Anxiety disorder

What is anxiety disorder?

Everyone gets anxious from time to time. But if you worry so much that you can't enjoy anything, your anxiety may have become an illness. Doctors call this illness generalized anxiety disorder. We'll call it anxiety disorder for short. We've looked at treatments for adults and for children and teenagers.

If anxiety is keeping you from enjoying life, you can get treatment.

Many people who have anxiety disorder don't realize it. They just think they are born worriers. ¹ Or they may think they have a physical illness. This is because anxiety disorder can give you symptoms such as headaches or palpitations (when you can feel your heart beating too fast). ²

If you have anxiety disorder, you can get help. There isn't a cure for this condition, but there are good treatments that can help you control your anxiety, and not have anxiety controlling you. ²

Key points for people with anxiety disorder

• Anxiety disorder is a real illness, and it can be treated.
• If you have it, you can't stop worrying, usually about ordinary, everyday things.
• Anxiety disorder is quite common, but many people don't realize they have it. Doctors find it hard to recognize, too.
• There's no cure for anxiety disorder, but treatment should help you control your worries.
• There are two kinds of treatment that work: "talking treatments" (or psychotherapy) and treatment with drugs.
• The best kind of psychotherapy is called cognitive behavioral therapy.
• Anxiety disorder can happen to children and teenagers, as well as adults.

There are some useful questions you can ask yourself if you think you may have problems with anxiety.

When worry becomes an illness

Anxiety is a normal human emotion. We all worry at times about things such as money, our families, or our jobs. But some people get more anxious than others.

Anxiety becomes an illness when you worry so much that it interferes with your life. You can't stop worrying even though you try. You probably worry over lots of different things, like work or school, your family, or your health. Your worry is out of proportion, and it makes you feel ill and tired. 

Doctors say you have an anxiety disorder if you worry too much on most days for at least six months. Your anxiety may make it hard for you to live life normally. You might find it difficult to get a job, go to college, or make friends.

Researchers don't really know what happens in your brain when you have anxiety disorder. X-rays or blood tests can't show what's wrong. But that doesn't mean that what you're going through isn't real.

Anxiety and other mental health problems

If you have anxiety disorder, it's likely that you've already had another mental health problem, such as depression. Many people with anxiety disorder have another mental illness at some point in their lives.

Some of these extra problems are similar to anxiety disorder.

Sometimes these illnesses lead to problems with alcohol or drug abuse. If you have problems with alcohol or drugs, tell your doctor and get treatment.

Anxiety disorder: why me?

Your doctor won't be able to tell you why you have anxiety disorder. We don't know exactly what causes it, but scientists believe that many things may play a part. They are studying how we are affected by our genes, stressful experiences, everyday worries, and unhappiness in childhood. They're also looking at the balance of chemicals in the brain. All these things seem to affect how much you worry and how anxious you are.Studies show that some things can make it more likely that you will get anxiety disorder. You may be more at risk if you:

• Lose a parent when you are very young
• Experience stressful events, such as the death of someone close, divorce, or the loss of a job
• Have more than the usual number of constant daily hassles to cope with, such as car repairs, household tasks, or missed appointments, and find these more stressful than other people
• Get bullied
• Live through a disaster, such as a flood, hurricane, or plane crash
• Are a woman. Women are twice as likely as men to have anxiety disorder.

Your chances of having anxiety disorder may also be higher if you are:

• Unemployed
• A homemaker. About a quarter of women with anxiety disorder don't have a job outside the home
• Separated, divorced, or widowed.

However, we don't know whether any of these things actually lead to anxiety disorder, or whether having anxiety disorder just makes you more likely to fall into some of these groups.

It's possible, for example, that people with an anxiety disorder find it hard to get or keep a job. Or they might find relationships difficult, and so are more likely to separate or divorce.

Safe Use of Acetaminophen

Reducing Fever in Children: Safe Use of Acetaminophen

You’re in the drug store, looking for a fever-reducing medicine for your children. They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.

This could be a dangerous mistake.

This use of concentrated drops in much larger amounts—as would be given with a teaspoon—can cause fatal overdoses, says Sandra Kweder, M.D., deputy director of the Food and Drug Administration’s Office of New Drugs.

You can’t just give an older child more of an infant’s medicine, adds Kweder. “Improper dosing is one of the biggest problems in giving acetaminophen to children.”

Confusion about dosing is partly caused by the availability of different formulas, strengths, and dosage instructions for different ages of children.

Sold as a single active ingredient under such brand names as Tylenol, acetaminophen is commonly used to reduce fever and relieve pain. It is also used in combination with other ingredients in products to relieve multiple symptoms, such as cough and cold medicines. Acetaminophen can be found in more than 600 over-the-counter (OTC, or non-prescription) and prescription medicines.

Improper dosing is one of the biggest problems in giving acetaminophen to children.

Acetaminophen is generally safe and effective if you follow the directions on the package, but if you give a child even a little more than directed or give more than one medicine that contains acetaminophen, it can cause nausea and vomiting, says Kweder.

In some cases—in both adults and children—it can cause liver failure and death. In fact, acetaminophen poisoning is a leading cause of liver failure in the U.S.

Advice From Outside Experts

An FDA Advisory Panel of outside experts met May 17-18, 2011, to discuss how to minimize medication errors and make children’s OTC medicines that contain acetaminophen safer to use.

The panel recommended:

·         That liquid, chewable, and tablet forms be made in just one strength. Currently, there are seven strengths available for these forms combined.

·         That dosing instructions to reduce fever be developed for children as young as 6 months. Current instructions apply to children ages 2 to 12 years and for those under 2, only state “consult a doctor.”

·         That dosing instructions be based on weight, not just age.

·         Setting standards for dosing devices, such as spoons and cups, for children’s medicines. Currently, some use milliliters (mL) while others use cubic centimeters (cc) or teaspoons (tsp).

“FDA is considering these recommendations,” says Kweder, and for those that the agency adopts, “we will work with manufacturers to try to get them in place on a voluntary basis.” The process of getting a regulation finalized could take several years, she adds, so having the drug industry act voluntarily would help make acetaminophen safer sooner.

Drug makers have already agreed to phase out the concentrated infant drops to reduce confusion for parents who try to use them for older children. On May 4, 2011, the Consumer Healthcare Products Association, a trade group representing the makers of OTC medicines, announced plans to convert liquid acetaminophen products for children to just one strength (160 mg/5 mL). In addition, the industry is voluntarily standardizing the unit of measurement “mL” on dosing devices for these products.

FDA Acts to Change Prescription Labels

Under a 2009 FDA regulation, manufacturers must place the word “acetaminophen” on the front of the package of all OTC products that contain the ingredient and on the “Drug Facts” label on the container and packaging.

However, prescription medicines don’t have Drug Facts labels. Instead, the pharmacy places a computer-printed label based on the doctor’s prescription on the container before giving it to the consumer. Pharmacies often use the acronym “APAP” (N-acetyl-p-aminophenol) or a shortened version of acetaminophen to represent the ingredient. If parents don’t know these abbreviations, they might not recognize that a prescription medicine contains acetaminophen and could accidentally overdose a child by giving a prescription and an OTC acetaminophen medicine at the same time.

FDA’s Safe Use Initiative, which fosters collaborations within the health care community to help prevent harm from medications, has been working to bring about the complete spelling of acetaminophen on prescription containers.

Tips for Giving Acetaminophen to Children

·         Never give your child more than one medicine containing acetaminophen at a time. To find out if an OTC medicine contains acetaminophen, look for “acetaminophen” on the Drug Facts label under the section called “Active Ingredient.” For prescription pain relievers, ask the pharmacist if the medicine contains acetaminophen.

·         Choose the right OTC medicine based on your child’s weight and age. The “Directions” section of the Drug Facts label tells you if the medicine is right for your child and how much to give. If a dose for your child’s weight or age is not listed on the label or you can’t tell how much to give, ask your pharmacist or doctor what to do.

·         Never give more of an acetaminophen-containing medicine than directed. If the medicine doesn’t help your child feel better, talk to your doctor, nurse, or pharmacist.

·         If the medicine is a liquid, use the measuring tool that comes with the medicine—not a kitchen spoon.

·         Keep a daily record of the medicines you give to your child. Share this information with anyone who is helping care for your child.

·         If your child swallows too much acetaminophen, get medical help right away, even if your child doesn’t feel sick. For immediate help, call the 24-hour Poison Control Center at 800-222-1222, or call 911.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

FDA Acts to Reduce Harm from Opioid Drugs

FDA Acts to Reduce Harm from Opioid Drugs

The White House on Tuesday unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the U.S.—including an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.

Gil Kerlikowske, director of the White House Office of National Drug Control Policy, says the plan—a collaborative effort involving agencies of the departments of Justice, Health and Human Services, Veterans Affairs, Defense, and others—provides a national framework for reducing prescription drug abuse and the diversion of prescription drugs for recreational use.

“The toll our nation’s prescription drug abuse epidemic has taken in communities nationwide is devastating,” says Kerlikowske. “We share a responsibility to protect our communities from the damage done by prescription drug abuse.”

Key elements of the plan—called Epidemic: Responding to America’s Prescription Drug Abuse Crisis—include:

·         expansion of state-based prescription drug monitoring programs

·         recommending convenient and environmentally responsible ways to remove unused medications from homes

·         supporting education for patients and health care providers

·         reducing the number of “pill mills” and doctor-shopping through law enforcement

FDA Opioid Strategy

In concert with the White House plan, the Food and Drug Administration (FDA) is announcing a new risk reduction program—called a Risk Evaluation and Mitigation Strategy—for all extended-release and long-acting opioid medications.

Opioids are synthetic versions of opium that are used to treat moderate and severe pain.

FDA experts say extended-release and long-acting opioids—including OxyContin, Avinza, Dolophine, Duragesic, and eight other brand names—are extensively misprescribed, misused, and abused, leading to overdoses, addiction, and even deaths across the United States. FDA says a 2007 survey revealed that more than half of opioid abusers got the drug from a friend or relative.

Opioids—such as morphine and oxycodone—are used to treat moderate and severe pain. Over the past few decades, drug makers have developed extended-release opioid formulas to treat people in pain over a long period.

The new REMS plan focuses primarily on: educating doctors about proper pain management, patient selection, and other requirements and improving patient awareness about how to use these drugs safely. As part of the plan, FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.

FDA wants drug makers to work together to develop a single system for implementing the REMS strategies. Toward that goal, FDA is now notifying opioid makers that they must propose a REMS plan within 120 days.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, says this risk management strategy is designed to improve pain management, while preserving patient access to these needed medications.

“This will be an important step toward addressing what has become a critical public health problem,” she says.

Doctor training, patient counseling, and other risk reduction measures developed by opioid makers as part of the REMS are expected to become effective by early 2012. They will be required for various brand name products known under the generic names:

·         hydromorphone

·         oxycodone

·         morphine

·         oxymorphone

·         methadone

·         transdermal fentanyl

·         transdermal buprenorphine

Widespread Problem

FDA estimates that more than 33 million Americans age 12 and older misused extended-release and long-acting opioids during 2007—up from 29 million just five years earlier. And in 2006, nearly 50,000 emergency room visits were related to opioids.

"Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients, but we know that they pose serious risks when used improperly—with serious negative consequences for individuals, families, and communities," says FDA Commissioner Margaret A. Hamburg, M.D. “The prescriber education component of this Opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks." 

Although doctor training is not mandatory under the REMS plan, other federal agencies are working to get Congress to link mandatory physician training to the already required Drug Enforcement Administration registration number that doctors must have to prescribe controlled substances.

FDA will also require the risk management plan to include a way to determine if the education programs are helping to reduce problems associated with long-acting and extended-release opioids, as well as allowing patients who need opioids to get them.

FDA has had the power to request companies to develop REMS since 2007. The plans may also include medication guides and patient package inserts.