The massive recall of children's Tylenol, Motrin, Zyrtec, and Benadryl has parents fuming, and for good reason. There's not a parent I know who doesn't keep all these medicines on hand for soothing symptoms of childhood colds, flu, and allergies. They're usually among the first things that pediatricians recommend, too, especially since over-the-counter children's cold remedies have been banned as unsafe for children under age 2, and are discouraged for use with older kids, because there's no proof they relieve cold symptoms, and have been implicated in injuries and deaths to children.
The Food and Drug Administration on April 20 inspected the McNeil Consumer Healthcare factory in Fort Washington, Pa., that made the Johnson & Johnson products, and inspectors said they found many problems with quality control, including raw materials tainted with bacteria. (Read the FDA inspectors' report.) The finished products tested negative for bacteria, FDA officials said, and shouldn't have put children at risk. But since this is the fifth recall of McNeil Consumer Healthcare products since last fall, including a huge recall in January of Tylenol, Motrin, Benadryl and other products that smelled moldy and sickened some people, it's hard not to be worried, and mad.
"McNeil has done several recalls on Tylenol in the past year," web user Christina of Mississippi wrote on the U.S. News website this week. "That is why my trust in them has been severely shaken. My two children ages 3 and 4 years old use a generic form of Tylenol and Motrin now. Not only is it cheaper but it works the exact same way as Tylenol and Motrin."
Jen of Connecticut, who labels herself "Angry Mother!", writes: "This whole recall upsets me! I have 5 bottles of meds, Tylenol, Benadryl, and Motrin that have been recalled! I have 2 sons 9 and 7 months, my oldest uses Benadryl to help with his asthma. If his allergies act up so does his asthma! My 7-month-old uses Tylenol for teething! These companies should test and be sure these meds are safe for our kids!"
Amen to both. I'm fuming because I've been dosing my child with brand-name Zyrtec for allergies, presuming there is better quality control than with generics. Now the FDA says the generic medications are a safer choice. Unfortunately, shoddy and fraudulent medications pose a growing health threat, as I reported in a U.S. News investigation back in 2007. Americans "should be quite concerned," Roger Williams, CEO of US Pharmacopeia, a private organization that creates the nation's official quality standards for drugs, told me then. The FDA has taken a newly activist stance toward drug safety, and it sounds like there will be more action soon on the children's medication recall. But oversight of drug manufacturing hasn't changed much for the better overall.
Once again here's a situation where parents have to stay on top of the news and be proactive in managing their children's health.
Switching to generic cold and allergy remedies is just a short-term fix, however, since the same sloppy manufacturing practices and lax oversight could crop up with generic manufacturers, too. I'll leave the last word on that to another U.S. News reader, who writes: "Isn't it more important to protect infants than Pharma giants?" Legislation is pending in Congress that would give the FDA more muscle to oversee our country's increasingly complex and globalized medication pipeline. Let's hope Congress thinks children's health comes before Big Pharma, too.