Eyelash Lengthener Draws Lashes From FDA

In San Jose, California, officials have confiscated more than 12,600 applicator tubes of Age Intervention Eyelash as they are alleged to cause a decline in eyesight.

The product meant for thickening and lengthening eyelashes is manufactured by a San Jose company ; Jan Marini Skin Research, Inc. The seizure was on the request of the U.S. Food and Drug Administration .

Authorities have fixed the sales value of the seized tubes at approximately $2 million.

FDA officials inform that the Age Intervention Eyelash product is an unapproved and misbranded drug . This is because Jan Marini Skin Research has promoted it as something that increases eyelash growth, give the officials.

FDA officials say this claim has not been approved , and on the contrary the eyelash lengthener may in fact damage eyes.

Before a new drug product may be legally marketed, it must be proven to be safe and effective, and approved by FDA, officials gave.

The FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product is said to contain bimatoprost, an active ingredient in an FDA-approved drug meant for treating elevated intraocular pressure (elevated pressure inside the eye).

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For patients who use the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage. This is because the extra dose of bimatoprost may decrease the prescription drug's effectiveness, say officials. The officials have added that damage to the optic nerve may lead to decreased vision and possibly blindness.

Use of Age Intervention Eyelash may cause other adverse effects in certain people due to the presence of bimatoprost. This includes macular edema (swelling of the retina) and uveitis (inflammation in the eye), all of which may lead to decreased vision, say FDA officials .

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The U.S. attorney's office for the Northern District of California had filed the complaint requesting the seizure . FDA officials give that they recommended the seizure as a way of showing they take their responsibility of protecting Americans from unapproved drugs , seriously.

Meanwhile, Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost , the year before itself.

The FDA recommends that consumers, dermatologists, and aestheticians who may still have Age Intervention Eyelash cease using it and throw away any remaining product. The FDA also recommends that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product's use.



Source-Medindia
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