Pfizer issues recalls for Akrimax OCs
Pfizer issues recalls for Akrimax OCs
Has your clinic telephone been ringing recently with calls from women who have heard about a birth control pill recall? Chances are, few, if any, of your patients were using the affected oral contraceptives (OCs).
The voluntary recall was announced Jan. 31, 2012 by the manufacturer of the drug, Pfizer of New York City. The recall involves 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of norgestrel and ethinyl estradiol tablets (generic) contraceptives labeled under the Akrimax Pharmaceuticals brand. The product is distributed to warehouses, clinics, and retail pharmacies nationwide. (See the table, below, for the affected lots.)
While the recall includes around one million pill packets, it is likely few of your patients were using them. The two pills are not often prescribed; according to 2010 sales data from IMS Health, they represent less than 2% of the OC market.1 [Did you receive the Contraceptive Technology Update bulletin on the recall? To receive future bulletins, provide your e-mail address to AHC Media customer service at (800) 688-2421 or [email protected].]
What happened?
According to a Pfizer press release, a company investigation found that some blister packs of the drug might contain an inexact count of inert or active ingredient tablets and that the tablets might be out of sequence. The company says the cause of the packaging error has since been rectified. The pills were packaged at a manufacturing plant in Rouse's Point, NY.1
"As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception and at risk for unintended pregnancy," the company press release states. "These packaging defects do not pose any immediate health risks; however, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately."
The company also advises patients who have affected product to notify their healthcare provider and return the product to the pharmacy. [Any adverse events that might be related to the use of the affected product should be reported to Akrimax Medical Information by telephoning (877) 509-3935, 8 a.m. to 7 p.m. Monday-Friday, Central Time. Adverse events also may be reported to the Food and Drug Administration's MedWatch Program. Go to www.fda.gov/Safety/MedWatch/default.htm, and click on "Report A Serious Medical Product Problem Online" to access Form FDA 3500. Events may be entered online, or the form may be printed and mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxed to (800) 332-0178.]
Recalls aren't new
Family planners are familiar with product recalls. Qualitest of Huntsville, AL, pulled multiple lots of oral contraceptives Sept. 15, 2011, after the manufacturer detected a packaging error that could lead to incorrect administration of several brands of its pills. In 2003, Barr Laboratories of Pomona, NY, issued a recall of certain lots of its Nortrel 7/7/7 OC after the company received two reports that color-coded tablets in the drug's blister card were not in correct order.
Other contraceptive recalls include the 2000 alert regarding the Norplant contraceptive implant and the 2002 recall on the Lunelle contraceptive injection. Neither of those products is on today's market.
What should you do in the event of such a recall? Offer women emergency contraception, advocates Susan Wysocki, WHNP-BC, FAANP, president & chief executive officer of iWomen's Health in Washington, DC. EC is available in the form of the behind-the-counter emergency contraceptive pills Plan B (Teva Pharmaceuticals, Woodcliff Lake, NJ) and Next Choice (Watson Pharmaceuticals, Parsippany, NJ); prescription-only Ella (HRA Pharma, Paris, France); or the Copper T 380A intrauterine device (ParaGard, Teva Pharmaceuticals).
Reference
- Todd S. Odds may be on Pfizer's side after birth control packaging mistakes. Star-Ledger Feb. 12, 2012. Accessed at http://bit.ly/zXIq1B.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.