New FDA restrictions on GlaxoSmithKline Rosiglitazone – Avandia, Avandamet, Avandaryl

Opinion by Patricia L Johnson

The Risk Evaluation and Mitigation Strategy (REM) evaluation conducted by the FDA in May of 2011 will be bringing about the following changes in the manner in which the drug Rosiglitazone – Avandia®, Avandamet®, Avandaryl® is distributed.

Withdrawal of Rosiglitazone medications from the current supply chain will be effective November 18, 2011.  After that date Rosiglitazone will no longer be available in retail pharmacies, not enrolled in the Restricted Access Program. Access to these medications is being restricted due to the potential increased risk of Myocardial Infarction [heart attack].

Drug withdrawal from pharmacies not enrolled in Restricted Access Program will apply to the following medications:

Avandia® (rosiglitazone maleate) Tablets

Avandamet® (rosiglitazone maleate and metformin hydrochloride Tablets

Avandaryl® (rosiglitazone maleate and glimepiride Tablets

Product Description National Drug Code (NDC)
Avandia (rosiglitazone maleate) tablets 2 mg 0029-3158-18
Avandia (rosiglitazone maleate) tablets 4 mg 0029-3159-13 & 00
Avandia (rosiglitazone maleate) tablets 8 mg 0029-3160-13 & 59
Avandia (rosiglitazone maleate and metformin HCL) tablets 2 mg/1000 mg 0007-3163-18
Avandamet (rosiglitazone maleate and metformin HCL) tablets 2 mg/500 mg 0007-3167-18
Avandamet (rosiglitazone maleate and metformin HCL) tablets 4 mg/1000 mg 0007-3164-18
Avandamet (rosiglitazone maleate and metformin HCL) tablets 4 mg/500 mg 0007-3168-18
Avandaryl (rosiglitazone maleate and glimepiride) tablets 4 mg/2 mg 0007-3152-13
Avandaryl (rosiglitazone maleate and glimepiride) tablets 4 mg/4 mg 0007-3153-13
Avandaryl (rosiglitazone maleate and glimepiride) tablets 8 mg/2 mg 0007-3148-13
Avandaryl (rosiglitazone maleate and glimepiride) tablets 8 mg/4 mg 0007-3149-13

Healthcare providers prescribing rosiglitazone-containing medications for outpatient or long term care use will be specially certified through enrollment in the Rosiglitazone REMS program at GlaxoSmithKline.

© 2011 Patricia L Johnson

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3 Responses to New FDA restrictions on GlaxoSmithKline Rosiglitazone – Avandia, Avandamet, Avandaryl

  1. Fiona B. says:

    Rosiglitazone is a controversial drug to be taken with caution. I wonder if the restricted access program is enough though. I was reading more about it, and see that there are some very serious side effects:

    http://www.theheart.org/article/1228223.do
    http://en.wikipedia.org/wiki/Rosiglitazone

    • Administrator says:

      Thank you for your comment Fiona,

      The problem with a drug liked Rosiglitazone is it does provide a tremendous amount of benefit to those suffering from Diabetes; therefore the decision to withdraw it from the market also creates major problems for those that do benefit from the drug. People die from taking Rosiglitazone, yet it also provides life to others, so there aren’t any simple answers to the question of whether or not the restricted access program is enough. My guess is sooner or later the drug will be banned completely, but…. time will tell.

      Pat Johnson

  2. Pingback: New FDA restrictions on GlaxoSmithKline Rosiglitazone – Avandia … | avandia lawsuit

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