FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

Here’s what we know.

Reumofan Plus contains diclofenac sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines.

  • Prescription drugs that contain dicofenac include Cambia, Cataflam, Voltaren, Voltarol, and Zipsor.
  • It’s also sold as Arthrotec 50/200 combined with misoprostol.

Reumofan Plus also contains methocarbamol, a prescription muscle relaxant that may cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

  • Methocarbamol is sold as the prescription drugs, Rabdolax and Robaxin.

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. It is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various Internet sites.

The bottom line?

Consumers who are taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately.

Side effects associated with the use of diclofenac include the following.

  • diarrhea
  • constipation
  • gas or bloating
  • headache
  • dizziness
  • ringing in the ears

Some side effects can be serious.

  • unexplained weight gain
  • excessive tiredness
  • lack of energy
  • nausea
  • loss of appetite
  • itching
  • pain in the upper right part of the stomach
  • yellowing of the skin or eyes
  • flu-like symptoms
  • fever
  • blisters
  • rash
  • hives
  • swelling of the eyes, face, tongue, lips, throat, arms, hands, feet, ankles, or lower legs
  • difficulty breathing or swallowing
  • hoarseness
  • pale skin
  • fast heartbeat
  • cloudy, discolored, or bloody urine
  • back pain
  • difficult or painful urination

Prescription drugs are potentially very dangerous. The only reason we gain benefit from them is because they have been tested, carefully labeled for reasonably safe use, and monitored by a physician or pharmacist.

None of this has been done with this “natural remedy.” Using Reumofan Plus is short sighted and risky to your health.

6/4/12 14:43 JR

Hi, I’m JR

John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at www.Vicus.com, a complementary and alternative medicine website.