
Washington - A drug reviewer brought a drug manufactured by Merck & Company, Mevacor, into question earlier Tuesday. The drug was reviewed as part of a routine examination about the merits of having the drug become available over the counter.
Mevacor is often prescribed to help patients struggling with high Cholesterol, and currently is only available through a doctor’s prescription.
The Merck Company had given for submission documents that they hoped would show patients are able to decide for themselves if they should take the drug. This self-directed ability for prospective patients is key if the drug is to be sold without a prescription.
A U.S. Drug reviewer stated in documents that said that the directions that are provided with each package of Mevacor are not clear. The reviewer went on to say that instructions are confusing for patients. This directly draws into question Merck’s efforts to promote the drug for over the counter status.
The reviewer, Eileen Craig from the FDA, submitted her review regarding the unclear directions on Tuesday. “I am not completely convinced that adequate protection is afforded the consumer. Nor do I believe that consumers can comprehend the label on the product to use this medication safely” said Mrs. Craig.
The medication review is not the last word, and other information will be considered on Thursday from outside reviewers and experts, according to Mrs. Craig. Craig prepared her summary report of the FDA Advisory Panel.
A spokesman for Merck, Mr. Ronald Rogers was upbeat despite the negative review. “If you examine the documents we submitted, we are very upbeat and pleased overall with the nature and balance of these reviews.” Said Mr. Rogers. The Food and Drug Administration distributed five hundred thirty seven pages of files that they received from Mevacor, which were turned over to reviewers.
No comments for Mevacor Use Questioned
No comments yet.
Sorry, the comment form is closed at this time.