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FDA's MetWatch Safety Alerts: March 2011

Posted Apr 08 2011 11:24am

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After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.

FDA encourages health care professionals and consumers to report problems with medical products, including

  • unexpected and undesirable side effects
  • quality problems, such as a drug with an unusual odor or color, or a device with defective parts
  • unclear or confusing instructions
  • failure to deliver the expected benefit

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • Fax: 800-FDA-0178
  • Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness, or death.

Here are some of the most recent safety alerts prompted by reports FDA has received through MedWatch.

FDA intends to remove some unapproved prescription cough, cold, and allergy drugs from the U.S. market that have not been evaluated by the agency for safety, effectiveness, and quality.

Risk: Some of these drugs may contain risky combinations of ingredients, while others—marketed as “timed-release”—may release active ingredients too slowly, too quickly, or inconsistently. Some products may be inappropriately labeled for use by infants and young children.

Recommendation: If you believe you are taking an unapproved prescription cough, cold, or allergy drug, contact your health care professional to discuss other options.

For More Information

List of Unapproved Prescription Cough, Cold, and Allergy Drugs

Questions and Answers About Unapproved Prescription Cough, Cold, and Allergy Drugs

Consumer Update: FDA Intends to Remove Unapproved Drugs from Market

Pradaxa (dabigatran etexilate mesylate) capsules require special storage and handling.

Risk: This blood thinner medication may break down from moisture and become less effective if stored and handled incorrectly.  

Recommendations

  • Store Pradaxa in the original bottle or blister package, both of which are designed to protect the drug from moisture.
  • Do not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers.
  • For Pradaxa bottles:
    • Open only one bottle at a time. Once the bottle is opened, use the capsules within 60 days. Write an expiration date on the bottle to remind you when 60 days have elapsed.
    • Remove only one capsule at the time you want to take it, then close the bottle tightly right away.
  • For Pradaxa blister packages: Open the blister package at the time you want to take a capsule. Do not open or puncture the blister any earlier.
  • Read the medication guide (a paper handout that comes with some drugs) for Pradaxa each time you get your prescription refilled.

For More Information

Drug Safety Communication on Pradaxa

Greenstone LLC, a subsidiary of Pfizer, announced a recall of the following medicines:

• Citalopram 10 mg Tablets (100-count bottle), lot number FI0510058-A

• Finasteride 5 mg Tablets (90-count bottle), lot number FI0510058-A

Incorrect labels may have been placed on the bottles containing these very different medications, which have the same lot number. Those labeled as containing citalopram (used to treat depression) may mistakenly contain finasteride (used to treat an enlarged prostate).

Risk: Women who are or may become pregnant should not take or handle finasteride because the drug may cause abnormal development of the external sex organs of a male newborn. And patients who unknowingly stopped taking citalopram could experience a worsening of depression.

Recommendations

Prescription medicines in a class of drugs called proton pump inhibitors (PPIs) may cause low levels of magnesium in the blood (hypomagnesemia) if taken for a long time—in most cases, longer than one year. PPIs reduce the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

Prescription PPIs include

  • Nexium (esomeprazole magnesium)
  • Dexilant (dexlansoprazole)
  • Prilosec (omeprazole)
  • Zegerid (omeprazole and sodium bicarbonate)
  • Prevacid (lansoprazole)
  • Protonix (pantoprazole sodium)
  • AcipHex (rabeprazole sodium)
  • Vimovo (a combination product that contains the PPI esomeprazole magnesium along with another drug, naproxen)

Over-the-counter PPIs include

  • Prilosec OTC (omeprazole)
  • Zegerid OTC (omeprazole and sodium bicarbonate)
  • Prevacid 24HR (lansoprazole)

Unlike prescription PPIs, over-the-counter PPIs are marketed at low doses and are only intended to be used for short periods of time. FDA believes that there is very little risk of hypomagnesemia when over-the-counter PPIs are used according to the directions on the label.

Risk: Hypomagnesemia can result in serious side effects, such as muscle spasm, irregular heartbeat, and seizures. However, patients do not always have these symptoms. Hypomagnesemia is generally treated with magnesium supplements.

Recommendations

  • Call your health care professional immediately if you or your child has an irregular heartbeat, seizure, painful tensing of a muscle (muscle spasm), or shaking movement of the hands, arms, or other parts of the body (tremor) while taking a PPI drug. In children, irregular heartbeats may cause tiredness, upset stomach, dizziness, and lightheadedness.
  • Tell your health care professional if you have ever been told you have low magnesium levels in your blood, or if you take the heart medicine digoxin, diuretics, or other drugs that may cause hypomagnesemia.
  • Do not stop taking your prescription PPI drug without talking to your health care professional.
  • If you take an over-the-counter PPI drug, carefully follow the directions on the package.
  • Tell your health care professional if you have been taking an over-the-counter PPI drug for a long time.

For More Information

Drug Safety Communication on PPIs

Consumer Update: Possible Increased Risk of Bone Fractures With Certain Antacid Drugs

Roche Insulin Delivery Systems Inc. has recalled its ACCU-CHEK FlexLink Plus infusion set because a tube may become kinked or bent. This can result in low or no delivery of insulin.

The recall only applies to the ACCU-CHEK FlexLink Plus infusion sets that were distributed from Nov. 1, 2010, through Feb. 20, 2011. ( See the list of lot numbers here. )

ACCU-CHEK Ultraflex and other Accu-Chek infusion sets or insulin pumps are not affected by this recall and may continue to be used.

Risk: Not getting enough insulin can lead to high blood glucose levels (hyperglycemia), which can result in many serious health complications or death.

Recommendations

  • Do not use the ACCU-CHEK FlexLink Plus infusion set.
  • Contact your health care professional to find out if your treatment needs to change and how to temporarily continue treatment without the ACCU-CHEK FlexLink Plus infusion set.
  • For questions about this recall, contact ACCU-CHEK Customer Care at 800-688-4578, 24 hours a day, seven days a week.

For More Information

Photo of ACCU-CHEK FlexLink Plus infusion set

FDA Recall Notice

New data show an increased risk of oral clefts in infants born to women treated with the drug Topamax (available as generic topiramate) during pregnancy. Oral clefts are defects in the formation of the upper lip (cleft lip) or roof of the mouth (cleft palate).

Topamax, or topiramate, is used to treat people with epilepsy who have certain types of seizures. It is also used to prevent migraine headaches.

Recommendations

  • Before starting topiramate, pregnant women and women of childbearing age should talk to their health care professional about other treatment options for seizures or migraines.
  • Women taking topiramate should tell their health care professional right away if they are planning to or become pregnant.
  • Do not stop taking topiramate without talking to a health care professional, even if you are pregnant.
  • If you become pregnant while taking topiramate, talk to your health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry (phone: 888-233-2334), a group that collects information about the safety of antiepileptic drugs during pregnancy.

For More Information

Q&As on the risk in infants born to mothers taking Topamax (topiramate)

Premature babies may be at increased risk for health problems after receiving Kaletra (lopinavir/ritonavir) oral solution, an antiviral medication used with other drugs to treat HIV-1 infection in infants 14 days of age or older and in adults.

A revised drug label will include a new warning.

Risk: Kaletra oral solution contains the ingredients alcohol and propylene glycol. Premature babies have a decreased ability to eliminate propylene glycol, which could lead to serious heart, kidney, or breathing problems.

Recommendations

  • Call your health care professional right away if your baby appears too sleepy or your baby’s breathing has changed while taking Kaletra oral solution.
  • Do not stop giving Kaletra oral solution without talking to your health care professional.
  • Taking more than the usual dose of Kaletra all at once can make your baby sick. Contact your local poison control center or emergency room right away if you think this may have happened.

For More Information

Drug Safety Communication on Kaletra

FDA has received seven reports of serious health problems—including decreased kidney function, heart arrhythmia, vomiting, and diarrhea—occurring in people using Soladek Vitamin Solution. Tested samples of this unapproved product contained levels of vitamins A and D that were many times more than the recommended daily allowances.

Soladek is marketed with claims that it treats a wide variety of conditions, including rickets, fractures, and infection. A vial of the solution is sold in a box labeled in Spanish.

Risk: Taking excessively high levels of vitamins A or D can make you sick. Symptoms of too much vitamin A include anemia, anorexia, loss of hair (alopecia), joint pain, bone weakness, bulging eyes, liver abnormalities, and—if you are pregnant—birth defects.

Symptoms of too much vitamin D include weakness, tiredness, headache, nausea, vomiting, diarrhea, mental changes, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.

Recommendations

  • Stop using this product immediately.
  • If you have been using Soladek and are experiencing any of the above symptoms, see a health care professional immediately.

For More Information

FDA Press Release

H&P Industries Inc. has recalled all Povidone Iodine Prep Pads because they may be contaminated. The products may be sold under the brand names of

  • Cardinal Health
  • Medical Specialties
  • VHA
  • Triad
  • Triad Plus
  • North Safety
  • Total Resources

Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes, and burns. They are also used to disinfect the skin before surgery. These products were distributed nationwide and are sold in individual packets and in a box of 100 packets.

Risk: Testing showed the presence of the bacterium Elizabethkingia meningoseptica, which could lead to life-threatening infections. Treatment options are limited for infections caused by this bacterium.

Recommendations

  • Do not use Povidone Iodine Prep Pads.
  • Return the product to the place where you bought it for a full refund or call H&P Industries customer service at 262-538-2900 Monday through Friday between 8:30 a.m.and 4:00 p.m. Central Time.

For More Information

Photos of Povidone Iodine Prep Pads

FDA has warned consumers not to use several unapproved drug products that are being marketed as dietary supplements. Each product contains an active ingredient of an FDA-approved prescription drug. The active ingredient is not listed on the product label.

Risk: The active ingredients could cause harm, especially to people with certain health conditions. These ingredients may also interact with other medications being taken and result in serious side effects, as shown in the table below.

Recommendations

  • Stop using these products immediately.
  • Contact your health care professional if you have experienced any problems that may be related to using these products.
Product Name Active Drug Ingredient Risk Identifying Information For More Information

U-Prosta Natural support for prostate health

terazosin hydrochloride, found in a prescription drug to treat enlarged prostate

May cause abnormally low blood pressure, dizziness, or fainting

Sold nationwide in retail stores, on Internet, and by mail order; packaged in white plastic bottles and a one-capsule blister pack; the following are recalled:

  • 30 capsules, UPC code 689076499255
  • 60 capsules, UPC code 88858100030
  • 1 capsule, no UPC code

Call USA Far Ocean Group Inc. at 626-576-1299, seven days a week, 9 a.m. to 5 p.m. Pacific Time

See Consumer Update

Black Ant

sildenafil, found in Viagra—a prescription erectile dysfunction drug; the product tested had three times the starting dose for Viagra

May interact with nitrates (such as nitroglycerin) found in some prescription drugs and may lower blood pressure to dangerous levels

Sold on Internet; falsely states it is a “natural sexual enhancer” and has “no known side effects”

See Public Notification

See Consumer Update

X-Hero and

Male Enhancer

sulfosildenafil (in X-Hero) and tadalafil (in Male Enhancer), found in erectile dysfunction drugs

May interact with nitrates (such as nitroglycerin) found in some prescription drugs and may lower blood pressure to dangerous levels

Sold nationwide in retail stores, on Internet, and by mail order; see recalled products and lot numbers listed here

Call USA Far Ocean Group Inc. at 909-839-3058 seven days a week, 9 a.m. to 5 p.m. Pacific Time

See Consumer Update

Celerite Slimming Tea

sibutramine, found in a weight-loss drug

May increase blood pressure or pulse rate and harm people with a history of heart disease or stroke

Sold nationwide on Internet

Call Shaping Beauty Inc. at 800-728-2850 Monday through Friday, 9:00 a.m. to 5:30 p.m. Eastern Time

See Consumer Update

For More Information

2011 Safety Alerts for Human Medical Products

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

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

Posted April 8, 2011

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