The controversial smoking cessation drug known as Chantix in the U.S., was introduced by Pfizer as Champix nearly two years ago in Great Britain.  The drug is known generically as varenicline in both countries and, in Great Britain, about 400,000 prescriptions have been written says BBC News’ online site.  Internationally, says the BBC, about nine million prescriptions have been written.

The BBC explains that Chantix is a nicotine-mimicking drug that enables the body to reduce its urge for cigarettes while also reducing its withdrawal symptoms.  However, in studies, the drug did not provide increased efficacy over other methods of smoking cessation.  Despite this, notes the BBC, Pfizer earned over $883 million from the drug in its first year. (more…)

A quarter of all trials submitted to the U.S. Food and Drug Administration (FDA) for new drug applications are still unpublished five years after completion.  What’s more, discrepancies exist between what drug trials are reviewed by the FDA, and which ones are published.  These are the conclusions of a recent study published by the journal PLoS Medicine, a publication of the Public Library of Science.

According to a press release reprinted by Science Daily, inconsistencies appeared between what was submitted to the FDA and what was subsequently published.  As a result, what was published generally presented the drugs—in medical literature geared to medical professionals—in a positive light.  Some of the differences  between the submitted and published trials included outcome additions or deletions, changes in the statistical significance of reported outcomes, and changes in overall trial conclusions, the release said. (more…)

The revelation earlier this week that some U.S.-made baby formula had tested positive for the industrial chemical melamine has some consumer advocates calling for a product recall, according to a report in the Associated Press.  Meanwhile, the Food and Drug Administration (FDA) continues to insist that the amount of melamine found in the baby formula poses no risk, and that U.S.-made baby formula is safe.

Earlier this week, the FDA said tests on 77 samples of U.S.-made formula detected “trace” amounts of melamine in one sample. According to a report in the Associated Press,  the melamine was found in Nestle’s Good Start Supreme Infant Formula with Iron.  That formula had two positive tests for melamine on one sample, with readings of 0.137 and 0.14 parts per million. (more…)

R.J. Reynolds is getting ready for the national debut of Camel Snus, a new type of smokeless chewing tobacco.  According to a report in The New York Times, R.J. Reynolds is hoping Camel Snus catches on with consumers as a more “socially acceptable” form of tobacco.  But health officials are worried about the product’s potential to cause health problems.

According to the Associated Press, Snus was invented in Sweden where it has been popular for decades.  However, the European Union banned Snus in 2004 over cancer worries.  Unlike regular chewing tobacco, users can swallow the juice Snus produces, so there is no spitting.  And unlike cigarettes, there is no second hand smoke.  Apparently, those properties are what R.J. Reynolds thinks will make Camel Snus, which is currently being test marketed nationwide, more “socially acceptable.”   (more…)

A salmonella outbreak linked to ConAgra’s Banquet Pot Pies sickened 401 people last year, according to the Centers for Disease Control (CDC).  According to a new report on the ConAgra salmonella pot pie outbreak, confusing microwave cooking instructions contributed to many of the illnesses.

In October 2007, ConAgra’s Banquet and store brand pot pies were linked to dozens of cases of Salmonella poisoning. At that time, ConAgra issued a health alert about the salmonella pot pie outbreak, warning consumers not to eat any of its 7-ounce store brand or Banquet Pot Pies with the codes “P-9” or “Est 1059” on the package. Despite the health alert, ConAgra did not recall the tainted pot pies. On October 11, ConAgra finally did issue a pot pie recall. (more…)

The U.S. Consumer Product Safety Commission (CPSC), in collaboration with the firms named below, announced the two following recalls.

In the first, JCPenney is recalling about 24,000 of its Arizona® Newborn and Infant Denim Pants due to a choking hazard.  The Arizona® Newborn and Infant Denim Pants were made in Bangladesh and imported by JCPenney Company, of Plano, Texas.  Only pants made in Bangladesh are involved in the recall; pants made in China are not affected; the country of origin can be found on a label sewn into the waistband.  While no injuries or incidents have been reported, the Arizona® Newborn and Infant Denim Pants contain a metal snap at the waist that can detach posing a choking hazard to infants. (more…)

The Food and Drug Administration (FDA) will be interviewing over 1,500 consumers, says the Associated Press (AP), in order to determine if television drug advertisements should be required to include a toll-free number consumers can use to report side effects associated with their medications.

And, while this appears to be a sound requirement, opponents feel that the information could “distract” consumers away from important drug safety data, reports the AP.  Print ads contain the FDA’s toll-free information, which is now required by law.  According to the AP, that law, which was passed last September,  called for the FDA to report to Congress about making such information mandatory in TV  drug ads.  The requirement was supposed to have been met last March; however, the FDA asked for an extension and is expected to begin its study shortly, the AP reported. (more…)

Mars Petcare has issued yet another recall of pet food, extending a prior recall issued on October 27, 2008 that involved dry dog and cat food made at its Allentown, Pennsylvania facility.  The recall was issued because the pet food may be contaminated with salmonella.

According to the a press release posted on Market Watch, the Mars Petcare recall involves products sold at BJ’s Wholesale Club, ShopRite Supermarkets, and Wal-Mart locations in the following states:  Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia.  The new recall adds all sizes of SPECIAL KITTY(R) Gourmet Blend dry cat food produced at the Allentown facility on August 11, 2008 as well SPECIAL KITTY(R) made on September 25, 2008 at the Allentown facility, which also tested positive for Salmonella.  (more…)

The U.S. Food and Drug Administration (FDA) has issued two immediately effective recalls involving potentially dangerous nutritional supplements.  Both recalls have been implemented over undeclared, prescription-level ingredients, which classifies them as unapproved drugs.

In the first recall, Balanced Health Products, Inc. is voluntarily recalling Starcaps Dietary Supplement Capsules because they were found to contain an undeclared drug ingredient:  Bumetanide at a level of 0.8 mg per capsule.  The lot number involved is 12/2011–84810 and the supplements were sold in 30-capsule plastic bottles.  The bottles—1,974 in total—were distributed nationwide from August 2008 to October 30, 2008 to retail outlets and via online sales. (more…)

The doctor who founded All Kinds of Minds, a Durham, North Carolina institute dedicated to teaching children with learning disabilities, has resigned amid allegations of child molestation.  According to the Durham News & Observer, Dr. Mel Levine announced Tuesday that he would leave All Kinds of Minds in June, when his contract expires.

Levine denies the abuse allegations, and his lawyer told the News & Observer that his resignation is not related to them. (more…)