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Entries in adderall (8)

Wednesday
Jan302013

Adderall Knockoffs Are Unapproved, Potentially Dangerous

iStockphoto/Thinkstock(NEW YORK) -- Students hoping to bolster their grades may want to study the ingredients of some new products being marketed as prescription-strength study aides.

Two companies, Gentech Pharmaceuticals and NexGen Biolabs, are engineering products touted as alternatives to Adderall, a prescription drug used to help improve focus in patients diagnosed with attention deficit hyperactivity disorder.

While the websites for these Adderall alternatives say there is no prescription needed, they also say their supplements include synthetic amphetamines, the active ingredient in Adderall.

"Some of the chemicals we're talking about are only in prescribed medicines," said Dr. Philip Cole, director of pharmacology and molecular sciences at Johns Hopkins University in Baltimore.  "The notion that they're also in dietary supplements is a significant concern."

But Dr. Stan Headley, the medical director at Gentech Pharmaceuticals, said it's difficult to make a direct comparison betwen the active ingredient in his company's Adderall-like pill, called "ADDTabz," and the amphetamines found in Adderall.

Headley said companies like Gentech take the ingredients in popular drugs and reformulate the compounds to create a very similar product.

"It's a unique niche that we have," he said.  "Our product is stronger than something you would find at a health food store, but yet not as potent, not as strong as prescriptions."

Although they may be more potent than a product you could find in a store that sells vitamins, these Adderall knockoffs are listed as dietary supplements, which are not as regulated by the U.S. Food and Drug Administration as prescription drugs.

Under the Dietary Supplement Health and Education Act of 1994, companies that manufacture dietary supplements do not need FDA approval to sell their products.  The law also states that the manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.

However, according to the FDA, there is no provision under any law that requires a company to share the information they have about the safety of their dietary supplements with the FDA.  The only time a company needs to disclose information regarding the safety of their supplement is if it contains an ingredient engineered after 1994.

Companies using new ingredients are required to file a New Dietary Ingredient Notification, which requires that the manufacturer demonstrate to the FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement.

Neither Gentech nor Nexgen submitted a New Dietary Ingredient Notification with the FDA for their amphetamine-like compounds, according to a FDA spokesperson.  Neither company immediately responded to an ABC News request for a comment on the missing paperwork.

The FDA, though, can do little to stop the sale of unapproved products. I f it deems an ingredient unsafe, it can send a warning letter to companies asking that they stop manufacturing a product.  But checking the ingredients of the countless supplements available online and in stores is a daunting task for the administration, which leads to new, unapproved ingredients hitting the market.

Copyright 2013 ABC News Radio

Tuesday
Sep042012

Harvard Crimson Pulls Ad for Adderall Alternative

iStockphoto/Thinkstock(NEW YORK) -- Coming right after Harvard’s recent cheating scandal, the staff at its student newspaper, The Harvard Crimson, may be a little red in the face today after approving an ad for a pill that promises to improve brain function without a prescription.

The ad was quickly yanked on Monday, but not before it caught the attention of Jezebel.com, which skewered the paper for sponsoring a supplement that purports to give students a chemically-enhanced leg up on the competition.

The ad was hawking ADDTabz, a supplement promoted as a non-prescription alternative to the ADHD drug Adderall. Increasingly, college students are misappropriating this sort of good-grade pill without a prescription and without a real medical need.

Gentech Pharmaceutical, the Florida-based distributor of ADDTabz, says on its website the supplement “improves memory and learning,” “enhances cognitive ability,” “improves total brain function” and “reduces anxiety and improves mood.” Those could be pretty tempting claims to a student looking for an edge in the pressure cooker of college.

It’s a little unclear how ADDTabz differs from the real deal. Prescription Adderall is a potentially addictive amphetamine which lists insomnia, changes in appetite and high blood pressure among its most common side effects. Unless you have a legit prescription to use it as a treatment for ADHD or another attention disorder, possession is illegal.

On the Gentech website, ADDTabz is described as “NOT an herbal supplement but rather a designer non-prescription pharmaceutical analog providing superior results without the side effects of its chemical cousin’s amphetamine spectrum.” Gentech did not respond to a request for comment.

Harvard Crimson president Ben Samuels said ads for the paper are brokered by a third party or direct sales. He said he’s not sure how this one was posted, but it wasn’t up for very long.

“There’s been little reaction from the student community,” he said, adding that the newspaper has run several stories about Adderall abuse on Harvard’s campus.

Not everyone is giving the paper a pass. “It’s irresponsible of the Crimson to publish such an ad when it should be encouraging students to stand on their own two feet,” said Dr. Marcia Angella, a senior lecturer in the department of social medicine at Harvard. “It’s part of a culture to cut corners and this promotes another way to do it.”

According to University of Kentucky research, the use of “smart pills” is rampant. Researchers found more than 30 percent of college students have taken stimulant drugs without a prescription.  Most buy from friends with legitimate prescriptions or they fake attention disorder symptoms to score their own.

But is it cheating? Some say taking the attention-focusing pills is the brain equivalent of taking steroids to enhance physical performance, giving users an unfair advantage over non-users. At the very least, it probably violates the honor code of most academic institutions.

Angella said she views it as more of a shortcut. “Drugs help you stay awake longer but you could still be ignorant,” she said. “You still have to learn for yourself.”

Copyright 2012 ABC News Radio

Wednesday
Jun272012

Adderall Use on the Rise for Mothers

iStockphoto/Thinkstock(NEW YORK) -- All over America, moms are turning to the prescription drug Adderall for relief. Adderall is a drug for attention deficit hyperactivity disorder, but these women don't have ADHD; they say they need Adderall to be better mothers.

Between 2002 and 2010, there's been a 750 percent increase in Adderall prescriptions for women between 26 and 39.  Critics say clearly not all of these women need the drug for ADHD.

ABC News spoke with Betsy Degree from suburban Minneapolis, who started taking the prescription drug to keep up with the demands of being a mother of four.

"I grew up in a house where my mom was very neat," she said.  "Everything was really clean, beautiful dinners every night and that didn't come naturally for me."

Several years ago, one of Degree's children was prescribed Adderall, a central nervous system stimulant, for ADHD.  In a moment of desperation she stole a pill from her own child and the addiction was almost immediate.

"I was able to get all the stuff done around the house," Degree said.  "I was able to cook the dinner and have everything perfect."

Degree tells ABC News she felt like supermom and would stay up until 3 a.m. doing loads of laundry.  She says she thought she'd only take it once.

"I couldn't stop," she said.  "I could not stop taking them.  I'd say I'm just going to take them one more time."

When she ran out she resorted to tricking the family doctor into writing more prescriptions.

"I would call and say we lost them.  I would call and say that dose isn't right so can we try a different dose," said Degree.  "[I was trying] every trick in the book."

Addiction doctors say the situation is getting out of control.

"This is a significant problem," said Dr. Marvin Seppala, chief medical officer at Hazelden, an addiction treatment facility.  "We've got an increase in women using drugs like Adderall ending up in our treatment programs. ... We know from a medical perspective it's dangerous and can cause seizures, strokes, heart attacks, even death."

Adderall sent Degree, who admits she struggled with addiction issues all of her life, down a dangerous path.  When she decided she could no longer fool her doctor she switched from Adderall to meth.  She lost her business and she says she nearly lost her kids.

She is now clean and has this simple advice for any mom considering taking Adderall, "don't."

"It's pretty addictive," said Degree.  "It can happen to anybody."

Copyright 2012 ABC News Radio

Wednesday
May302012

Fake Adderall Sold Online Gets FDA’s Attention

iStockphoto/Thinkstock(WASHINGTON) -- Beware of fake versions of ADHD medication Adderall that are being sold on the Internet, the U.S. Food and Drug Administration has warned.

The agency issued the warning Tuesday after receiving complaints from the manufacturer Teva Pharmaceutical Industries that the 30 mg tablets, which do not even resemble the authentic version, were being sold online under the company name, FDA spokesperson Shelly Burgess told ABC News.

Adderall is approved by the FDA to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy.

“We issued the warning to warn the public of the risks of buying from Internet sellers,” said Burgess.

The agency, which conducted lab tests on some of the counterfeits, found the counterfeit version did not contain the correct active ingredients for Adderall.  Instead, it contained acetaminophen and tramadol, which are used to treat acute short-term pain.

Since there is no tracking system for rogue websites that sell fake medication, it is unclear how many people have bought the imitations online.

The nationwide shortage of Adderall in pharmacies may have led some to purchase the medication on the Internet. The FDA’s website lists many dosages of Adderall manufactured by Teva pharmaceuticals have been in short supply since at least October 2011.

According to the FDA, counterfeit Adderall may be white instead of orange, contain no markings on a tablet, and come in a blister package. There may also be misspellings on the package.

Trustworthy websites are licensed by state board of pharmacy and contain a list of the boards on the site. The site should also have a licensed pharmacist available to answer questions the consumer may have. Sound websites also require prescription verification before dispensing any pharmaceutical medication.

“If it offers dramatically low prices from market value, this is a red flag,” said Burgess.

Anyone who suspects they have purchased the counterfeit version should stop taking the medication and report any side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, said Burgess.

The agency is grappling with how best to regulate rogue online sites that sell fake and potentially harmful medications. The FDA can issue warning letters to the sites highlighting its unsafe practices, but are not able to ensure that it can be stopped.

“These sites can shut down and pop back up under a different name the next day,” said Burgess.

Copyright 2012 ABC News Radio

Tuesday
Jan032012

Adderall Drug Shortage Will Continue in 2012, Gov't Officials Say

iStockphoto/Thinkstock(NEW YORK) -- A contentious relationship between drug manufacturers and the Drug Enforcement Agency may cause a continuing shortage of the attention deficit medication Adderall, which the Food and Drug Administration just added to its official drug shortages list, the New York Times reported.

As of 2007, about 9.5 percent of school-aged children, or 5.4 million, were diagnosed with Attention Deficit Hyper Disorder (ADHD), according to the Centers for Disease Control and Prevention. Since then, prescriptions for Adderall have numbered in the millions and continue to increase. And as demand for the drug grows, more and more patients have found the medication is out of stock at local pharmacies.

Experts say it’s difficult to say where the reason for drug shortage lies. To manage controlled substances that can potentially be abused, the DEA sets manufacturing quotas for drug ingredients each year to control supplies like Adderall. But Adderall drug manufacturers, which include Shire Plc and Novartis, Teva and CorePharma LLC, say they cannot meet the growing demand for the product without looser limits from the DEA.

The DEA questions whether there is actually a shortage of generic supplies, which are at an especially low supply, or whether the drug companies want to sell more of the expensive brand-name drugs.

Despite the growing demand, Special Agent Gary Boggs of the DEA’s office of diversion control told the New York Times, "We believe there is plenty of supply."

Copyright 2012 ABC News Radio

Tuesday
Oct252011

Should Preschoolers Take Ritalin and Other Stimulants?

Comstock/Jupiterimages/Thinkstock(NEW YORK) -- Diagnosis of attention deficit hyperactivity disorder (ADHD) has been steadily on the rise in the past few decades, and so has the use of drugs to treat it. But now even younger children might be considered prime targets for prescriptions of the drugs, an idea that is sparking persistent concerns about the long-term effects of giving stimulants such as Ritalin and Adderall to children.

“We don’t have enough information to know the long-term effects of these medications on young developing brains,” said Rahil Briggs, director of Healthy Steps program at Children’s Hospital at Montefiore Medical Center in New York City. “Young brains are like a sponge, they’ll soak up anything. Serious medication of this sort might affect them disproportionately as well.”

A September survey published in the American Journal of Psychiatry found that use of stimulant medications to treat ADHD had risen in the past 15 years, and the number of children between 13 and 18 taking the drugs had risen 6.5 percent each year since 1996.

The American Academy of Pediatrics released new guidelines last week recommending that children as young as 4 should be screened for ADHD. The guidelines also endorsed prescribing ADHD medications such as Ritalin for preschool-aged kids who have moderate to severe symptoms and who don’t seem to benefit from behavioral therapy.

The use of methylphenidate, the active ingredient in ADHD drugs such as Ritalin and Concerta, in preschool-aged kids is an off-label use of the drug because the U.S. Food and Drug Administration has approved the drug only for children 6 and older.

The idea of giving powerful stimulants to young children gives many parents and pediatricians pause. But the American Academy of Pediatrics’ new guidelines are particularly cautious when it comes to recommending drugs for preschoolers.

For preschoolers who do wind up taking the drugs, scientists know fairly little about how the medications affect them. Only one large study, conducted by the National Institutes of Mental Health, has investigated how these drugs affect preschool-aged kids. The Preschool ADHD Treatment Study looked at 303 kids between 3 and 5 being treated for ADHD. If behavioral interventions failed, the children took daily doses of methylphenidate.

The study’s results showed that preschoolers who took the drug didn’t benefit from it as much as older children do, and they were also more likely to experience adverse side effects. One out of 10 kids who took the drug had to drop out of the study because the drug’s side effects were so intolerable.

Despite these results, some experts note that medication can offer relief to parents and children for whom all other approaches have failed.

“ADHD is common disorder that can lead to significant impairment,” said Dr. Chris Kratochvil, professor of psychiatry and pediatrics at the University of Nebraska Medical Center. “The concern is that if clinicians don’t take the time to really evaluate the child or don’t understand what ADHD would look like in a preschool child, that might lead to inappropriate use of these medications.”

Ultimately, child development experts say parents and doctors should always take a cautious approach when it comes to prescribing ADHD drugs for young children.

“It’s got to be the very last solution we turn to after exhausting everything else that we know works really well,” Montefiore’s Briggs said.

Copyright 2011 ABC News Radio

Monday
May092011

ADHD Drug Shortage Leaves Patients Scrambling to Find It

Comstock Images/Thinkstock(NEW YORK) -- A nationwide shortage of the generic form of Adderall XR, a drug used for attention-deficit hyperactivity disorder (ADHD) in children and adults, has sent many patients scrambling from pharmacy to pharmacy to find it and has left others wondering what they'll do if their pharmacies run out.

The companies that make the drug, known in its generic form as mixed amphetamine salts, say the shortage is caused by supply problems and blame other manufacturers and the Drug Enforcement Administration for restricting the amount of amphetamines available, which the DEA denies.  The companies say they don't know when supply will increase.

Although the brand name drug is in adequate supply, it's still been difficult for many people to get it.

"Patients have had to run around to other pharmacies trying to find the generic, or try to get their insurance companies to cover the brand name product," said Erin Fox, manager of the Drug Information Service at the University of Utah Hospital in Salt Lake City, which tracks drug shortages nationwide.  "Some pharmacies don't even carry the brand name."

Those who live with ADHD and doctors who treat it know how debilitating the condition can be.  Without their medication to keep it under control, the consequences can be serious.

"Adults are more likely to get divorced, underperform at work, have motor vehicle accidents, and if they're not treated, tend to have higher rates of substance abuse," said Dr. Lenard Adler, director of the Adult ADHD Program at NYU Langone Medical Center in New York.

Children, he said, may have academic problems and place a lot of stress on families because of their hyperactivity.

Adler added that if people with ADHD need to switch medications, it can lead to a number of problems.  The dosage may not be correct and it will take time to adjust it appropriately, or they may not respond as well to other drugs.

Copyright 2011 ABC News Radio

Thursday
Oct282010

Drug Seeking Behavior in ER Doubles, Feeds Growing Addiction to Pain Pills

Photo Courtesy - Getty Images(NEW YORK) -- Sherry Ragan tracked down her brother in a local Utah emergency room. He wasn't hurt or sick; he had run out of Adderall and needed a new prescription to feed his addiction to the drug.

Ragan told the nurse and the doctor about her brother's drug-seeking behavior, and that he and his doctor had been trying to wean him off the drug. But the doctor said he'd give him a little bit of Adderall despite her concerns. Ragan said she's not sure whether the doctor didn't have the time, didn't want to be bothered, or was simply not well-versed in substance abuse. At any rate, she was upset by the outcome.

"If my brother can do this, that means everyone coming here can get whatever they want," said Ragan, a Utah County drug prosecutor. "I work with people who work their whole lives trying to help addicts, and to find out that we're being undercut was really shocking."

Janet Frank, spokesperson for Intermountain Healthcare, said, "We don't have permission to talk about that instance due to federal privacy laws, but we are acutely aware of the prescription drug problem in our community as well as across the nation, and all of our staff in all of our staff are committed to being a part of the solution."

Although Adderall is not a pain medication, which is the more common sought-after type of drugs in emergency rooms, the story brings to light a growing problem of prescription drug addicts who find their fix in the ER. According to the Centers for Disease Control and Prevention, the number of ER visits that involved non-medical use of narcotic pain medications more than doubled in the United States between 2004 and 2008.

"This is a huge issue for emergency departments because, unlike the office setting, the ED treatment of pain is frequently indicated without the benefit of an established doctor-patient relationship and often in an environment of limited resources," said Dr. Jason Hoppe, assistant professor in the department of Emergency Medicine at the University of Colorado School of Medicine.

According to Hoppe, prescription opioids are currently the number one cause of poisoning deaths in the country, surpassing cocaine and heroin as causes of drug associated death.

"This problem has increased tremendously over the past years," said Dr. Ziad Kazzi, an assistant professor of Emergency Medicine at Emory University. "It is hard for me to estimate its frequency in my practice but I would like to say it is at least once per shift." 

Copyright 2010 ABC News Radio







ABC News Radio