The pregnancy risks associated with prescription drugs and biologic products will soon be more clearly delineated on product labels with a new system that requires three subsections — “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential” — rather than the current letter-based system (A, B, C, D, and X), the FDA announced on Wednesday.
The “Pregnancy” section will discuss dosing considerations, possible risks to the fetus, and other information relevant to prenatal use. It will also note whether there’s a registry that maintains data on how pregnant women are affected by the product.
The “Lactation” section will note the amount of drug that may be in breast milk and the potential effects on the child, among other considerations.
The “Females and Males of Reproductive Potential” section will include information about pregnancy testing, contraception, and infertility as it relates to the product.
The new system will go into effect at the end of June 2015.
FDA news release
There is some evidence suggesting that the use of Benzodiazepines like Ativan, Xanax, Clonazepam, Valium, is associated with excess risk for dementia; however, benzodiazepines are sometimes prescribed for prodromes of dementia, (e.g., anxiety, insomnia). In this case-control study, investigators examined the association between exposure to benzodiazepines and risk for developing Alzheimer disease (AD).
The association was stronger for long-acting benzodiazepines ( Valium) than for short-acting benzodiazepines (Xanax).
Billioti de Gage S et al. BMJ 2014 Sep 9.
Noncaloric artificial sweeteners, such as Splenda, Sweet and Low, Equal were introduced in the hope to control body weight and lower risk for diseases linked to obesity. Yet the epidemic of type 2 diabetes and obesity seems to coincide with introduction of noncaloric sweeteners. Most of us assume that the epidemic of obesity and type 2 diabetes led to more use of noncaloric sweeteners. However, researchers in Israel report that the opposite might be true: Use of noncaloric sweeteners might have contributed to the epidemic.
Mice that are given noncaloric sweeteners develop glucose intolerance quickly, compared with mice that are given sucrose or glucose. Introduction of dietary noncaloric sweeteners promptly alters the mouse microbiome to favor biochemical pathways that enhance absorption of calorie-rich glucose and short-chain fatty acids. Giving antibiotics to the glucose-intolerant mice eliminated glucose intolerance, and transplanting feces from sweetener–fed animals into germ-free animals produced glucose intolerance in these control animals, whereas feces transplanted from glucose-fed mice into controls didn’t produce glucose intolerance.
Seven healthy human volunteers who did not regularly consume noncaloric sweeteners were placed on a diet that contained noncaloric sweeteners. Within 1 week, four participants developed glucose intolerance. Stool from these people, when transplanted to mice, also produced glucose intolerance. Stool from the three humans who did not develop glucose intolerance did not produce glucose intolerance in mice.
This report argues that, although artificial sweeteners lack calories, they can change the gut microbiome in a way that leads to absorption of more calories and that compromises glucose tolerance.
Suez J et al., Nature 2014 Oct 9; 514:181
High milk consumption in adults is associated with increased mortality and, among women, increased fracture risk, according to an observational study in BMJ.
Women who reported drinking 3 or more glasses of milk daily had a near doubling of risk for total mortality relative to those who drank less than a glass daily. Men drinking 3 or more glasses daily had a smaller, but still significant, increase in mortality.
Among women, high milk consumption was also associated with increased risk for any fracture and hip fracture.
The authors note that D-galactose, found in milk, has been shown to induce oxidative stress damage and chronic inflammation in animals, and such changes have been associated with cardiovascular disease, cancer, bone loss, and sarcopenia in humans. Nonetheless, the authors caution that their findings “merit independent replication before they can be used for dietary recommendations.”
The American College of Physicians has issued a new set of recommendations to prevent recurrent kidney stones.
Published in the Annals of Internal Medicine, the guidelines recommend the following:
Patients with a history of kidney stones should be encouraged to increase their fluid intake, with a goal of producing at least 2 liters of urine a day.
In patients with active disease in whom higher fluid intake is not sufficient, treatment with a thiazide diuretic, citrate, or allopurinol is recommended.
Patients should also be encouraged to avoid colas, which are acidified with phosphoric acid. The recommendation does not apply to fruit-flavored soft drinks, which are often acidified with citric acid.
Annals of Internal Medicine article
Nearly 12,000 boxes of Assured brand naproxen tablets (220 mg) have been recalled because, after a packaging error, some contain ibuprofen (200 mg) instead. The recalled pills are sold at Dollar Tree.
FDA MedWatch safety alert
According to a research letter in JAMA, dietary supplements recalled because of the presence of pharmaceutical adulterants still contain the banned ingredients months after the recall.
They looked at 27 dietary supplements that were recalled between 2009 and 2012 because of pharmaceutical adulterants. Researchers purchased the supplements at least 6 months after recall for analysis of banned ingredients.
Roughly two thirds of the products tested positive for at least one pharmaceutical adulterant — usually the same ingredient identified at the time of the recall. One fifth of all products contained additional banned ingredients. Among the adulterants identified were sibutramine (wt loss agent), sildenafil (Viagra), fluoxetine (antidepressant), and anabolic steroids.
The researchers conclude: “Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the US marketplace.” They call for “more aggressive enforcement of the law, changes to the law to increase the FDA’s enforcement powers, or both.”