Drug maker Pfizer Inc. recalled about a million packs of birth-control pills that weren't packaged correctly, which raised the risk of unplanned pregnancies among women who relied on the pills, Wall Street Journal reports.
Pulled from shelves were Lo/Ovral-28 pills and their Norgestrel generic versions, which doctors have been prescribing for years to tens of thousands of women. The pills come in blister packs containing a mix of 21 active tablets and seven that are inert. As guided by the packs, women are supposed to take a certain pill each day in order to prevent pregnancy, taking the inert pills at the end of a monthly cycle.
Pfizer said Wednesday that it believes only 30 packs had packaging problems, including having the active and inert tablets out of order, or lacking the proper amount of each kind of pill. The company said it recalled a million packs in the U.S. to be safe.
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The Food and Drug Administration hasn't received any reports of adverse events, such as unintended pregnancies, and the agency is investigating, according to an agency spokeswoman. Pfizer said it hadn't received reports either, while noting that it had only just alerted the public.
The pills were made and shipped last year by a Pfizer plant in upstate New York, on the Canadian border. To encourage proper use, active pills in the packs are colored white, while the inert tablets are pink. An alert customer noticed that her pack had a pink pill where a white one should have been, and complained to the company on Oct. 19, a Pfizer spokeswoman said.
Investigating the complaint, Pfizer discovered that some blister packs of pills had an extra active pill at day 22 or 28, one pack lacked an active tablet at day 10 and another pack lacked a placebo tablet at day 24, the FDA spokeswoman said. Pfizer identified three glitches in its production of the packs that could, on rare occasion, result in improper packaging, a Pfizer spokeswoman said.
Women who miss birth-control pills—say, by taking an inert pill when they should take an active one—are at risk of an unintended pregnancy because they may ovulate in the absence of the hormonal medicines meant to prevent it. Carolyn Westhoff, a professor of obstetrics and gynecology at Columbia University, cautioned that the risk from missing one or two pills is likely low. "Usually the women who ovulate have missed a larger number," said Dr. Westhoff, who has studied the ovarian effects of missing birth-control pills.
Yet Eve Espey, an obstetrics and gynecology professor at the University of New Mexico, said the risk could be compounded because women also tend to miss pills on their own. It was unclear how many of the pills were already used and how many remain in the hands of women. Pfizer said it didn't know.
Scandal URIAS : Milioane de femei, in pericol sa ramana insarcinate. Tone de pilule contraceptive retrase
O mare companie farmaceutica a retras de pe piata peste 1 milion de cutii cu pastile anticonceptionale, dupa ce si-au dat seama ca din cauza unei erori de dozare femeile care iau aceste pilule pot ramane insarcinate.
Pfizer va retrage un million de cutii cu pastile contraceptive, dupa ce a sesizat o grava eroare in dozarea hormonilor in aceste pilule.
Loturile care nu respecta standardele necesare au data de expirare cuprinsa intre iulie 2013 si martie 2014.
Unele din pilulele incluse in aceste loturi au o concentractie prea mare de hormoni, in timp ce altele au o concentratie prea scazuta. Din aceasta cauaza, ele isi pierd efectul contraceptiv.
Produsele care vor fi retrase de pe piata sunt: LO/OVRAL 28 si Norgestrel 0,3 mg/Ethinyl Estradiol 0.03 mg. Produsele vizate au fost distribuite DOAR pe piata din Statele Unite. Autoritatile europene nu au anuntat pana acum nicio sesizare din partea companiei farmaceutice.
Acesta este al doilea scandal de acest gen din ultimele sase luni. In septembrie 2011, compania Qualitest Pharmaceuticals a retras de pe piata peste 1,4 milioane de pachete, pentru ca din cauza unei erori de ambalare, pilulele contraceptive nu erau eficiente.
In ambele cazuri, pastilele luate de femei nu le afecteaza sanatatea, dar nu au efectul dorit, prin urmare trebuie luate masuri suplimentare de protectie impotriva unei sarcini nedorite.
In cazul Qualitest Pharmaceuticals, eroarea a constat in ambalarea gresita a pastilelor in blister, asftel incat acestea nu respectau zilele din saptamana in care ar trebui luate, efectul contraceptiv disparand in acest fel.
Loturile retrase vizeaza urmatoarele pastile: Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1,5/30, Gildess FE 1/20, Orsythia, Previfem, Tri-Previfem.
Pachetele cu erori au fost distribuite in farmacii de peste un an de zile si nu se poate sti numarul femeilor care au folosit aceste pastile.
