When you take OTC (over the counter) or prescription medications you may also take a regular vitamin too or some other type of dietary supplement. There may be a danger in mixing dietary supplements with regular medications you’re taking.

Medical officer Robert Mozersky who works at the FDA says that some dietary supplements impact the metabolism and increase it while some other dietary supplements decrease the metabolism.

The metabolism, absorption, or excretion of a medication can be impacted so the potency is changed. You may be getting too much or too little of the medication you’re taking now.

Medications and dietary supplements combined together may have dangerous or even life-threatening consequences. Drugs used for heart disease, HIV/AIDS, depression, birth control pills, and drugs for organ transplant treatment are made less effective when taking with the herbal supplement St. John’s Wort. It depends on the medication being taken, but the results may be serious.

Prescription blood thinner warfarin, herbal supplement ginkgo biloba, aspirin, and vitamin E supplements can thin the blood. If these are taken together there could be a stroke or internal bleeding.

Dietary supplements are commonly used and include minerals and vitamins as well as other less common substances such as, amino acids, botanicals, herbals, as well as enzymes. The (NHANES) or National Health and Nutrition Examination Study from 2005-2008 of the Centers for Disease Control and Prevention (CDC) said that 72 million people or 34% of participants in the United States took some type of dietary supplement with prescription medication. Many take supplements to ensure they get the right essential nutrients, but dietary supplements shouldn’t be used as a replacement for eating a wide variety of foods we need for a healthy diet.

Consumers are under the false impression that “natural products such as an herbal supplement or fish oil won’s hurt them, but natural doesn’t mean that it’s safe to take. A weight loss product might be herbal or “natural,” but might be unsafe for people to take that have certain medical conditions.

Children can be harmed by taking both medications and supplements. The metabolism of a child is unique and when they are at different ages, the metabolism works at different rates. For children ingesting dietary supplements with medication can increase the chances of adverse events taking place.

If you plan to have some type of surgery, dietary supplements can harm you as you may have medication you take before, after, or during the surgery procedure. Your doctor may have you stop using supplements about 2-3 weeks before you medical procedure is to take place. You may have blood pressure, heart rate, or bleeding risks if you continue take supplements before the procedure date.

If you’re breastfeeding or pregnant you need to discuss dietary supplements with your doctor to understand your risks.

It’s the season when you take a timeout from school and your absence is actually excused. But if you’re traveling for spring break, you’ve got to stay safe.

The Office of Women’s Health (OWH) at the Food and Drug Administration (FDA) is taking new steps to ensure that young women have access to timely wellness information. OWH has launched a new web page with information about health issues to help you stay safe on vacation and beyond. The page is the latest in its ongoing College Women’s Campaign, a collaboration with more than 160 schools across the country to disseminate OWH health publications at college health centers and other campus locations.

“We know college women face a lot of pressures, and we want to make sure they take time to care for their health while they’re in school and on break,” explains Marsha Henderson, FDA’s assistant commissioner for women’s health.

The campaign spans a variety of topics, and here are five themes for spring break. So follow these tips, and enjoy your trip.

Be Safe in the Sun

You may be tempted to “pre-tan” and then tan some more once you arrive. But don’t. Any increase in skin pigment (called “melanin”) is a sign of damage. Ultraviolet radiation from the sun can cause wrinkles and dark spots among other problems—and tanning puts you at higher risk for skin cancer. But the beach can still be a high point of your trip.

  • Protective clothing. Wear a hat and protective clothing, and stay in the shade.
  • Sunscreens. Wear a broad spectrum sunscreen that protects against UVA and UVB rays, and choose an SPF of 15 or higher. You need at least one ounce of sunscreen lotion (the size of a golf ball) to cover your body. Reapply at least every 2 hours, or every 40 to 80 minutes when swimming or sweating, according to the directions on the product label. And limit the time your skin is exposed to the sun between 10 a.m. and 2 p.m.
  • Tanning beds. The lamps in the beds emit ultraviolet radiation that can be more intense and harmful than the sun. FDA recommends carefully reading the instructions and warnings before using these beds, and tanning pills and accelerators are not approved by the agency.
  • Spray tans and bronzers. Know that spray-on tanning or bronzing products are not UV protective.

Use Medications Wisely

Prepare for your trip by asking your health care professional any questions, including those about side effects and interactions, before you go. Then follow his or her directions. Don’t skip doses, don’t share medication, and don’t take more than the suggested dose. Also check expiration dates in advance and keep your medicine with you when traveling. (If you’re flying, you don’t want to land in Cancun and have your prescriptions land in Cleveland.) Finally, keep a detailed list of what you’re taking. Ideally your travels will be smooth. But if you need to seek medical care this list will be helpful.

Be Careful With Contact Lenses

They’re convenient but can expose you to serious conditions such as eye infections and corneal ulcers—something you don’t want to deal with on vacation. To avoid problems, first make sure your contacts are prescribed by an eye care professional. Skip colored or decorative lenses sold in beauty supply stores and at the boardwalk, since they can damage your eyes. Second, wash your hands before touching lenses, and use sterile solution. Never expose your lenses to saliva or non-sterile water, including that from the tap, bottle or ocean. Non-sterile water can put you at risk for an eye infection. So remove your contacts before swimming or getting in the hot tub and follow your eye care professional’s other care and removal instructions. If your vision changes, your eyes get red, you have lots of tears, or your eyes hurt or feel itchy, take out your lenses and seek medical attention.

Think Twice About Getting Tattoos or Henna

Whether you’re considering a non-permanent (e.g., henna) or a permanent addition (including makeup), think before you ink. Tattoos can cause allergic reactions and put you at risk for infections like HIV or hepatitis from unclean tools, practices or products. FDA has not approved any inks for injecting into your skin and does not regulate tattoo parlors. FDA also hasn’t approved henna or hair dye for skin use, and some people have reported serious problems after using henna, including allergic reactions such as rashes and scarring.

Stay Hydrated and Remember Tips for Healthy Eating

Time flies when you’re having fun, but take a few moments to sip H2O throughout the day. “When you’re traveling, it’s easy to become dehydrated because sometimes you don’t have access to water,” explains Shirley R. Blakely, Ph.D., R.D., a senior nutrition advisor with FDA. So when you spend a late afternoon at the beach (remember sun safety!) bring water and drink even before you feel thirsty, she advises. Also beware of ice or tap water in places where water isn’t safe to drink. If you don’t have access to safe water, Blakely recommends drinking an internationally known brand of a sugar- and caffeine-free carbonated beverage. Finally, Blakely says, “When traveling, you may find yourself overindulging.” For healthy eating, Blakely recommends following the dietary guidelines by making half your plate fruits and vegetables, and half your grains whole, to get enough fiber and other essential nutrients. “And if you’re faced with a smorgasbord, build your plate with fruits, vegetables and whole grains first, then add the protein source.”

Following actions by the Food and Drug Administration (FDA), a Texas-based company has agreed to recall and destroy a dietary supplement linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants.

In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials that it will destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA will oversee the destruction of the product.

“As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC),” said Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs. “Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace.”

FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.

The supplement was advertised as an aid to losing weight and building muscles. FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.

While FDA’s investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1.

Earlier this year, a stockpile of another formulation of OxyElite Pro was destroyed after being held through an FDA administrative detention order. A stimulant included in those products, DMAA, or dimethylamylamine, can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.

After removing DMAA from its products, USPLabs substituted aegeline, among other ingredients, in certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree (Agele marmelos).

“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law,” said Fabricant. “Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”

Evidence of Danger

On Sept. 13, 2013, FDA learned of a cluster of seven Hawaii residents with acute liver failure/non-viral hepatitis.

A joint investigation by the Hawaii Department of Health and CDC revealed that the patients all had consumed OxyElite Pro products. FDA meanwhile identified patients outside of Hawaii with similar liver dysfunction after using OxyElite Pro.

The FDA urged the public to avoid using products labeled as OxyElite Pro or VERSA-1 while the agency investigated further.

On Oct. 11, 2013, FDA warned the company that certain OxyElite Pro and VERSA-1 products were deemed adulterated and that failure to immediately cease distribution of both products could lead to enforcement actions. The FDA also outlined its findings of harm linked to OxyElite Pro.

As of the end of October 2013, there were 56 cases of acute liver failure or acute hepatitis linked to OxyPro Elite, 43 of them in Hawaii. The investigation continues.

Rare Acetaminophen Risk

September 8, 2014

Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).

Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin. If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.

Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription medicines. Tylenol is one brand name of the pain reliever sold over the counter, but acetaminophen is also available as a generic under various names. It is also used in combination with other medicines, including opioids for pain and medicines to treat colds, coughs, allergy, headaches and trouble sleeping.

“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction. “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”

Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions. Advil and Motrin are among the common brand names that include ibuprofen as an active ingredient. Aleve and Midol Extended Relief are among the best-known brand names that include naproxen as an active ingredient.

FDA is requiring that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen. FDA will work with manufacturers to get the warnings added to the labels of over-the-counter (OTC) medicines containing acetaminophen.

On OTC medicines, the word “acetaminophen” appears on the front of the package and on the Drug Facts label’s “active ingredients” section. On prescription medications, the label may spell out the ingredient or use a shortened version such as “APAP,” “acet,” “acetamin” or “acetaminoph.”

 

Medicines are powerful. They can cure disease, relieve symptoms, and help you stay healthy. But they can also do a lot of damage if taken incorrectly, when not needed, when prescribed inappropriately, or in case of medicine overdose.

The Food and Drug Administration (FDA) believes that many medication-related risks can be prevented if everyone committed to the safe use of medicines works together. Acting on that belief, the agency launched the Safe Use Initiative in November 2009 to foster collaborations within the health care community that will help prevent medication errors, misuse, and abuse.

Studies estimate that up to 50 percent of harm from medication use could be prevented. According to the Institute of Medicine, this would translate into about 1.5 million preventable incidents each year.

The goal of the Safe Use Initiative is to

  • identify specific, preventable harm related to medication use
  • develop methods (interventions or strategies) to reduce harm
  • identify ways to measure the success of these interventions

Tens of millions of people in the U.S. take prescription or over-the-counter (non-prescription) medicines each year, says Karen Weiss, M.D., director of the Safe Use Initiative. “If we can reduce injury that occurs because people are not prescribing or taking medications optimally, we can improve their individual health and the health of the public.”

Bogus STD Products

June 27, 2011

Federal regulators say some companies are selling products that make unproven claims to treat sexually transmitted diseases—claims that could pose a threat to public health.

The Food and Drug Administration (FDA) says only prescription medicines and diagnostic tools available through a health care professional are effective for STD diagnosis and treatment.

FDA and the Federal Trade Commission (FTC) are warning manufacturers and distributors that they could face legal action if the products aren’t removed from the market. The agencies say at least 15 products claim to treat, prevent, or cure STDs and  are being sold online and at some retail outlets.

FDA expert Debbie Birnkrant, M.D., says she’s concerned that someone with an STD will waste precious time using a product that doesn’t work, leading to a delay in medical treatment and possible spread of the infection.

“If you aren’t treating your STD with an FDA-approved medication, you’re not just putting your own health at risk—you could be endangering your partner,” she says.

Prescription Only

Birnkrant says there are no non-prescription drugs or dietary supplements that can treat, cure, or prevent sexually transmitted disease. Condoms are the only non-prescription product that can prevent STDs by reducing the chance that an infected person will pass on the disease. STDs can only be diagnosed and treated under the supervision of a health care professional.

Some STDs have symptoms that include sores or a discharge, but the majority of infected people have no symptoms at all. Because of this, Birnkrant says people who are sexually active, have had unprotected sex, or have been exposed to a sexually transmitted disease should get medical attention, especially if they have these symptoms:

  • burning sensation with urination
  • pelvic pain
  • discharge from the penis or vagina
  • blisters
  • sores

There are FDA-approved medications available to treat many sexually transmitted diseases. These products have met federal standards for safety, effectiveness, and quality—and they’re available only by prescription, Birnkrant says.

Some weight-loss supplements don’t live up to their claims. Even worse, they can cause serious harm, say federal regulators, who have found dozens of products being touted as dietary supplements but that actually contain hidden prescription drugs or compounds that have not been adequately studied in humans.

“These products are not legal dietary supplements,” says Michael Levy, director of the Food and Drug Administration’s (FDA’s) Division of New Drugs and Labeling Compliance. “They are actually very powerful drugs masquerading as ‘all-natural’ or ‘herbal’ supplements, and they carry significant risks to unsuspecting consumers.”

FDA has found weight-loss products tainted with the prescription drug ingredient sibutramine. This ingredient was in an FDA-approved drug called Meridia, which was removed from the market in October 2010 because it caused heart problems and strokes. FDA has also found other prescription drug ingredients that have been removed from the market or never approved at all.

“We’ve found other weight-loss products marketed as supplements that contain dangerous concoctions of hidden ingredients including seizure medications, blood pressure medications, and other drugs not approved in the U.S.,” says Levy.

Many of these tainted products are imported and sold through the Internet, but some can also be found on store shelves. FDA has made it a priority to seek out these dangerous products, stop them from being imported, and take legal action against firms that manufacture and distribute them.

But the problem is so big that FDA needs help. The agency is reaching out to the dietary supplement industry to help eliminate the availability and sale of these products. And FDA is enlisting the help of consumers.

Advice for Consumers

Generally, if you are using or considering using any product marketed as a dietary supplement, FDA suggests that you

  • check with your health care professional or a registered dietitian about any nutrients you may need in addition to your regular diet
  • ask your health care professional for help distinguishing between reliable and questionable information
  • ask yourself if it sounds too good to be true
    • Be cautious if the claims for the product seem exaggerated or unrealistic.
    • Watch out for extreme claims such as “quick and effective” or “totally safe.”
    • Be skeptical about anecdotal information from personal “testimonials” about incredible benefits or results obtained from using a product.