Victims of the Casa Fiesta Salmonella outbreak in Norwalk, Ohio,  now number more than six dozen. Officials believe that as many as 64 patrons of Casa Fiesta Restaurant became sick after eating at the establishment in late April. Authorities have not yet been able to identify the source of the Salmonella outbreak and health officials cannot confirm how many people ate at the Mexican restaurant. Laboratory tests confirmed that 36 patrons were infected with Salmonella; however, 28 patients who complained of Salmonella-like symptoms opted against testing.

The Centers for Disease Control and Prevention (CDC) report that about 40,000 cases of Salmonellosis are reported annually. Salmonella can occur when food is improperly stored or handled and when preparers do not wash their hands or do not sanitize implements involved in meat storage. Salmonella is a common organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain and cramping within 12 to 72 hours of infection. Laboratory testing is required to determine the presence of Salmonella; additional testing can determine the specific type and which antibiotics are needed. Generally, the illness lasts a week and most recover without treatment; however, in some, hospitalization is required because the infection may have spread from the intestines to the blood stream and other body sites. (more…)

Solodyn, —generically known as minocycline HCL, USP— has been recalled due to a product mixup.  According to the Food & Drug Administration, Medicis issued a voluntary recall of the 90 Mg, “Extended Release” Soldyne tablets with Lot Number B080037 and expiration date Exp: 12/09 and Lot Number B080038 with expiration date Exp: 12/09. The recalled tablets were distributed in 30-count bottles (NDC 99207-461-30). This recall is being conducted in cooperation with the contract manufacturer of the products and with the knowledge of the FDA.

Solodyn is an antibiotic that is part of the class of broad spectrum tetracycline antibiotics, has an even broader spectrum than other like drugs in its class, and is also considered a bacteriostatic antibiotic with higher serum levels compared to other such medications. Solodyn is primarily used to treat acne and other skin infections, is sometimes used in the treatment of lyme disease, had been used in the treatment of Neisseria meningitides—although that use is not generally recommended due to dizziness and vertigo side effects—and may also be used to treat some strains of Methicillin-resistant Staphylococcus aureus (MRSA) infection and disease resulting from use of drug-resisitant Acinetobacter. (more…)

 An article in the New England Journal of Medicine says that migraine medications known as triptans can cause serotonin syndrome, a potentially fatal disorder.  It has long been known that triptans, when taken along with selective serotonin reuptake inhibitors (SSRIs) such as Paxil and Zoloft, could cause serotonin syndrome.  But this is the first time that triptans alone have been linked to the disorder.

Reporting in the May 15 issue of the New England Journal of Medicine, researchers from Georgetown University and the Food and Drug Administration (FDA) detail 11 cases of serotonin syndrome associated with the use of triptans alone that were reported to the FDA’s Adverse Event Reporting System (AERS). The average age for someone experiencing serotonin syndrome associated only with triptan therapy was 39.9 years, and the most common symptoms included tremor, stiffness, palpitations, high blood pressure and agitation, according to the study. Five people required hospitalization, and two cases were classified as “life-threatening.” Four of the 11 cases cleared up within an hour of treatment.  The researchers recommended that people using triptans consult with their doctors if they experience any symptoms of serotonin syndrome. (more…)

The Salmonella outbreak at Princeton University keeps getting bigger. Officials at the Ivy League school say that the food-borne disease has now been confirmed in 20 students and eight staff members. Meanwhile, lab tests to confirm if as many as 70 people are suffering from Salmonella are still pending.

The first case of Salmonella at Princeton was confirmed on April 29 through lab tests. So far, Salmonella has been confirmed in 20 students and eight staff members. According to The Princeton Packet, the New Jersey Department of Health and Senior Services had completed more than 85 “control interviews”. The control interviews consisted of health officials talking both to people on campus who fell ill and also those who didn’t to see if there were commonalties between the food case histories of the two groups. (more…)

As more heparin makers step up production to make up for the recent Baxter heparin recall, some are concerned that shipments of the drug in unfamiliar packaging and quantities could lead to accidental overdoses.  The concern is so great, according to an article in Newsday, that the Institute for Safe Medication Practices near Philadelphia is planning to warn about the higher risk of medication error in the next newsletter it sends to the country’s 6,000 hospitals.

Even before the recent problems, heparin overdose was a cause for concern. In February 2007, the  Food & Drug Administration (FDA) and Baxter International issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors did not occur. The 2007 alert was issued after three infants died in Indiana when they were mistakenly given adult doses. In December 2007, actor Dennis Quaid and his wife named Baxter in a lawsuit after their newborn twins were mistakenly given potentially fatal overdoses of heparin. In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of heparin since 2001. But some the recent upheaval in the heparin supply may have increased the chances that heparin overdoses will occur. (more…)

Trasylol is being permanently removed from the market. The move comes after a study showed that Trayslol increased the risk of death among heart surgery patients by 54 percent. Preliminary findings of that study, conducted in Canada, had prompted Bayer AG to suspend sales of Trasylol last November. Even before this announcement, Bayer already faced nearly 80 lawsuits over Trasylol. As late as February, the company had maintained that it would eventually return Trasylol to the market.

The Canadian study is just one of several that have illustrated the deadly consequences of Trasylol, and many health advocates believe it should have been removed from the market years ago. In September 2006, Dr. Dennis Mangano presented a study he authored to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death. Ealier this year, Mangano told “60 Minutes” the he believes Trasylol should have been taken off the market when he published his study in 2006. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month.” (more…)

Many parents of autistic children have suspected that thimerosal, a mercury-based preservative used, until recently, in some vaccines, was responsible for the disorder.  But their concerns have been dismissed by government regulators.  But a disturbing report released several years ago indicates that federal officials knew there might be something to the thimerosal-autism link, but worked to cover it up.

According to the 2005 report authored by Robert F. Kennedy, Jr., in June 2000, a group of government scientists and health officials met for a secret, highly-secluded meeting convened by the Centers for Disease Control and Prevention (CDC) to discuss issues over the safety of a variety of ubiquitous childhood vaccines routinely given to infants and young children. The CDC issued no public announcement of the session; 52 private invitations were sent to attendees including high-level CDC and Food and Drug Administration (FDA) officials, the top vaccine specialist from the World Health Organization (WHO) in Geneva, and representatives from every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth, and Aventis Pasteur. Meeting information was strictly “embargoed”; there would be no copying or removing documents. (more…)

US regulators are no closer to figuring out how a counterfeit ingredient got into tainted heparin that has killed at least 81 people in the US, and sickened scores more here and in Germany. That’s because officials in China – where heparin ingredients were sourced – have not fully cooperated with the Food & Drug Administration (FDA) investigation. Yet, the FDA won’t get tough on China, and still allows heparin ingredients to be imported to the US from that country. Instead, Health & Human Services Secretary Michael Leavitt – whose depatment includes the FDA – recently insisted heparin sourced from China is now safe. How Leavitt can be so confident in the face of Chinese obstruction is astonishing.

In January Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme – and in some cases fatal – allergic reactionsafter being administered the products. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. Recently, researchers in the US were able to show that the chondroitin sulfate could produce reactions like those seen in patients in lab animals. (more…)

The thimerosal-autism issue has been hotly debated and vigorously studied in recent years. And, yes, autism diagnoses have increased exponentially in recent decades; however, there is ongoing disagreement regarding the link. Some parent groups and lawmakers feel the preservative, which contains mercury, has caused a rash of new autism cases.

Testimony resumed this week in the U.S. Court of Federal Claims in a long-running case that involves thousands of children with autism. The children’s parents claim regressive autism—in which normally developing children suddenly exhibit learning disorders and behavioral problems; age of onset is typically between ages one and two—was triggered by an early childhood vaccination containing thimerosal. (more…)

The story of Patrick Sheahan, who required a corneal transplant due to botched LASIK surgery, is just one example of the devastating injuries that can occur with this procedure. Prior to his LASIK procedure, Patrick’s vision problems were so mild, he hardly needed glasses.  But the then 23-year-old hoped improved vision would help further his law enforcement career. When Patrick—a street police officer—went in for a consultation at LASIKPlus they said he was a perfect candidate.  But not long after the procedure, Patrick’s left eye began to deteriorate until all he could see out of it was light; he experienced daily dizzy spells and migraine headaches. Patrick began taking painkillers and consulted with his optometrist who told him his left cornea was severely damaged and misshapen.

When Patrick Sheahan realized something had gone wrong with his procedure, he made an appointment with Dr. Gerald Horn of LASIKPlus, the man who performed the botched LASIK surgery. Horn kept Patrick and his grandfather waiting an unbelievable five hours before finally examining Patrick and admitting to a major complication. Horn blamed the laser, saying there may have been a malfunction and there was nothing further he could do. In addition to shoddy surgical work, Horn was extremely rude to Patrick and his grandfather, rushing the two men out before answering their questions, saying he had a meeting to attend and if they had more questions, they would have to make another appointment to see him. Horn offered no options for vision correction and no sympathy toward his now-blind patient. (more…)