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Effectiveness of Sunscreen Products

On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens currently sold over-the-counter (OTC) (i.e. non-prescription). These requirements support the Agency’s ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness.

sunscreen_broad_spectrumPrior rules on sunscreens dealt almost exclusively with protection against sunburn, which is primarily caused by ultraviolet B (UVB) radiation from the sun, and did not address ultraviolet A (UVA) radiation, which contributes to skin cancer and early skin aging. After reviewing the latest science, FDA determined that sufficient data are available to establish a “broad spectrum” test for determining a sunscreen product’s UVA protection. Passing the broad spectrum test shows that the product provides UVA protection that is proportional to its UVB protection.

Sunscreen products that pass the broad spectrum test are allowed to be labeled as “Broad Spectrum.” These “Broad Spectrum” sunscreens protect against both UVA and UVB rays. Scientific data demonstrated that products that are “Broad Spectrum SPF 15 [or higher]” have been shown to reduce the risk of skin cancer and early skin aging when used with other sun protection measures, in addition to helping prevent sunburn. Other sun protection measures include limiting time in the sun and wearing protective clothing.

These measures are necessary, says Lydia Velazquez, PharmD, in FDA’s Division of Nonprescription Regulation Development, because “our scientific understanding has grown. We want consumers to understand that not all sunscreens are created equal.”

“This new information will help consumers know which products offer the best protection from the harmful rays of the sun,” Velazquez says.  “It is important for consumers to read the entire label, both front and back, in order to choose the appropriate sunscreen for their needs.”

Everyone is potentially susceptible to sunburn and the other detrimental effects of exposure to UV radiation.

Products that pass the broad spectrum test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA).  Sunburn is primarily caused by UVB.  Both UVB and UVA can cause sunburn, skin cancer, and premature skin aging.  A certain percentage of a broad spectrum product’s total protection is against UVA.

Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage will be labeled “Broad Spectrum” and “SPF 15” (or higher) on the front.

The new labeling will also tell consumers on the back of the product that sunscreens labeled as both “Broad Spectrum” and “SPF 15” (or higher) not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging. For these broad spectrum products, higher SPF (Sun Protection Factor) values also indicate higher levels of overall protection.

By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.

In addition to the final regulations, in June 2011 FDA proposed a regulation that would require sunscreen products that have SPF values higher than 50 to be labeled as “SPF 50+.” FDA does not have adequate data demonstrating that products with SPF values higher than 50 provide additional protection compared to products with SPF values of 50.

FDA also requested data and information on different dosage forms of sunscreen products.  The agency currently considers sunscreens in the form of oils, creams, lotions, gels, butters, pastes, ointments, sticks, and sprays to be eligible for potential inclusion in the OTC sunscreen monograph – meaning that they can be marketed without individual product approvals.

The agency currently considers wipes, towelettes, powders, body washes, and shampoo not eligible for the monograph. Therefore, they cannot be marketed without an approved application.

For sunscreen spray products, the agency requested additional data to establish effectiveness and to determine whether they present a safety concern if inhaled unintentionally.  These requests arose because sprays are applied differently from other sunscreen dosage forms, such as lotions and sticks.

In addition, FDA issued a draft guidance to help sunscreen manufacturers understand how to label and test their products in light of the final and proposed regulations and the data request on dosage forms.

Sun Safety Tips

Spending time in the sun increases the risk of skin cancer and early skin aging.  To reduce this risk, consumers should sun_plus_must_havesregularly use sun protection measures including:

  • Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed.
  • Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense.
  • Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants, sunglasses, and broad-brimmed hats.
  • Reapply sunscreen at least every 2 hours, more often if you’re sweating or jumping in and out of the water.
  • Hydrate!  Drink lots of water and good fluids! (Soda products will just make you more thirsty, so try homemade lemonade or iced tea, or just plain water.
  • Wear protective eye ware! Even children should wear real sunglasses with UV protection, not just those play sunglasses.

Located here, are a couple of helpful videos.

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Sunscreen; Children & Teens

Sun safety is never out of season. Summer’s arrival means it’s time for picnics, trips to the pool and beach—and a spike in the number of sunburns. But winter skiers and fall hikers should be as wary of the sun’s rays as swimmers. People who work outdoors need to take precautions, too.

The need for sun safety has become clearer over the past 30 years. Studies show that exposure to the sun can cause skin cancer. Harmful rays from the sun—and from sunlamps and tanning beds—may also cause eye problems, weaken your immune system, and give you skin spots, wrinkles, or “leathery” skin.

Sun damage to the body is caused by invisible ultraviolet (UV) radiation. People recognize sunburn as a type of skin damage caused by the sun. Tanning is also a sign of the skin reacting to potentially damaging UV radiation by producing additional pigmentation that provides it with some—but often not enough—protection against sunburn.

Whatever our skin color, we’re all potentially susceptible to sunburn and other harmful effects of exposure to UV radiation. Although we all need to take precautions to protect our skin, people who need to be especially careful in the sun are those who have

  • pale skin
  • blond, red, or light brown hair
  • been treated for skin cancer
  • a family member who’s had skin cancer

If you take medicines, ask your health care professional about sun-care precautions; some medications may increase sun sensitivity.

Reduce Time in the Sun

It’s important to limit sun exposure between 10 a.m. and 2 p.m., when the sun’s rays are strongest. Even on an overcast day, up to 80 percent of the sun’s UV rays can get through the clouds. Stay in the shade as much as possible throughout the day.

Dress with Care

Wear clothes that protect your body. If you plan on being outside on a sunny day, cover as much of your body as smart_sun_sense_childrenpossible. Wear a wide-brimmed hat, long sleeves, and pants. Sun-protective clothing is now available. However, FDA only regulates such products if the manufacturer intends to make a medical claim. Consider using an umbrella for shade.

Be Serious about Sunscreen

Check product labels to make sure you get

  • a “sun protection factor” (SPF) of 15 or more. SPF represents the degree to which a sunscreen can protect the skin from sunburn.
  • “broad spectrum” protection—sunscreen that protects against all types of skin damage caused by sunlight
  • water resistance—sunscreen that stays on your skin longer, even if it gets wet. Reapply water-resistant sunscreens as instructed on the label.

Look For:  Active Ingredients: Zinc Oxide, Titanium Dioxide, Mexoryl SX, or Avobensone(3%)

Look For:  SPF of 15 to 50, depending on your skin tone and the sun’s intensity – being near or in the water, or taking a walk through a wooded park.

Look For:  Lotions, not sprays or powdered formulas – you have more control over coverage.

Look For:  A Water Resistant formula for the beach or swimming pool, or for boating.

Avoid:  Salicylates – Salicylates were first used in cosmetics as Benzyl salicylates. Currently octyl salicylate is the major salicylate component of sunscreen.  Salicylates protect against a small part of the UVB spectrum and must be used in high concentrations. They are aspirin-like substances.

With the increased use of sunscreens it is not surprising that there has been an increase in reports of adverse reactions to sunscreens.

Avoid: Vitamin A (retinyl palmitate) which causes skin cancer in laboratory tests.

Avoid: Oxybensone – a hormone disruptor and skin allergen

Avoid: High SPF’s – it is misleading and offers little additional benefits

Tips for Applying Sunscreen

  • Apply the recommended amount evenly to all uncovered skin, especially your lips, nose, ears, neck, hands, and feet.
  • Apply sunscreen 15 minutes before going out in the sun.
  • If you don’t have much hair, apply sunscreen to the top of your head, or wear a hat.
  • Reapply at least every two hours.
  • Give babies and children extra care in the sun. Ask a health care professional before applying sunscreen to children under 6 months old.
  • Apply sunscreen to children older than 6 months every time they go out.

Protect the Eyes

Sunlight reflecting off snow, sand, or water further increases exposure to UV radiation and increases your risk of developing eye problems.

Tips for eye-related sun safety include:

  • When buying sunglasses, look for a label that specifically offers 99 to 100 percent UV protection.childrens_sunglasses
  • Eye wear should be labeled “sunglasses.” Otherwise, you can’t be sure they will offer enough protection.
  • Pricier sunglasses don’t ensure greater UV protection.
  • Ask an eye care professional to test your sunglasses if you don’t know their level of UV protection.
  • People who wear contact lenses that offer UV protection should still wear sunglasses.
  • Wraparound sunglasses offer the most protection.
  • Children should wear real sunglasses (not toy sunglasses!) that indicate the UV protection level.

Never give a child up to the age of 19 aspirin or aspirin containing products because you could trigger a deadly disease known as Reye’s Syndrome.

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Kids and Sunscreen (Infants)

You’re at the beach, slathered in sunscreen. Your 5-month-old baby is there, too. Should you put sunscreen on her? Not usually, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

The best approach is to keep infants under 6 months out of the sun,” Sachs says, “and to avoid exposure to the sun in the hours between 10 a.m. and 2 p.m., when ultraviolet (UV) rays are most intense.”  infants_and_sunscreen

Sunscreens are recommended for children and adults. What makes babies so different?

For one thing, babies’ skin is much thinner than that of adults, and it absorbs the active, chemical ingredients in sunscreen more easily, explains Sachs. For another, infants have a high surface-area to body-weight ratio compared to older children and adults. Both these factors mean that an infant’s exposure to the chemicals in sunscreens is much greater, increasing the risk of allergic reaction or inflammation.

The best protection is to keep your baby in the shade, if possible, Sachs says. If there’s no natural shade, create your own with an umbrella or the canopy of the stroller.

If there’s no way to keep an infant out of the sun, you can apply a small amount of sunscreen—with a sun protection factor (SPF) of at least 15—to small areas such as the cheeks and back of the hands. Sachs suggests testing your baby’s sensitivity to sunscreen by first trying a small amount on the inner wrist.

Cover Up

The American Academy of Pediatrics (AAP) suggests dressing infants in lightweight long pants, long-sleeved shirts, and brimmed hats that shade the neck to prevent sunburn. Tight weaves are better than loose. Keep in mind that while baseball caps are cute, they don’t shade the neck and ears, sensitive areas for a baby.

Summer’s heat presents other challenges for babies.

Younger infants also don’t sweat like we do, Sachs says. Sweat naturally cools the rest of us down when we’re hot, but babies haven’t yet fully developed that built-in heating-and-cooling system. So you want to make sure your baby doesn’t get overheated.

In the heat, babies are also at greater risk of becoming dehydrated. To make sure they’re adequately hydrated, offer them their usual feeding of breast milk or formula, says Sachs. The water content in both will help keep them well hydrated. A small of amount water in between these feedings is also okay.

sun_hat_baby

Make this oh-so-cute Sun Hat for Baby!

Here are some things to keep in mind this summer when outside with infants:

Keep your baby in the shade as much as possible. If you do use a small amount of sunscreen on your baby, don’t assume the child is well protected.

  • Make sure your child wears clothing that covers and protects sensitive skin. Use common sense; if you hold the fabric against your hand and it’s so sheer that you can see through it, it probably doesn’t offer enough protection.
  • Make sure your baby wears a hat that provides sufficient shade at all times.
  • Watch your baby carefully to make sure he or she doesn’t show warning signs of sunburn or dehydration. These include fussiness, redness and excessive crying.
  • Hydrate! Give your baby formula, breast milk, or a small amount of water between feedings if you’re out in the sun for more than a few minutes. Don’t forget to use a cooler to store the liquids.
  • Take note of how much your baby is urinating. If it’s less than usual, it may be a sign of dehydration, and that more fluids are needed until the flow is back to normal.
  • Avoid sunscreens containing the insect repellent DEET on infants, particularly on their hands. Young children may lick their hands or put them in their mouths. According to AAP, DEET should not be used on infants less than 2 months old.
  • If you do notice your baby is becoming sunburned, get out of the sun right away and apply cold compresses to the affected areas.
  • Make sure you talk with your pediatrician, or pharmacist if your baby is taking medications of any kind.  Sun and some Medications can cause bad interactions.
  • Never give an Infant or Child under the age of 19 aspirin, or use aspirin (salicylate) containing products as it could trigger Reye’s Syndrome, a deadly disease.

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Multiple Combination Medicines and Your Child

Know Active Ingredients in Children’s Meds

childrensdrugs

If your child is sneezing up a storm, it must be allergy season once more.

And if your child is taking more than one medication at the same time, there could be dangerous health consequences if those medicines have the same active ingredient, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

A medicine is made of many components. Some are “inactive” and only help it to taste better or dissolve faster, while others are active. An active ingredient in a medicine is the component that makes it pharmaceutically active—it makes the medicine effective against the illness or condition it is treating.

Active ingredients are listed first on a medicine’s Drug Facts label for over-the-counter (OTC) products. For prescription medicines, they are listed in a patient package insert or consumer information sheet provided by the pharmacist.

Many medicines have just one active ingredient. But combination medicines, such as those for allergy, cough, or fever and congestion, may have more than one.

Take antihistamines taken for allergies. “Too much antihistamine can cause sedation and—paradoxically—agitation. In rare cases, it can cause breathing problems, including decreased oxygen or increased carbon dioxide in the blood, Sachs says.

“We’re just starting allergy season,” says Sachs. “Many parents may be giving their children at least one product with an antihistamine in it.” Over-the-counter (OTC) antihistamines (with brand name examples) include diphenhydramine (Benadryl), chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), fexofenadine (Allegra), loratadine (Claritin, Alavert), and cetirizine (Zyrtec).

multiple_combination_medicinesBut parents may also be treating their children for a separate ailment, such as a cough or cold. What they need to realize is that more than one combination medicine may be one too many.

“It’s important not to inadvertently give your child a double dose,” Sachs says.

Other Health Complications

The same goes for other active ingredients, often found in combination products for allergies but also used to treat other symptoms, such as fever, headache or nasal congestion:

  • Acetaminophen (in Tylenol and many other products), a pain reliever often used to treat fevers, mild pain or headache. Taking too much can cause liver damage.
  • Ibuprofen (for example, Advil or Motrin), another common medicine for relieving mild to moderate pain from headaches, sinus pressure, muscle aches and flu, as well as to reduce fever. Too much ibuprofen can cause nausea, vomiting, diarrhea, severe stomach pain, even kidney failure.
  • Decongestants such as pseudoephedrine or phenylephrine (found in brand name drugs such as Actifed and Sudafed) taken in large amounts can cause excessive drowsiness in children. They can also cause heart rhythm disturbances, especially if combined with products and foods containing caffeine. In the form of nasal sprays and nose drops, these products, as well as oxymetazoline (the active ingredients in products such as Afrin), can cause “rebound” congestion, in which the nose remains stuffy or gets even worse.

Never give a child aspirin or aspirin containing products, as you risk triggering Reye’s Syndrome, a deadly disease!

Any of the above symptoms may indicate a need for immediate medical attention. “The bottom line is that neither you, nor your children, should take multiple combination medicines at the same time without checking the active ingredients and consulting your health care professional first,” recommends Sachs.

Furthermore, two different active ingredients may serve the same purpose, Sachs says. For example, both acetaminophen and ibuprofen help reduce pain and fever. So there’s generally no need to give your child both medicines for the same symptoms.

Write It All Down

Whether you’re treating your child’s condition with OTC medicines from the drug store or ones prescribed by your doctor, it’s essential that you keep track of every medicine and the active ingredients each contains, Sachs says.

“It’s easy to forget which medicines you’re giving your child,” Sachs says. “And if you have more than one child, it can get even more complicated.” She recommends making it a habit to write down the name of any medicine you give your child, whether it’s OTC or prescription (download a daily medicine records template).

“It’s really a good idea to carry that list with you when you go to see your pediatrician or even when you go to the pharmacy,” she adds. You should also note whatever vitamins or supplements your child is taking, as these can interact unfavorably with certain medicines, too.

Most importantly, Sachs says parents should always read the Drug Facts label on OTC products, and the patient package insert or consumer information sheet that comes with prescription medicines, every time they’re considering a medication for their child, even if they think they already know the ingredients. They should know that the ingredients can change without an obvious change in the packaging. And they should contact their health care professional with any questions.

A list of ingredients to avoid, (other names for aspirin) can be downloaded here, or you can email the NRSF for a wallet size card(s) you can carry with you when shopping for medications.

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Breastfeeding and Drugs: Drugs Deemed Safe

Information about what drugs are safe to use during breastfeeding.breastfeeding

A common reason for the cessation of breastfeeding is the use of medication by the nursing mother and advice by her physician to stop nursing.  Of course, if you don’t have to take drugs, whether they are over the counter, or prescription, it is always for the best.

This information is important not only to protect nursing infants from untoward effects of maternal medication but also to allow effective pharmacological treatment of breastfeeding mothers.

Below is a list of drugs deemed safe to take by the American Academy of Pediatrics.

Maternal Medication Usually Compatible With Breastfeeding and any effects on the baby :

Acetaminophen
Acetazolamide
Acitretin
Acyclovir — Drug is concentrated in human milk
Alcohol (ethanol) — With large amounts, drowsiness, diaphoresis, deep sleep, weakness, decrease in linear growth, abnormal weight gain; maternal ingestion of 1 g/kg daily decreases milk ejection reflex
Allopurinol
Amoxicillin
Antimony
Atropine
Azapropazone (apazone)
Aztreonam
B1 (thiamin)
B6  (pyridoxine)
B12
Baclofen
Barbiturate
Bendroflumethiazide  — Suppresses lactation
Bishydroxycoumarin (dicumarol)
Bromide  — Rash, weakness, absence of cry with maternal intake of 5.4 g/d
Butorphanol
Caffeine — Irritability, poor sleeping pattern, excreted slowly; no effect with moderate intake of caffeinated beverages (2–3 cups per day)
Captopril
Carbamazepine
Carbetocin
Carbimazole — Goiter
Cascara
Cefadroxil
Cefazolin
Cefotaxime
Cefoxitin
Cefprozil
Ceftazidime
Ceftriaxone
Chloral hydrate —  Sleepiness
Chloroform
Chloroquine
Chlorothiazide
Chlorthalidone — Excreted slowly
Cimetidine — Drug is concentrated in human milk
Ciprofloxacin
Cisapride
Cisplatin — Not found in milk
Clindamycin
Clogestone
Codeine
Colchicine
Contraceptive pill with estrogen/progesterone — Rare breast enlargement; decrease in milk production  and protein content (not confirmed in several studies)
Cycloserine
D (vitamin) —  follow up infant’s serum calcium level if mother receives pharmacological doses
Danthron — Increased bowel activity
Dapsone —  sulfonamide detected in infant’s urine 191, 219
Dexbrompheniramine maleate with d-isoephedrine — Crying, poor sleeping patterns, irritability
Diatrizoate
Digoxin
Diltiazem
Dipyrone
Disopyramide
Domperidone
Dyphylline — Drug is concentrated in human milk
Enalapril
Erythromycin — Drug is concentrated in human milk
Estradiol — Withdrawal, vaginal bleeding
Ethambutol
Ethanol (cf. alcohol)
Ethosuximide — drug appears in infant serum
Fentanyl
Fexofenadine
Flecainide
Fleroxacin — One 400-mg dose given to nursing mothers; infants not given breast milk for 48 hours
Fluconazole
Flufenamic acid
Fluorescein
Folic acid
Gadopentetic (Gadolinium)
Gentamicin
Gold salts
Halothane
Hydralazine
Hydrochlorothiazide
Hydroxychloroquine — Drug is concentrated in human milk
Ibuprofen
Indomethacin — Seizure (1 case)
Iodides — May affect thyroid activity; see iodine
Iodine — Goiter
Iodine (povidone-iodine, eg, in a vaginal douche) — Elevated iodine levels in breast milk, odor of iodine on infant’s skin
Iohexol
Iopanoic acid
Isoniazid– acetyl (hepatotoxic) metabolite secreted but no hepatotoxicity reported in infants
Interferon-a
Ivermectin
K1 (vitamin)
Kanamycin
Ketoconazole
Ketorolac
Labetalol
Levonorgestrel
Levothyroxine
Lidocaine
Loperamide
Loratadine
Magnesium sulfate
Medroxyprogesterone
Mefenamic acid
Meperidine
Methadone
Methimazole (active metabolite of carbimazole)
Methohexital
Methyldopa
Methyprylon — Drowsiness
Metoprolol — Drug is concentrated in human milk
Metrizamide
Metrizoate
Mexiletine
Minoxidil
Morphine — infant may have measurable blood concentration
Moxalactam
Nadolol — Drug is concentrated in human milk
Nalidixic acid — Hemolysis in infant with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Naproxen
Nefopam
Nifedipine
Nitrofurantoin — Hemolysis in infant with G-6-PD deficiency 305
Norethynodrel
Norsteroids
Noscapine
Ofloxacin
Oxprenolol
Phenylbutazone
Phenytoin — Methemoglobinemia (1 case)
Piroxicam
Prednisolone
Prednisone
Procainamide
Progesterone
Propoxyphene
Propranolol
Propylthiouracil
Pseudoephedrine — Drug is concentrated in human milk
Pyridostigmine
Pyrimethamine
Quinidine
Quinine
Riboflavin
Rifampin
Scopolamine
Secobarbital
Senna
Sotalol
Spironolactone
Streptomycin
Sulbactam
Sulfapyridine — Caution in infant with jaundice or G-6-PD deficiency and ill, stressed, or premature infant; appears in infant’s milk
Sulfisoxazole — Caution in infant with jaundice or G-6-PD deficiency and ill, stressed, or premature infant; appears in infant’s milk
Sumatriptan
Suprofen
Terbutaline
Terfenadine
Tetracycline — negligible absorption by infant
Theophylline — Irritability
Thiopental
Thiouracil — drug not used in United States
Ticarcillin
Timolol
Tolbutamide — Possible jaundice
Tolmetin
Trimethoprim/sulfamethoxazole
Triprolidine
Valproic acid
Verapamil
Warfarin
Zolpidem

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Breastfeeding and Drugs: Drugs Deemed Not Safe

Information about what drugs are NOT safe to use during breastfeeding.

A common reason for the cessation of breastfeeding is the use of medication by the nursing mother and advice by her breastfeedingphysician to stop nursing.  Of course, if you don’t have to take drugs, whether they are over the counter, or prescription, it is always for the best.

This information is important not only to protect nursing infants from untoward effects of maternal medication but also to allow effective pharmacological treatment of breastfeeding mothers.

Below is a list of drugs deemed NOT safe to take by the American Academy of Pediatrics.

Cytotoxic Drugs That May Interfere With Cellular Metabolism of the Nursing Infant:

Cyclophosphamide  — Possible immune suppression; unknown effect on growth or association with carcinogenesis; neutropenia
Cyclosporine —  Possible immune suppression; unknown effect on growth or association with carcinogenesis
Doxorubicin* — Possible immune suppression; unknown effect on growth or association with carcinogenesis
Methotrexate — Possible immune suppression; unknown effect on growth or association with carcinogenesis; neutropenia
* Drug is concentrated in human milk.

Drugs of Abuse for Which Adverse Effects on the Infant During Breastfeeding Have Been Reported*

Amphetamine† — Irritability, poor sleeping pattern
Cocaine — Cocaine intoxication: — irritability, vomiting, diarrhea, tremulousness, seizures
Heroin — Tremors, restlessness, vomiting, poor feeding
Marijuana — Only 1 report in literature; no effect mentioned; very long –half-life for some components
Phencyclidine — Potent hallucinogen
* The Committee on Drugs strongly believes that nursing mothers should not ingest drugs of abuse, because they are hazardous to the nursing infant and to the health of the mother.
† Drug is concentrated in human milk.

Radioactive Compounds That Require Temporary Cessation of Breastfeeding*

Copper 64 (64Cu) — Radioactivity in milk present at 50 h
Gallium 67 (67Ga) — Radioactivity in milk present for 2 wk
Indium 111 (111In) — Very small amount present at 20 h
Iodine 123 (123I) — Radioactivity in milk present up to 36 h
Iodine 125 (125I) — Radioactivity in milk present for 12 d 42
Iodine 131 (131I) —  Radioactivity in milk present 2–14 d, depending on study
Iodine131 — If used for treatment of thyroid cancer, high radioactivity may prolong exposure to infant
Radioactive sodium — Radioactivity in milk present 96 h
Technetium 99m (99mTc), 99mTc
macroaggregates, 99mTc O4 — Radioactivity in milk present 15 h to 3 d
* Consult nuclear medicine physician before performing diagnostic study so that radionuclide that has the shortest excretion time in breast milk can be used. Before study, the mother should pump her breast and store enough milk in the freezer for feeding the infant; after study, the mother should pump her breast to maintain milk production but discard all milk pumped for the required time that radioactivity is present in milk. Milk samples can be screened by radiology departments for radioactivity before resumption of nursing.

Drugs for Which the Effect on Nursing Infants Is Unknown but May Be of Concern*

Anti-anxiety:
Alprazolam
Diazepam
Lorazepam
Midazolam
Perphenazine
Prazepam†
Quazepam
Temazepam
Antidepressants:
Amitriptyline
Amoxapine
Bupropion
Clomipramine
Desipramine
Dothiepin
Doxepin
Fluoxetine — Colic, irritability, feeding and sleep disorders, slow weight gain
Fluvoxamine
Imipramine
Nortriptyline
Paroxetine
Sertraline†
Trazodone
Antipsychotic:
Chlorpromazine — Galactorrhea in mother; drowsiness and lethargy in infant; decline in developmental scores
Chlorprothixene
Clozapine†
Haloperidol — Decline in developmental scores
Mesoridazine
Trifluoperazine
OTHERS:
Amiodarone — Possible hypothyroidism
Chloramphenicol — Possible idiosyncratic bone marrow suppression
Clofazimine — Potential for transfer of high percentage of maternal dose; possible increase in skin pigmentation
Lamotrigine —  Potential therapeutic serum concentrations in infant
Metoclopramide† — dopaminergic blocking agent
Metronidazole — In vitro mutagen; may discontinue breastfeeding for 12–24 h to allow excretion of dose when single-dose therapy given to mother
Tinidazole  — See metronidazole
* Psychotropic drugs, the compounds listed under anti-anxiety, antidepressant, and antipsychotic categories, are of special concern when given to nursing mothers for long periods. Although there are very few case reports of adverse effects in breastfeeding infants, these drugs do appear in human milk and, thus, could conceivably alter short-term and long-term central nervous system function.
† Drug is concentrated in human milk relative to simultaneous maternal plasma concentrations.

Drugs That Have Been Associated With Significant Effects on Some Nursing Infants and Should Be Given to Nursing Mothers With Caution*

Acebutolol — Hypotension; bradycardia; tachypnea
5-Aminosalicylic acid — Diarrhea (1 case) ,  Aspirin; Reye’s Syndrome
Atenolol — Cyanosis; bradycardia
Bromocriptine — Suppresses lactation; may be hazardous to the mother
Aspirin — (salicylates) Metabolic acidosis (1 case),  Reye’s Syndrome
Clemastine — Drowsiness, irritability, refusal to feed, high-pitched cry, neck stiffness (1 case)
Ergotamine — Vomiting, diarrhea, convulsions (doses used in migraine medications)
Lithium — One-third to one-half therapeutic blood concentration in infants
Phenindione — Anticoagulant: increased prothrombin and partial thromboplastin time in 1 infant; not used in United States
Phenobarbital — Sedation; infantile spasms after weaning from milk containing phenobarbital, methemoglobinemia (1 case)
Primidone — Sedation, feeding problems
Sulfasalazine (salicylazosulfapyridine) — Bloody diarrhea (1 case), Reye’s Syndrome
* Blood concentration in the infant may be of clinical importance

 

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Grapefruit, Drug Interactions

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Grapefruit causes problems when taken with certain medications

Sometimes the juice just isn’t worth the squeeze…especially when combining grapefruit with medicines.

While it can be part of a balanced and nutritious diet, grapefruit can have serious consequences when taken with certain medications. Currently, there are more than fifty prescription and over-the-counter drugs known to the U.S. Food and Drug Administration that can have negative interactions with grapefruit.

As little as one cup of juice or two grapefruit wedges can alter the way your medicines work. When taken with medicine, grapefruit can delay, decrease, or enhance absorption of certain drugs; as a result, the patient does not receive the prescribed dosage of the medication. If the label on your medicine reads “DO NOT TAKE WITH GRAPEFRUIT” or has similar words, heed the warning. It can save you a bushel of problems.

How it does or doesn’t work

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Depending on the active ingredient, grapefruit can reduce the effectiveness of a drug or worse, create potentially dangerous drug levels in the body. Grapefruit can interfere with transporters in the intestine that help absorb drugs. When this happens, less of the drug reaches the bloodstream and the patient receives no benefit.

Grapefruit can also interfere with enzymes that break down drugs in your digestive system. This can result in the body absorbing too much of the drug, which can potentially cause serious problems.

Help may be on the way

Scientists are currently working on breeding hybrid grapefruits that will be safe to mix with medications. In the near future you may be able to enjoy these tasty mounds without compromising your safety. But until the new fruit containers start to arrive, follow these tips:

  • Ask your pharmacist or other health care professional if you can have fresh grapefruit or grapefruit juice while using your medication. If you can’t, you may want to ask if you can have other juices with the medicine.
  • Read the Medication Guide or patient information sheet that comes with your prescription medicine to see if it interacts with grapefruit juice. Some information may advise not to take the drug with grapefruit juice. If it’s OK to have grapefruit juice, there will be no mention of it in the guide or information sheet.
  • Read the Drug Facts label on your non-prescription medicine, which will let you know if you can have grapefruit or other fruit juices with it.
  • If you can’t have grapefruit juice with your medicine, check the label of bottles of fruit juice or drinks flavored with fruit juice to make sure they don’t contain grapefruit juice.
  • Seville oranges (often used to make orange marmalade) and tangelos (a cross between tangerines and grapefruit) affect the same enzyme as grapefruit juice, so avoid these fruits as well if your medicine interacts with grapefruit juice.

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