When infants or young children need surgery, does anesthesia affect their developing brains?

With more than 1 million children under age 4 requiring anesthesia for surgery in the United States each year, the Food and Drug Administration (FDA) and other health organizations are working together to answer this question.

Previous scientific studies in young animals have shown that commonly used anesthetics can be harmful to the developing brain. However, results have been mixed in children. Some studies of infants and young children undergoing anesthesia have reported long-term deficits in learning and behavior; other studies have not.

These conflicting results show that more research is needed to fully understand the risks anesthesia may pose to very young patients.

To close these research gaps, FDA and the International Anesthesia Research Society (IARS) started an initiative called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots). SmartTots seeks to ensure that children under age 4 will be as safe as possible when they need anesthesia during surgery. Studies have shown that this is a period of significant brain development in young children.

“Our hope is that research funded through SmartTots will help us design the safest anesthetic regimens possible,” says Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products at FDA. “This research can potentially foster the development of new and safer anesthetic drugs for use in pediatric medicine.”

According to SmartTots steering committee co-chair James Ramsay, M.D., young children usually do not undergo surgery unless the procedure is vital to their health. “Therefore, postponing a necessary procedure may itself lead to significant health problems and may not be an option for the majority of children,” Ramsey says.

Ongoing Research

SmartTots was launched in 2010 in part to fund research that would build on the work done at FDA and several universities.

Since 2003, Merle Paule, Ph.D., director of the Division of Neurotoxicology at FDA’s National Center for Toxicological Research (NCTR), and colleagues have been exploring the effects of ketamine—an anesthetic commonly used on children-on the brains and learning ability of young rhesus monkeys.

“Earlier research has shown that exposing young rat pups to ketamine caused learning problems when they became adults, but we wanted to see what would happen with primates,” said Paule. Primates, such as the rhesus monkey used in this research, more closely resemble humans in physiology and behavior. All animal procedures were approved by the NCTR Institutional Animal Care and Use Committee, and conducted in accordance with the Public Health Service Policy on the Humane Care and Use of Laboratory Animals.

“The learning of concepts such as matching (see a triangle, match it with another triangle from among other symbols) took much longer in the ketamine-treated monkeys And even after basic concepts were learned, the ketamine-exposed animals performed less accurately than animals in the control group,” Paule says.

The same holds true for the test monkeys even today, Paule says. Six years after their ketamine treatment, they’re still showing below-normal brain function.

What might that mean for young children who have been exposed to ketamine or other anesthetics during surgery?

“We can’t know with certainty at this time,” says Rappaport, a member of the steering committee that coordinates, manages and oversees the SmartTots initiative. “We need to definitively answer the questions of whether anesthetic use in children poses a risk to their development and, if so, under what circumstances.”

FDA and other health-related organizations recognize the importance of learning more on this topic. For example, do other forms of anesthesia similarly affect the brain’s ability to, learn and remember? How long might these deficits last?

The Food and Drug Administration (FDA) is warning the public that a product distributed and sold under the name ‘WOW’ is really just another product in disguise, one that can cause serious harm.

Earlier in 2012, FDA twice warned the public about taking Reumofan Plus—marketed as a “natural” dietary supplement for the treatment of many conditions, including arthritis and bone cancer—because, in reality, it contains undeclared active ingredients found in prescription drugs that should only be used under the supervision of a health care professional.

Brad Pace, regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch, says some distributors have deliberately put a new label and a new name, WOW, on bottles of Reumofan Plus to deceptively sell remaining supplies. Pace says WOW has been distributed to online retailers and other distributors, as well as directly to consumers.

Serious Health Risks

Since June, FDA has received dozens of reports from consumers who used Reumofan Plus of serious, and sometimes fatal, outcomes. The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression and stroke.

FDA laboratory analysis confirmed that WOW contains the same undeclared prescription drug ingredients that are in Reumofan Plus:

  • dexamethasone—a corticosteroid used to treat inflammatory conditions such as asthma and rheumatoid arthritis, that can increase the risk of infection, and cause increased blood sugar levels, changes in blood pressure, damage to bones, psychiatric problems. When taken for a prolonged period at high doses, it can cause adrenal suppression.
  • diclofenac sodium—a non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events, such as heart attack, as well as serious gastrointestinal problems.
  • methocarbamol—a muscle relaxant that can cause sedation, dizziness and low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

In addition to causing injury on their own, the hidden drugs found in these products could interact with other medications, resulting in serious health consequences.

FDA has notified health care professionals and warned consumers not to use skin creams, beauty and antiseptic soaps or lotions that might contain the toxic metal mercury. These products, found in at least seven states, claim to be skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles. Adolescents may use them to treat acne. They are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods, and online—or brought to the U.S. from other countries. FDA and state health officials have found more than 35 products containing unacceptable levels of mercury.

Risk: Mercury poisoning can cause damage to the kidneys and the nervous system, and interfere with brain development in unborn children and very young children.

Recommendations

  • Check the label of any skin lightening, anti-aging, or other skin product. If there is no label or no ingredients listed, do not use the product.
  • Do not use—or immediately stop using—products that list these ingredients: mercurous chloride, calomel, mercuric, mercurio or mercury.
  • Thoroughly wash hands and any other body parts that have come in contact with the product.
  • Contact a health care professional or medical clinic for advice.

When flu season arrives this fall, a liquid form of Tamiflu—the most widely used anti-viral flu medication—will be available in a new, lower concentration to reduce the possibility of medication errors.

The change applies to the oral suspension form of Tamiflu and not the capsule. Oral suspension is a powder form of the prescription medication that a pharmacist mixes with water to make a liquid treatment easier to take by children or adults who are unable to swallow a Tamiflu capsule.

Tamiflu is FDA-approved to treat adults and children older than 1 year who have had influenza symptoms for two days or less. Tamiflu stops the virus from spreading in the body and can help shorten the duration of such symptoms as a stuffy or runny nose, sore throat, cough and muscle aches.

Because there are no quality issues with the 12 mg/mL concentration Tamiflu, it will remain on the market until supplies run out and can be used until its expiration date.

With both dose concentrations being available during the flu season this fall, Kendall Marcus, safety deputy in FDA’s Division of Antiviral Products, cautions that pharmacists and physicians will have to be particularly careful in prescribing and dispensing the medication.

After the next flu season, only the 6 mg/mL concentration will be available.

Marcus says consumers need to know the following:

  • You could receive either the 6 mg/mL or the 12 mg/mL version at your local pharmacy during the next flu season. If you have any questions about how to use the product safely, speak to your pharmacist or other health care provider.
  • If you have taken oral suspension Tamiflu in the past, the container and label will look different.
  • The new oral dosing device is different and the volume (mL) of your dose may differ from past prescriptions.
  • If you have any problems with the medication, report them to your health care provider and to FDA’s MedWatch program.

Marcus notes that pediatric strength Tamiflu capsules (30 mg and 45 mg) have not changed and are still available for children who can swallow capsules. Another option for parents is to open the capsule and mix its contents with a flavored food, like chocolate syrup.

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.