Monkey, now eight years old, saw my packet of isotretinoin pills (also known as Accutane and other names) on the kitchen counter this weekend. He asked Jennifer, “Momma, what’s that?”
“Well, honey, take a look at the picture. What do you think it’s telling you?”
He scrunched and wrinkled his face as he thought about it. “Um, it means that fat people shouldn’t take those pills?”
“That’s…that impression actually kind of makes sense. And yes, I suppose there might be some medicines that overweight people shouldn’t take. But, no. Those are the pills that Rachel’s taking and the picture tells us that women shouldn’t get pregnant when they’re taking that medicine.”
One of the things that made a big impression on me when I started on isotretinoin was the medicine packaging, and how annoying it was to fill the prescription and pry open the packaging. Read on for why that’s so.
The packaging for Claravis, the brand name of the isotretinoin made by Barr Pharmaceuticals, is pretty eye-catching. It’s a lot more packaging than my usual prescriptions; I’m used to getting just a bottle of pills with a printed insert.
Each month’s supply of Claravis that I’ve received comes in a big box, with thee inner blister-packs of 10 pills. Both the big box and the blister packs have printed in big red letters, “PATIENT: READ INFORMATION CAREFULLY“.
Here’s the printed information sheet (unfolded) that comes with the medicine. It’s printed in teeny-tiny lettering on both sides. I’ve included a jar of Cetaphil in the shot (off to the side) so you can get a feel for how big this thing really is, and how microscopic the print is. Folding and unfolding the sheet evokes memories of wrestling with roadmaps on long car-trips in the days before GPS.
And just in case you misplaced the sheet, or perhaps if you wanted to wallpaper a room with them, there’s a copy of that roadmap stuck on the inside of each blister pack in addition to the copy that comes inside each big box.
The front has the picture which Monkey asked about, which very helpfully reminds you, “CAUSES BIRTH DEFECTS” and “DO NOT GET PREGNANT”. And, apparently to make sure you get the point, the “NOT FOR FAT PEOPLE”, scuse me, I mean “NOT FOR PREGNANT WOMEN” graphic appears on the punch-out backer for each pill.
So as you might imagine, for me, extracting the pills from the blister pack each night is an exercise in adaptive equipment. Before I started on the isotretinoin, ripping off the cardboard cutout and peeling back the foil and then pushing the pill through the opening was exactly the kind of fine-motor manipulation requiring finger strength that I have the most trouble with. And even with the increased finger flexibility I’ve experienced on the isotretinoin, it’s not easy. Our solution has been for Jennifer to prepare each package for me by (slightly) bending back each blister, and for me to finish the process with the use of some adaptive equipment — usually, a pair of pliers and a small pocket knife.
There are more annoying logistics, too. I can only fill a single 30 day’s supply of Claravis each time, so that means I need to head back to the dermatologist each month. Each time, my dermatologist’s nurse needs to call in the order. Both the dermatologist and the pharmacist have the be on the electronic “iPLEDGE” system, and I had to sign a bunch of paperwork on that system before I could get my first set of pills.
Fortunately, since I’m not considered to be a woman “of childbearing potential”, I don’t need to take monthly pregnancy tests at my dermatologist’s office, nor have I been under the requirements to use two separate forms of birth control. But women who could potentially get pregnant have that added layer of annoyance. The iPLEDGE system is designed so women “of childbearing potential” have their (negative) pregnancy test results recorded by the pharmacist before they get their month’s supply of isotretinoin.
It’s a very burdensome system. And ironically, only isotretinion (Accutane) falls under the rigid iPLEDGE system. Other systemic retinoids like acitretin (also known as Soriatane and other names) also can cause birth defects, but aren’t subject to the isotretinoin-specific regulations.
Accutane’s been on the market in the U.S. since 1985, and the iPLEDGE system has been around since 2006. If you’ve been keeping up with our blog posts about retinoids and isotretinion, you know that isotretinoin isn’t just used to treat severe ichthyosis. It’s common use is to treat severe acne, and one source I saw asserts that over 16 million people have gotten isotretinoin (Accutane) prescriptions.
And of those folks, there are many who have filed lawsuits. The same source (which I’m not linking to, since it’s a bit click bait-y) claims that there have been over 7,000 lawsuits filed. Would it surprise you to hear that many of those lawsuits are still pending? In New Jersey, the home of Accutane’s original maker, Roche Pharmaceuticals (now Hoffmann-La Roche), they’re handled as “mass tort” claims, and the list of New Jersey Accutane lawsuits as of January 2014 is 152 pages long. (The most recent individual suit on the list was filed on January 13, 2014.) There are also apparently large numbers of Accutane lawsuits in Pennsylvania.
On the federal-court level, the cases were consolidated for pretrial proceedings before a federal judge in Tampa, Florida. The full case cite is “In re: Accutane Products Liability Litigation, MDL 1626. Master Case #8:04-md-2523-T-30TBM (M.D. Fla).” I looked up the case and just the docket sheet (the case index listing the attorneys involved and the documents that have been filed) is currently 282 pages!
(Disclosure: One of the law firms I worked for, many years ago, represented a defendant in MDL 1626. I never worked on the case.)
I don’t think there’s any doubt that isotretinoin causes birth defects, and that women who might become pregnant shouldn’t take it. The packaging and the iPLEDGE stuff is very annoying, though. For me, it’s all an interesting daily reminder about how law, lawsuits and medicine can crash together in interesting (or annoying) ways. And it’s a pretty stark reminder about how the pill I’m now taking each night has caused some severe side effects in some people.