FDA to discuss status of Mevacor
ROCKVILLE, Md. The proposed switch of Merck’s Mevacor statin (lovastatin) is on the Food and Drug Administration advisory committee meeting docket again, according to a report published by the Tan Sheet Monday morning citing FDA documents submitted for publication in Tuesday’s Federal Register.
According to the report, the agency’s nonprescription drugs and endocrinologic and Metabolic drugs committees will meet Dec. 13 in Silver Spring, Md.
FDA advisory committees have twice before voted against switching Mevacor to OTC status, most recently criticizing a patient’s ability to adequately self-select use for a condition with no acute symptoms.
Another Merck statin, Zocor (simvastatin), has already gained behind-the-counter status in the United Kingdom, whereby a U.K. pharmacist must consult with a patient on the use of Zocor Heart-Pro before dispensing the medicine.
The FDA is hosting a separate meeting Nov. 14 to discuss a potential BTC status in the United States.
FDA committees vote against cough-cold products for children under six
SILVER SPRING, Md. Purveyors of cough and cold medicines were today dealt a significant blow immediately before the cough and cold illness season.
A pair of advisory committees for the Food and Drug Administration Friday afternoon voted against recommending any cough or cold products to any child under the age of six.
Specifically, the committees, representing both the Nonprescription Drugs Advisory Committee as well as the Pediatric Advisory Committee, voted almost unanimously that cold medicines should not be used for children under the age of two; and voted 13 to 9 in favor of not advising cold medicine use on children under the age of six. However, the committees leaned the other direction with regard to children between the ages of six and less than 12—seven committee members recommended that cold medicines not be used in this population and 15 members suggested that cough and cold medicine use in children of this age group was appropriate.
The Consumer Healthcare Products Association earlier this month announced that its member companies have voluntarily recalled all products marketed toward infants and babies, or children under the age of two.
Part of the concern in taking any of these medicines off the market expressed by several committee members is one of unintended consequences. What will parents do if these cold products are not made available to them?
Hopefully consult their pharmacist, or another healthcare professional on alternative remedies or the practice of not administering any remedies, commented Winnie Landis, president of the American Pharmacists Association. If these products are removed from the market, Landis expressed a concern that parents will make a go at treating their children without consulting a healthcare professional. APhA was on hand before the committee to recommend that use of medicines should not be recommended for children under the age of two, in accordance with the CHPA position, and that line extensions within the same brand name of products should be limited as these line extensions tend to add to the confusion in shopping the OTC cough/cold aisle.
On the other side of the argument, several committee members expressed concern that there appears to be no evidence proving efficacy of cold medicines in children. Consequently, it would be irresponsible to recommend the use of these products given known serious adverse events, however rare those events might be. “The discussion I’ve heard regarding efficacy is that there is none demonstrated,” commented Robert Daum, professor of pediatrics at the University of Chicago Medical Center and member of the Pediatrics Advisory Committee. However, Mary Tinetti, chairman of the Nonprescription Drug Advisory Committee and professor of medicine, epidemiology and public health at the Yale University School of Medicine, countered that lack of evidence of efficacy does not necessarily mean lack of efficacy.
“I do not believe that these” products should be removed from the market, commented Amy Celento, a temporary voting member for this committee representing patients and families. “There are many, many adults who will … administer adult products to children” if products specifically marketed toward children are removed from the market.
The Food and Drug Administration will be unable to implement any hard and fast regulatory changes in the immediate future, however, suggested that the advisory committee recommendations may be a prompt for the agency to consult with industry on more immediate action. “That doesn’t prevent us from having a meeting with industry and say ‘Look, you need to go down this path because this is where we’re heading,’” commented Charles Ganley, director of FDA’s office of nonprescription products.
Report calls into question marketing of OTC cold medicines for children
BOSTON The Prescription Project on Thursday released a report showing that companies producing over-the-counter cough and cold medicines spent more than $50 million marketing these products for children under the age of 6 despite evidence of risks and lack of effectiveness in treating children.
The report, titled Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children, was released to coincide with today’s Food and Drug Administration’s Nonprescription Drug Advisory Committee hearing on the potential dangers of these products for children under the age of 6.
The Prescription Project report, which analyzed FDA, industry, and epidemiological documents on OTC remedies, found a lack of efficacy data but a significant number of reported injuries and deaths associated with overdosing of these products. “Especially when it comes to over-the-counter drugs, physicians and patients rely on the FDA to ‘calculate’ the benefits versus risks and communicate this to the public,” stated John Santa, a consultant to the Prescription Project and former medical director of the Drug Effectiveness Review Project. “In this case, it appears the benefits are close to zero while the risks are significant.”
The Consumer Healthcare Products Association contends that OTC cough and cold medicines administered to children over the age of two, when used as directed, is safe and effective. Overdosing and misuse, such as using an antihistamine to sedate a child, are legitimate concerns, the Association has noted, that should be addressed through increased education.