Sunday, April 30, 2006

Paxil Update

During the great cleanup of 2006, aka my slightly manic period of spring cleaning, I came across the documents regarding Sweet M's experience with the Paxil liquid suspension, which I wrote about last year.

Finding the paperwork reminded me that I hadn't ever really followed up with GlaxoSmithKline to find out what, if anything, they'd done about the fact that people using the liquid formula of Paxil were getting erratic dosing (because the suspension, as packaged and labelled, did not resuspend evenly.)

So I called GSK.

And what had they done?

According to the person who took my call, they're doing exactly nothing. Nada. Zip.

But she took great pains to reassure me that they are concerned, saying over and over and over again, "We so appreciate your feedback. We are, like you, very concerned about the safety of our products."

As you may recall, when I called GSK about the problem with the suspension, the person I spoke with told me that Sweet M was not the first patient who'd had this problem. He said, "We are aware of this problem." And I said, "Does that mean it has happened to other people?" And he said, "Yes."

So when I got off the phone with the GSK rep, even after listening to the consumer placation mantra, I was deeply unsatisfied.

It seems that someone will have to sue GSK to get them to do something about this problem with the Paxil.

When people complain about ours being a litigation-happy country, they forget that corporations like GSK don't seem to do anything to ensure consumer safety unless they are faced with litigation. And since the misery that Sweet M went through the year that her medication dose was varying from week to week does not create visible permanent damage or death, this would not be a very appealing case to litigators. Beyond that I'm not exactly litigious, or in a position to sue.

So I took the citizen route, and called the FDA to make a complaint. But the way the FDA works, the investigation is handled by inspectors in the town where the medication is manufactured, i.e. it's handled by people who probably socialize with folks who are, for the most part, employeed by the manufacturer. Does it seem as though there is something wrong with this picture?

In spite of a huge sense of futility, I'm filling out the FDA MedWatch forms, sending them along, and hoping that they'll have an interest in ensuring that drugs sold in the U.S. are safe. After the Vioxx debacle that probably makes me a dreamer, but dream on I do.



kristina said...

Keep fighting the good fight!

Maybe you could start a Paxil Watch site---

Neurodivergent K said...

Do what you need to do. Paxil is an AWFUL thing to have changing levels at will in one's system. It isn't fair to the kids, old people, and people who can't swallow pills for other reasons who take it.

Reasonable reason to complain. Unlike some complaints I've seen about meds (and I see a lot, I help on a site soley ABOUT psychotropics, one by & for the people taking them).

I hope you get somewhere.

MothersVox said...

Thanks, Kassiane and Kristina.

I don't think doing a Paxil Watch site is in my future. I just want them to change the labeling by adding an explanation about how to resuspend the suspension.

Once you know how to do it, it's easy to do.

You just take the new, unopened bottle, turn it upside down, and tap it a couple of times against a counter or hard surface. The suspension will resuspend.

But if you try to shake it, you can be shaking it until the proverbial cows come home and the active ingredient will not be evenly distributed.

All it would take is a little label change. Maybe a little diagram. It's not rocket science. But if you don't know to do this, you can find yourself, or those you care about, in real trouble.