A proposal is being considered by the US Department of Agriculture (USDA) to omit retailer information when tainted meat is recalled.  The exception to this would be in the case of serious health risks. The USDA has been under a great deal of pressure from the food industry to adopt such a policy.

Last month, the USDA announced that the Hallmark/Westland Meat Packing Company was recalling 143 million pounds—65 million kilos—of meat, following a videotape of plant workers forcing unfit cattle into slaughter.  Most of the meat was likely consumed; at least 37 million pounds were used for school lunches and federal nutrition programs, according to the USDA.  Now, people are wondering if anyone fell ill from the recall and if E. coli was involved.  Had the proposal been in place last month, the public not have known if their stores sold meat from the Hallmark/Westland Meat Packing Company. (more…)

According to the Food and Drug Administration (FDA), a recent study—The Data Collection on Adverse Events of Anti-HIV Drugs or, D:A:D, Study—indicates GlaxoSmithKline, PLC and Bristol-Myers Squibb Company HIV drugs lead to a higher heart attack risk as compared with other HIV medicines.  US health officials are reviewing the safety of AIDS drugs and the FDA is evaluating the data on Glaxo’s Ziagen and Bristol-Myers’ Videx.  The FDA said that the review “may result in the need to revise labeling for the products; however, until evaluation is complete, healthcare providers should evaluate the potential risks and benefits” of each HIV drug their patients are taking.  Researchers reviewed heart attack risk among patients taking certain medicines from the NRTI class—nucleoside reverse transcriptase inhibitor—of AIDS drugs.

The FDA notice was issued as part of an effort to notify the public about early signs of potential safety concerns before officials have reached a final conclusion. (more…)

Lauren Brown, a researcher with the University of Alberta’s School of Public Health, Canada, found that antidepressants are linked to type 2 Diabetes.  While reviewing information from Saskatchewan health databases, Brown discovered that people with a history of depression had a 30 percent increased risk of developing type 2 Diabetes.  Brown then studied the medical history of 2,400 people who were diagnosed with depression and were also taking antidepressants in order to determine whether there was a clear correlation between that disease and type 2 Diabetes.

Brown divided the group into four categories:  People who took antidepressants that were considered older therapies, patients who were using newer treatments, patients using a combination of both an old and new treatments, and those who were switching medications.  Brown’s study revealed that the risk of diabetes almost doubled for the patients who were using two types of therapies at the same time:  Ticyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs).  Brown says people are usually prescribed multiple medications “if they have severe depression or if they are having a problem finding the right therapy” and believes these results, and results of previous studies demonstrating an increased risk of type 2 diabetes in people with depression, emphasize the need for more regular screening for type 2 diabetes in people suffering from depression, particularly those who are taking more than one antidepressant.  She also encourages diabetes and depression organizations to educate their members about this disease-medication link. (more…)

Regranex, a gel used by diabetics to treat leg and foot wounds, has been linked to an increased incidence of cancer and deaths, prompting the Food & Drug Administration (FDA) to announce a Regranex safety review.

Regranex, manufactured by Johnson & Johnson, is a topical medicine that was approved by the FDA in 1997 to treat leg and foot ulcers in patients with diabetes. Patients with diabetes - a disease in which the body cannot make insulin and affects blood sugar levels - are more susceptible to developing leg and foot wounds because they are less able to feel their feet. (more…)

A new study by University of Chicago researchers reveals free drug samples can cost patients in the long run.  Apparently, patients given free samples tend to spend nearly 40 percent more on medications in the first six months and 20 percent more the six months, running significantly higher out-of-pocket expenses versus those not receiving free samples.  “The notion that people have is that if you receive samples, it helps with out-of-pocket costs because you don’t have to go out and buy the drugs,” said Anirban Basu, a study author and assistant professor of medicine at the University of Chicago.  “What we found, actually, was that their out-of-pocket expenditures increased.  Most surprising was that those out-of-pocket expenditures continued even after the samples stopped.”

The study, published in this week’s journal Medical Care, renews the question of the role of over $18 billion in free pharmaceutical samples distributed annually, which drug industry representatives describe as a cost-saving alternative for the poor.  “This builds on a growing body of literature that shows that samples are not aimed to help the uninsured and the poor, but to increase the sales of the branded drugs,” said Dr. William Shrank, an instructor at Harvard Medical School, who has studied the issue. (more…)

Castleberry’s Food Company says it plans to restart its Augusta, Georgia plant sometime this week, following a decision by federal regulators to suspend the plant’s operating license earlier this month.  The Augusta plant was the same one that had shut down for more than two months last year, after canned foods made there were found to be contaminated with botulism toxin.

In July, Castleberry’s initiated a food recall after four cases of botulism poisoning were tied to Castleberry’s hot dog chili sauces. Tests had confirmed that two Texas children and an Indiana couple were suffering from botulism. All four of those victims had eaten one of Castleberry’s hot dog sauces. The recall was later expanded to include 80 types of sauces, beans, stew, chili, hash and pet foods produced at the company’s plant. The Castleberry’s hot dog chili sauce botulism outbreak was the first related to commercially canned foods in more than forty years. (more…)

The number of salmonella cases from tainted water in a small Colorado town are steadily rising.  But there’s not much more that Alamosa residents can do beyond flushing their toilets now that the municipal water system is off-limits for every other use.  Schools and restaurants are closed, the National Guard is handing out bottled water, and it could be weeks before life in Alamosa returns to back to normal.

The Alamosa Water Department, collaborating with crews from Denver Water, started its flushing of the municipal system at 9:00 am Tuesday.  The flush water has chlorine concentrations of 25 parts per million; three times more than what is found in chlorinated swimming pool water.  The super-chlorinated flush is the first of three phases for cleaning the system.  In the second phase, the chlorine levels will be elevated, but lower than that of the first phase.  It is during the second phase that people will be allowed to bathe.  In the third and final phase, Alamosa residents will be permitted to drink the water. (more…)

Defective drugs are more likely to be approved by the Food & Drug Administration (FDA) because of tight time constraints the agency must work under, new research has found. A new study by Harvard researchers who have analyzed decades of drug approvals has revealed that those drugs that are approved under quick reviews tend to be more likely to cause problems and be recalled.  Take, for instance, some of the medications which have been recalled in the recent past, such as Vioxx, Bextra, Rezulin, and Baycol.  The Harvard research team noticed that those drugs that received approval by the FDA exactly on their deadlines seem to be more likely than not to have had safety problems versus those medications which were cleared by the FDA with time to spare.

Critics of the tight deadlines oppose the fact that Congress had set strict time limits for the FDA to rush approvals for new medications.  The Harvard team’s study was published in today’s New England Journal of Medicine and provides the first scientific evidence supporting some critics of speedy FDA drug passage. The FDA disagreed and provided its own numbers to back its claims. (more…)

Singulair, a popular drug used to control asthma, might be linked to suicidal thoughts and behavior, the Food & Drug Administration (FDA) said today. The agency has decided to undertake a safety review of Singulair, and is advising that patients taking Singulair be monitored for behavioral changes, including suicidal thoughts and behavior.

Singulair, marketed by Merck & Co,. is one of a class of drugs called leukotriene receptor antagonists. Singulair was approved to treat asthma and the symptoms of allergic seasonal allergies and to prevent exercise-induced asthma. Side effects of Singulair include gastrointestinal disturbances, hypersensitivity reactions, sleep disorders and increased bleeding tendency. Other leukotriene modifying medications include Accolate, which is also a leukotriene receptor antagonist and Zyflo and Zyflo CR, which are leukotriene synthesis inhibitors. (more…)

Drug coated stents should be subject to more stringent clinical trials before approval, and makers of such devices should conduct long-term follow-up studies after drug coated stents are brought to market, according to the Food  & Drug Administration (FDA). Those recommendations were part of the FDA’s proposed guidelines for drug coated stents that were released yesterday.  While the proposal is not binding, companies often seek the FDA’s advice during product development, and will follow such guidelines in order to ensure approval of medical devices.

Stents are lattice-like devices that act like scaffolding to hold a blood vessel open.  According to the FDA, each year in the United States, approximately 1 million patients undergo procedures to treat coronary atherosclerosis, also known as hardening or blockages of the heart arteries — a condition that can cause angina and heart attacks. Some 650,000 patients are treated with drug-eluting stents that are coated with a medication that prevents the growth of scar tissue. Currently, Johnson & Johnson, Boston Scientific Corp and Medtronic Inc make the drug-coated stents now on the market. Abbott Laboratories Inc also is expected to receive approval for a new drug-coated stent. (more…)