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| New considerations for ADT in advanced prostate cancer and the emerging role of GnRH antagonists |
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| Lupron, Estradiol and the Mitochondria: A Pathway to Adverse Reactions - Hormones Matter |
The US Food and Drug Administration (FDA) spotted possible safety blips on its radar for 14 drugs or drug classes in the first 3 months of 2017, which put them on the agency's latest watch list.
The watch list, posted last week on the FDA website, reflects potential signals of serious risk or new safety information gathered by the FDA Adverse Event Reporting System (FAERS).
The FDA notes that a drug's appearance on a quarterly FAERS watch list does not mean that the agency has determined a causal relationship between the drug and the adverse event. What it does mean is further study. If the FDA concludes that there is a causal link, it can collect more data to better describe the risk, change the drug's label, order a risk evaluation and mitigation strategy, or pull the product from the market.
Lupron, Estradiol and the Mitochondria: A Pathway to Adverse Reactions- Hormones Matter
Adverse events have been reported when Lupron and other Gonadotropin-releasing hormone agonists have been used for non-prostate cancer cases such as premature puberty and female issues.Leuprolide, more commonly known as Lupron, is the GnRH agonist prescribed for endometriosis, uterine fibroids, cysts, undiagnosed pelvic pain, precocious puberty, during infertility treatments, to treat some cancers, and a host of other off-label uses. It induces a chemical castration in both women and men. In women, Lupron stops menstruation and ovulation and crashes endogenous estradiol synthesis rapidly and completely, inducing menopause and menopause-associated symptoms like hot flashes, sweats and osteoporosis, to name but a few. In men, where it is used as a treatment for prostate cancer, it prevents the synthesis of testosterone, pharmacologically castrating its users and evoking a similar constellation of symptoms.
Related/Background
- HIGHLIGHTS OF PRESCRIBING INFORMATION LUPRON DEPOT -PED
- FDA Adverse Events Reporting System (FAERS) > FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk/New Safety Information | Additional Information (as of June 30, 2017) |
|---|---|---|
| Gonadotropin-releasing hormone agonists Lupron (leuprolide acetate) injection Lupron Depot PED (leuprolide acetate for depot suspension), injection, powder, lyophilized, for suspension Supprelin LA (histrelin acetate) subcutaneous implant Synarel (nafarelin acetate) nasal solution |
Musculoskeletal and connective tissue pain and discomfort | FDA is evaluating the need for regulatory action. |
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