PHARMACY

Health care providers, patients ignore FDA warnings about patches

BY Drew Buono

WASHINGTON Health care providers are overlooking the dangers of drug patches even though the Food and Drug Administration has issued warnings about their uses, according to the Los Angeles Times. The two biggest patches in question are the pain patch Fentanyl and the birth-control patch Ortho Evra.

The problem with the patches is they maintain a steadier level of the drug in the body after consumption as compared to a pill. For example, the Ortho Evra exposes women to a higher level of a hormone linked to blood clots than do oral contraceptives.

The effect of any patch can vary considerably from patient to patient. “Some people may not get enough of the drug, which defeats the purpose of taking it. And some may get too much … which is going to hurt some people,” said Dr. Curt D. Furberg of the Wake Forest University medical school.

He along with many other doctors are asking for the patches to be examined more carefully by the FDA. The FDA though is stating that everything is fine on their end when it comes to product safety and effectiveness.

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PHARMACY

Teva receives final FDA approval for generic Famvir, but will delay marketing until patent hearing

BY Drew Buono

JERUSALEM Teva Pharmaceuticals has been granted final approval on its application to market famciclovir, the generic version of Novartis’ Famvir in the 125, 250 and 500mgs.

Now with the approval from the Food and Drug Administration, Teva is also awarded a 180-day period of market exclusivity. But the company will hold off marketing the item until at least Sept. 5, 2007.

On that day, a hearing will be held involving a patent infringement suit brought against Teva regarding the famciclovir. The hearing is scheduled to meet at the U.S. District Court for the District of New Jersey regarding Novartis’ motion for a preliminary injunction. Therefore, both parties have agreed to not launch a generic version of Famvir until after the hearing.

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Forest, Daiichi Sankyo sign agreement for Azor

BY Drew Buono

NEW YORK Forest Laboratories and Daiichi Sankyo have signed a co-promotional agreement for Daiichi Sankyo’s new antihypertension drug Azor. Azor is a combination of the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil.

Under the agreement, Forest will pay Daiichi Sankyo an upfront payment of $20 million and will receive a payment based upon product sales. The agreement is for three years, after which, Daiichi Sankyo will make residual payments to Forest.

The drug is still under review by the Food and Drug Administration with a decision expected by late September. Hypertension affects roughly 72 million people in the U.S., with about 65 percent of those diagnosed having trouble keeping it under control.

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