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January 23: When Reumofan was taken off the market FDA stated that an ingredient in the pill created ulcer-like problems. This side effect is found in a number of over-the-counter pain relievers. What is FDA doing to approve a Reumofan alternative?

CDER Director's Mailbag

The question incorrectly assumes that the Reumofan products were lawfully marketed and, subsequently, “taken off the market” because of adverse effects.  Rather, in June 2012, FDA alerted the public that Reumofan products, marketed as a “natural” dietary supplement for pain relief and other serious conditions, were found to contain several active pharmaceutical ingredients not listed on the label that could be harmful. The ingredients in the Reumofan products can pose considerable dangers to consumers who may take these products without knowing that the ingredients are present, that the ingredients may be associated with death or serious injury, or that they may interact in dangerous ways with other products consumers may be taking. FDA received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).

Dietary supplements, in general, are not FDA-approved. Under the law (Dietary Supplement Health and Education Act of 1994), dietary supplement firms do not need FDA approval before marketing their products. It is the company’s responsibility to ensure their products are safe and that any claims are true. The Reumofan products that were the subject of FDA’s alert were never legally marketed and sold in the United States. The Reumofan products are, in fact, not dietary supplements because FDA laboratory analysis of Reumofan Plus found that it contains hidden prescription drugs.    Prescription drugs can be only safely used under the supervision of a licensed health care practitioner. Only a licensed healthcare professional can decide whether the benefits of a drug to the particular patient outweigh any risks of adverse events associated with the prescription drug.  Likewise, only a licensed health care practitioner can ensure that if side effects occur, they are promptly recognized and minimized.   

Regarding the question of a “Reumofan alternative,” as you state, there are over-the-counter, pain-relieving drugs on the market; they do not contain the serious risks associated with Reumofan Plus. Further, FDA-approved treatments exist for the health conditions for which Reumofan was illegally and fraudulently promoted. Patients should speak to their health care providers about their health conditions to receive the most appropriate treatment.

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