Talking About Side Effects With Your Health Care Team
Side effects may occur with any new treatment, including new medications, placement of a new medical device, surgery, or even physical or occupational therapy. We usually think of side effects when we begin to experience bad changes —when the treatment introduces new worrisome symptoms or problems. Most treatments have some sort of side effect associated with them, and many of us may wonder if side effects are simply the price we must pay for a necessary treatment.
But side effects shouldn’t be taken lightly, for a number of reasons. At their most extreme, side effects raise the alarm when you are having harmful and even potentially fatal treatment reactions. Even somewhat mild side effects like a dry mouth, sleepiness, or minor muscle aches may still interfere with your daily life. Sometimes side effects bother some people so much that they skip doses or give up a treatment altogether, which can derail care and put them at risk for both short- and long-term complications.
Before treatment begins, here are a few questions you can discuss with your health care team: Read more »
*This blog post was originally published at Prepared Patient Forum: What It Takes Blog*
The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults. The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups. In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.
We have blogged on 1-800-Get-Thin and Lap-band surgery in general before. Read more »
*This blog post was originally published at Truth in Cosmetic Surgery*
One of the major areas of research in the medical device industry is how to effectively deliver drugs to their target sites. The gold standard for systemic delivery of drugs is an intravenous (IV) injection, though it is not a great way to deliver meds that address chronic needs because of the pain and inconvenience. There have been exciting developments in transdermal delivery, such as the nicotine and birth control patches, though certain molecules and drugs do not easily diffuse through the epidermal layer to reach the more vascularized layers below.
One potential solution is to Read more »
*This blog post was originally published at Medgadget*
The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
*This blog post was originally published at iMedicalApps*
FDA has published an announcement about regulations regarding medical mobile applications.
The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:
a. are used as an accessory to medical device already regulated by the FDA
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or
b. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
(For example, Read more »
*This blog post was originally published at ScienceRoll*