Nature-Throid NT-1/4 16.25 mg (1/4 grain) tablets, 100s (NDC 64727-3298-01), RLC
Nature-Throid NT-1/2 32.4 mg (1/2 grain) tablets, 100s (NDC 64727-3299-01), RLC
Nature-Throid NT-1 64.8 mg (1 grain) tablets, 100s (NDC 64727-3300-01), RLC
Nature-Throid NT-2 129.6 mg (2 grain) tablets, 100s (NDC 64727-3308-01), RLC
Nature-Throid NT-3 194.4 mg (3 grain) tablets, 100s (NDC 64727-3312-01), RLC

 

Reason for the Shortage

• Several thyroid (desiccated) products have been discontinued. The manufacturers would not provide a reason for the discontinuations; however these products are not FDA-approved.
• Forest states that the shortage of Armour Thyroid is due to a shortage of raw material.
• Major and RLC will not provide a reason for the shortage.

 

Estimated Resupply Dates

• Thyroid (desiccated) products are not FDA-approved and therefore cannot be AB-rated.
• Major has available 120 mg tablets (100 count, NDC 00904-0762-60). All other presentations are on back order and the company cannot estimate a release date.
• Forest has all Armour Thyroid presentations on back order and the company cannot estimate a release date.
• RLC has all presentations of Nature-Throid on back order and the company estimates a release date of late-November to early-December, 2009.
• RLC also has all presentations of Westhroid on back order and the company estimates a release date of late-November to early-December, 2009.

 

 

 

 

Related Shortages

• Liothyronine Tablets— Resolved
• Liotrix Tablets

 

 

Updated

September 21, 2009; September 10, 2009; August 31, 2009; July 31, 2009; July 6, 2009; June 9, 2009; May 26, 2009; April 24, 2009; March 23, 2009; March 11, 2009; February 26, 2009; February 5, 2009; January 16, 2009; December 18, 2008; November 25, 2008; November 4, 2008; October 2, 2008; August 21, 2008, University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT

Discontinued Products

Thyroid (desiccated) capsules (Bio-Tech Pharm) - discontinued
Thyroid (desiccated) tablets (Qualitest) - discontinued
Thyroid (desiccated) tablets (Time-Cap) - discontinued

FOR IMMEDIATE RELEASE FOR MORE INFORMATION

January 9, 2008 Joshua Wenderoff

202-777-3502

jwenderoff@clsdc.com

FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones

Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term “Bio-identical”

 

MISSOURI CITY, Texas – In a series of warning letters to compounding pharmacies across the country, the Food and Drug Administration (FDA) has asserted a policy that would deny hundreds of thousands of women access to many commonly compounded bioidentical hormones, substituting its judgment for that of doctors. Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned

the FDA to do so in October 2005. More than 70,000 doctors, patients, and pharmacists filed comments with the FDA opposing Wyeth’s petition, the vast majority of whom opposed the petition.

“Under this policy, patients will suffer while Wyeth profits,” said L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP). “Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate, sometimes because Wyeth’s products are found to be ineffective or produce side effects. This is a decision that should be left to doctors.”

In the letters, the FDA states that it will “halt” compounding of medications containing estriol, an estrogen produced by the human body. Estriol is one of the most widely prescribed hormones and is regularly compounded with other bio-identical hormones pursuant to doctors’ prescriptions for women suffering from symptoms of menopause. Like many commonly prescribed drugs, estriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.

The FDA also stated in its letters that pharmacies may not use the term “bio-identical” to characterize compounded hormone therapies, even though the chemicals used in such compounds are chemically identical to what is produced by the human body.

IACP

Furthermore, manufacturers of drugs containing the same bio-identical hormones commonly use the term to characterize their products. The chemical structure of these drugs is indisputable.

Pharmacy compounding is a long-standing, state-regulated and medically vital practice. Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For them, customized, compounded medications prescribed or ordered by licensed physicians or veterinarians and mixed safely by trained, licensed compounding pharmacists are the only way to better health.

To file opposition to the the FDA's complaint, please visit www.savemymedicine.org.  With a few clicks you can personalize a form letter and send your message to your members of Congress, your U.S. Representative and Andrew Von Eschenbach, M.D., of the FDA.  Please act now to "choose women's health over Wyeth's wealth!"

 

About IACP

The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 2,000 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.

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