Health and Medical News and Resources

General interest items edited by Janice Flahiff

FDA issues final rule on safety information during clinical trials

A news release on this US Food and Drug Administration (FDA) may be found here.

Excerpt

The new rule requires that certain safety information that previously had not been required to be reported to FDA be reported within 15 days of becoming aware of an occurrence. These reports include:

  • findings from clinical or epidemiological studies that suggest a significant risk to study participants
  • serious suspected adverse reactions that occur at a rate higher than expected
  • serious adverse events from bioavailability studies which determine what percentage and at what rate drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug

September 29, 2010 Posted by | Health News Items | | Leave a comment

Purchasing Pet Drugs Online: Buyer Beware (video)

From the US Food and Drug Administration (FDA)

Consumers should be cautious when buying pet drugs online and should not let Internet pharmacies evaluate their pets. Watch this video to learn more and/or read this article.

Excerpt

“Discount pet drugs—no prescription required” may appeal to pet owners surfing the Web, but FDA experts say it can be risky to buy drugs online from sites that tout this message and others like it.

Some of the Internet sites that sell pet drugs represent legitimate, reputable pharmacies, says Martine Hartogensis, D.V.M., deputy director of the Office of Surveillance and Compliance in FDA’s Center for Veterinary Medicine (CVM). But others are fronts for unscrupulous businesses operating against the law.

FDA has found companies that sell unapproved pet drugs and counterfeit pet products, make fraudulent claims, dispense prescription drugs without requiring a prescription, and sell expired drugs.

Pet owners who purchase drugs from these companies may think they are saving money, says Hartogensis, but in reality, they may be short-changing their pet’s health and putting its life at risk.

September 29, 2010 Posted by | Uncategorized | , | Leave a comment

Better Screening Urged for Self-Injury in Teens

Not all kids who intentionally cut or burn themselves meet ‘classic profile,’ expert says

Excerpt:

MONDAY, Sept. 27 (HealthDay News) — Doctors often fail to screen their adolescent eating-disorder patients for evidence of self-inflicted physical harm in the form of cutting or burning, new research reveals.

The observation stems from work conducted by researchers at the Stanford University School of Medicine and Lucile Packard Children’s Hospital in Palo Alto, Calif.

Led by Dr. Rebecka Peebles (who conducted the study while a Stanford pediatrics instructor), the research team published its findings in the Sept. 28 online edition of the Journal of Adolescent Health.[As a pre-publication, only available by individual subscription,  for more information, ask a reference librarian at any academic or medical institution]

Peebles and her colleagues noted that eating disorders typically found among adolescents, such as bulimia and anorexia, are often associated with a higher risk for self-inflicted injury. This, Peebles noted in a Stanford news release, often stems from a troubled patient’s need to try “to feel pain.”

“Patients describe a feeling of release that comes when they cut or burn themselves,” she said. “They’ll cut with a razor or a scissor blade. Sometimes we’ve even had kids who will take the tip of a paper clip and gouge holes. To burn themselves, they’ll heat up a metal object and press it to their skin, or they’ll use cigarettes.”

Prior research has indicated that between 13 percent and 40 percent of all American adolescents engage in some form of self-injury. The practice is also linked to a higher risk for suicide, the study authors noted.

September 29, 2010 Posted by | Health News Items | , , | Leave a comment

   

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