Cardiovascular, diabetes risk associated with prostate cancer drug class
SILVER SPRING, Md. Patients taking a certain class of drugs mostly used for prostate cancer may be at higher risk of heart disease and diabetes, the Food and Drug Administration warned on Wednesday.
The FDA said it would require manufacturers to add new warnings to gonadotropin-releasing hormone agonists. GnRH agonists suppress the production of testosterone and are used in androgen-deprivation therapy in men with prostate cancer. Some of the drugs also are used to treat women with endometriosis and children with precocious puberty. GnRH agonists include Abbott’s Lupron (leuprolide acetate), Sanofi-Aventis’ Eligard (leuprolide acetate), Watson Pharmaceuticals’ Trelstar (triptorelin pamoate) and several other branded and generic drugs.
The agency said in May that analyses had found that patients taking GnRH agonists had a small increased risk for diabetes, heart attack, stroke and sudden death.
CRC risk may be highest among men with Type 2 diabetes, study finds
NEW YORK There may be a link between Type 2 diabetes and colorectal cancer among men, according to a new study published in Gastroenterology.
In a final study of 73,312 men and 81,663 women — which were participants selected from the prospective study "Cancer Prevention Study II Nutrition Cohort" — 1,567 men (227 with Type 2 diabetes) and 1,242 women (108 with Type 2 diabetes) were diagnosed with colon or rectal cancer by 2007. Among men, Type 2 diabetes was associated with increased risk of incident CRC compared with not having Type 2 diabetes. CRC risk was higher for those participants with Type 2 diabetes regardless of whether or not they used insulin.
Among women, Type 2 diabetes and insulin use were not associated with CRC risk, the authors said, which may support recent observations that the association may be more prominent in men than in women, and raise the possibility of a stronger association among individuals with a family history of CRC. The authors speculated that the lack of an association between Type 2 diabetes and CRC risk among women might relate to improved glucose control among women with Type 2 diabetes in recent years.
"While our study supports an association of Type 2 diabetes with colorectal cancer incidence among men, our results also suggested that insulin use is associated with a slight, but not a substantially increased, risk of colorectal cancer among men with Type 2 diabetes," said Peter Campbell of the American Cancer Society and lead author of this study. "Prevention strategies should emphasize adherence to guidelines intended for the general population, such as smoking cessation, weight management, exercise and regular early detection exams."
NACDS to IRS: Delay health debit card changes
ALEXANDRIA, Va. The National Association of Chain Drug Stores on Tuesday released a letter addressed to the Internal Revenue Service requesting clarifications of provisions regarding over-the-counter and prescription medications in the Patient Protection and Affordable Care Act.
First and foremost, NACDS is concerned that current IRS guidance would prohibit the use of debit cards in the purchase of not only any prescribed OTC medicine, but also any prescription-only therapy.
“Currently, there is no robust interaction between pharmacy dispensing systems and [inventory information approval systems; the systems used to substantiate purchases for flexible spending accounts]; an IIAS cannot distinguish between a medication for which a prescription is required and an OTC that has been prescribed,” NACDS explained. “As a result, a prohibition on using debit cards for prescribed OTC medications could have the practical effect of prohibiting the use of debit cards for all prescribed medications. … IRS’ prohibition on using debit cards for prescribed OTC medications greatly diminishes the value of the IIAS infrastructure unless pharmacies invest even more capital to modify the IIAS infrastructure to comply with the new guidance.”
There is significant capital at stake, NACDS argued, as the IIAS modifications to distinguish prescription-only and OTC across all stakeholders could take as long as two years to implement. NACDS requested IRS allow the use of debit cards to purchase prescribed OTCs; otherwise, the association requested that the two-week delay the IRS has allowed for implementation be extended by two years.