View Full Version : GlaxoSmithKline recalls drug used for epilepsy, bipolar disorder


Andi
04-08-05, 08:24 AM
PHILADELPHIA - GlaxoSmithKline is recalling about 100,000 starter kits of Lamictal, used to treat epilepsy and bipolar disorder, after finding the wrong dosage in two of the kits.

The kits are designed so that patients gradually increase their dosage of the drug, lamotrigine, over several weeks. The errant kits supplied a white 25 milligram pill rather than a pink 100 milligram pill for the fifth week, company spokeswoman Ramona DuBose said Thursday.

"Anybody that has a prescription for Lamictal does not need to worry. There's no problem with the tablets or with the bottles," DuBose said.

About 150,000 epileptics use the drug to ward off seizures and another 100,000 people use it to treat bipolar disorder.

The starter kits, distributed nationwide, are packaged by a third party, but DuBose declined to name the contractor or disclose its location.

GlaxoSmithKline is not notifying consumers of the recall but is sending notices to physicians, wholesalers, retailers and its sales force, DuBose said.

The recall follows the federal seizure last month of all doses of Paxil CR and Avandamet due to concerns about a GSK manufacturing plant in Puerto Rico.

U.S. sales of Lamictal, which is manufactured at GSK's facility in Zebulon, N.C., totaled $278 million last year. Shares of GlaxoSmithKline fell 17 cents or .37 percent on the New York Stock Exchange on Thursday, closing the day at $46.

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http://www.miami.com/mld/miamiherald/business/national/11337878.htm

KnittingJunkie
04-08-05, 10:58 AM
The first thing I did when I saw the title of this thread was go, "Ohhh, no." The first thing I did when I saw "Lamictal" was *gulp* and go "Ohhhhhhh NO!" and try to remember if I can potentially get some refills earlier than I technically should...whew. As long as they're not technically taking the drug away from those who've been prescribed it (without the starter pack issue), I'm ok.

Hope no one got hurt...:eyebrow:

Chrys

Andi
04-08-05, 03:35 PM
I wonder what the mg difference was...a significant drop can cause a seizure in some patients...I was a little shocked and unhappy with this. I just hope there are no more mistakes.

Andrew
04-08-05, 09:24 PM
The good news is, the FDA is finally getting on the Pharmaceutical industry's case about quality control. The bad news is, unless you hear about it in the ADD Forums (thank you, Andi), you're likely not going to hear about it, unless your doctor remembers to tell you (unlikely).

I'm personally concerned about this particular med being of lower quality than expected, and will anxiously watch this topic for the latest information.