Dispose of Unused Medicines

How to Dispose of Unused Medicines

Is your medicine cabinet filled with expired drugs or medications you no longer use? How should you dispose of them?

Most drugs can be thrown in the household trash, but consumers should take certain precautions before tossing them out, according to the Food and Drug Administration (FDA). A few drugs should be flushed down the toilet. And a growing number of community-based "take-back" programs offer another safe disposal alternative.

Guidelines for Drug Disposal

FDA worked with the White House Office of National Drug Control Policy (ONDCP) to develop the first consumer guidance for proper disposal of prescription drugs. Issued by ONDCP in February 2007 and updated in October 2009, the federal guidelines are summarized here:

·         Follow any specific disposal instructions on the drug label or patient information that accompanies the medication. Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so.

·         Take advantage of community drug take-back programs that allow the public to bring unused drugs to a central location for proper disposal. Call your city or county government's household trash and recycling service (see blue pages in phone book) to see if a take-back program is available in your community. The Drug Enforcement Administration, working with state and local law enforcement agencies, is sponsoring National Prescription Drug Take Back Days throughout the United States.

·         If no instructions are given on the drug label and no take-back program is available in your area, throw the drugs in the household trash, but first:

o    Take them out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.

o    Put them in a sealable bag, empty can, or other container to prevent the medication from leaking or breaking out of a garbage bag.

FDA's Deputy Director of the Office of Compliance Ilisa Bernstein, Pharm.D., J.D., offers some additional tips:

·         Before throwing out a medicine container, scratch out all identifying information on the prescription label to make it unreadable. This will help protect your identity and the privacy of your personal health information.

·         Do not give medications to friends. Doctors prescribe drugs based on a person's specific symptoms and medical history. A drug that works for you could be dangerous for someone else.

·         When in doubt about proper disposal, talk to your pharmacist.

Bernstein says the same disposal methods for prescription drugs could apply to over-the-counter drugs as well.

Why the Precautions?

Disposal instructions on the label are part of FDA's "risk mitigation" strategy, says Capt. Jim Hunter, R.Ph., M.P.H., senior program manager on FDA's Controlled Substance Staff. When a drug contains instructions to flush it down the toilet, he says, it's because FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal that presents the least risk to safety.

Drugs such as powerful narcotic pain relievers and other controlled substances carry instructions for flushing to reduce the danger of unintentional use or overdose and illegal abuse.

For example, the fentanyl patch, an adhesive patch that delivers a potent pain medicine through the skin, comes with instructions to flush used or leftover patches. Too much fentanyl can cause severe breathing problems and lead to death in babies, children, pets, and even adults, especially those who have not been prescribed the drug. "Even after a patch is used, a lot of the drug remains in the patch," says Hunter, "so you wouldn't want to throw something in the trash that contains a powerful and potentially dangerous narcotic that could harm others."

Environmental Concerns

Despite the safety reasons for flushing drugs, some people are questioning the practice because of concerns about trace levels of drug residues found in surface water, such as rivers and lakes, and in some community drinking water supplies. However, the main way drug residues enter water systems is by people taking medications and then naturally passing them through their bodies, says Raanan Bloom, Ph.D., an environmental assessment expert in FDA's Center for Drug Evaluation and Research. "Most drugs are not completely absorbed or metabolized by the body, and enter the environment after passing through waste water treatment plants."

A company that wants FDA to approve its drug must submit an application package to the agency. FDA requires, as part of the application package, an assessment of how the drug's use would affect the environment. Some drug applications are excluded from the assessment requirement, says Bloom, based on previous agency actions.

"For those drugs for which environmental assessments have been required, there has been no indication of environmental effects due to flushing," says Bloom. In addition, according to the Environmental Protection Agency, scientists to date have found no evidence of adverse human health effects from pharmaceutical residues in the environment.

Another environmental concern lies with inhalers used by people who have asthma or other breathing problems, such as chronic obstructive pulmonary disease. Traditionally, many inhalers have contained chlorofluorocarbons (CFC's), a propellant that damages the protective ozone layer. The CFC inhalers are being phased out and replaced with more environmentally friendly inhalers.

Depending on the type of product and where you live, inhalers and aerosol products may be thrown into household trash or recyclables, or may be considered hazardous waste and require special handling. Read the handling instructions on the label, as some inhalers should not be punctured or thrown into a fire or incinerator. To ensure safe disposal, contact your local trash and recycling facility.

Limit Use of 80 mg Simvastatin

Limit Use of 80 mg Simvastatin

The Food and Drug Administration is recommending that the use of drugs containing 80 mg of simvastatin—the highest approved dose of the popular cholesterol-lowering statin—be sharply curtailed because of the risk of muscle injury.

FDA says this dose should only be used by patients who have been taking it for 12 months or longer without ill effect.

“Our overall goal is to get doctors to not start patients on 80 mg of simvastatin,” says Eric Colman, M.D., deputy director of FDA’s Division of Metabolism and Endocrinology Products.

And if health care professionals find that patients now taking 40 mg of simvastatin aren’t meeting their LDL cholesterol goal, FDA is advising them to choose a different statin rather than raising the simvastatin dose to 80 mg, says Amy Egan, M.D., deputy director for safety in the FDA division.

All statins, despite their proven benefit in lowering the risk of heart attacks and strokes, carry some risk of an injury called myopathy, characterized by unexplained muscle weakness or pain. 

But the risk is greater for patients who take the 80 mg doses of simvastatin, especially in the first year of treatment. Colman says the muscle damage is often caused by interactions with other medications. And some people are genetically predisposed towards simvastatin-related myopathy, he says.

Last year, an estimated 2.1 million people were prescribed a medication containing 80 mg of simvastatin, says Egan. “It is the most potent statin available in generic form and is relatively inexpensive,” she notes.

The statin is sold under the brand name Zocor and as a single-ingredient generic drug. It is also sold in combination with ezetimibe as Vytorin, and niacin as Simcor.

FDA has revised the drug labels for simvastatin and Vytorin to include the new restrictions for the 80 mg dose, says Egan. The labels of simvastatin, Vytorin and Simcor have all been changed to include dosing recommendations when these drugs are used with medicines that can increase the level of simvastatin in the body, thus increasing the risk of myopathy.

Like all statins, simvastatin is used to lower the amount of low-density lipoprotein (LDL) cholesterol—known as “bad cholesterol”—in the blood. And the 80 mg dose of simvastatin has been shown to lower LDL cholesterol by an additional 6% over the 40 mg dose.

But myopathy can be debilitating. Moreover, a rare form of myopathy, called rhabdomyolysis, can lead to kidney failure and death.

Colman says one thing FDA does not want patients to do is stop taking their statins without consulting their doctor. “The benefits of the treatment far outweigh the risks,” he says, calling occurrences of rhabdomyolysis “extremely rare.”

But Egan says you should contact your health care professional if you have:

·         Muscle pain, tenderness or weakness

·         Dark or red-colored urine

·         Unexplained fatigue

The FDA recommendation was prompted by a comprehensive review of clinical trial data and data from the agency’s Adverse Event Reporting System, one of FDA's most important tools for tracking the safety of drugs once they are on the market.

Egan explained that FDA did not want to risk the health of patients who have been successfully treated with the medication for a year or more by pulling it off the market. During the next year, the agency will monitor prescription data to determine if the labeling changes are successful in limiting the use of 80 mg simvastatin.

FDA Unveils New Cigarette Health Warnings

FDA Unveils New Cigarette Health Warnings

Consumers are getting a glimpse of warnings images that will be alternating on all cigarette packages and advertisements within 15 months—an effort by health officials to discourage smoking by bringing Americans face to face with tobacco-related disease.

The Food and Drug Administration unveiled the nine, color images—including some of  bodies ravaged by disease—at a news conference. The images, which are paired with text health warnings, are required under the 2009 Family Smoking Prevention and Tobacco Control Act. They must appear on every cigarette pack, carton, and advertisement by September 2012.

“President Obama is committed to protecting our nation’s children and the American people from the dangers of tobacco use. These labels are frank, honest and powerful depictions of the health risks of smoking and they will help encourage smokers to quit, and prevent children from smoking,” said Health and Human Services Secretary Kathleen Sebelius.

Nine Warnings

In November, FDA officials posted 36 images on the Internet and gave the public 90 days to comment. The agency received more than 1,700 comments from the public, retailers, health professionals, advocacy groups, the tobacco industry, state and local public health agencies, and others.

Regulators used the comments, scientific literature, and the results of an 18,000-person study to narrow the images to nine. Each of the images—a mix of illustrations and photos depicting the negative health consequences of smoking—will be paired with one of these nine printed warnings:

·         WARNING: Cigarettes are addictive—with an image of a man smoking through a hole in his throat 

·         WARNING: Tobacco smoke can harm your children—with an image of a parent holding a baby as smoke drifts towards them

·         WARNING: Cigarettes cause fatal lung disease—with an image of a disease-riddled lung and a healthy lung 

·         WARNING: Cigarettes cause cancer—with an image of an open sore and stained teeth on the lips and mouth of a smoker with mouth cancer

·         WARNING: Cigarettes cause strokes and heart disease—with an image of a man who needs an oxygen mask to breathe

·         WARNING: Smoking during pregnancy can harm your baby—with an illustration of a crying newborn in an incubator and hooked-up to a monitor

·         WARNING: Smoking can kill you—with the image of a dead man with a surgery-scarred chest  

·         WARNING: Tobacco smoke causes fatal lung disease in nonsmokers—with an image of a grieving family member

·         WARNING: Quitting smoking now greatly reduces serious risks to your health—with an image of a man wearing an “I Quit” T-shirt

Expected Impact

FDA Commissioner Margaret A. Hamburg, M.D., says she’s hopeful the graphic images will give smokers the incentive to quit and prevent potential smokers from ever starting. In fact, the phone number for the smoking cessation hotline—1-800-QUIT-NOW—will accompany each warning.

“The Tobacco Control Act requires FDA to provide current and potential smokers with clear and truthful information about the risks of smoking—these warnings do that,” she says. 

The bold health warnings will cover the top 50 percent of the front and rear panels of all cigarette packages and at least 20 percent of each advertisement. They are expected to decrease the number of smokers, which will save lives and increase life expectancy.

The Centers for Disease Control and Prevention says tobacco use is the leading cause of premature and preventable death in the United States, responsible for 443,000 deaths each year. Tobacco addiction costs the U.S. economy nearly $200 billion every year in medical costs and lost productivity.