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Entries in Prescription (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

Wednesday
Apr042012

New Rx Sleep Drug: Promising or Perilous?

iStockphotos/Thinkstock(NEW YORK) -- Your eyes snap open, but the room is dark and the alarm clock reads 2 a.m.

It's a frustrating but all-too-familiar scenario for many. A new sleep aid called Intermezzo, available in pharmacies with a prescription starting on Thursday, aims to address this problem. The Food and Drug Administration approved Intermezzo in November, but some physicians have questioned its usefulness and safety.

Forty-two percent of Americans reported waking up in the middle of the night, according to the 2008 Sleep in America Poll conducted by the National Sleep Foundation, and 29 percent said they found it difficult to fall back to sleep. Known as middle-of-the-night insomnia, it is the most common form of insomnia, the survey reported. Other sleep aids on the market were designed to be taken before falling asleep, and work for eight hours, which is great if your problem is not being able to get to sleep but not so great if you wake up at, say, 3 a.m., and have only a few hours left of shut-eye.

Purdue Pharma, the company behind Intermezzo, said the new pill could be taken by those who wake up mid-sleep and may have only four hours or so left to doze. This makes it the only FDA-approved drug for middle-of-the night insomniacs. The drug contains zolpidem tartrate, the same active ingredient in the popular prescription sleep aid Ambien, but at a lower dose. It is also taken in a different way. Whereas Ambien is swallowed, Intermezzo is left to dissolve under the tongue, so it works more quickly.

But some doctors said Intermezzo's side effects may be considerable. Since the drug is in the same class as previous sleep aids, it carries with it all of the same potential side effects, including behavioral disturbances, sleep walking and possible worsening of depression or suicidal thoughts.

Worry that the drug could negatively affect a person's ability to drive in the a.m. held up FDA approval of Intermezzo for roughly two years. In highway driving studies conducted in 2010, those who had taken Intermezzo were found to be impaired for up to three hours. Driving was deemed safe at the four-hour mark, although there was still a small difference between drivers who'd taken the drug and those who had not.

"I would probably use this drug in patients who not only had four hours of sleep remaining but could also afford to wait an additional one to two hours before driving," said Dr. Stanley Wang, a cardiologist and director of the Sleep Disorders Center at Heart Hospital of Austin in Texas, in an email to ABC News.

Whether having Intermezzo on the market will lead to more consumption of prescription sleep drugs is a matter of debate. In 2010, medications containing zolpidem tartrate, the most common ingredient in sleeping aids, were collectively the 15th most-popular prescription drug in the country, with more than 38 million prescriptions dispensed, according to pharmaceutical data firm IMS Health.

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Copyright 2012 ABC News Radio

Friday
Oct222010

Medical College Educates Americans on Prevention of Prescription Drug Abuse

Photo Courtesy - PRNewsFoto | American College of Emergency Physicians(WASHINGTON) -- The American College of Emergency Physicians is challenging Americans to participate in a new initiative called the American Medicine Chest Challenge.  The challenge is intended to educate the public about safe disposal of expired, unused and unwanted prescription medications. 

The main event, which is scheduled to take place nationwide on Nov. 13, will encourage Americans to do five things:

1) Take inventory of over-the-counter and prescription medications.
2) Lock all medicine cabinets.
3) Dispose of unwanted, unused and expired medications at designated disposal sites.
4) Take medications as prescribed.
5) Talk to children about the dangers of prescription drug abuse.

"Emergency physicians see first-hand the dangers of prescription drug abuse, which is why we recommend that everyone take stock of the medicines in their homes," said ACEP president, Sandra Schneider, MD, FACEP. "Prescription drugs are the most abused drugs in America other than marijuana, and parents are the first line of defense between kids and the prescription medications.   If you don't need the medicines in your medicine chest, then your kids don't need them either."

Copyright 2010 ABC News Radio

Monday
Sep272010

DEA Pushes New Medication Disposal Initiative To Combat Teen Addiction

Photo Courtesy -- Getty Images

(NEW YORK) -- The Drug Enforcement Agency is urging Americans to safely dispose of their unused, unwanted and expired medications at approximately 4,000 "take back" drop off points set up nationwide.  This new initiative is an effort to thwart one of America's fastest growing drug problems where kids are seeking to get high not from drugs bought in the street, but rather drugs found in their homes.  Laurie Decrescenzo told ABC News she's had several bottles of prescription drugs in her home for nearly 30 years. "I didn't know what to do with them so I just pushed them to the back of my cabinet," Decrescenzo said.  "This effort symbolizes DEA's commitment to halting the disturbing rise in addiction caused by their misuse and abuse," DEA Acting Administrator Michele Leonhart said. The DEA is taking action on the matter after increasing reports have surfaced involving teenage addiction and physical harm stemming from prescription medications found at home.  The DEA is updating its list of drug drop-off points regularly at its website, www.dea.gov, to provide the public with further information on the initiative.  The DEA is updating its list of drug drop-off points regularly at its website, www.dea.gov to provide the public with further information on the initiative.

Copyright 2010 ABC News Radio







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