The Food and Drugs Administration (FDA) issued a public warning against selected anti-vertigo drugs and an ophthalmic preparation after having been found out to be unregistered in their agency. The FDA said that these drugs may pose health risk if taken.
Based on FDA Advisory No. 2016-084, it issued public health warning against purchase and intake of Betahistine dihydrochloride (Serc) 8 mg tablet made by Highnoon Laboratories Ltd.; Cinnarizine (Stugeron) 25 mg tablet of Johnson & Johnson – Pakistan (Private); Betahistine diHCl (Serc) 16 mg tablet of Abbott Healthcare SAS; and Ketorolac Tromethamine (Ketorocin-0.5) Ophthalmic Solution 5 mL made by Appasamy Ocular Devices Pvt Ltd Pharma Division.
FDA reminds establishments and pharmacies that a corresponding penalty will be given to those who will violate the directive.
Serc is an anti-vertigo drug. It is commonly prescribed for balance disorders or to alleviate vertigo symptoms associated with Ménière’s disease. Stugeron is an antihistamine and a calcium channel blocker. It is known to promote cerebral blood flow, but it is more commonly prescribed for nausea and vomiting due to motion sickness or other sources such as chemotherapy, vertigo and also Ménière’s disease. Ketorocin ophthalmic solution is a non steroidal anti-inflammatory drug that is indicated to temporarily relieve itching eyes caused by seasonal allergies. It is also used to prevent and treat eye swelling due to a certain type of eye surgery (cataract removal).