What is going on with the FDA??

What the heck is going on with the FDA lately? I keep getting warning after warning about how we are killing our patients by prescribing generic medications that have been on the market for 20+ years.

First it’s Haldol. Then it’s Rocephin. The latest generic medications on the hit list are cold remedies. Suddenly medications that have been used probably billions of times since 1969 are a threat to our children’s health due to the possibility of “life threatening overdoses.”

This AP article states that between 1969 and 2006, the FDA found “54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine” and “69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine.”

Gee. 38 years of using these medications and the FDA is just getting around to drawing its conclusions now? I feel safe.

This CBS News article states that pediatricians from “around the country” want the FDA to require labels that OTC cold preparations shouldn’t be used to treat children younger than 6. They argue that these products have “never been proven to benefit children so young.”

So when is the FDA going to do something about all the pediatricians that prescribe antibiotics for snot noses when antibiotic use in such situations “never been proven to benefit” ANYONE? Has the FDA studied how many kids die or have adverse effects from inappropriate antibiotic use? Can anyone say “MRSA”? Maybe the FDA should require that pharmacies put a label on all amoxicillin and Zithromax prescriptions stating “If your pediatrician prescribes this for a cold or a cough (yes, even for “bronchitis”), he or she is a moron.”

I haven’t read the studies, but my first impression is not to give much credibility to the reports of deaths with OTC cold medications. Notice how the reports say that the deaths are “associated with” OTC cold preparations, not “caused by” these medications. What a bunch of doublespeak.

For example, I would venture an educated guess that just about every case of death due to asthma is “associated with” albuterol use. Any patient with an acute asthma attack gets an albuterol treatment - hence the “association.” STOP THE PRESSES! Albuterol is associated with people dying from asthma. The FDA needs to issue a warning on albuterol, too — before it “is associated with” any other deaths. Besides, issuing an FDA ALERT on albuterol would fit the FDA’s recent modus operandi — making physicians too afraid to prescribe a generic drug that has been used for 20+ years.
Xopenex is probably a good substitute — it is still on patent and costs about four times as much as albuterol. We’ll have to wait another 15-20 years for the FDA to determine whether Xopenex will kill us. By then, there will be some new asthma medication out that costs $500/dose.

Want another example? Check this out. Fentora - the nongeneric (i.e. “more expensive”) form of the pain medication fentanyl - has been available in the US for less than a year. This medication has resulted in the death of patients from “life threatening overdoses” — just like the OTC cold medications.
Does the FDA get rid of this one? Nope.
No “FDA ALERT.”
No cadre of angry pediatricians demanding labeling changes.
Only a little “public health advisory” telling everyone to adhere to prescribing guidelines. One site calls the FDA’s warning on Fentora a “mere formality.”

I call it something else.