Are anti-prostate drugs like Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard and Synarel safe? The US Food and Drug Administration is looking into whether these drugs increase the risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving them for prostate cancer but has not made any conclusions yet.
From the FDA release:
FDA’s review is ongoing. The agency has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer.
In the meantime, here’s what the FDA recommends while it conducts its safety review:
At this time, FDA recommends that:
- Healthcare professionals should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment.
- Patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease.
- Health care professionals should manage cardiovascular risk factors for patients, such as smoking and increases in blood pressure, cholesterol, blood sugar, and weight, according to current clinical practice.
- Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.
Additional Information for Patients
- FDA has not concluded that receiving GnRH agonists increases your risk of diabetes and cardiovascular events. The Agency will continue to review information relating to this safety concern as more information becomes available.
- GnRH agonists are sold as the brand names – Lupron, Zoladex, Trelstar, Viadur, and Eligard.
- Do not stop your treatment with GnRH agonists unless told to do so by your healthcare professional.
- Before receiving GnRH agonists, tell your healthcare professional if you have diabetes, heart disease, a previous heart attack or stroke, or any cardiovascular risk factors like high blood pressure, high cholesterol, or cigarette smoking.
- If you have any concerns about receiving these medicines, talk to your healthcare professional.
Additional Information for Healthcare Professionals
- FDA has not concluded that GnRH agonists increase the risk of diabetes and cardiovascular events in patients using these medications for prostate cancer.
- Most of the studies reviewed by FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists.
- Follow the recommendations in the drug label when prescribing GnRH agonists.
- Carefully weigh the known benefits and risks of GnRH agonists when determining appropriate treatment for prostate cancer.
- Monitor patients for diabetes and cardiovascular events in patients receiving GnRH agonists.
- Ensure that cardiovascular risk factors such as blood pressure, cholesterol, blood sugar, weight, and smoking are managed according to current clinical practice.
Here’s a Wall Street Journal story on this issue:
The U.S. Food and Drug Administration is conducting a safety review of hormone-therapy drugs that are used to treat prostate cancer to see if the treatments increase the risk of heart attacks, strokes and diabetes.
The drugs, which fall into a class of products known as gonadotropin-releasing hormone agonists, are sold under brand names that include Abbott Laboratories’ (ABT) Lupron, AstraZeneca PLC’s (AZN, AZN.LN) Zoladex and Sanofi Aventis SA’s (SNY, SAN.FR) Eligard. The products are designed to lower levels of male hormones, which can shrink prostate tumors and slow the growth of prostate cancer.
The FDA said Monday it was reviewing data from several published studies that involved patients undergoing hormone therapy for prostate cancer compared to patients who weren’t on hormone therapy.
The agency said six studies showed a “small increased risk of diabetes and/or cardiovascular disease in patients” undergoing hormone treatment.
“However, these studies have design limitations that make it difficult to confirm a cause-and-effect relationship,” the agency said in a statement on its website.
Other products involved in the review include Trelstar, marketed by Watson Pharmaceuticals Inc. (WPI) and Endo Pharmaceuticals Holdings Inc.’s (ENDP) Vantas. Another drug in the same class Synarel, from Pfizer Inc. (PFE), is approved to treat endometriosis in women and to early puberty in children. Zoladex is approved to treat certain women with advanced breast cancer in addition to being approved as a prostate cancer treatment.
