The Food and Drug Administration (FDA) is charged with protecting the general health and well being of Americans with medicines and certain treatment equipment. Sometimes these medications or treatment equipment fail, don’t work as indicated or cause serious, life threatening side effects. Reporting these events is important so the FDA can track and monitor these issues allowing them to further evaluate the safety and efficacy of a product.
The Food and Drug Administration’s (FDA) has a program called MedWatch which is designed to report:
1- Serious Reactions
2- Product Quality Problems
3- Therapeutic Failure
4- Product Use Errors
5- Human Medical Products
The reporting of negative side effects should include problems with drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
If you believe that you or someone in your family has experienced a serious reaction to any medical product, you should take the reporting form to your healthcare provider and ask for their help in filling it out. Your healthcare provider can provide clinical information based on your medical record that can help the FDA evaluate your report.
If you wish not to include your healthcare provider in making a report or if your healthcare provider elects not to complete the report you may complete the Online Reporting Form yourself.
Once you have submitted the form and the FDA receives it you will receive an acknowledgement from them. The FDA staff reviews all reports no matter who submitted them. You will be personally contacted only if the FDA needs additional information.
Submitting Adverse Event Reports to the FDA Use one of the methods below to submit voluntary adverse event reports to the FDA:
1. Report Online
2. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help filling out the form, see MedWatchLearn.
3. Call the FDA at 1-800-FDA-1088 to report by telephone
4. Reporting Form FDA 3500 commonly used by health professionals. View Instructions for Form FDA 3500
For more information on reporting adverse effects go to the FDA website at:
Joel T. Nowak, M.A., M.S.W.
Something we hope our prostate cancer won’t cause to our loved ones.
Eventually is a collection of first person video testimonials about significant loss and bereavement. In each account, participants reflect upon their own experience, recount events leading up to and around the death of their family member or loved one, talk about how they have coped, and explore what their loss has meant to them. During their testimonial, participants also remember the person who died. The stories are deeply personal yet in them we discover common threads in the grieving process. The intention behind Eventually is to provide a platform for those who are coming to terms with the meaning of significant loss in their lives, as well as offer catharsis to those who give testimony.
You are invited to participate…please email your interest at http://eventually.be/contact/
According to an article in today’s USA Today, many more doctors will not be accepting medical insurance plans offered through Affordable Care Act exchanges. The reason cited is that these plans often have lower reimbursement rates than the commercial plans. The article indicated that “some doctors are limiting how many new patients they take with these policies, physician groups and other experts say.”
In some cases some commercial insurance contracts require that their physicians accept their exchange-plan patients along with those on commercial plans. However, the lower rates are making some doctors reluctant to sign on to the plans in the first place.
“The National Association of Insurance Commissioners is developing a new standard for what is an adequate number of doctors and hospitals in insurance networks,” and starting next year the CMS will be certifying that these networks for exchange plans are big enough.
In the Daily Caller (10/28, Hurtubise, 475K) there was also a report that the number of physicians nationwide that are refusing to accept health plans from ACA exchanges are growing. They came to this conclusion based on a study from the American Action Forum (AFA). According to the AFA as of May 2014, “over 214,000 doctors wouldn’t participate in Exchange plans. Exchange plans on average pay doctors “significantly less than plans in the private market and even Medicare, according to AAF.”
If you are in an exchange plan and want to see a doctor who you have not yet seen now is a good time to make that first appointment. Doctors who decide not to take patients from the Exchanges might be willing or be required to keep existing patients, so become an existing patient while it is possible.
Joel T Nowak, M.A., M.S.W.
Day 25 of Xofigo shutdown. We’re hearing from men who have lost the opportunity to continue their treatment on schedule. We’re hearing from deeply worried spouses. We want to hear from you, too. Malecare continues to investigate. Malecare contacted factory workers at the Bayer plant in Norway. Predictably, they wouldn’t answer Malecare’s questions about when production might or might not start up again. We are glad that we tried and will continue to seek more creative ways to nail down better information. Malecare is driven by your concerns. We know that for many men, the hope of living longer is diminished by the simple fact of “not knowing.”
Please tell us your thoughts about the Xofigo shutdown. Please email Joel at email@example.com about how the Xofigo shutdown has affected your life.
Some good news for my European brothers, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adapted a positive opinion in support of the label expansion of enzalutamide (XTANDI) to include the treatment of men with metastatic castrate resistant prostate cancer (MCRPC) who are asymptomatic or mildly symptomatic after the failure of androgen therapy (ADT) in whom chemotherapy is not yet clinically indicated.
CHMP’s decision is driven by the positive phase 3 results of the Prevail trial where Xtandi reduced the risk of death by 29% compared to placebo. Additionally, men who were treated with Xtandi had a 17 month delay in time to their initiating chemotherapy over the placebo group.
In normal circumstances the actual decision by the European Commission usually takes 60 days from the release of CHMP’s opinion. Once this last hurdle is cleared we should finally see Xtandi available in Europe.
It is good to see that Europe will catch up and this vital treatment be made available to men prior to their having chemotherapy.
Joel T Nowak, M.A., M.S.W.
In a poster presentation at the recent European Society of Medical Oncologists (ESMO) there was a very interesting poster presented updating a phase 3 clinical trial (CA184-043) which evaluated the overall survival (OS) with radiotherapy (RT) followed by either the immunologic drug Ipilimumab (Ipi) or with a placebo. This trial did not meet its endpoint and was considered to have failed (Kwon ED, et al. Lancet Oncol 2014 in press), but it still remains of significant interest. The update included an additional year of data.
In the trial 799 men were randomized to receive a single dose of radio therapy to their bone metastases followed by either Ipi (N = 399) or placebo (N = 400). An updated overall survival analysis was performed.
Updated OS analysis with survival rates up to 3 years was consistent with the primary analysis. Also consistent with previous reports, pre-specified subgroup analyses suggest greater activity in men with lower disease burden [e.g., Ipi vs. placebo with (HR 1.17, 0.89–1.53) or without (0.74, 0.61–0.89) visceral metastases].
The safety profile with extended follow-up was similar to that reported previously, which included immune-related AEs (irAEs) (gastrointestinal, dermatologic, endocrine, and hepatic). Most irAEs were manageable with established Ipi treatment algorithms.
With an additional year of follow-up, the activity observed for Ipi + RT in post-docetaxel mCRPC pts is maintained. In addition, subgroup analyses suggest men with lower disease burden may be more likely to benefit from Ipi treatment. Long-term OS and Ipi benefit in mCRPC men with lower disease burden (i.e., no visceral metastases) will be evaluated in the ongoing phase 3 study, CA184-095.
These results are not surprising and are totally consistent with what we have learned about immune therapy. IT TAKES TIME TO WORK, so men with lower disease burdens will survive longer allowing the immune therapy the time it requires to become active and effective. This is why treatments like Provenge should be taken as soon as a man becomes castrate resistant, while their disease burden is lower.
Annals of Oncology (2014) 25 (suppl_4): iv255-iv279. 10.1093/annonc/mdu336; K. Fizazi1, C.G. Drake2, E.D. Kwon3, A. Bossi4, A.J. van den Eertwegh5, H.I. Scher6, T.M. Beer7, M.B. McHenry8, D. Liu8, W.R. Gerritsen9, C. Logotheti
Joel T. Nowak, M.A., M.S.W.