and Drug Administration. Read more here about the heparin standard and here about the glycerin standard.
