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FDA's MedWatch Safety Alerts: February 2011

Posted Mar 18 2011 1:23pm

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After the Food and Drug Administration (FDA) approves a product and it is on the market, the agency continues to monitor that product for unexpected and undesirable side effects (adverse events).

Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products 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: 1-800-FDA-0178
  • Phone: 1-800-332-1088

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

Here are some of the most recent safety alerts prompted by reports FDA has received from health care professionals and patients.

An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets was found incorrectly labeled as Phenobarbital Tablets. Both products are manufactured by Qualitest Pharmaceuticals.

The recall includes the following products:

  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, 60 count, lot numbers T150G10B, T120J10E, and T023M10A 
  • Phenobarbital Tablets, USP 32.4 mg, 1000 count, lot numbers T150G10B, T120J10E, and T023M10A

Risk: Unintentional use of hydrocodone can lead to serious side effects including decreased rate of breathing, decreased heart rate and alertness, coma, and death. Unintentional use of acetaminophen may result in liver damage in people taking other medicines that contain acetaminophen, people with an improperly functioning liver, or those who consume more than three alcoholic beverages a day. Additionally, people who miss their doses of phenobarbital could have seizures.

Recommendations

  • If you take either of these drugs, look at the lot number on the side of the bottle to see if they match the numbers listed above.
  • Consumers who have these products should stop using them and contact Qualitest at 800-444-4011 for a refund.

For More Information

Women who are pregnant or planning to become pregnant and who take some kinds of antipsychotic drugs may put their newborn at risk. The drugs include Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, and Symbyax.

Risk: These drugs may cause abnormal muscle movements and withdrawal symptoms in newborns whose mothers were treated with the drugs in the third trimester of pregnancy. Symptoms in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding.

Recommendations

  • Contact your health care professional if you become pregnant or intend to become pregnant while taking an antipsychotic medication.
  • Do not stop taking your antipsychotic medication if you become pregnant without first talking to your health care professional. 

Terbutaline, given by injection, should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor. 

Risk: Serious heart problems and death of the mother may occur. Also, oral terbutaline has not been shown to be effective to prevent or treat preterm labor.

Recommendations

  • Be aware that serious side effects, including maternal heart problems and death, have been reported after lengthy use of terbutaline to manage preterm labor.
  • Be aware that there are serious situations where a health care professional may decide that using terbutaline injection for a short time in the hospital may benefit a pregnant woman.
  • Oral terbutaline should not be used either to treat preterm labor or prevent repeated preterm labor.
  • If you are taking terbutaline for another medical condition (for example, asthma), talk to your health care professional if you are pregnant or become pregnant to determine whether terbutaline is still right for you.

Several unapproved drug products marketed as dietary supplements have been recalled:

  • Svelte 30 orange & gray capsules: Marketed as a natural herb for weight loss, this product is packaged in plastic bottles containing 30 capsules per bottle. The recalled products have UPC numbers from 04-3000 to 04-5999, manufacturing date of 10/22/2010, and expiration date of 10/21/2012.
  • Extenze Tablets: Two lots of counterfeit products sold nationwide are packaged as a card of four packs (lot 0709241) and a box of 30 tablets divided into two 15-tablet blister packs (lot 0509075). It is possible that there may be other counterfeit products on the market that have not yet been identified.

Svelte 30 and Extenze were found to contain sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons. Several lots of Extenze were also found to contain prescription drugs used to treat erectile dysfunction.

Risk: FDA has not approved these products as drugs; therefore, their safety and effectiveness are unknown. Sibutramine is known to substantially increase blood pressure or pulse rate in some people and may be especially risky for those with a history of heart problems or stroke. Drugs used to treat erectile dysfunction may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Recommendations

  • Do not use the Svelte 30 or Extenze products described above. Return them to the place where you bought them for a refund.
  • If you have questions about Svelte 30, contact the company (Pedro A. Lopez at 407-350-5940, Monday through Friday, 10 a.m. to 5 p.m. Eastern time).
  • If you have questions about Extenze, call the company (626-775-6334 Monday through Friday, 9 a.m. to 4 p.m. Pacific time).

For More Information

Svelte 30 product photo

The following Triad products may be contaminated:

  • sterile lubricating jelly
  • alcohol prep pads
  • alcohol swabs
  • alcohol swabsticks
  • IV PREP antiseptic wipes

The jelly product is used to more easily insert a catheter, suppository, or other medical device or medicine. The product may be contained in kits, packs, or trays that have been packaged after December 2010 by other firms.

The pads, swabs, swabsticks, and wipes are used to disinfect the skin before an injection. They may be sold by themselves over-the-counter or packaged with some medical devices and prescription medicines for injection. The recalled disinfecting products list the manufacturer as either "Triad Group" or one of the following names: Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, and Conzellin.

Risk: The use of contaminated products could lead to life-threatening infections, especially in people who have a weakened immune system (for example, those with diabetes or cancer).

Recommendations

  • Do not use any of the products listed above.
  • Return the product to the place where you bought it for a full refund.

For More Information

Triad Sterile Lubricating Jelly

Triad Antiseptic Wipes and Alcohol Prep Pads, Swabs, and Swabsticks

FDA has issued a medication guide to be given to patients at the pharmacy along with the drugs Avandia, Avandamet, and Avandaryl. These drugs contain the active ingredient rosiglitazone.

A medication guide is a paper handout that explains the risks of a particular drug or class of drugs. It contains FDA-approved information that can help patients avoid serious harm.

Rosiglitazone is intended to be used along with diet and exercise to improve glucose (blood sugar) control in people with Type 2 diabetes mellitus.

Risk: Rosiglitazone may increase the risk of a heart attack and other heart and blood vessel (cardiovascular) problems. Because of these risks, FDA is restricting the use of medicines containing rosiglitazone to

  • people already being treated with these medicines
  • people whose blood sugar cannot be controlled with other anti-diabetic medicines and are unable to take Actos (pioglitazone), the only other drug in this class

Recommendations

  • Read the medication guide you get along with your medicine that contains rosiglitazone. It explains the risks linked to using the drug.
  • You may continue to take a medicine that contains rosiglitazone if directed by your health care professional, but it is important that you understand the risks and benefits of the drug.

For More Information

FDA Drug Safety Communication on Rosiglitazone

FDA has learned more about NPWT safety concerns since notifying health care professional and patients in November 2009.

NPWT devices can help heal open wounds by creating a vacuum (negative pressure) on the wound to remove fluids and infectious materials.

Risk: Deaths and serious complications, especially bleeding and infection, have been linked to NPWT devices. Since FDA’s prior notification Nov. 13, 2009, an additional six deaths and 97 injuries have been reported. From 2007 to Nov. 13, 2009, six deaths and 77 injuries were reported. Most deaths occurred when the patients were at home or in a long-term care facility.

Recommendations

If your doctor has determined that you are a good candidate for using NPWT at home, you should:

  • Receive adequate training from your doctor, nurse, or home health care provider so that you understand how to use your NPWT device. Make sure you are familiar with your device’s safety alarms. Demonstrate to your trainer how to use NPWT to make sure you are doing it properly.
  • Understand the possible problems and watch especially for bleeding, such as bright red blood in the tubing or canister, which can be life-threatening. If you see signs of bleeding, call your doctor immediately.
  • Be aware that problems, such as infection and bleeding, may occur during and after your dressing has been changed.
  • Get NPWT patient instructions from your doctor, home health care provider, NPWT distributor, or the manufacturer’s website. Keep these instructions where you can easily find them.
  • Talk to your doctor if you do not feel you can manage the NPWT device at home. He or she might recommend that you have help from an appropriate caregiver.

For More Information

Consumer Update: Negative Pressure Wound Devices Draw FDA Notice, Advice

Advice for Patients - Serious Complications with Negative Pressure Wound Therapy Devices

FDA Safety Communication – Negative Pressure Wound Devices

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

Posted March 17, 2011

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