J&J recalls lots of Infants’ Mylicon Gas Relief Dye Free
FORT WASHINGTON, Pa. Johnson & Johnson-Merck Consumer Pharmaceuticals Company Monday evening voluntarily recalled approximately 12,000 units of Infants’ Mylicon Gas Relief Dye Free (simethicone-antigas) non-staining sold in 1-ounce plastic bottles that were distributed after Oct. 5 because some of the bottles could include metal fragments that were generated during the manufacturing process.
Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.
The company is taking this action in consultation with the Food and Drug Administration, J&J reported.
P&G adds updated versions of DayQuil, NyQuil with vitamin C
CINCINNATI Procter & Gamble recently combined the multi-symptom relief of its DayQuil and NyQuil brands with more than 150 percent of the recommended value of vitamin C in DayQuil Plus Vitamin C and NyQuil Plus Vitamin C respectively.
The idea is that while consumers are seeking cold symptom relief, they can take something to help boost their immune system in one remedy. Last cough/cold season, Bayer Healthcare followed a similar line of thinking with its introduction of Alka-Seltzer Plus Immunity Complex, effervescent get-better tablets that contain all supplements, however, as opposed to a supplement and OTC combo.
Bayer did however recently launch a supplement/OTC combination product, Bayer With Heart Advantage, which contains 81 mg of aspirin and 400 mg of phytosterols. That product generated a warning letter from the Food and Drug Administration on Oct. 28, in which the agency suggested that supplement/OTC combinations may run afoul of regulations. “The FDA considers these products new drugs and thus they must undergo the FDA’s drug approval process,” Mike Chappell, the FDA’s acting associate commissioner for regulatory affairs, said. Speaking to the Bayer products, FDA noted that the solution is labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug.
That’s not to suggest that P&G is marketing a product without FDA approval. Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval, the agency noted. These drugs must comply with applicable monographs as well as the indications for which the drugs can be marketed.
CRN comments on data on male cardiovascular health and vitamins C, E
WASHINGTON The Council for Responsible Nutrition on Sunday commended research to be published in the Nov. 12 issue of the Journal of the American Medical Association. While that research concluded there appears to be no prevention of cardiovascular events in male physicians supplementing with vitamins E and C, it did not wholly discount the possible benefits of supplementing with vitamins E or C, either.
“We commend the researchers for undertaking this important prevention trial which sought to confirm positive results demonstrated by earlier observational trials on these antioxidant vitamins. Although the results did not demonstrate an overall benefit, the results also do not discount the earlier epidemiological data showing that people with high intakes of vitamins E and C may have a lower risk of cardiovascular disease,” stated Andrew Shao, vice president of scientific and regulatory affairs for CRN. “Nutrition research is extremely complex, and doesn’t always provide clear-cut answers. This study raises an interesting set of scientific challenges as to why the benefits found in observational studies have not been confirmed in this kind of trial.”
Shao acknowledged that this research could be frustrating for consumers, however. “The truth is, we don’t have conclusive scientific evidence in the form of randomized, controlled trials that demonstrate exactly how to prevent cardiovascular disease. We do know there are some well-known practical approaches—like not smoking, maintaining a healthy weight, consuming a diet with a variety of foods, regular exercise, seeing your physician and responsible use of vitamin supplements,” he said. “[But] consumers should not take vitamins expecting that vitamins alone will prevent cardiovascular disease … they should continue to take vitamins for the general health benefits they provide.”
“This important study is another in a series of clinical trials that generally have failed to confirm hopes of identifying a strong preventive effect of vitamin E, vitamin C or other antioxidants in relation to cardiovascular disease, commented Annette Dickinson, consultant and past-president of CRN. “These results do not of course negate other evidence of benefits for vitamin E and vitamin C for other conditions, including immune function, mental acuity and eye health. Consumers would be well advised to ensure adequate intakes of all essential nutrients through a good diet plus use of a multivitamin, and selected other nutrients including vitamins E and C, vitamin D, calcium, and EPA and DHA omega-3 fatty acids.”