The Food and Drug Administration (FDA) recently warned women who use over-the-counter vaginal creams, such as Monistat, and also use prescription blood thinning agents such as warfarin, to consult with their pharmacist or physician before using the over-the-counter products. This warning, announced in early March, includes a requirement that new packaging labels be developed which provide a warning statement.
The FDA Press Office has posted the details of this notification on their website. The new package warning states, "Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur." It was prompted after two adverse events were reported to the FDA. The warning is already posted on blood thinning products such as warfarin, however it has not until now been required on the over-the-counter products.
They warn that any product containing vaginal miconazole carries a risk of bleeding and bruising may occur. Medical journals reported that women taking both medications were observed to have bruising, bleeding gums and nose bleeds as a result of the interaction between the two medications. The FDA press release states that this adverse interaction has been known in the past, but recent events focused attention on the problem and prompted the action of the agency.
Many over-the-counter medications contain miconazole, including the recently approved Monistat combination pack. The warning advises patients and physicians that appropriate monitoring should be done if a patient is using both medications. The FDA advises that before using both products, patients should be aware of the potential risks. The FDA announcement is numbered 301-827-6242, and includes a telephone number, 888-INFO-FDA, for patients to call if they require more information.
In my mind, this action comes too late to do anything but prevent future adverse reactions, and I wonder why, since the FDA itself says that the interaction was well known, it was not taken sooner. The FDA, in its own mission statement says, "FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. Our work is a blending of law and science aimed at protecting consumers."
My question is this. If the FDA knew about the problem and did not take action, how is this accomplishing their stated mission. Is this another case of waiting until adverse events start becoming public knowledge before action is taken? What prevented them from posting these warnings on these products as soon as the problem was observed? Was it caution, or was it pressure from the manufacturers? As consumers, we have the right to know.
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