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MedWatch Safety Alerts, June 2012

Posted Jul 11 2012 12:54pm

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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.

 

The manufacturer of ondansetron—marketed as Zofran, ondansetron hydrochloride and generics—has announced changes to the drug’s label based on preliminary study results suggesting that a 32 mg single intravenous dose may affect the heart’s electrical activity. FDA agrees with the changes and will work with manufacturer GlaxoSmithKline to explore an alternative single dose regimen that is both safe and effective.

Zofran is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery.

Risk: Changes in the heart’s electrical activity known as QT interval prolongation could make it more likely for patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.

The updated label will state that health care professionals can continue to use the drug in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the drug label.

Recommendations

  • Health care professionals should avoid the use of a single 32 mg intravenous dose of ondansetron. 
  • Electrolyte abnormalities should be corrected prior to the infusion of ondansetron.
  • The new information does not change any of the recommended oral dosing regimens for ondansetron, including the single oral dose of 24 mg for chemotherapy induced nausea and vomiting.

For More Information

 

Standard Process has recalled three dietary supplements due to potential Salmonella contamination:

  • Cataplex ACP (product number 0700 and 0750) Lot 114
  • Cataplex C (product number 1650 1655) Lot 114
  • Pancreatrophin PMG (product number 6650) Lot 114

This recall resulted during a routine FDA record inspection which revealed that one of the ingredients used in these products potentially contained the bacteria.

Risk: Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

The products, all tablets, were distributed in 60 cc and 200 cc amber glass bottles with Best Used By dates of 5/13 indicated on both the bottles and the boxes. No other products or lot numbers are affected. They were sold through health care professionals.

Recommendations

  • Return any of these three products with specific lot codes of L114 to the place of purchase for a full refund.
  • Consumers with questions can contact Standard Process Inc. at 866-397-3237.

For More Information

 

Botanical Laboratories Inc. has recalled its Wellesse Digestive 3 in 1 Health liquid dietary supplement. A supplier of one of the ingredients has indicated that the ingredient has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. This concern is based on the fact that a sample taken by the supplier had tested positive for Salmonella, although the bacteria was not found in lots of the finished product.

Risk: Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses, such as arterial infections (infected aneurysms), endocarditis (an inflammation of the heart’s inner lining), and arthritis.

Product lots affected by this recall include:

  • 16 oz. size with "LOT 34441C (followed by a four digit time code) A EXP 03/2014" on the bottom of the bottle. 
  • 33.8 oz. size with "LOT 34552C (followed by a four digit time code) A EXP 03/2014" on the bottom of the bottle.

Both sizes of the supplement bottles were distributed nationwide after May 1, 2012 through retail stores and online retailers.

Recommendation

  • Consumers who have purchased Wellesse Digestive 3 in 1 Health with one of the above referenced lot numbers should return it to the place of purchase for a full refund, or contact the company at 1-800-232-4005 with questions.

For More Information

 

Sandoz has recalled 10 lots of its generic oral contraceptive Introvale (levonorgestrel and ethinyl estradiol) in the U.S. after receiving a report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”).

Risk:  The three-month blister card contains 84 peach-colored active tablets and seven white placebo (inactive) tablets in 13 rows, each representing one week.
While the white inactive tablets can be clearly distinguished from the peach-colored active tablets, a patient taking the wrong tablet over several days is at risk for an unintended pregnancy.

The lot numbers involved in the recall are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. They were distributed only in the U.S. between January 2011 and May 2012.

Recommendation

  • Consumers who find a white placebo tablet in any position other than the 13th and final row (Week 13) should immediately begin using a non-hormonal form of contraception and contact their health care professional.
  • They should also report the finding to the Sandoz Drug Information Direct Line at 800-525-2492, 24 hours/day, seven days a week, or email qa.druginfo@sandoz.com .

For More Information

 

FDA warns that Reumofan Plus, promoted as a natural dietary supplement for use in the treatment of arthritis, muscle pain, osteoporosis, bone cancer and other conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

Reumofan Plus is labeled in Spanish and manufactured in Mexico by Riger Naturals.  It is sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product. 

Risks: FDA has received multiple reports of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps and adrenal suppression associated with the use of Reumofan Plus. Adrenal suppression leads to decreased production of certain hormones in the body.

An FDA laboratory analysis of Reumofan Plus found that it contains:

  • Diclofenac Sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal (GI) problems that could include  bleeding, ulceration, and a fatal perforation of the stomach and intestines
  • Methocarbamol, a prescription muscle relaxant that can cause sleepiness, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant. These ingredients also may interact with other medications and result in serious complications.

Recommendation

  • Consumers who are currently taking or who recently stopped taking Reumofan Plus should consult a health care professional immediately.

For More Information

 

The Menz Club, LLC has issued a nationwide recall of certain lots of V Maxx Rx due to the presence of sulfoaildenafil, which is an undeclared ingredient. Sulfoaildenafil is substantially similar to sildenafil, an FDA-approved prescription drug used to treat erectile dysfunction (ED), making V Maxx Rx an unapproved new drug. The firm has not received any reports of health problems related to this recall.

Risks: Sildenafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

The affected products may have been ordered online at www.vmaxxrx.com or www.themenzclub.net and were distributed nationwide. This product is marketed as a dietary supplement intended for use as a male enhancement product and is packaged in one- and five-count blister packs and 10-count bottles.

The lot numbers:

  • Single Count, UPC Code 2802803561, Lot Nos. 101108, 101009, 101010, 101011
  • Five Count, UPC Code 0972859402, Lot Nos.: 101108, 101109, 101110
  • 10 Count, UPC code 0913251017, Lot Nos.: 301000, 301001

Recommendation

  • Any consumer who has V Maxx Rx should immediately stop using it and destroy the unused product, or return it to ATTN: Product Returns, The Menz Club, LLC, P. O. Box 906, Madison, MS 39110. Consumers with questions may call (601) 866-6746 Monday through Friday, 9:00 AM – 4:30 PM CDT.
  • Contact your health care provider if you have experienced any problems that may be related to using these products.

For More Information

 

Nidek Medical Products is recalling its Mark 5 Nuvo, Nuvo 8, and Nuvo Lite oxygen concentrators due to a risk of fire and loss of supplemental oxygen.  Oxygen concentrators are used to supply supplemental oxygen to patients within a home setting.

Risk: A malfunction in these devices may result in a fire hazard and loss of supplemental oxygen, causing serious adverse health consequences, including death.

Affected products include serial numbers from 042-10000 through 102-09335, manufactured from January 1, 2004 to May 15, 2010.

Recommendation

  • Notify your equipment provider if you have an affected product in your home or place of business. According to the firm, patients may continue to use the device while waiting for a replacement for the corrected component.
  • Consumers may contact Nidek Medical Products at 205-856-7200 ext 242 or by e-mail at fieldcorrection@nidekmedical.com

For More Information

 

In May 2012, FDA required safety labeling changes to be made to 41 drug products. They include Lotensin (benazepril hydrochloride), used for the treatment of hypertension, which should not be used in pregnancy due to the risk of reduced fetal kidney function and fetal death.

In addition, several proton pump inhibitor (PPI) drugs, including Protonix (pantoprazole sodium), Prevacid (lansoprazole) and Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide should not be taken with higher doses of methotrexate, used in the treatment of several cancers, psoriasis and rheumatoid arthritis. Use of the drugs together may lead to toxic levels of methotrexate in the blood. PPIs reduce stomach acid and are used to treat such conditions as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

For More Information

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

July 11, 2012

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