Content about Drug safety

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older. The approval will move Plan B from behind the pharmacy counter into the family planning set of the pharmacy. 

Just about every healthcare practitioner recommends over-the-counter medicines to their patients. And nearly 3-out-of-4 make that OTC recommendation as the first therapy option, according to a recent survey released by the Consumer Healthcare Products Association. 

This is another proof point that OTC medicines play an important role in holding down cost. 

WASHINGTON — Patients around the country "strongly" oppose laws that have been proposed to change popular OTC drugs to prescription-only, according to a new survey.

The survey, conducted online by Harris Interactive on behalf of the Asthma and Allergy Foundation of America, polled 2,020 adults in January who had asthma, allergies, cold, cough or flu in the past 12 months and who had purchased OTC drugs for at least one condition during that time.

As many as 26% of consumers increased their usage of over-the-counter products in the past year, according to an online survey of more than 900 AccentHealth viewers conducted in September. Anticipated increases in OTC use for the upcoming year are driven by those who have already reported a rise in usage in the past year.


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The lower cost of OTCs was cited as the primary reason viewers have increased and plan to increase their OTC usage. 


SILVER SPRING, Md. — The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention. 

The committee voted five in favor and six opposed, also citing concerns that men might inappropriately choose to use the product as well. 

ALLEGAN, Mich. — Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

Zegerid OTC (omeprazole and sodium bicarbonate capsules 20 mg/1,100 mg), a proton-pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the lastest 12 months.

WASHINGTON — The Community Anti-Drug Coalitions of America and the Consumer Healthcare Products Association are mobilizing communities to stop prescription and over-the-counter medicine abuse during National Medicine Abuse Awareness Month, the groups announced Monday.

SAN DIEGO — The Food and Drug Administration has accepted a regulatory application for an opioid painkiller made by Zogenix, the company said Monday.

The drug maker announced the FDA's acceptance of its application for Zohydro (hydrocodone bitartrate) extended-release capsules, designed for moderate to severe chronic pain. The company expects the FDA to decide whether or not to approve the drug by March 1, 2013.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has submitted a regulatory approval application to the Food and Drug Administration for a drug designed to increase the blood levels of certain drugs for HIV.

RARITAN, N.J. — The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

SCOTTSBORO, Ala. — Government authorities are working to educate independent pharmacy owners on prescription drug abuse, an independent pharmacy network said.

In an event sponsored by American Associated Pharmacies in San Diego, Drug Enforcement Administration deputy assistant administrator for the Office of Diversion Control Joseph Rannazzisi discussed topics related to prescription drug abuse. Rannazzisi explained how drug abusers divert prescription drugs through doctor shopping, forged prescriptions, theft and the Internet.

WASHINGTON — The House of Representatives will vote to repeal limitations on the use of tax-advantaged accounts for the purchase of over-the-counter medications as early as June 4, according to a report published online by The Hill, a Washington, D.C.-based political newspaper.

The paper cited a planning memo from majority leader Eric Cantor, R-Va.