And then there was one: Barr withdraws Preven

Rewind to September 1998. Gynétics of Somerville, NJ, introduces the Preven Emergency Contraceptive Kit, the first product for emergency contraception (EC) approved by the Food and Drug Administration (FDA). Now fast-forward six years to the present. The drug’s new owner, Barr Pharmaceuticals of Pomona, NY, announces that it will no longer manufacture the product.

Family planning providers who wish to use a dedicated EC product now have just one option: Plan B, which is also manufactured by Barr Pharmaceuticals. Barr acquired Plan B from Washington, DC-based Women’s Capital Corp. in 2003 and Preven from Gynétics in early 2004. Providers also can opt to use one of the 19 other contraceptive pills approved for EC use by the FDA. (See list, below.)

Contraceptive Pills Approved for EC
  • Wyeth-Ayerst, Philadelphia: Ovral, Lo/Ovral, Ovrette, Triphasil, and Alesse
  • Watson Pharmaceuticals, Corona, CA: Ogestrel, Low-Ogestrel, Levora, and Trivora
  • Berlex Laboratories, Montville, NJ: Levlen, Levlite, and Tri-Levlen
  • Barr Laboratories, Pomona, NY: Aviane, Lessina, Portia, Enpresse, Cryselle, and Seasonale
  • King Pharmaceuticals, Bristol, TN: Nordette

"As a result of our acquisition of Women’s Capital Corp., Barr acquired Plan B emergency contraceptive and made the decision not to market two different emergency contraceptive products," says Carol Cox, Barr Pharmaceuticals spokeswoman. "As a result, we are focusing our efforts on Plan B emergency contraceptive, a product that is better tolerated and has a better safety profile."1

When it’s out, it’s gone 

The pills in the Preven Emergency Contraceptive Kit contain 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol. According to Cox, Barr manufactured Preven for Gynétics for many years, but it recently discontinued manufacturing the active ingredient used in the product and no longer manufactures commercial quantities of Preven.

While there still is Preven product in the trade channels, Barr is no longer manufacturing new quantities, she confirms. The last remaining inventory of Preven product was shipped in April 2004; the company is starting to see outages of product, says Cox.

"This will increase over time since there is no additional product to ship; however we will be making every effort to notify patients and customers that Plan B is available in all pharmacies and at the wholesalers," she reports. "We will also make every effort to let patients know that Plan B is a better-tolerated product and has a better safety profile than Preven."

If results of the 2003 CTU Contraceptive Survey are any indication, the removal of Preven may not be a hardship when it comes to dispensing EC. About 58% of 2003 survey responses indicated Plan B use, while just 12% named Preven. Eighteen percent said they used one of the 19 other contraceptive pills approved for EC use by the FDA. About 12% provided no response.

Get the word out 

The Preven web site, www.preven.com, still is active. When will it be taken off-line if the product is no longer available for sale?

"The Preven web site is still active and will remain active as the Preven product is still is available in the trade channels today and for sometime in to the future," states Cox. "Prescriptions are still being written and filled for Preven, and because the Preven package makes reference to the web site, the web site will remain available so that patients can access it."

Although the web site will remain active for a time, Cox says Barr Labs is working to update it so that in the future, if patients visiting the web site have a need for EC, they will be aware of the Plan B product and the fact that it is replacing Preven. The company also intends to link the web site to the Plan B web site, www.go2planb.com, and to Barr’s web site, www.barrlabs.com, she adds.

As of CTU press time, the Preven web site had not been updated, a fact that concerns James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University, who works with the EC web site, www.not-2-late.com.

"Keeping the [Preven] web site unchanged is a disservice to providers and women," he says. The EC web site carries a notice on its site that Preven no longer is available, Trussell reports.

Reference

1. Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998; 352:428-433.