Shortage of ethinyl estradiol 50 mcg and norethindrone 1 mg tablets

The American Society of Health-System Pharmacists reports a shortage of ethinyl estradiol 50 mcg and norethindrone 1 mg tablets. From the generic names, you can probably tell that this is an oral contraceptive tablet. Warner-Chilcott manufactures this particular dosage combination under the brand name Ovcon 50, and gave "manufacturing delays" as the reason for the shortage. The reason for the shortage is better explained in this FDA warning letter. To summarize, the ethinyl estradiol in the tablets is not as stable as it is supposed to be, and Warner-Chilcott has failed to investigate the reason and correct the cause. This means that a certain number of women may become pregnant even though they are taking the pills correctly before the expiration date on the package. As the ASHP bulletin mentions, the manufacturer has discontinued the package containing tablets for six menstrual cycles in hopes of alleviating this stability problem on both levels, the woman taking the tablets and the FDA. The FDA has expressed in writing that this solution is unsatisfactory. The women who have been taking Ovcon 50 may be particularly dissatisfied, even if they didn't become pregnant, because the FDA has been dealing with this problem for five years. That means five years of possibly subpotent birth control tablets being sold. See FDA warns Warner Chilcott for 5 years of Puerto Rico failings at in-Pharma.