The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Public Citizen, a nonprofit national public interest organization, sent a petition to the FDA earlier this month urging them to ban third generation oral contraceptives that increase the risk of blood clots (venous thrombosis) and death.

The petition specifically requests the following:

Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately ban the third generation oral contraceptives containing desogestrel due to the approximately doubled risk of venous thrombosis (30 cases for every 100,000 users per year of third generation oral contraceptives compared to 15 cases for every 100,000 users of second generation oral contraceptives) and lack of evidence of clinical benefit as compared to the second generation oral contraceptives. The third generation oral contraceptives containing desogestrel are:

Desogestrel and Ethinyl Estradiol (Duramed/Barr and Watson Pharmaceuticals)
Desogen (Organon)
Mircette (Duramed/Barr)
Velivet (Duramed)
Apri-28 (Duramed/Barr)
Kariva (Duramed/Barr)
Ortho-Cept (Ortho-McNeil)
Reclipsen (Watson)
Cyclessa (Organon)

It further cites that women fill an estimated 7.5 million prescriptions for these third generation oral contraceptives from Nov. 2005 to Oct. 2006.

Comments are closed.

Of Interest