Albuterol Metered-Dose Inhalers

12 January 2009

Products Affected - Description

Chlorofluorocarbon (CFC) Products

Albuterol Metered-Dose Inhalers (CFC)
17 gram (NDC 62037-0794-44) - Andrx - discontinued
17 gram (NDC 17270-0721-01) - Armstrong - discontinued
17 gram (NDC 00172-4390-18) - IVAX Pharmaceuticals - discontinued
17 gram (NDC 59930-1560-01) - Warrick - discontinued
17 gram refill (NDC 59930-1560-02) - Warrick - discontinued

Proventil Metered-dose Inhaler (CFC), Schering
17 gram (NDC 00085-0614-02) - discontinued

Reason for the Shortage

Albuterol metered dose inhalers (MDIs) were in short supply.^1-6 To decrease depletion of the ozone layer, the Food and Drug Administration (FDA) announced that all albuterol MDIs containing CFC propellant must be withdrawn from the market by December 31, 2008.⁷ The Environmental Protection Agency (EPA) and FDA have limited the availability of CFC propellants. IVAX Pharmaceuticals discontinued their CFC inhalers due to a lack of raw materials.⁵ GlaxoSmithKline and Teva (formerly IVAX Laboratories) albuterol products were in short supply while their products were transitioned from CFC-based propellants to HFA.^{3, 4} Schering has discontinued the Proventil CFC MDI and Warrick generic albuterol CFC MDI.^6,8

Estimated Resupply Dates

• Armstrong discontinued albuterol metered dose inhalers (MDIs) with CFC propellant in December, 2008.¹
• Andrx was a distributor of albuterol inhalers. However, Andrx has recently been purchased by Watson. Watson will not be supplying albuterol inhalers.²
• GlaxoSmithKline has available Ventolin HFA with a dose-counter. The new NDC number is 00173-0682-20. GlaxoSmithKline discontinued production of Ventolin CFC products in 2003.³
• IVAX Pharmaceuticals has discontinued their albuterol CFC MDIs. The company has no remaining supplies.⁴
• Teva (formerly IVAX Laboratories) has albuterol HFA (ProAir) MDI available.⁵
• Schering has discontinued both Proventil CFC products and the generic Warrick brand. The Proventil HFA inhalers are readily available.^6,8

Implications for Patient Care

Albuterol MDIs are labeled for the treatment or prevention of bronchospasm in adults and children.^9,10 Albuterol MDIs are also used to manage patients with chronic obstructive pulmonary disease (COPD).⁹

Alternative Agents & Management

• FDA issued a health advisory recommending patients switch from CFC formulations as quickly as possible (http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm048717.htm).
• No dosing adjustments are required for patients switching from a CFC formulation to an HFA formulation.^10-13 Potential alternatives for selected situations are listed in the Table.
• Reformulated albuterol MDIs are technically not equivalent as they are not AB-rated. A new prescription is required to switch patients from a CFC to an HFA product, or to switch between HFA products.

Related Shortages

• Ephedrine Injection
• Levalbuterol Concentrated Inhalation Solution— Resolved
• Phenylephrine Parenteral— Resolved
• Terbutaline Injection— Resolved

1. Armstrong, (personal communications). February 2 and 24, March 8 and 20, May 1, June 2 and 23, August 3, September 14, October 16, and December 13, 2006; March 7, April 19, July 25, and November 14, 2007; and March 19, and June 2, 2008.
2. Andrx, (personal communications). December 20, 2005; and January 3 and 23, February 2 and 24, March 8 and 20, April 5, May 1, June 2 and 23, August 3, September 11, October 16, and December 13, 2006; and March 7, and April 19, 2007.
3. GlaxoSmithKline, (personal communications). December 20, 2005; and January 3 and 23, February 2 and 24, March 8 and 20, April 3, May 1, June 2 and 23, August 3, September 11, and December 13, 2006; and March 7, April 19, July 25, and November 14, 2007; and March 19, 2008, and January 12, 2009.
4. IVAX Pharmaceuticals, (personal communications). December 20, 2005; and January 3 and 23, February 2 and 24, and March 8 and 20, April 6, May 2, June 2 and 23, and August 3, 2006.
5. Teva Laboratories (formerly IVAX Laboratories), (personal communication). March 8 and 20, April 5, May 1, June 2, September 11, October 16, and December 13, 2006, March 7, April 19, July 25, 2007 and November 14, 2007; March 19, 2008.
6. Schering, (personal communications). December 20, 2005; and January 3 and 23, February 2 and 24, and March 8 and 20, April 5, May 1, June 2 and 23, August 3, September 11, and December 13, 2006; and March 7, April 19, July 25, and November 14, 2007; March 19, 2008; and January 12, 2009.
7. U.S. Food and Drug Administration. Questions and Answers on Final Rule of Albuterol MDI's. Accessed on March 8, 2006.
8. Varghese, ST. Dear Doctor Letter: Important Information on the Availability of Albuterol CFC Inhalers. Kenilworth, NJ: Schering-Plough, October 2006.
9. Albuterol, Albuterol Sulfate, Levalbuterol Hydrochloride. In: McEvoy GK, Litvak K, Welsh OH, et al, eds. American Hospital Formulary Service. Bethesda, MD: American Society of Health-System Pharmacists; 2005; 1259 - 1270.
10. Albuterol, USP Inhalation Aerosol. Prescribing Information. Reno, NV: Warrick Pharmaceuticals; May 2004.
11. Ventolin HFA (albuterol sulfate HFA inhalation aerosol). Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; December 2004.
12. Proventil HFA (albuterol sulfate HFA inhalation aerosol). Prescribing Information. Kenilworth, NJ: Key Pharmaceuticals Inc.; October 2001.
13. ProAir HFA (albuterol sulfate HFA). Prescribing Information. Waterford, Ireland: IVAX Pharmaceuticals; October 2005.
14. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma - Update on Selected Topics 2002 (EPR-2002). Available at: http://www.nhlbi.nih.gov/guidelines/asthma/index.htm. National Heart, Lung, and Blood Institute. Accessed on March 8, 2006.
15. Xopenex HFA (levalbuterol tartrate inhalation aerosol). Prescribing Information. Marlborough, MA: Sepracor; June 2005.
16. Xopenex (levalbuterol tartrate inhalation solution). Prescribing Information. Marlborough, MA: Sepracor; June 2005.
17. MAXAIR Autohaler (pirbuterol acetate inhalation aerosol). Prescribing Information. Northridge, CA: 3M Pharmaceuticals; July 2003.

Updated

Updated January 12, 2009 by M. Christina Beckwith, Pharm.D., Drug Information Specialist. Created March 9, 2006 by Erin R. Fox, Pharm.D., Drug Information Specialist. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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