Yesterday I turned another year older and was so mesmerized by that fact that I was unable to write a posting – forgive me. Also, I’ve got that "end-of-August-I-don’t-want-to-go-back-to-school" feeling that I’ve never been able to shake in adult life. That said, yesterday, Eye on FDA set a personal best for the number of subscribers. Thanks everyone!
Even given the time of year though, there are a few things going on that I want to report, and I want to use the Weekly Roundup to regularly update readers as to what is new on the Eye on FDA YouTube channel, which in one week has picked up more subscribers than any of the pharmaceutical companies posting vids and more than the FDA. Woo hoo! Thanks everyone!
And, I also have a new personal record of the number of folks following me on Twitter, among whom are PRWeek, WUSA9 in Washington and NBC4. Thanks everyone!
Here is a little bit of news:
- FDA Set to Hold Public Meeting on Children’s OTC Cold Medicines – A joint meeting of the Pediatric Drugs Advisory Committee and the Non-prescription Drugs Advisory Committee will occur to discuss the safety and efficacy of over-the-counter (OTC) cough and cold products marketed for pediatric use. held on August 25 that it is holding a public meeting on OTC cold medicines for children. The meeting will be held on October 18 and 19, 2007,
from 8 a.m. to 5 p.m. at the National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Ave., Silver Spring. - FDA Clears Test to Help Doctors Manage Heart Transplant Patients – The agency announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection. XDx Inc. of Brisbane, California developed the device called AlloMap using blood and biopsy samples and other information collected from heart transplant recipients at nine U.S. heart transplants centers participating in the Cardiac Allograft Rejection Gene expression Observational study (CARGO). CARGO provided data from 153 patients on 300 medical visits at various times after heart transplant study.
- FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts – Also this week, the agency approved Amgen‘s Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. This approval demonstrates a company successfully managing the RiskMap process – see this from the FDA’s press release about the approval.
During six months of treatment, patients who received Nplate had significantly higher platelet counts and maintained those higher counts compared to those who did not receive the drug. The response to Nplate was higher in those patients who still had their spleen than in those patients who had undergone a splenectomy. In those patients who did not receive Nplate, only one experienced a sustained increase in platelet counts.
Safety concerns with Nplate include fibrous deposits in the bone marrow and the possibility that once Nplate is stopped, platelet counts could drop below what they were before beginning treatment.
Additional risks include blood clots due to excessive increases in platelets and, if Nplate were given to patients with an abnormal blood condition known as myelodysplasia, a risk for a form of blood cancer known as acute leukemia. Myelodysplasia, which is associated with low platelet counts, predisposes some patients to leukemia. In a study of 44 patients who had myelodysplasia and received Nplate, four patients developed leukemia. Further clinical trials in patients with predisposing conditions for leukemia will be needed to determine whether the development of leukemia may relate to the use of Nplate. Nplate is approved only for use among patients with chronic ITP.
A Risk Evaluation and Mitigation Strategy (REMS) has been developed to address the risks of Nplate therapy. Under the Food and Drug Administration Amendments Act of 2007, FDA has determined that a REMS is necessary for the benefits of Nplate to outweigh the risks of the product. The REMS will include a Medication Guide for patients and requires that all prescribers and patients enroll in a special program to track the long term safety of Nplate therapy.
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Several New Vid Posted to EyeonFDA YouTube Channel – I’m not going to list each individually, especially right now as I’m aggregating health videos from several sources to build a large collection of vids on a variety of topics. However, this week I added about two dozen vids and added a new playlist on Alzheimer’s Disease. I also added several diabetes vids, especially in the wake of the fact that the LillyDiabetes channel got pulled. And I’ve added several corporate vids to the playlist, especially those of Abbott. I also issued a Web News Release about the launch of the YouTube channel – check it out .
That’s it for me today folks. Have a good long weekend. Next week we’re back to school and Congress will be returning and all in all, life in Washington will CHANGE!
