Medicare Part D Formulary Change
Effective September 23, 2007, the following product NDCs will no longer be covered under the Medicare Part D benefit.
This change will only impact the specific dosage form represented by these NDC numbers:
| Drug Name |
NDC Number |
| Morphine 10 Mg Soluble Tab |
63304070601 |
| Morphine Sulfate 15 Mg Tab |
63304070701 |
| Morphine Sulfate 30 Mg Tab |
63304070801 |
| Pamine |
00482006101 |
| Pamine Forte |
00482006206 |
| Wellbutrin XL |
00173073101 |
| Zofran |
00173044604 |
| Zofran |
00173044704 |
| Zofran |
00173048900 |
| Zofran |
00173068000 |
| Zofran ODT |
00173056900 |
| Zofran ODT |
00173057004 |
FDA Alert – Avandia (rosiglitazone)
The FDA is issuing a safety warning to patients who are taking Avandia (rosiglitazone), especially those who are known to have underlying heart disease or who are at high risk of a heart attack. This safety warning arose from clinical trials that showed a potentially significant increase in the risk of heart attack and heart-related deaths in patients treated with Avandia.
The FDA has not asked the drug maker, GlaxoSmithKline, to remove the drug from the market or to take any action at this time. Patients are advised to talk to their doctor about this information as they evaluate treatment options for type 2 diabetes.
The FDA is continuing its analysis of all available data and has not yet confirmed the clinical significance of the reported increased risk in the context of other studies.
For additional information on this safety issue, refer to the FDA’s website at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html.
FDA Alert – trimethobenzamide hydrochloride suppositories
At the FDA’s request, companies that manufacture and distribute unapproved suppository drug products containing trimethobenzamide hydrochloride are voluntarily withdrawing these drugs from the market. Trimethobenzamide hydrochloride is used to treat nausea and vomiting in adults and children.
The products, marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz, lack evidence of effectiveness in suppository form. This withdrawal does not affect FDA-approved oral capsules and injectable products containing trimethobenzamide. Alternative products approved to effectively treat nausea and vomiting are available in a variety of forms.
For additional information on this recall, refer to the FDA’s website at: http://www.p1source.com/common/ads/click.asp?at=8&a=2090&c=762&z=40&u=62300
FDA Alert – Permax (pergolide) recall
The companies that manufacture and distribute Permax, also known as the generic drug pergolide, have voluntarily withdrawn the drug from the market due to the potential for heart valve damage.
The companies’ decision to cease shipping this medication to wholesalers in the United States is immediate; however, some Permax (pergolide) may be available for a short time as inventories are depleted.
For additional information on this recall, refer to the FDA’s website at http://www.fda.gov/cder/drug/advisory/pergolide.htm.
If you have any questions, call Pharmacy Services at 1-800-396-4139.
FDA Alert – Zelnorm (tegaserod maleate) recall
Effective immediately at the Food & Drug Administration’s (FDA) request, Novartis Pharmaceuticals Corporation, the company that sponsors Zelnorm, also known as the generic drug tegaserod maleate, has voluntarily withdrawn the drug from the market.
This recall is due to a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm.
For additional information on this recall, refer to the FDA’s website at http://www.fda.gov/cder/drug/advisory/tegaserod.htm.
If you have any questions, call Pharmacy Services at 1-800-396-4139.
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