By Matthew Perrone | Associated Press
The outside experts said they were mostly confident that women of all ages could use the drug appropriately without seeing a health provider first. But the panel largely set those concerns aside, emphasizing the benefits of providing more effective birth control — particularly to young people and lower-income groups — than what’s available over the counter now, like condoms and gels.
Some women should not take it, particularly those with breast cancer, because of the risk that it could accelerate tumor growth. Women who have unusual vaginal bleeding are instructed to speak with a doctor before using it, because bleeding could indicate a serious health issue. Perrigo said its 880-patient study of the drug showed that women will consistently take the pill daily if it’s made available over-the-counter. But the FDA found several problems in the study, including more than 30% of participants who erroneously reported taking more pills than they were actually supplied. FDA reviewers said the problem called into question the company’s overall conclusions about the drug’s use and effectiveness.
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