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Baycadron FDA Alerts

The FDA Alert(s) below may be specifically about Baycadron or relate to a group or class of drugs which include Baycadron (dexamethasone).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for dexamethasone

Mayhem: Public Notification - Undeclared Drug Ingredients

Nov 14, 2014

Audience: Consumer

ISSUE: FDA is advising consumers not to purchase or use Mayhem, a product labeled as a dietary supplement that is promoted to increase appetite and muscle growth, because it contains an undeclared corticosteroid and antihistamine. FDA laboratory analysis found that Mayhem contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment.
 
Consumers are advised that corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness.
 
In addition, these undeclared drug ingredients in Mayhem may cause serious side effects when combined with other medications.

BACKGROUND: Mayhem is manufactured by Chaotic-Labz and is sold in some retail stores and on various websites, including www.chaoticlabz.com

RECOMMENDATION: Consumers taking Mayhem are urged to immediately consult with their health care provider to safely discontinue use of this product. This risk of withdrawal from corticosteroids should be assessed by a health care professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/13/2014 - Public Notification - FDA]
[11/14/2014 - Tainted Body Building Products - FDA]

Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems

Apr 23, 2014

Audience: Pain Management, Anesthesiology

Including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone

[Posted 04/23/2014]

ISSUE: FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use. 

FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.

BACKGROUND: To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized. FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

RECOMMENDATION: Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. See the Drug Safety Communication for a Data Summary and additional information for both patients and healthcare professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[04/23/2014 - Drug Safety Communication - FDA]
 

Reumofan Plus: Recall - Undeclared Drug Ingredient

Feb 19, 2013

Audience: Consumer, Health Professional, Emergency Medicine

Reumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenac. The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug. One illness has been reported to date in connection with this problem.

[UPDATED 8/28/2012]

Samantha Lynn Inc. is voluntarily recalling 500 lots of Reumofan Plus Tablets to the consumer level due to findings of undeclared drug ingredients. The FDA sample analysis has found the product to contain methocarbamol and diclofenac. The affected Reumofan Plus lots may include the following lot number(s): 99515 ex096 and expires: 2016. The product is marketed in a green bottle containing 30 lavender round tablets and is distributed nationwide via the internet.

[UPDATED 08/21/2012]

FDA is issuing an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional.

Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome

Because of the possible risks, consumers should not buy or start using these products.

[Posted 06/01/2012]

ISSUE: 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. An FDA laboratory analysis of Reumofan Plus found that it 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, and Methocarbamol, a prescription 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.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.

BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked 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.

RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[08/21/2012 - News Release - FDA]
[08/21/2012 - Consumer Update - FDA]
[06/01/2012 - News Release - FDA]

Reumofan Plus Dietary Supplement Relabeled and Sold as “WOW”: Public Warning - Undeclared Drug Ingredients

Dec 19, 2012

Audience: Consumers, Healthcare Professionals

ISSUE: The U.S. Food and Drug Administration (FDA) is warning the public that the potentially harmful dietary supplement product Reumofan Plus is being relabeled and sold under the name “WOW.”  The product is being marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.  FDA laboratory analysis confirmed that “WOW” contains the same prescription drug ingredients that are in Reumofan Plus, including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocarbamol (a muscle relaxant).  These ingredients have the potential to cause serious injury.

BACKGROUND: FDA warned the public of the harm of Reumofan Plus on June 1, 2012, and again on August 21, 2012.  Since June, FDA has received dozens of adverse event reports, many of them serious, from consumers who used Reumofan Plus.  The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression, stroke, and even death.

Reumofan Plus and “WOW” products are sold on various websites, including www.gonepainfree.com and www.browerent.com.  The products are manufactured by Riger Naturals S.A.  In addition to websites selling “WOW,” FDA has become aware that various websites, including www.reumofanusa.com, owned by Reumofan USA, LLC, continue to sell Reumofan Plus even after previous FDA warnings. Please see the link to the FDA public warning for product photos.

RECOMMENDATION: Consumers currently taking or who have taken Reumofan Plus or “WOW” should immediately consult a health care professional.  Health care professionals are urged to ask their patients about the use of Reumofan Plus, “WOW,” and other similar products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, psychiatric changes, or the use or abrupt discontinuation of corticosteroids.
Additionally, health care professionals should evaluate patients who have used Reumofan Plus and/or WOW for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of Reumofan Plus products and “WOW” to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

 

[12/19/2012 - FDA Public Warning - FDA]

Previous Related Safety Alert:
[08/21/2012 - Reumofan Plus MedWatch Safety Alert - FDA]

Reumofan Plus: Recall - Undeclared Drug Ingredient

Aug 21, 2012

Audience: Consumer, Health Professional, Emergency Medicine

[UPDATED 08/21/2012]

FDA is issuing an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional.

Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome

Because of the possible risks, consumers should not buy or start using these products.

 

[Posted 06/01/2012]

ISSUE: 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. An FDA laboratory analysis of Reumofan Plus found that it 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, and Methocarbamol, a prescription 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.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. 

BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked 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. 

RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[08/21/2012 - News Release - FDA]
[08/21/2012 - Consumer Update - FDA]
[06/01/2012 - News Release - FDA]  

Reumofan Plus: Recall - Undeclared Drug Ingredient

Jun 1, 2012

Audience: Consumer, Health Professional, Emergency Medicine

ISSUE: 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. An FDA laboratory analysis of Reumofan Plus found that it 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, and Methocarbamol, a prescription 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.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. 

BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked 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. 

RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[06/01/2012 - News Release - FDA]  

American Regent Injectable Products: Recall - Visible Particulates in Products

Jun 7, 2011

Audience: Pharmacy

  • Methyldopate HCL Injection, USP 5ml Single Dose Vial
  • Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial
  • Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial
  • Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials
  • Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple Dose Vials
  • Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages
  • Sodium Thiosulfate Injection USP 10%
  • Potassium Phosphates Injection, USP

 

[UPDATED 06/07/2011] Methyldopate HCL Injection, USP 5ml Single Dose Vial recalled.

[UPDATED 05/06/2011] Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial recalled.

[UPDATED 04/27/2011] Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial recalled.

[UPDATED 03/18/2011]  Dexamethasone Sodium Phosphate Injection products recalled.

[UPDATED 03/17/2011] Concentrated Sodium Chloride Injection products recalled.

[Posted 02/05/2011]

ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[06/06/2011 - Press Release, Methyldopate HCL Injection - American Regent]
[05/05/2011 - Press Release, Caffeine & Sodium Benzoate Injection - American Regent]
[04/26/2011 - Press Release, Ammonium Molybdate Injection - American Regent]
[03/16/2011 - Press Release, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release, Bacteriostatic Sodium Chloride - American Regent] 
[03/15/2011 - Press Release, Concentrated Sodium Chloride - American Regent] 
[02/04/2011 - Press Release, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release, Potassium Phosphates - American Regent]   

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection]
[12/29/2010 - Sodium Bicarbonate Injection]

More Baycadron Resources