Entries in Medications (26)


FDA: Beware Buying Prescription Drugs Online

iStockphoto/Thinkstock(WASHINGTON) -- A moving target of as many as 40,000 active online pharmacies, a huge majority of them fly-by-night start-ups, may sell products at a cut-rate price but they may also deliver expired, contaminated and fake drugs that can harm consumers, the FDA said Friday.

"You have no guarantee of the safety, efficacy or quality of those products," Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, told ABC News. "You want to go to an online pharmacy that is licensed, located in the United States, [and] importantly, that will ask for a prescription from a doctor."

On Friday, the FDA launched BeSafeRx, a national campaign to alert consumers to the possible dangers of buying pharmaceuticals online.

"This a real problem. In fact, it is a growing problem, it is a problem that we are doing everything we can ... to try and protect the safety and security of the drug supply chain," Hamburg said. "The consumers have a role to play, as well, and that's why we want them to be informed about how to recognize a safe and legal online pharmacy so they can get those drugs that they really do need."

In May, the FDA surveyed more than 6,000 adults and found that almost a quarter of Internet shoppers bought prescription drugs online, and three in 10 said they weren't confident they could do so safely.

What many consumers don't realize is they are more likely online to get fake drugs that are contaminated or past their expiration date, or contain no active ingredient, the wrong amount of active ingredient or even toxic substances such as arsenic and rat poison.

They could sicken or kill people, cause them to develop a resistance to their real medicine, cause new side effects or trigger harmful interactions with other medications being taken.

Just how easy is it to set up an online pharmacy?

Two University of California, San Diego medical researchers showed ABC News how they set up their own fake drug store using search engines, Facebook and Twitter to draw potential buyers, and no pharmaceutical degree or any medical license, is required to set up any of these websites.

Timothy Mackey, a doctoral student in the joint doctoral program between San Diego State University and the University of California, San Diego created a fake pharmacy in less than 15 minutes and for less than $80.

"We basically created a Web app which is very descriptive and has a medical professional, a picture of a person that we just purchased, and we were able to post it online without any verification or requirements at all," Mackey said.

A hit-and-run pharmacy is lightning fast to start and even faster to disappear -- all before authorities can catch up.

"The bad guys know when they're getting chased, so they just shut down with a minute, and then literally within another hour they've set themselves right back up again," said Brian Liang, head of the Center for Patient Safety at the University of California, San Diego School of Medicine. "What it's telling us is that there's clearly no enforcement, and Facebook and others in this space are making money off of illicit drug sales."

Liang and Mackey said their mock sites saw more than 1,000 unique users in the 10 months they were active. The outgoing links they included went to a "dead page," and they did not actually sell any pharmaceuticals.

While there are some legitimate online pharmacies, about two percent according to the Alliance for Safe Online Pharmacies, how can you tell which are legitimate and which are fake?

According to the FDA, watch out for sites that ...

1. ... allow you to buy drugs without a prescription;
2. ... offer deep discounts that seem too good to be true;
3. ... send unsolicited emails offering cheap drugs;
4. ... are located outside of the United States, beyond the reach of regulators.

"If you find out about the website because of spam or unsolicited email, be very, very careful," Hamburg said. "If the price is bedrock cheap and it seems too good to be true, it probably is too good to be true. And if it is not located in the United States and it's offering to ship drugs worldwide, another red flag; don't go there."

Liang added that when they were searching for online pharmacies, the first 10 pages of hits was comprised entirely of fake pharmacies, and they did not come to a legitimate site until page 10 in the Google search results.

The new "BeSafeRx" website allows consumers to check a pharmacy's license through state boards of pharmacy, as well as providing tips for shopping online and seeing the signs of a fake pharmacy.

"We want consumers to be able to get safe, effective, high-quality drugs," Hamburg said. "And if they want to order them online that is terrific, but use a safe and legal online pharmacy."

"The important messages," Hamburg added, "are have a prescription, know your online pharmacy, make sure it is safe and take your medication as directed."

The National Association of Boards of Pharmacy also recommends only using Internet pharmacies accredited through Verified Internet Pharmacy Practice Sites or Vet-VIPPS program. It also provides a listing of "Not Recommended Sites."

Copyright 2012 ABC News Radio


Should Kids Be Prescribed ADHD Medications Sooner?

iStockphoto/Thinkstock(NEW YORK) -- Children with attention deficit hyperactivity disorder (ADHD) who start taking medications as early as fourth grade may be more likely to score better academically than those who start taking medication in middle school, according to a study published Monday in the journal Pediatrics.

ADHD is a developmental disorder characterized by problems focusing and erratic behavior.  Since 2007, 5.4 million children ages 4 to 17 have been diagnosed with ADHD, and 66 percent reported taking medication to treat their symptoms, according to the U.S. Centers for Disease Control and Prevention.  A majority of children are diagnosed with ADHD by age 7.

Researchers looked at data of nearly 12,000 Icelandic children born between 1994 and 1996, each of whom began taking medication for ADHD sometime between fourth and seventh grades.  By the time the children reached seventh grade, those who had begun taking medications within the first year of fourth grade showed only a 0.3 percent drop in their math score, compared to a 9 percent drop among children who started medication around sixth or seventh grade.

"Performance of kids with ADHD tends to decline over time, especially if medication is delayed," said Helga Zoega, an epidemiologist at the Institute for Translational Epidemiology at Mount Sinai School of Medicine in New York, and lead author of the study.  "Starting medication earlier may halt this decline."

The girls among the group only showed improvement in math after starting medication.  The boys showed improvement in both math and language arts.

A majority of kids are diagnosed with ADHD by age 7, Zoega said.

Besides medication, treatments for ADHD include behavioral interventions, education plans and parental training.  The interventions may be the first line of treatment before medication, or may be used in combination with medication.

The study data did not show whether the children received other forms of treatment besides medication, and whether these additional treatments may have influenced their performance.

Copyright 2012 ABC News Radio


US Has Drug Recall Problem, Study Says

Comstock/Thinkstock(BOSTON) -- Drug recalls in the U.S. happen frequently -- about once every month -- according to researchers at Brigham and Women’s Hospital in Boston.

In a new study published Monday in the Archives of Internal Medicine, the researchers found that although the U.S. Food and Drug Administration has systems for communicating these recalls, they might not be enough to warn health care providers of important drug recall information.

Researchers also found that the FDA issued official public notices for only about half of the recalls deemed the most serious, called Class I recalls.

”The FDA offers this communication service, and we anticipate that a lot of providers may rely on it and in doing so may not be getting the information they need when drugs are recalled,” said Joshua Gagne, an epidemiologist at Brigham and Women’s Hospital and one of the authors of the study.

Gagne and his colleagues analyzed eight years of data from the FDA’s Enforcement Reports and the archives of the agency’s two chief drug recall-reporting systems: the Recall Alert System and the FDA MedWatch Safety Alert database.  According to the study, FDA records show 1,734 drug recalls from 2004 to 2011; 91 of those recalls were tagged Class I recalls, meaning they had the greatest likelihood to cause patients serious harm, even death.

Of the 91 Class I recalls, the FDA issued official Recall Alert System notices for 55 of them.  For the remaining 36, half were reported through the FDA’s MedWatch system.  The remaining 18 Class I recalls were not communicated through either system.

Gagne also noted that the Recall Alert System is used also for recalls of products that have no bearing on patient care, such as veterinary drugs.

“It’s very possible that these important recalls are being lost in the less important ones,” Gagne said.

Responding to the article, FDA spokeswoman Sarah Clark-Lynn said the agency used many different methods of communicating information about drug recalls and safety, including email list serves, news releases, Twitter and text messaging.  And recalls, she said, were not up to the FDA alone.

“The recall system depends on full and open disclosure [by manufacturers], trust and the industry’s acceptance of its responsibilities to protect the public from violative products,” Clark-Lynn said in an email.

Gagne said the study didn’t look into how many times manufacturers notified physicians about drug recalls, which they frequently do via “Dear Doctor” letters sent directly to health care providers.

The researchers also found that drug recalls weren’t usually limited to a few pills here and there.  Of the Class I recalls from 2004 to 2011, 34 percent affected more than 100,000 units of a drug, and 64 percent of recalled drugs had been distributed nationwide.  Forty percent of the recalls were because of contaminated drugs, and 25 percent of the drugs were recalled for having the wrong doses or release mechanisms.  The rest were the result of product mix-ups or mislabeling.

Copyright 2012 ABC News Radio


Foster Kids on Too Many Meds: Is the Government Taking Action?

iStockphoto/Thinkstock(WASHINGTON) -- The senator who spurred the Government Accountability Office to investigate the startling numbers of foster children being put on powerful, mind-altering drugs is calling on the Obama administration to follow through on its vow to find solutions to the issue.

“This is a deeply disturbing problem that demands immediate attention,” Sen. Tom Carper, D-Del., wrote in a letter to Health and Human Services Secretary Kathleen Sebelius provided exclusively to 20/20. "…Unless our Medicaid policies properly reflect best medical practices, the result will be damaging to the program’s financial bottom line but, more importantly, to the health and welfare of our nation’s foster care children.” (See the full letter here.)

As 20/20 and World News reported during ABC News’ own extensive investigation of the medication of foster children late last year, the GAO found that doctors prescribe psychotropic medications to foster children at a rate of up to 13 times that of children in the general population. The GAO investigation was launched at the request of the Senate Federal Financial Management Subcommittee, which is chaired by Carper.

[Watch 20/20′s full report on overmedication in the foster care system here.]

A spokesman for the Health and Human Services Department said that the agency received the letter Tuesday and will be responding as soon as possible.

Copyright 2012 ABC News Radio


Z-Pak Antibiotic Raises Death Risk for Some, Says Study

iStockphoto/Thinkstock(NASHVILLE, Tenn.) -- Patients prescribed the antibiotic azithromycin are more likely to die than those prescribed a different antibiotic, according to a study published in the New England Journal of Medicine on Wednesday. These results were especially pronounced for those who died from heart attacks, strokes, sudden cardiac death and other cardiovascular causes.

Azithromycin, commonly known by the trade name Z-Pak, is prescribed to almost 50 million Americans every year. Like the popular antibiotic amoxicillin, azithromycin is commonly prescribed to help fight off bacterial infections. But while they are often prescribed for similar conditions, the two drugs work differently from one another.

Wayne Ray, professor of preventive medicine at Vanderbilt University, in Nashville, Tenn., and lead author of the study, says he thinks many doctors prescribe azithromycin instead of amoxicillin because of its easier regimen; patients on azithromycin take fewer pills over fewer days, which means they are more likely to finish their entire course of medicine. Finishing the entire course not only leads to more effective treatment, but it also lessens the risk of the patient developing a drug-resistant bug.

But, Ray says of azithromycin, “the risk of death may outweigh convenience and compliance, at least for high-risk patients.”

These high-risk patients would seem to be those who have certain types of cardiovascular disease. Some doctors have suggested that azithromycin may cause irregular heartbeats known as arrhythmias, which in some people can lead to death. In Ray’s study, which looked at Medicaid patients from 1992 to 2006 and analyzed millions of prescriptions, he and his colleagues found that patients on azithromycin had two and a half times the odds of dying from a cardiovascular cause while taking their medication than did patients on amoxicillin. The gap was widest when looking at the 10 percent of patients with the worst cardiovascular disease.

The study wasn’t able to tease out which patients were on azithromycin because they had allergies to amoxicillin.

Cardiologist Leonard Ilkhanoff, director of the Inherited Arrhythmia Program at Northwestern University’s Feinberg School of Medicine, in Chicago, says that while it’s impossible to know what precisely is causing the increased risk of death, the study is very interesting. But he cautions that patients on azithromycin should not panic.

“Patients shouldn’t be thinking, ‘If I’m on azithromycin, I’m going to die,’” he says, adding that sometimes azithromycin really is the proper antibiotic for a patient.

“It’s appropriate, though, to discuss the risks and benefits with your doctor.”

Copyright 2012 ABC News Radio


Rx Drug Scam Uses DEA Identities to Terrify Victims into Paying Up

Hemera/Thinkstock(FORT WORTH, Texas) -- The websites seem so simple, so inviting -- buy prescription diet pills or sleep aids without a prescription. But it could be a trap.

A few clicks on certain websites can lead to phone calls that sound like this: "This is officer James Kashin. If you and your wife don't call me back you are going to jail."

Or this: "This is special agent David Brown. We are going to bring you in, in custody, with criminal charges for medication from overseas."

It's all part of an elaborate scam, including the alleged law enforcement phone calls.

According to DEA officials, criminal scam artists first sell prescription drugs online through websites they sometimes operate. After customers input their personal information and make a purchase, the criminals can use the information to blackmail and extort them.

Scammers pose as federal drug enforcement agents, even use actual agents' names, when they make threatening phone calls to thoroughly scare their marks, but then the fake agents offer their victims a lifeline. The caller tells his victims that they have a choice -- either they pay up by a certain deadline and their names will be cleared, or they will be charged as suspects in a criminal investigation and face jail time.

"Basically he wanted me to pay $1,500," said Kesha Howell, a victim of the scam.

"He's got you in such a panic state that by the time he offers you the money, I mean really, that's a no-brainer. Just tell me how much and if I can afford to do it, I'm in," said Darren Dutil, another victim.

Victims of this scam say the phone calls sound authentic and are genuinely terrifying because the person on the other end has all of their personal information.

"He was very calm, cool, but very intimidating. He knew things about me. He had legit information on me and that's what was so scary," Howell said.

"I was ready to call my wife and kids and say, 'Hey look, see you all later. I'm obviously going to be gone for a while,'" Dutil said.

Another victim, who didn't want his name revealed, said he got a call from the scammers and fake DEA agents actually showed up at his house in suburban Fort Worth, Texas.

"They pulled up in a black SUV, right there at the driveway. Two white males got outside, stood beside the truck, and a slender 5-10, 5-11 black male came toward me with black wavy hair," he said.

In the end, he said he didn't fall for the scam, but he admitted he came close.

But Carolyn Sirek, a legal secretary from Joshua, Texas, fell into the trap and accepted the buyout option after receiving the scamming calls. According to her husband Dan Sirek, Carolyn went into a local Walmart and wired the scammers the money through Western Union.

"It depleted our savings account, let's put it that way," Dan Sirek said.

Very often, after one payment, the scammers come back for more. Carolyn Sirek was apparently so upset and scared about what happened that she shot and killed herself in her backyard. Her husband said he found her with a bullet hole in her chest.

Thousands of victims, many of whom have paid the scammers, have called the DEA hotline for help. Officials believe several of these people have shelled out thousands of dollars in the extortion and that the operation is being run out of the Dominican Republic.

The DEA has indicted 11 Dominican men, but as of yet, those men have not been arrested. Agents told ABC News they are working with the Dominican government to have the suspects extradited to the United States, and are investigating other groups operating similar scams.

Copyright 2012 ABC News Radio


Pharmacies Fueling Prescription Drug Trade?

iStockphoto/Thinkstock(WASHINGTON) -- The prescription drug trade is booming and the Drug Enforcement Administration believes some rogue pharmacies could be fueling the epidemic.

On Friday, the DEA confirmed that it is now investigating Walgreens, the nation’s biggest drugstore.

In Florida, six Walgreens stores were investigated after inspectors spotted a major red flag, a huge spike in the amount of the highly addictive painkiller Oxycodone the stores were ordering from distributors.

One of the stores under scrutiny bought 95,000 doses in 2009 and over 2.1 million doses in 2011, about 30 times the amount a typical pharmacy would buy.

Two Florida CVS pharmacies with similar massive purchases were recently banned from selling painkillers altogether after the DEA determined there was “imminent danger to the public health.”

Both pharmacy chains have said they are cooperating with the DEA.

The DEA fears rogue pharmacies could be illegally filing prescriptions for greedy doctors involved in black market distribution networks, or selling painkillers directly to addicts.

The potential profits are huge. One estimate put the number of prescription drug abusers at seven million.

Copyright 2012 ABC News Radio


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


Bias Can Exaggerate Drugs’ Effectiveness

Stockbyte/Thinkstock(PORTLAND, Ore.) -- Doctors -- and patients -- might not be getting all the information they need about the safety and effectiveness of certain drugs because of “publication bias,” the tendency of researchers and medical journals to favor positive results over negative ones.

Researchers running drug trials are required to submit detailed results to the U.S. Food and Drug Administration. But when it comes to reporting trial results publicly in medical journals, “it’s an entirely different ballgame,” according to Dr. Erick Turner, lead author of a study published Tuesday in PLoS Medicine.

“Doctors are trained to regard medical journals as the gospel truth,” said Turner, assistant professor of psychiatry and pharmacology at Oregon Health and Science University in Portland. “But what we’re learning here is it’s not necessarily the whole truth and nothing but the truth.”

Turner and colleagues reviewed the results submitted to the FDA for eight antipsychotic drugs used to treat schizophrenia. They then compared the results to those published in medical journals. Four trials submitted to the FDA, all of which had unflattering results for the drug under study, were unpublished.

“It’s kind of like grade inflation,” said Turner. “Say you’ve got a class full of kids. Some are excellent students and some should be failing. If you give everyone an A, an outside person is not going to be able to appreciate there’s a difference between these two sets of kids.”

Even when the studies were published, the journal articles often overemphasized the drugs’ effectiveness.

“Some of what we found could constitute spin, some would fall into the category of shenanigans,” said Turner. “The take-home message is there are loopholes in the publication process by which doctors may be relying on information that’s incomplete or somehow skewed. The drug’s effects may be exaggerated or its safety concerns may be downplayed.”

Turner said researchers working for a drug company might be inclined to withhold data that’s seen as damaging, adding “there’s no law says they have to publish.” But certain medical journals are also less likely to accept negative trials for publication. Bias, Turner said, could be mitigated by leaving the results out of the decision to publish.

“The person reviewing the study for the journal should be thinking, ‘Is this good science?’ rather than basing a decision on the results,” he said.

Copyright 2012 ABC News Radio


New Drug Promising Against Deadly Melanoma

iStockphoto/Thinkstock(NEW YORK) -- When Richard Kaminski had an unusual mole removed from his cheek in 1998, he thought it was the end of his experience with melanoma.

But more than 10 years later, Kaminski developed a cough that didn't go away. Medical tests confirmed the diagnosis: metastatic melanoma that had spread to his lungs.

Melanoma is a form of skin cancer that kills 85 percent of its victims within five years if it has spread. It is responsible for about 9,000 deaths in the United States a year, according to the American Cancer Society.

Kaminski was floored. "I had this awful thing working in my lungs," he said.

Doctors treated Kaminski with a drug typically used against this form of cancer, but without success. It was only when his oncologist put him in touch with Dr. Anna Pavlick at New York University, who enrolled him in a clinical trial of a medication called vemurafenib, that he began to turn the corner on the deadly illness.

Before treatment, Kaminski recalled, "I had great difficulty breathing. I couldn't put sentences together because I couldn't get a deep breath. I had pain in my chest." Three weeks after beginning the drug, "A lot of that was greatly diminished," he said.

Within three months, Kaminski's symptoms disappeared. Scans showed his tumors starting to regress. By the end of 2010, the tumors were gone.

Kaminski, now 65, is understandably thankful.

"In two weeks, I will be two years on this drug," he said. "It was a lifeline."

On Wednesday, the results of the clinical trial in which Kaminski was enrolled appeared in the New England Journal of Medicine. In the study conducted at 13 centers in the U.S. and Australia, researchers followed 132 patients with Kaminski's type of melanoma who had failed to respond to standard treatment. In about half of them, vemurafenib shrunk their tumors. For another third of the patients, the tumors showed no progression once the drug regimen had kicked in. Dr. Lynn Schuchter at the University of Pennsylvania, another of the study's authors, called these numbers "unprecedented."

"I've treated patients [with melanoma] for almost 25 years and never seen a drug with this kind of activity," Schuchter said. "It's so much better than the therapies that have been available to us before."

Also impressive was the improvement in survival; patients on the drug lived, on average, for an additional 15.9 months after treatment began, compared with the six to 10 months typically seen with the disease. A larger trial, also published this year in the New England Journal of Medicine, showed that the drug brought about improved survival at six months. But the authors of the new study were able to follow some of their patients much longer -- for more than a year after they'd started treatment.

For patients like Kaminski who fail standard treatment, the new drug offers hope. Unlike many other cancer drugs, vemurafenib was just as effective in patients who had failed a previous treatment as it was in patients who had received the drug right off the bat -- a rare finding when it comes to cancer treatments.

The drug is not without its limits. In targeted therapy, cancer cells can mutate slightly and stop being a target, a process called resistance. In this study, cancer tended to recur in patients after about seven months of treatment. Dr. Kelly McMasters, chairwoman of surgery at the University of Louisville who treats melanoma patients, points out, "It can cause the tumors to shrink, but they will recur on average in about six months."

That being said, McMasters said, "In some patients...vemurafenib offers the hope to shrink the tumors enough to allow [surgical removal]."

So far, resistance hasn't been an issue for Richard Kaminski. Two years into treatment, he continues to enjoy a relatively normal life. He loves to garden, although he does have to take precautions out in the sun since one of the side effects of the medication is sun sensitivity.

Copyright 2012 ABC News Radio

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