FDA: Include warnings on risk for class of prostate cancer drugs

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration asked manufacturers to add new warnings to labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer. The warnings would alert patients and their health care professionals to the potential risk of heart disease and diabetes in men treated with these medications.

In May, the FDA said that a preliminary and ongoing analysis found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke, and sudden death. The new labels will include updates in the Warnings and Precautions section about these potential risks.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. This year an estimated 217,730 new cases of prostate cancer will be diagnosed and about 32,050 men will die from the disease, according to the Centers for Disease Control National Center for Health Statistics and the National Cancer Institute.

GnRH agonists are drugs that suppress the production of testosterone, a hormone involved in the growth of prostate cancer. This type of treatment is called androgen deprivation therapy, or ADT. Suppressing testosterone has been shown to shrink or slow the growth of prostate cancer.

GnRH agnoists are marketed under the brand names: Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex. Several generic products are available.

For more information:

Most Popular Now

Novartis announces plan to initiate clinical trial…

Novartis today announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the effic...

Gilead announces results from Phase 3 trial of inv…

Gilead Sciences, Inc. (Nasdaq: GILD) announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigation...

AstraZeneca and Oxford University announce landmar…

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine a...

Sanofi and Regeneron provide update on U.S. Phase …

Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzar...

Roche's COVID-19 antibody test receives FDA Emerge…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) (1) for its new Elecsys® Ant...

Pfizer and BioNTech dose first participants in the…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 va...

Arthritis drug may improve respiratory function in…

A small study in Greece found that the clinically approved anti-inflammatory drug anakinra, used to treat rheumatoid arthritis, improved respiratory function in patients ...

Early indicators of vaccine efficacy

Ludwig-Maximilians-Universität (LMU) in Munich researchers have shown that a specific class of immune cells in the blood induced by vaccination is an earlier indicator of...

Frankfurt researchers discover potential targets f…

A team of biochemists and virologists at Goethe University and the Frankfurt University Hospital were able to observe how human cells change upon infection with SARS-CoV-...

Vitamin D linked to low virus death rate

A new study has found an association between low average levels of vitamin D and high numbers of COVID-19 cases and mortality rates across 20 European countries. The r...

Loss of smell associated with milder clinical cour…

Following an earlier study that validated the loss of smell and taste as indicators of SARS-CoV-2 infection, researchers at UC San Diego Health report in newly published ...

Can an existing HIV medication slow the spread of …

A team of scientists from St. Michael's Hospital, Sinai Health and Sunnybrook Health Sciences Centre have launched a clinical trial to understand whether an existing drug...