Products found to contain undeclared medicines
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| The United States: Public Notification: Ortiga Mas Ajo Rey Extra Forte contains hidden drug ingredients diclofenac, dexamethasone and methocarbamol |
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The US Food and Drug Administration (FDA) is advising consumers not to purchase or use Ortiga Mas Ajo Rey Extra Forte, a product promoted and sold for joint pain and arthritis on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that Ortiga Mas Ajo Rey Extra Forte contains diclofenac, dexamethasone and methocarbamol not listed on the product label.
Consumers taking Ortiga Mas Ajo Rey Extra Forte should immediately consult with their health care professional to safely discontinue use of this product. The risks 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.
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. In addition, the undeclared dexamethasone in Ortiga Mas Ajo Rey Extra Forte may cause serious side effects when combined with other medications.
Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/medication-health-fraud/public-notification-ortiga-mas-ajo-rey-extra-forte-contains-hidden-drug-ingredients
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Apr 22, 2022
Issued at HKT 16:00
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