Earlier this week, the Agency issued a statement warning consumers not to use or purchase Pain Flex, sold as a dietary supplement for joint pain, as it contains undeclared dexamethasone and methocarbamol. Both ingredients have the potential to cause significant serious adverse events in some users.
The Agency says that dexamethasone is a “corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can 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. Abrupt discontinuation can cause withdrawal symptoms. Additionally, the undeclared dexamethasone may cause serious side effects when combined with other medications.”
“Methocarbamol is a muscle relaxant that can cause sedation, dizziness and low blood pressure. Methocarbamol also can impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery.”
The FDA advises consumers to immediately contact their healthcare providers for advice on how to discontinue this product safely. This is yet another in a continuing series of FDA warnings concerning products marketed as dietary supplements that contain undeclared dangerous prescription-only active pharmaceutical ingredients. As the FDA continues to monitor the dietary supplement market for these dangerous and illegal products, it can become an overwhelming process as, once enforcement action is taken on one illegal product, another appears in its place (aka playing the game of Whack-A-Mole).
