FDA Bans 500 Over-the-Counter Cold & Allergy Medications
By Dr. Paul Ehrlich
The other day, the Food and Drug Administration banned the sale of some 500 over-the-counter drugs for treating symptoms of colds and allergies.
These drugs are essentially survivors of a bygone era, the early 1960s, when the FDA was less robust. They have gone all these years without evaluation by the FDA for safety and effectiveness, and may be riskier than approved drugs.
“This action is necessary to protect consumers from the potential risks posed by unapproved drugs, because we don’t know what’s in them, whether they work properly or how they are made,” according to Deborah M. Autor, director of the agency’s Office of Compliance at the Center for Drug Evaluation and Research.
• the possibility of improper use in infants and young children
• potentially risky combinations of ingredients
• patients receiving too much or too little of the medication because of problems with the way some ”timed-release” products are made
This is now the third time we at asthmaallergieschildren.com have covered OTC drugs, the first being a post I did on OTC anti-histamines after going more than a month without prescribing one of the newer drugs, and the second, Larry’s and my joint piece about the impending withdrawal of Primatene. We follow non-prescription drugs closely because we believe people should have access to lower-price, convenient medication without having to go to the doctor (my accountant is moaning out there somewhere); thus, Claritin and Zyrtek, si. But we also believe that these medications should be safe; Primatene, no. (Although Primatene is only banned because of the propellant it uses.)
I was gratified to see that Mucinex escaped the ax on this round for a good reason—it is a safe, effective and CHEAP way to break up congestion. Many of the competitive, and now banned, medicines contained the same mucolytic agent guaifenesin as Mucinex, but in concentrations too low to be effective. In the old days, when all a parent could get was a variation on the word tussin, from tussis, the Latin word for cough. I told them to use more of it than the label directed because otherwise it wouldn’t work. When Mucinex appeared, I didn’t have to, because it got the job done without any of the alcohol that made some potions so attractive to teenagers in search of a cheap, legal drunk.
Many of the now-banned drugs also contain pseudoephedrine, which is also the precursor drug for crystal meth, and indeed, Mucinex-D, which itself contains pseudoephedrine, will not be on the shelves but behind the counter.
You can find a full list of the newly banned drugs here.