OPINION: Parents need a more aggressive FDA

Dr. Marc Siegel is an associate professor of medicine and medical director of "Doctor Radio" at New York University Langone Medical Center.

Parents of young children everywhere were frightened to learn that 43 products and 1,500 lots of commonly used children's medicines were being pulled from the shelves late last week.

Infants' and children's Tylenol, Motrin, Zyrtec and Benadryl manufactured by a McNeil plant in Pennsylvania were voluntarily recalled because of quality control concerns. It's a huge number of units, but the response is hardly sufficient when you consider how precious and defenseless our children are, how easily they may be adversely affected by too much of an active chemical, and just how unacceptable the conditions were at the plant.

This isn't the first time this year that a finger has been pointed at McNeil (a division of Johnson & Johnson). Just this past January, the company was compelled to recall several hundred batches of adult over-the-counter medicines (manufactured at a plant in Puerto Rico) - including Benadryl, Motrin and Tylenol - after consumer complaints about the smell of mold in their bottles.

The April Food and Drug Administration investigative report that led to the current recalls is simply shocking, citing the plant for not only using raw materials contaminated with bacteria but also lacking "process control procedures," proper labeling, and "test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality, and purity."

Back in 1982, the public was horrified when several people died after taking Tylenol pills poisoned with cyanide. Johnson & Johnson responded with a national recall and strong product scrutiny. The question now is whether it will take the current fiasco as seriously.

If J&J doesn't police itself, the FDA must bare its teeth and launch a full-scale investigation into the entire McNeil division, to ensure that quality controls and sterile techniques are in place throughout the plants. The Pennsylvania plant may well need to be shuttered for good: The FDA report reveals dust, debris and contaminants, and raises concerns that the products contain inactive particles as well as a variation in the amount of active ingredients.

In the meantime, it's important to remember that the chances are extremely high that kids who took one of the recalled products are safe - even though parents should stop using all of the products on the list.

The FDA needs to be much more aggressive, especially when it comes to children's products. Too much acetaminophen (the active ingredient in Tylenol) can be toxic to the liver; too much ibuprofen (the active ingredient in Motrin) can harm the stomach and kidneys; and too much antihistamine (such as Zyrtec and Benadryl) can cause heart arrhythmias and change of behavior. Parents should consider whether they've been relying too much on these treatments to begin with - especially since they only relieve symptoms and are not cures. Why not consider alternatives like chicken soup, nasal spray and old fashioned neti pots?

Parents' responsibility is to recognize that as small people, children can be sensitive to the medicines we give them - especially over-the-counter treatments that are not subject to a pediatrician's direct review.

The FDA's responsibility is to investigate the manufacturing process at all companies that make these products, brand-name and generic. Our children are too important to have it any other way.