USA FDA ALERT Pain Medication Over The Counter (otc)

The FDA has issued a second warning to consumers about the potential health risks of two products marketed as natural dietary supplements for the treatment of various chronic pain disorders. The products––Reumofan Plus and Reumofan Plus Premium––contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.


The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including stroke and even death. Other reports include liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and adrenal suppression (problems with kidney functioning).

Ongoing FDA laboratory analyses of Reumofan Plus found that it contains the following prescription drug ingredients:

  • Dexamethasone – a corticosteroid, commonly used to treat inflammatory conditions, that can impair the body’s ability to fight infections and cause high blood sugar levels, bone and muscle injuries, and psychiatric problems. Dexamethasone can also cause adrenal suppression when taken for a prolonged period of time or at high doses. Sudden discontinuation of corticosteroids after long-term use or use at high doses can result in a withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood sugar levels, fever, dizziness, and muscle and joint pain.
  • Diclofenac sodium – a 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 of the stomach and intestines.
  • Methocarbamol – a muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks, such as driving a motor vehicle or operating machinery.

A separate FDA lab analysis of Reumofan Plus Premium found that it contains two of the ingredients listed above, diclofenac sodium and methocarbamol. These hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium may also interact with other medications and result in serious adverse events.

If you are taking or have recently stopped taking Reumofan Plus or Reumofan Plus Premium, you should immediately consult a health care professional because, as mentioned above, abrupt discontinuation of corticosteroids after long-term or high dose use can cause fatigue, nausea, low blood pressure, low blood sugar levels, fever, muscle, and joint pain, dizziness, and fainting.

Reumofan Plus and Reumofan Plus Premium are manufactured in Mexico by Riger Naturals and sold in the U.S. in some retail outlets, at flea markets, and on various popular Internet sites. They are usually labeled in Spanish, however, versions of these products may also exist with English labeling. FDA is working closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

Despite the warnings and the recall, these products are still readily available on the Internet. It is being advertised as “effective in the treatment of arthritis, rheumatism, osteoporoses, fibromylgia and tendonitis” as well as “muscle pain along with knee, hand, shoulder, back, wrist, ankle, hip, neck and heel spur pain.”

If you have taken Reumofan Plus or Reumofan Plus Premium and experienced any adverse events, you are encouraged to report them to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Online at;
  • By phone at 800-FDA-1088 (800-332-1088); or,
  • By returning FDA form 3500, available on the MedWatch “Download Forms” page by mail to the address on the pre-addressed form or by fax at 800-FDA-0178.



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