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Drug Recalls Occur by FDA about Every Month
The FDA recalls potentially harmful drugs about once every month, but they could be doing a better job of letting doctors and patients know about them, according to a new study. The study showed that over an eight-year span, the FDA failed to send notifications for one in five of the most serious recalls through its two electronic systems used to alert doctors and the public. These Class I recalls, according to the FDA, are issued for drugs that, if taken, have the potential to cause "serious adverse health consequences or death."
http://www.reuters.com/article/2012/06/04/us-drug-recalls-idUSBRE8530ZK20120604
Expired Drugs Often Found in Physicians' Samples
Experts say physicians do not track the dates on their samples, and they should either monitor samples carefully or stop accepting them. According to a recent study, one in seven drug packages stored in physicians' pharmaceutical sample closets has expired, and an estimated $2.2 billion worth of drug samples go to waste each year.
Although it is unlikely that the expired medications would pose much of a danger to patients, the drugs do lose potency with time, and dispensing ineffective medication could lead to future mistakes in care, the study authors said.
Clinic office closets must be kept organized, regularly checked for expired medicines, and comply with drug recalls. There is a wide variation in the organization of the closets with some of them looking like the Hogwarts castle after it was destroyed, with books lying everywhere-a total mess, according to the report.
http://www.ama-assn.org/amednews/2012/06/04/prsc0605.htm#top
FDA: Teething Pain Remedies Dangerous
The FDA has warned that rubbing topical anesthetics such as Anbesol or Orajel on the throbbing gums of a teething baby can lead to methemoglobinemia and—in extreme cases—death. These OTC products contain benzocaine, and that is the source of the FDA's concern. The risk appears greatest among children less than 2 years old, the age range at which most children experience teething pain.
http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/33006
Lawmakers Moving To Close Legal Loopholes on 'Bath Salts'
Bath salts, which first emerged in Europe, have gained wider attention in the U.S. after a man suspected of being on the drug at the time attacked and consumed the flesh of a homeless man in Miami. The designer drugs are the subject of a federal bill as lawmakers and enforcers scramble to close loopholes in regulating an evolving substance. The provision would outlaw synthetic marijuana alongside MDPV (methylenedioxypyrovalerone), mephedrone, and possibly, methylone—the main stimulants found in the drugs. Even though drugs' active compounds were placed on an emergency ban by the DEA, they can still be found in convenience stores, smoke shops, and online where it is sold in packets or jars and often labeled as "not intended for human consumption."
http://blogs.wsj.com/health/2012/06/06/lawmakers-moving-to-close-legal-loopholes-on-bath-salts/
FDA to Let Women Try New Breast Drugs Earlier
A new FDA guidance document will allow drug companies to test their medications for a few months on women with highly aggressive breast cancers before they have surgery, instead of waiting until the drug has been proven first in gravely ill patients.
The aim of this therapy would be to cure the woman of breast cancer by moving a very promising drug into an early stage of the disease with a curative intent. This is a significant change from the current approach, in which promising drugs only are tested in earlier stage cancers after they have first proven to be safe and effective in advanced, metastatic cancer.
http://www.reuters.com/article/2012/06/03/us-cancer-trials-fda-idUSBRE85208720120603
FDA Approves the SoloHealth Station
SoloHealth has received approval from the FDA for its next-generation SoloHealth Station. This is an interactive, comprehensive health and wellness screening kiosk for consumers. The SoloHealth Station accommodates health screenings for vision, blood pressure, weight, and body mass index, a symptom checker as well as an overall health assessment free of charge.
http://www.pharmacynewsflash.com/opha/Story.nsp?story_id=173497329
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