Similac Recall; Preventing Birth Defects

"Abbott is initiating a proactive, voluntary recall of certain Similac-brand, powder infant formulas in the U.S., Puerto Rico, Guam and some countries in the Caribbean." For more information, visit the Abott website here.

This recall is being conducted by lot number rather than by NDC number. The lot number is a unique number assigned to a specific production run from a particular time and place. The NDC number is a more general number that is assigned to a particular strength, formulation and size of a medication, regardless of production run.

The recent recall of some common over-the-counter pediatric suspensions (e.g., Tylenol, Motrin and Benadryl) had been conducted by the more general NDC number. I thought this was silly because in fact not every lot had been at risk. On the other hand an NDC recall provides better protection for the manufacturer, which has to assume that the average consumer is an idiot. So rather than leave it to the customer to figure out whether the bottle they have at home is from an affected lot, the company simply recalls every lot.

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A few days ago the FDA approved the marketing of Beyaz, which combines a popular oral contraceptive product (YAZ) with folate (actually a folate metabolite). The FDA explains (here) that "a known association of low folate levels and neural tube defects (e.g., spina bifida) has resulted in recommendations that women of childbearing age supplement their diet with folate."

My initial reaction was to chuckle. Why combine a birth control product with an additional ingredient that can contribute to a healthier baby? But of course many patients who use birth control will eventually discontinue it in order to conceive and it makes sense to combine a medication that patients may not immediately recognize as important with a second medication that they take religiously. (Actually it might not bad idea to combine many other medications with birth control formulations in order to improve patient compliance.)

The truth is that many insurance companies don't cover YAZ, but don't start reaching for your cash even if your doctor sees a benefit in the new Beyaz. You can simply continue using your regular birth control and take the folate supplementation separately.