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Entries in Over the Counter (4)

Wednesday
May012013

FDA Approves Over-the-Counter Plan B for Woman 15 and Older

Scott Olson/Getty Images(WASHINGTON) -- The Food and Drug Administration has approved Plan B One-Step, a brand of emergency contraceptive, to be available for women 15 and older without a prescription.

This comes almost a month after a federal judge ordered the FDA to make Plan B available to everyone over-the-counter, which will go into effect on May 5, unless the FDA appeals the ruling.

"The Department of Justice is considering next steps in the litigation," the FDA said in a statement. "In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older."

Judge Edward Korman ordered emergency contraceptive to be made available over the counter on April 5, citing "bad faith" that resulted in restricted access to the drug in the past. Prior to that, it was available to everyone 17 and older without a prescription.

When Korman, who presides over the District Court of Eastern New York, wrote his ruling, Teva Pharmaceutical Industries, which makes Plan B One-Step, had an application pending with the FDA to get the prescription-free age lowered from 17 to 15, according to the FDA statement.

"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," said President of Planned Parenthood Federation of America's President Cecile Richards.

The morning-after pill is intended to be used when other contraception fails, such as when a condom breaks. Containing the synthetic hormone levonorgestrel, the pill works by preventing a fertilized egg from attaching itself to the uterine wall. But it must be taken within 72 hours of unprotected sex. It cannot terminate an existing pregnancy.

Although Wednesday's FDA approval means women seeking Plan B will need to have identification to prove they are of age to purchase it, the drug will no longer be available only when the pharmacy is open, according to an FDA statement. Instead, it will be available in the family planning and female health aisles.

In December 2011, Health and Human Services Secretary Kathleen Sebelius sparked controversy when she overruled the FDA after it recommended that emergency contraception be sold over the counter. The FDA spent 10 months reviewing scientific data before making its decision, but Sebelius said there wasn't enough data to declare the product safe.

"Indeed, it is hardly clear that the secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious and unreasonable," Korman wrote in his ruling.

Although the FDA has not yet made an announcement regarding Korman's order, some women's health organizations are concerned.

"The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a press release.

She said requiring proof of age is a "significant barrier that all too many women of all ages will still find" even with the prescription-free age lowered to 15.

"These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances," she said. "And we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women."

Copyright 2013 ABC News Radio

Sunday
May272012

Over-the-Counter Lice Treatment No Longer Effective?

Stockbyte/Thinkstock(KUNA, Idaho) -- Last week, a Kuna, Idaho, elementary school closed for two days after 60 students and nine staff members were diagnosed with head lice.

An estimated 12 million cases of head lice are diagnosed in the United States each year, and medical experts say that while they don't kill, they can be an irritating nuisance for parents and a public relations embarrassment for schools.

Officials at Kuna's Indian Creek Elementary School did not return calls from ABC News, but sent a letter to parents urging them to check their children and get treatment while the school was cleaned.

In the past, over-the-counter products like Nix and RID have been effective, but now many cases are becoming drug resistant, so head lice outbreaks like the one in Idaho are on the rise.

"People get really freaked out when their kids get it," said Dr. Ari Brown, an Austin, Texas, pediatrician and author of "Baby 411."

"They think, 'Oh, my gosh, my kids are dirty.' But lice don't care what economic class you are in," she said. "Parents also worry that they are going to get it, too. They are disgusted by the whole concept."

Head lice are small, wingless insects about the size of a sesame seed that only live in the human scalp and feed by sucking blood, according to the Centers for Disease Control and Prevention. The crawling lice or their eggs, known as nits, can be found attached to the hair.

"Lice have this social stigma and all kinds of stuff wrapped up in it and it's certainly no fun to deal with -- but it's not such a big deal," said Brown.

To the dismay of health-conscious parents, when standard treatments don't work, they must turn to expensive prescription drugs that contain pesticides, like malathion.

Copyright 2012 ABC News Radio

Monday
Jan092012

Novartis Recalls Excedrin, Bufferin, NoDoz and Gas-X as Precaution

Michele Tantussi/Bloomberg via Getty Images(PARSIPPANY, N.J.) -- Novartis Consumer Health Inc., one of the world’s largest drug companies, announced on Sunday that it is voluntarily recalling several over-the-counter products after complaints of chipped and broken pills and inconsistent bottle packaging.

The Switzerland-based company described the move as a precaution to strengthen its standards, and said these issues have led to no adverse events.

The drugs being recalled are the pain reliever Excedrin and the caffeine tablets NoDoz with expiration dates of Dec. 20, 2014 or earlier, and the aspirin Bufferin and stomach medicine Gas-X Prevention with expiration dates of Dec. 20, 2013 or earlier.  The drugmaker says these bottles may contain pills of other Novartis products, or pills that are chipped and broken.

[CLICK HERE TO SEE THE FULL LIST OF IMPACTED PRODUCTS]

Novartis has suspended operations and shipments from its factory in Lincoln, Neb.  The company said it plans to work with the Food and Drug Administration to make improvements before resuming operations.

Copyright 2012 ABC News Radio

Wednesday
Dec012010

Dangerous Dose? Kids' Meds Are Hard to Measure

Photo Courtesy - Getty Images(NEW YORK) -- Dosing directions for children's over-the-counter medications are misleading and hard for parents to understand, according to a study from the New York University School of Medicine.

Researchers sampled 200 of the top-selling cough/cold, allergy, analgesic and gastrointestinal over-the-counter (OTC) liquid medication for children and found that inconsistencies between labeled dosage and the provided measuring device could increase the likelihood of mis-dose when medicine is administered by caretakers in the home.

One-in-four OTC medications didn't even include a measuring device, despite guidelines from the Food and Drug Administration that recommend all children's medications to include them.

In response to growing concerns over accidental drug overdose in OTC children's medications, the FDA released new guidelines on how to create clear and easy-to-use dosing directions in November 2009.

The study examined over-the-counter products around the time the guidelines were released and documents the widespread inconsistencies in dosing directions and packaging that spurred the action by both the FDA and the Consumer Healthcare Products Association, which represents the makers of 95 percent of all OTC consumer medications.

"This study is intended to establish baselines.  The plan is to take another look in a year or so to see if changes have been made," says Dr. H. Shonna Yin, lead author on the study and assistant professor of pediatrics at NYU School of Medicine.

According to the CHPA, all member manufacturers are voluntarily participating in revisions to bring pediatric medications up to the new guidelines, though the results of these changes will not be reflected in the products immediately.

Copyright 2010 ABC News Radio







ABC News Radio