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Source: eFluxMedia
The US Marshals seized 12.682 tubes of Age Intervention Eyelash because they were likely to cause swelling of the retina and inflammation of the eye, even more it could lead to blindness according to a statement of the Food and Drug Administration. The applicator tubes had been sold and distributed by San Jose, California-based Jan Marini Skin Research, Inc. since September 2006 up to the moment the health officials retracted it from the market at the FDA’s request.
The FDA said that the product, promoted to increase eyelash growth, is considered dangerous because it contains bimatoprost, which is an active ingredient in a drug approved by the agency. This ingredient is used by patients with elevated pressure inside the eye. An increased quantity of this substance may damage the optic nerve “because the extra dose of bimatoprost may decrease the prescription drug's effectiveness,†the FDA said in a public statement.
The company’s president and chief executive, Jan Marini, said that the FDA’s decision is unfair since other companies use the same substance for their applicator tubes and no measures have been taken against them.
The company’s representative also added that they had proposed to destroy the product “but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizureâ€, Marini added.
Brad Swezey, FDA spokesperson said that, retracting the product from the market, is a matter of policy and they don’t know yet if any other company using the same ingredient “is or is not subject of an ongoing investigation.†The FDA said in a statement that the tubes seized were valued at $ 2 million.
They advised consumers, dermatologists and estheticians not to use the product anymore and also to consult a doctor if they encounter any discomfort related to the product.
"The agency takes seriously its responsibility to protect Americans from unapproved drugs," the FDA said in a statement.
The US Marshals seized 12.682 tubes of Age Intervention Eyelash because they were likely to cause swelling of the retina and inflammation of the eye, even more it could lead to blindness according to a statement of the Food and Drug Administration. The applicator tubes had been sold and distributed by San Jose, California-based Jan Marini Skin Research, Inc. since September 2006 up to the moment the health officials retracted it from the market at the FDA’s request.
The FDA said that the product, promoted to increase eyelash growth, is considered dangerous because it contains bimatoprost, which is an active ingredient in a drug approved by the agency. This ingredient is used by patients with elevated pressure inside the eye. An increased quantity of this substance may damage the optic nerve “because the extra dose of bimatoprost may decrease the prescription drug's effectiveness,†the FDA said in a public statement.
The company’s president and chief executive, Jan Marini, said that the FDA’s decision is unfair since other companies use the same substance for their applicator tubes and no measures have been taken against them.
The company’s representative also added that they had proposed to destroy the product “but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizureâ€, Marini added.
Brad Swezey, FDA spokesperson said that, retracting the product from the market, is a matter of policy and they don’t know yet if any other company using the same ingredient “is or is not subject of an ongoing investigation.†The FDA said in a statement that the tubes seized were valued at $ 2 million.
They advised consumers, dermatologists and estheticians not to use the product anymore and also to consult a doctor if they encounter any discomfort related to the product.
"The agency takes seriously its responsibility to protect Americans from unapproved drugs," the FDA said in a statement.
