Botox for Migraines? Let’s Read the Package Insert

Keep away from 1991 the FDA cleared Allergan’s prescription drug Botox® (botulinum toxin A, “Botox”) to treat crossed eyes (strabismus) and involuntary eyelid clenching (blepharospasm). Since then the label regarding Botox has been expanded to four or five additional therapeutic hints, most recently to treat chronic, severe migraines. First identified around 1897, botulinum toxin has become what Allergan’s executive VP for R&D calls a “pipeline in a vial. in Ka-ching!

What it really means when the FDA approves a meds or expands the number of uses for it, is that the drug’s maker is allowed to market the drug for that use. However , medical practitioners are free to use any approved drug for any use of their whole choosing — the FDA does not regulate the perform of medicine. In fact , there were hints of Botox’s potential reward to treat migraine over ten years ago and some off-label apply for migraine has occurred over the years. Now, Botox can be formally approved for that use, what professionals call an illustration. So , the only question remaining is how well does it really work??

Fortunately, the FDA. gov web site contains a treasure box full of technical literature gems called Package Inserts (PI). The PI is included with shipments of every approved drug so that physicians (and you and I) can read through all about it. To get your free copy of almost any PI, just click on Link 1 at the end of this report and also type in the name of your favorite drug. Occasionally, the drug’s company will post the PI prior to the FDA. Then, head to the company web site and search for the drug under Our Products and solutions or something like that. Such is the case for Botox. Hence from Link 2 at the end of this report, at the bottom of your linked page, click on “Please see full botox for migraines side effects Device Information, ” which will enable you to download a PDF of the recent PI for Botox.

Now, let’s read the PI together.

Yikes! This PI contains 25 pages with giant words written in tiny print. You may check with “Does every physician really read every word of each one PI for the drugs she prescribes? ” Did people read every word of every article in today’s newspaper? It is very important to read about what you need to know. What we need to know is how good Botox works to prevent migraines.

The first page-and-a-half of the PI is a bioquickie version, what is called the “Highlights. ” Pass-up it. Go right to the Full Prescribing Information section on-page two. Drugs with a particularly serious risk profile can have a so-called Black Box Warning right up front. Botox comestic injection has one and so does the antidepressant Zoloft. Lipitor, intended for high cholesterol, does not. Surprisingly, many biotech drugs, recombinant models of natural proteins, also have Black Box warnings. Most of these warnings put physicians on high alert for certain side effects; but , the understanding is that for the right patients, the particular drug’s benefits trump its risks. If, over time, the risks seem to be more prevalent or new risks appear, a medication may get a more ardent Black Box warning or perhaps it will even be withdrawn from the market. But many drugs with Charcoal Box warnings have been on the market for many years.

To repeat, typically the question we want to answer is how well does Botox injection work for migraines? Well, there are all sorts of fun information in such a PI, but to answer our question, we need to find along with focus on Clinical Studies. Please jump to page 16.

First, some background in migraines. Several drugs, just like GlaxoSmithKline’s Imitrex and Merck’s Maxalt, are FDA approved to cure a migraine attack. There are also several drugs, such as Perry & Johnson’s Topamax and Abbott’s Depakote, that are Recommended to prevent migraines. Botox was approved for prevention. Nonetheless wait, there’s more. One could try to prevent a migraine episode or try to decrease the number of headache days per 30 days. This distinction is exactly where Allergan ran into a dilemma.

The company sponsored a pivotal clinical trial called PREEMPT I which randomized 679 patients to receive either not one but two rounds of Botox injections (31 shots given at ten specified locations, see p. 4 of the PI) or maybe more rounds of placebo injections. Each injection cycle was presented with 12 weeks apart and the primary clinical endpoint (PCE) was the change from baseline in headache episode frequency. The outcome was that there were 5. 3 fewer headache symptoms per month, which isn’t bad. Unfortunately, that was in the placebo group. There were 5. 2 fewer episodes per month during the Botox group, essentially a wash. Given that all clients started the trial with 12-13 episodes a month, your roughly 40 percent reduction in migraine episodes is certainly medically meaningful, just not Botox dependent. Sadly, non-e of the facts in this paragraph are in your PI. The data were shared in a professional journal, Cephalalgia, in March of this year or so.

Here’s the rub. All PIs are composed by the provider hoping to sell its drug and edited by the MAJOR REGULATORY BODIES. A Package Insert is a negotiated document. Most people, as well as migraine sufferers, do not read the scientific literature, let alone Cephalalgia. Before now, I had never even heard of Cephalalgia, but I aren’t getting out much either.