IMPORTANT UPDATE REGARDING SLIM•FAST® RTD SHAKES IN A CAN

January 20, 2010-Thank you for your continued patience, support and loyalty through the Slim•Fast ready-to-drink (RTD) shakes in a can recall, which we announced on December 3, 2009. This was a very difficult decision for us to take, but was unquestionably the right one, as consumer safety is and always must be our top priority.

We're pleased to inform you that you may begin to see Slim•Fast RTD shakes in a can in stores later this month. As detailed below, all newly produced Slim•Fast RTD shakes in a can will be clearly marked to help you identify new RTD product from recalled RTD product.

• Individual Slim•Fast RTD shakes in a can: Manufacturing code information on bottom of cans is now in blue ink instead of black
• Slim•Fast RTD shake club packs: 3” x 3” round, gold metallic sticker on the side of club pack trays, which reads “Quality is our #1 priority”
• Slim•Fast RTD shake multi-pack cartons:  2” x 2” round, gold metallic sticker on top of cartons, which reads “Quality is our #1 priority” (see below image)

 

Unilever United States, Inc., in cooperation with the U.S. Food and Drug Administration (FDA), is conducting a nationwide voluntary recall of all Slim-Fast® ready-to-drink (RTD) products in cans, due to the possibility of contamination with Bacillus cereus, a micro-organism, which may cause diarrhea and possibly nausea and/or vomiting. The probability of serious adverse health consequences is remote.

The products were sold in stores nationwide.

Product Description:

The products are packaged in paperboard cartons and contain four, six or 12 steel cans that are 11 FL OZ (325 mL) each. Individual cans are also sold in certain retail outlets. The recall involves all Slim-Fast® RTD products in cans, regardless of flavor, Best-By date, lot code or UPC number. A listing of all RTD recalled products is attached to this press release.

No other Slim-Fast® products are affected by this recall. No Slim-Fast® powdered shakes, meal bars, or snack bars are affected by this recall.

The recall was initiated after the company conducted quality testing on Slim-Fast® RTD products in cans. Out of an abundance of caution, the company is recalling all RTD products in cans that are currently in distribution centers, on-shelf or in back rooms in retail outlets or in consumers’ homes. The company is in the process of identifying and correcting the production issue, and will resume production and shipment of the product when the issue has been addressed and corrected.

Consumers who have purchased Slim-Fast® RTD products in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund. The Consumer Services Center is open Monday – Friday, 8:30 AM – 6:00 PM ET. A recorded message is available 24/7.

The U.S. Food and Drug Administration is telling manufacturers of the drug
promethazine to include a boxed warning regarding the injectable form of the
drug. The warning, under FDA's authority to require safety labeling changes,
will highlight the risk of serious tissue injury when this drug is administered
incorrectly. The agency is also alerting health care professionals to the new
boxed warning for this product, which is used as a sedative and to treat nausea
and vomiting.

Promethazine should neither be administered into an artery nor administered
under the skin because of the risk of severe tissue injury, including gangrene,
the boxed warning says. There is also a risk that the drug can leach out from
the vein during intravenous administration and cause serious damage to the
surrounding tissue. As a result of these risks, the preferred route of
administration is injecting the drug deep into the muscle.

A requested revision in the Dosage and Administration section of the label
states that if health care professionals choose to administer promethazine
intravenously, they should limit the drug's concentration and rate of
administration and ensure a properly functioning intravenous line.

The companies that make promethazine are required to submit the requested safety
label changes to the FDA within 30 days or provide a reason why they do not
believe such changes are necessary. If they do not submit new language, or the
FDA disagrees with the language proposed by the companies, the agency can order
the label change as deemed appropriate to address the new safety information.

Promethazine was previously sold under the brand name Phenergan, but that
formulation was discontinued by Wyeth Pharmaceuticals Inc. A number of
companies currently market generic formulations of promethazine hydrochloride
injection.

The FDA previously informed consumers and health care professionals about the
risks of incorrect administration of promethazine in the December 2006 and
February 2008 editions of FDA Patient Safety News. Current prescribing
information for the drug contains information about the risk of tissue injury,
possibly including gangrene, if the drug is inadvertently administered in the
artery, but that information was not highlighted in a boxed warning.

Promethazine first went on the market in 1956. FDA has reviewed the published
literature and post-marketing adverse event reports submitted to the agency's
Adverse Event Reporting System from 1969 to 2009 and identified cases of
gangrene requiring amputation associated with administration of the drug.

FDA Gives Update on Botulinum Toxin Safety Warnings; Established Names of Drugs Changed

August 3, 2009-The U.S. Food and Drug Administration today announced an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009.

The boxed warning cautions that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life-threatening swallowing and breathing difficulties and even death.

These symptoms have mostly been reported in children with cerebral palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The affected products are:
- Botox (new established name: onabotulinumtoxinA)
- Botox Cosmetic (new established name: onabotulinumtoxinA)
- Myobloc (new established name: rimabotulinumtoxinB)
- Dysport (abobotulinumtoxinA) was approved in April 2009 with the boxed warning and is not making any name or label changes at this time.

No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines between the eyebrows or severe underarm sweating). As well, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes.

The revised labels also emphasize that the different botulinum toxin products are not interchangeable, because the units used to measure the products are different. To help reduce the potential for dosing errors, the botulinum toxin products have changed their established drug names (often referred to as the drug’s “generic” name). Neither the brand names nor the formulations of the products have changed.

'FDA SLAPS WARNING ON HEARTBURN DRUG REGLAN TIED TO SPASMS'

February 26, 2009: WASHINGTON – Federal health officials are adding their sternest warning to a heartburn drug that has been linked to muscle spasms.

The Food and Drug Administration said the drug, widely known as Reglan, has been shown to cause spasms and tics when used for long periods of time or at high doses. The problems include uncontrollable movement of the limbs, face and tongue, and are usually irreversible, even after patients stop taking the drug, according to the FDA's warning.

The agency is requiring drugmakers to add a black box warning, the most serious type available, to their products.

Manufacturers also will be required to distribute medication safety guides to patients.

The drug was marketed by Wyeth for a number of years. However, the Madison, N.J.-based company sold the tablet form to Schwarz Pharma in 2001 and the injectable form to Baxter International in 2002. The drug also is marketed by a number of generic companies.

The drug's current labeling already mentions risks of developing the spasms, called dyskinesia, but the agency's action Thursday elevates the warning to the top of the label. Reglan, known generically as metoclopramide, comes in a variety forms, including injections and edible syrups. The drug works by speeding up the muscles used in digestion and relieving painful stomach acid reflux.

More than 2 million U.S. patients use the drugs, according to the FDA.

"The chronic use of metoclopramide therapy should be avoided in all but rare vases where the benefit is believed to outweigh the risk," said Dr. Janet Woodcock, director of FDA's drug center.

Regulators said patients who face the greatest risks include the elderly, especially women, and those who have been taking the drug for more than three months.

The agency based its decision on recently published studies suggesting metoclopramide is the leading cause of pharmaceutical-related movement disorders. One study showed that roughly 20 percent of patients who take the drug longer than three months develop dyskinesia.

Prucalopride Relieves Constipation with No Signs of Heart Risk

By Charles Bankhead, Staff Writer, MedPage Today Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

ROCHESTER, Minn., May 28 -- Patients with severe, chronic constipation had a two- to three-fold improvement in bowel movements with the selective 5-HT4 receptor agonist prucalopride (Resolor) versus placebo, investigators here reported. In a 12-week trial, bowel function improved significantly with prucalopride, whether defined by total number of bowel movements or the percentage of patients with three or more movements weekly, Michael Camilleri, M.D., of the Mayo Clinic, and colleagues reported in the May 29 issue of the New England Journal of Medicine. The agent's stimulation of three or more bowel movements in significantly more patients "reflects the normalization of bowel function," the authors said. Moreover, the improved bowel function was associated with a 50% decrease in the need for rescue medication. Action Points   Explain to patients that an investigational drug for chronic constipation significantly improved bowel function in a randomized clinical trial. Note that the drug is not yet available and that the findings require confirmation in additional studies. Patients' satisfaction with bowel function and treatment and their perception of constipation severity also improved with both doses of prucalopride evaluated in the study. Additionally, the treatment caused no significant cardiovascular effects. Concern about cardiovascular effects led to the demise of two earlier 5-HT4 receptor agonists. Tegaserod was withdrawn from the U.S. market after evidence of ischemic events, and cisapride was pulled because of conduction abnormalities leading to a prolonged QT interval. The disappearance of those two agents left lubiprostone (Amitiza) as the only prescription drug approved in the U.S. for treatment of chronic constipation and constipation-predominant irritable bowel syndrome. Tegaserod, cisapride, and several other 5-HT4 receptor agonists are nonselective and exert effects on other types of 5-HT receptors and on the ether-a-go-go related (hERG) protein channel. The lack of specificity for 5-HT4 receptors may lead to an unfavorable cardiovascular profile, said Dr. Camilleri and colleagues. In contrast, prucalopride is highly selective for the 5-HT subtype 4 receptor. Prucalopride improves colonic motility and transit. In phase II trials, the drug significantly increased the frequency of bowel movement and patient satisfaction with bowel function. Clinical investigation of prucalopride continued in a phase III trial involving 620 patients with a history of chronic constipation, defined as two or fewer spontaneous, complete bowel movements weekly for at least six months. Additionally, patients had to pass hard or very hard stools, have a sensation of incomplete evacuation, or straining during defecation during at least 25% of bowel movements. Patients were randomized to placebo or to 2 or 4 mg of prucalopride daily for 12 weeks. The primary efficacy endpoint was the proportion of patients having three or more spontaneous, complete bowel movements weekly, averaged over the 12 weeks of the trial. At the end of the study, 30.9% of patients treated with 2 mg of prucalopride had three or more bowel movements weekly, as did 28.4% of the 4-mg prucalopride group, versus 12% in the placebo group (P<0.001). Additionally, 47.3% of the 2-mg group and 46.6% of the 4-mg group had an increase of at least one bowel movement weekly, averaged over the 12 weeks of the study (P<0.001). The overall patient-assessed symptom score decreased significantly with prucalopride versus placebo, as did the stool and abdominal symptom subscore (P=0.008 to P<0.001). Patients on active treatment reported significant improvement in quality of life (P<0.001 versus placebo) and significant reductions in the need for rescue medication for constipation (P<0.001 versus placebo). The most common treatment-related adverse events were headache and abdominal pain. Though encouraging, the results do not establish the cardiovascular safety of prucalopride, particularly given the relatively small number of patients who continued treatment for the entire 12 weeks of the study (85% of total), University of Rochester (N.Y.) cardiologist Arthur J. Moss, M.D., wrote in an accompanying editorial. Dr. Moss also expressed concern about the nine-year lag between the study's design and completion. Moreover, the reasons for temporary suspension of the trial in 2001 are unclear, he added. "It is not clear . . . why it took so long to bring this study to publication," said Dr. Moss.

 

dysfunction, but has also shown some benefit. Researchers at Johns Hopkins University found that part of the delay in stomach emptying occurs as a result of lack of nitric oxide in stomach tissues. The same basic molecular problem causes impotence in men. Experiments have shown that in mice Viagra reversed gastroparesis. Human trials are underway.

 

A public interest group petitioned the Food and
Drug Administration on Thursday to increase the warnings on the
popular cosmetic and drug Botox.
Dr. Sidney Wolfe of Public Citizen Health Research Group said severe
reactions including deaths have been linked to the product.

Botox and another drug, Myobloc, use botulinum toxin, which blocks
nerve impulses to muscles, causing them to relax.

But in a few cases, the toxin has spread to other parts of the body,
resulting in problems including paralysis of respiratory muscles and
difficulty swallowing, potentially leading to food or liquids
entering the lungs and causing aspiration pneumonia, Wolfe said.

Public Citizen sought so-called black box warnings on both products.