Products Affected - Description

Reason for the Shortage

• Bedford discontinued alprostadil in May, 2011 to concentrate on the manufacturing of other products. Bedford had previously discontinued their Novaplus presentation.¹
• Teva’s product is on long-term back order due to manufacturing difficulties.²
• Pfizer’s Caverject Impulse is on back order while the product is reformulated. The company has discontinued Caverject injection 10 mcg lyophilized powder and 20 mcg/mL solution for injection. Prostin VR Pediatric was on back order for unknown reasons.³
• Schwarz could not meet demand for product.⁴
• Actient has acquired several products from Schwarz (UCB) including Edex cartridges.⁵
• Meda Pharmaceuticals has acquired Muse from Vivus.⁶

Available Products

Estimated Resupply Dates

• Pfizer has Caverject Impulse 10 mcg and 20 mcg cartridges on back order with an estimated release date of January, 2014.³
• Teva has alprostadil 0.5 mg/mL ampule on long-term back order. The company cannot estimate a release date.²
  

Implications for Patient Care

• Alprostadil is prostaglandin E₁. It causes vasodilation and inhibits platelet aggregation.^8-10
• Alprostadil injection (Prostin VR Pediatric, generic) is labeled for intravenous administration for temporary palliative therapy in neonates with congenital heart defects to maintain the patency of the ductus arteriosus until surgery is performed. Alprostadil is also labeled for the treatment of erectile dysfunction, when administered by intracavernosal injection (Caverject, Caverject Impulse, Edex) or intraurethral insertion (Muse).^8-10

Safety

Administration route differs between Prostin VR Pediatric, Caverject lyophilized powder, Edex cartridges, and Muse urethral suppositories. Ensure that each specific product is administered via the correct route.^8-10

Alternative Agents & Management

• There are no alternatives to alprostadil injection for use in neonates to maintain the patency of the ductus arteriosus until surgery is performed.
• Caverject lyophilized powder, Edex cartridges, or Muse urethral suppositories may be used in patients with erectile dysfunction who require alprostadil therapy.

Related Shortages

• Amyl Nitrite Inhalation Solution— Resolved
• Dipyridamole Injection
• Doxazosin Tablets
• Isosorbide Dinitrate Immediate Release Tablets
• Nitroglycerin 2% Ointment
• Nitroglycerin Injection
• Papaverine Injection

1. Bedford (personal communications). April 29, May 12, June 25, August 6, September 22, October 6 and 16, November 3 and 24, December 8 and 12, 2008; January 5 and 28, February 23, April 14, June 15, July 29, September 28, and December 16, 2009; February 11, April 7, June 23, August 16, September 1, and October 13 and 26, 2010; January 5, March 30, and May 3, 2011.
2. Teva (personal communications). April 29, May 12, June 25, August 6, September 23, October 6 and 16, November 3 and 24, December 8, 2008; January 5 and 28, February 23, April 13, June 16, and December 16, 2009; February 12, April 7, June 23, August 16, September 3, and October 25, 2010; January 6, March 31, June 21, and August 31, 2011; February 17, 2012; February 21, and April 12, 2013.
3. Pfizer (personal communications). April 29, May 12, June 25, August 6, September 23, October 3, 6, and 16, November 3, 20, 24, and 25, December 8, 2008; January 5, 27, and 30, February 23, April 14, June 15, and December 16, 2009; February 11, April 7, June 23, August 17, and October 12, 2010; January 11, March 30, April 4, June 21, August 30, October 4, and December 12, 2011; February 14 and April 17, June 27, August 14, November 2, December 5 and 19, 2012; February 26, and April 11, 2013.
4. Schwarz Pharma (UCB) (personal communications). October 6, November 3 and 24, December 10, 2008; January 6 and 30, February 23, April 13, June 15, December 16, 2009; April 7, June 24, and August 18, 2010.
5. Actient (personal communications). August 18, September 2, and October 12, 2010; January 5, March 31, June 23, August 30, October 4, and December 12, 2011; February 15, April 17, June 27, November 2, 2012; February 22 and April 11, 2013.
6. Meda Pharmaceuticals (personal communications). June 28, August 30, October 4, and December 12, 2011; February 15, April 17, June 23, August 14, 2012; February 21 and April 11, 2013. 
7. Vivus (personal communications). October 6, November 3 and 24, 2008; January 7 and 30, February 23, April 13, June 15, and December 16, 2009; February 11, April 7, June 23, August 17, September 3, and October 12 and 25, 2010; January 4, and March 31, 2011. 
8. Wickersham RM, Novak KK, managing eds. Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc.; 2008.
9. McEvoy GK, ed. AHFS 2008 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2008.
10. Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Information Handbook. Hudson, OH: Lexi-Comp; 2007.

Updated

Updated April 12, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created November 20, 2008, by M. Christina Beckwith, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.