Off-label uses of medication

Here is a recent article from the AP entitled “FDA faulted over unapproved uses of medications.” The upshot of the article is that drug companies are only allowed to market their drugs to doctors for the express purpose of the medication. When pharmaceutical companies get a new drug, they send it through trials to make sure it’s better than nothing (a placebo) and/or as good as or better than another drug, without causing excess problems. You may not know this, but the medication in Viagra was intended for use as a blood pressure medication. Many of the human test subjects discovered that when they took sildenafil citrate, that they were able to have sex, although they had been impotent. The manufacturers quickly realized that it would be much more profitable to have the drug be used for that purpose than for reducing blood pressure, so they sent it through trials for the approved usage of treating erectile dysfunction. More frequently, though, it is after a drug is put on the market, that somebody will discover additional uses for it.

As the AP article put it,

“Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting their money. Some people have been harmed by unexpected side effects.”

I am not against all off-label uses of drugs; but I do think that patients need to be told that the doctor is prescribing and/or using this medication in a way that is not FDA-approved; or perhaps it could be phrased that the drug “hasn’t gone through trials for this indication, although a lot of people have gotten benefit from it, and I think you might too.” The problem arises when a person takes such a medication off-label, and is harmed instead of helped. As long as the person has been given full information and allowed to make the choice himself, then that is one thing; but when the person has essentially just been told, “Do as you’re told,” or even lied to about the benefit of the drug (because the drug rep may exaggerate the claims of the drug, or minimize the known risks), then that is another, because it is the patient who runs all the risks should the medication not work or indeed if it should harm him.

I remember when Vioxx and all the other cox-2 inhibitors came out — everybody and his brother was on them for arthritis or any other kind of pain. Doctors were eager to prescribe them to anyone with arthritis pain (even if ibuprofen or other NSAIDs worked just fine. Some people said the new drugs were better; most said they were about the same; other said they were worse. The new drugs were a lot more expensive than the generics, that’s for sure! And they simply didn’t have the safety record of drugs like ibuprofen that has been around for so many years. Consequently, the “rare but serious side effects” simply could not be known, until people started having problems.

Sometimes pregnant women need medications. I would suggest having a long talk with your doctor and pharmacist about how long the drug has been on the market, and what alternatives may exist, and the safety data for pregnant women and their babies for this and other drugs. There are drugs that have been around for decades — long enough for any major deleterious effects to be known in the fetal population. They may not be “safe” as in “never causing any problems whatsoever”; but their safety data is well-established. Newer drugs simply cannot have that. They may not be any worse than long-established drugs, and may in fact be safer; but for myself, if I had to have a drug, I’d go with the older drugs and the lowest dosages I could.

Finally, here is a link which talks about pharmaceutical drugs in labor and birth. Many drugs used in labor and birth are used off-label. Some drugs, such as Pitocin (oxytocin), are labeled only for medically-indicated inductions, but not for elective inductions; yet they are used for elective inductions every day. Drugs have risks and side effects. When there is a medical reason for the baby to be born (whether to benefit the mother or child or both), then the risks of continuing the pregnancy outweigh the risks of the drugs. But when there is no such medical reason, then there is only risk.


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