FDA Adds Heart Disease Risk, Diabetes Warning to Prostate Cancer Drugs
Federal drug regulators are calling for new heart disease and diabetes warnings to be added to a class of prostate cancer drugs that includes Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex.
On Wednesday, the FDA issued a drug safety alert, announcing that it was asking manufacturers to add the new warnings to all drugs belonging to a class known as gonadotropin-releasing hormone (GnRH) agonists. The warnings will alert patients and doctors that side effects of the drugs may include a small increased risk of diabetes and cardiovascular events, including heart attacks and strokes.
The FDA launched a safety review of GnRH agonists in May. That review is ongoing.
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Before the call for new label warnings, the FDA had already recommended that health care professionals be made aware of the potential risks and carefully weigh those risks before prescribing the drugs. The agency also recommended that patients prescribed a GnRH be monitored for diabetes and cardiovascular disease, and that cardiovascular risk factors, such as smoking and high blood pressure, be controlled while taking the medication. The FDA also warned patients not to stop treatment with GnRH’s unless instructed by their health care provider.
GnRH’s suppress the production of testosterone, limiting the ability of prostate cancer to grow. The class of drugs includes Sanofi-Aventis’s Eligard, Abbott Laboratories’ Lupron, and Pfizer’s Synarel, among other brand names, as well as generic products. The drugs are also often used to treat women suffering from pain caused by endometriosis, and to treat anemia and breast cancer. It is also used in children to treat central precocious puberty. However, these uses have not been approved by FDA.
The FDA estimates that there will be 217,730 new cases of prostate cancer among men this year, and that it will kill about 32,050 men, making it the second most common type of cancer among men in the U.S., behind skin cancer.
PetalNovember 11, 2010 at 10:12 am
Hello, My name is Petal J. from Trinidad. West Indies. I have had surgery in April 2008 for the removal of fibroid and my doctor insisted that I took the product Zoladex for six months. At the time I was 33 years old and I had gone thru menopause during the time I was taking the Zoladex. I had hot flashes, no period for six months etc. At present I am 35 years old and due to taking the product I[Show More]Hello, My name is Petal J. from Trinidad. West Indies. I have had surgery in April 2008 for the removal of fibroid and my doctor insisted that I took the product Zoladex for six months. At the time I was 33 years old and I had gone thru menopause during the time I was taking the Zoladex. I had hot flashes, no period for six months etc. At present I am 35 years old and due to taking the product I have had rapid weight gain. I am 190 lbs fighting an obesity a problem I have never had before. All these things happened due to the fact that I have been injected for six months with the Zoladex product in 2008.
ArthurOctober 23, 2010 at 2:09 pm
I am a Bahamian. About a year ago I was advised that there was a tiny nodule on my prostate and my PSA level had risen to about 12. A biopsy performed in Orlando, Fla indicated Stage 2 cancer, which I was told was treatable. Prior to this, and starting radiation treatment, I was able to reduce the PSA count to 1.2 after using a suppository produced by a local urologist, Dr Joseph Evans, marketed u[Show More]I am a Bahamian. About a year ago I was advised that there was a tiny nodule on my prostate and my PSA level had risen to about 12. A biopsy performed in Orlando, Fla indicated Stage 2 cancer, which I was told was treatable. Prior to this, and starting radiation treatment, I was able to reduce the PSA count to 1.2 after using a suppository produced by a local urologist, Dr Joseph Evans, marketed under the brand name Navophos, although I was later informed that the active ingredient - afemale hormone- which I can't recall at the moment, had been touted in a New York Times 1941 article as a breakthrough cure for cancer. At a local cancer forum, I was advised that "the cure" had been ordered withdrawn due to an association with heart attic susceptibility. On entering the local health system I was advised that I needed to switch to Zoladex in order to comply with eligibility requirements and also the fact that although 'Navophos' had been inquired about, it was not clear how it would impact the radiation treatment. After completing the radiation treatment, I was advised to have a new PSA test before a post-treatment assessment. However, at the time of the 'post-treatment' exam, I was advised that the result of the new PSA test had not been received and there would be no rectal exam as the effect of the radiation had probably left the area too sensitive for any 'probing', but I would be contacted about the results of the PSA test. After not being contacted after about three weeks I visited the local cancer radiation therapy centurion FridayOct 22 and was told the PSA test result had not yet been received and to check back the following week. Prior to this I visited my local GP and was told that my blood pressure, which had consistently been normal, was now somewhat lower. My occasional mild perspiring was attributed to 'hot flashes' as a result of the Zoladex. I am now awaiting the result of the PSA test. Another doctor has suggested that if it was him, he would have stayed on the Navophos even though it tended to leave one's breasts in a somewhat 'tender' state. Apart from awaiting the results and any commentary about the PSA test, my next appointment with the radiation centre is in mid Jan 2011. Apart from the above, I still feel reasonably physically healthy. My urologist has advised that while the radiation therapy has an approximately 70% cure rate, additional hormonal therapy treatment increases this to about 90%.
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