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FDA's MedWatch Safety Alerts: February 2013

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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 and ongoing safety reviews prompted by reports FDA has received through MedWatch.


Caution Urged in Giving Kids Codeine

New actions are being taken to address a safety concern with codeine use in certain children after surgery to remove tonsils or adenoids (excess tissue in the throat) to treat sleep apnea. Deaths have occurred in children who received codeine for pain relief following these surgeries.

A new boxed warning, FDA’s strongest warning, will be added to the drug label of codeine-containing products about the risk of codeine to relieve pain in children following surgery to remove tonsils or adenoids. A contraindication (a formal way for FDA to make a strong recommendation against the use of a drug in certain patients) will be added to restrict codeine from being used in this setting. Other sections of the drug label will also be updated.

FDA first informed the public that it was reviewing the safety of codeine in children in August 2012 due to serious side effects and seven deaths in children who were given codeine after having their tonsils or adenoids removed. Since then, FDA’s comprehensive safety review identified six more children whose deaths between 1969 and May 1, 2012, were associated with codeine—many of them were given the drug after surgery to remove tonsils or adenoids, or to treat a respiratory tract infection.

Risk: Most of these children, ages 21 months to 9 years, showed evidence of being ultra-rapid metabolizers, an inherited ability to convert codeine into life-threatening amounts of morphine in the body. High levels of morphine can lead to potentially fatal breathing difficulties.


  • If your child’s health care professional prescribes codeine after surgery to remove tonsils or adenoids, ask for another pain medicine.
  • If codeine is prescribed for other types of pain, it is often given on an “as needed” basis. Do not give codeine to a child on a scheduled basis unless the child requires the drug, as determined by a health care professional. Do not give more than six doses per day.
  • If your child shows signs of serious side effects of codeine (unusual sleepiness, confusion, or difficult or noisy breathing), stop giving codeine and immediately take your child to the emergency room or call 911.  

For More Information

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Recall: Anemia Drug Omontys Due to Reactions, Deaths

Omontys (peginesatide) Injection has been recalled because of reports of severe allergic reactions—including death—that occurred within 30 minutes after a small percentage of patients received their first dose of the drug through a vein (intravenously). The manufacturer of the drug said there have been no reports of subsequent serious reactions from patients who tolerated the initial dose, or from patients who have completed their dialysis treatment but are still taking the medication.

Omontys is used to treat anemia due to chronic kidney disease in adult dialysis patients. The drug is packaged in 10 mg and 20 mg multi-dose vials and distributed to dialysis centers nationwide, including Puerto Rico and Guam.

Additional products that stimulate the formation of red blood cells are available to treat anemia, including Procrit, Epogen and Aranesp.

Risk: According to the companies who represent Omontys, Affymax Inc. and Takeda Pharmaceutical Company Ltd., about 0.2 percent (about 50) of the 25,000 patients who received the drug after it was approved in March 2012 have reported some allergic reaction, with about a third of these reactions being serious. About 0.02 percent (about 5) of the 25,000 died after getting their first dose of the drug.

Recommendation: If you have any questions about Omontys, talk to your health care professional or call the manufacturer at 855-466-6689 Monday through Friday from 9 a.m. to 5 p.m. ET.

For More Information

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Recall: Reumofan Products Due to Hidden Drug Risk

 FDA continues to warn the public about Reumofan Plus—a product promoted as a dietary supplement for the treatment of arthritis, osteoporosis, bone cancer and other conditions. The product contains hidden prescription drug ingredients that can cause potentially fatal side effects. It could be labeled in Spanish and sold in some retail outlets, at flea markets and on the Internet.

This latest alert is for Reumofan Plus Tablets, Lot Number 99515, expiration date of 09/16.

Risk: Since June 2012, when FDA first warned the public about the dangers of Reumofan Plus and Reumofan Plus Premium, the agency has received reports of fatalities, stroke, dizziness, difficulty sleeping, high blood sugar levels, problems with liver and kidney functions, and severe bleeding in the esophagus, stomach and intestines, as well as corticosteroid (an anti-inflammatory drug) withdrawal syndrome.

FDA has analyzed the products and found the following drug ingredients:

  • methocarbamol—a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure and impairment of the ability to perform tasks such as driving a motor vehicle 
  • dexamethasone—a corticosteroid that can increase the risk of infection and cause increased blood sugar levels, changes in blood pressure, damage to bones and psychiatric problems
  • diclofenac sodium—a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause an increased risk of cardiovascular events, such as heart attack and stroke, as well as serious stomach and intestinal problems including  bleeding, ulceration and fatal perforation (small hole) of the stomach and intestines.


If you are currently taking or recently stopped taking these products, talk to a health care professional immediately. If you stop taking corticosteroids (such as dexamethasone found in Reumofan products) after long-term use, or after taking high doses, you run the risk of suffering from withdrawal syndrome. You should work with a health care professional to slowly and safely taper off the drug.

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Recall: Vistide Injection Due to Foreign Particles

Gilead Sciences Inc. is recalling one lot (B120217A) of Vistide (cidofovir injection) due to foreign particles found in some vials of this lot.

Vistide is used to treat cytomegalovirus retinitis (an infection in the eye that can cause blindness) in people with AIDS. This sterile, colorless solution is injected into the vein (intravenously) and is typically given in a hospital or doctor’s office.

Recommendation: Tell your doctor or other health care professional if you have experienced any problems after receiving Vistide. 

For More Information

Vistide (Cidofovir Injection) by Gilead: Recall - Presence of Particulate Matter

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Recall: Maxiloss Weight Advanced Softgels Due to Hidden Drug 

Olaax Corp. has recalled its product promoted as a dietary supplement under the brand name Maxiloss Weight Advanced Softgels because FDA testing found it contains sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons.

Maxiloss Weight Advanced Softgels are marketed as a natural herb for weight loss. The recall includes all lot numbers of both the authentic product and counterfeit versions of the product that have been found.

Any packaging types that are different from the authentic product are counterfeit. The authentic product is packaged in a green or blue box containing 3 x 12 blister packs per box and bearing "Batch Number: 001." The product was sold to distributors nationwide in the U.S. from January 2011 to November 2012. Versions known to be counterfeit are sold on various online sites.

Risk: Sibutramine is known to substantially increase blood pressure or pulse rate in some people, and may present a significant risk to patients with a history of heart disease or stroke. This product may also interact in life-threatening ways with other medications.


  • Stop using this product and throw it away.
  • Contact your doctor or other health care professional if you have taken this product and experienced any problems.
  • If you have questions on this recall, contact Olaax Corp. at 863-648-9581 Monday through Friday from 9 a.m. to 5:30 p.m. ET. 

For More Information

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Recall: Z Pro High Protein Supplement Due to Allergens Not Listed on Label

R-Kane Products Inc. has recalled its Z Pro High Protein Supplement because it contains soy and milk, allergens that are not listed on the labels of individual packets of this product.

The supplement was distributed nationwide between Jan. 1, 2006, and Jan. 24, 2013, to facilities and health care professionals who gave the product to patients who underwent bariatric (weight loss) surgery.

The recall followed an FDA inspection that found that these allergens were not listed on the inner packets of the product—only on the outer box containing 24 individual packets. Products shipped after Jan. 24, 2013, contain the allergen disclosure on individual packets.

Risk: People who have an allergy or severe sensitivity to soy or milk run the risk of a serious or life-threatening allergic reaction if they consume this product.

Recommendation: You can get information on what to do with the product by calling Robert Kaskey at 856-663-0644 Monday through Friday from 10 a.m. to 4 p.m. ET.

For More Information

Z Pro High Protein Supplement: Recall - Undeclared Soy and Milk

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Drug Safety Labeling Changes

In January 2013, FDA required safety labeling changes to be made to 27 drugs, including the antidepressant Prozac (fluoxetine HCl) and the antibiotics Cipro (ciprofloxin) and Augmentin (amoxicillin/clavulanate potassium).

In general, changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides (paper handouts for patients that come with many prescription medicines) to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.

For More Information

Monthly Safety Labeling Changes


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

March 14, 2013

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