Investigators from the Food & Drug Administration (FDA)  are visiting farms, warehouses and packing plants in parts of Mexico and Florida in their quest to track down the source of a Salmonella outbreak linked to tainted tomatoes. So far, tainted tomatoes have sickened more than 500 people across the country.

Salmonella is a potentially deadly type of food poisoning, symptoms of which include fever, abdominal pain, nausea, gas and bloody diarrhea. Symptoms appear within 36 hours of exposure, and usually last four to seven days. In very severe cases, Salmonella can lead to kidney failure and other complications. Salmonella can be particularly dangerous for children, the elderly and people with weakened immune systems. Some victims of Salmonella will develop a disease called Reiter’s Syndrome, a difficult- to- treat condition that causes severe joint pain, irritation of the eyes, and painful urination. Reiter’s Syndrome can plague its victims for months or years, and can lead to chronic arthritis.  (more…)

Despite its decision last month to water-down safety warnings, the Food & Drug Administration (FDA) says it is still concerned about potentially fatal side effects associated with the heart imaging agents, Definity and Optison. Just last month, the FDA dropped a ban on giving the agents to acutely ill patients, such as those with congestive heart failure. The FDA also changed monitoring requirements for the drugs. The black box warning had originally called for monitoring all patients for 30 minutes after they receive the agents, but the revised warning said only patients with pulmonary hypertension or unstable cardiopulmonary conditions need to be monitored.

Definity, marketed by Lantheus Medical Imaging, and Optison, distributed by General Electric, consist of microscopic gas-filled spheres that sharpen ultrasound pictures. Definity and Optison are used during echocardiograms, ultrasound imaging procedures that take a detailed, moving picture of the heart. If the image is unclear, contrast agents such as Definity and Optison can be given intravenously to help make the heart easier to see. (more…)

The number of people sickened by Salmonella tainted tomatoes has hit 552. According to the Food & Drug Administration (FDA) most of the reports represent people sickened weeks ago, but the outbreak is still considered to be ongoing. Because the tomato Salmonella outbreak is ongoing, the FDA is still advising consumers to avoid to avoid eating raw red plum, red Roma and red round tomatoes and products containing them. Cherry tomatoes, grape tomatoes and those sold with the vine have been deemed safe to eat. Red plum, red Roma and red round tomatoes are safe if they are known to have come from geographic areas listed on the FDA’s website.

The FDA said it is sending inspectors to parts of Florida and Mexico, the areas where the tainted tomatoes are most likely to have come from. Investigators will focus on big packing houses or distribution warehouses that had the capacity to process enough tomatoes to account for such a large outbreak. (more…)

According to the Food & Drug Administration (FDA), deaths reported following the administration of heparin surged since 2006. New figures released by the FDA show that the agncy has now received reports of 248 deaths among people who had taken heparin since January 1, 2007. Of those, 238 were reported to the FDA on or after January 1, 2008. Among the fatalities, 149 involved patients who suffered allergic reactions known to be associated with tainted heparin. In most deaths, the FDA said it didn’t have enough evidence to determine if heparin was to blame. The number of reported deaths spiked in January at 50 and declined to five last month.

The spike in allergic-type reactions – including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening – following administration of heparin prompted Baxter International to recall nearly all of its heparin injections in the US earlier this year. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products. (more…)

A neurologist who wrote two confidential reports on side effects of the epilepsy drug Neurontin said he told the drug’s maker that it needed warnings for depression and aggression. Unfortunately, Parke-Davis – now a unit of Pfizer – ignored his advice.

According to The Wall Street Journal, the neurologist, Michael R. Trimble from the University of London, has testified that in 1995 and 1996, he was hired to write the two reports for Parke-Davis because the company “was concerned about psychosis” as a potential side effect of Neurontin. Dr. Trimble said he was unable to find a link to psychosis, but did find one between the drug and depression and aggression. For the 1996 report, Dr. Trimble analyzed nine patients who had no previous symptoms of the side effects. Five of those patients exhibited depression and aggression after they had begun taking Neurontin. Dr. Trimble said he recommended to the company that the drug “should carry some kind of warning” for susceptible patients. (more…)

Enbrel should be approved to treat moderate-to-severe psoriasis in children, a Food & Drug Administration (FDA) panel said yesterday, despite concerns that it is linked to severe infections and cancer. The FDA advisory panel voted 7-5 with one abstention to recommend expanding Enbrel’s approval. The panel of outside medical experts said that Enbrel appears effective in treating psoriasis in children, but it expressed concern about whether the medicine will increase risks of malignancy and serious infections such as tuberculosis. Enbrel is already approved to treat psoriasis and rheumatoid arthritis in adults and juvenile arthritis in children.

Some panel members did express concern about giving a drug with unknown side effects to children with only moderate psoriasis. However, they did not recommend that Enbrel be approved only to treat severe psoriasis, saying that might limit whether insurance companies will cover the drug’s costs. The FDA is not bound to follow the recommendations of advisory panels, but the agency usually does so. (more…)

The Centers for Disease Control (CDC) says 383 people across the country have been sickened by Salmonella tomatoes, up 106 since Monday. At least 48 people have been hospitalized. While no deaths have been officially attributed to the tomato Salmonella outbreak, the CDC said that the disease may have contributed to the death of a cancer patient in Texas.

The Food & Drug Administration (FDA) is apparently no closer to identifying the source of the contaminated tomatoes. Most produce in the United States is not tracked from the farm — and that has made the job of finding the source of the current outbreak more difficult. The agency is still focusing on Mexico and parts of Florida as potential origins of the outbreak. But yesterday, David Acheson, director of food safety for the FDA, conceded that the source might never be known. (more…)

No one will ever know how many people were sickened by this year’s tomato Salmonella outbreak, but a report says that the the true number could be well over 8000.   The  Centers for Disease Control (CDC) has so far confirmed 277 cases of Salmonella St. Paul in 28 states and the District of Columbia, but unfortunately, the vast number of Salmonella incidents are never reported to health authorities.

Salmonella is a potentially deadly type of food poisoning, symptoms of which include fever, abdominal pain, nausea, gas and bloody diarrhea. Symptoms appear within 36 hours of exposure, and usually last four to seven days. In very severe cases, Salmonella can lead to kidney failure and other complications. Salmonella can be particularly dangerous for children, the elderly and people with weakened immune systems. Some victims of Salmonella will develop a disease called Reiter’s Syndrome, a difficult- to- treat condition that causes severe joint pain, irritation of the eyes, and painful urination. Reiter’s Syndrome can plague its victims for months or years, and can lead to chronic arthritis. (more…)

The Food & Drug Administration (FDA) says deaths possibly linked to tainted heparin have reached 149. According to the agency, it has now received reports of 248 deaths among people who had taken heparin since Jan. 1, 2007. Of those, 149 were people who suffered allergic reactions. In most deaths, the FDA said it didn’t have enough evidence to determine if heparin was to blame. The number of reported deaths spiked in January at 50 and declined to five last month. The FDA said yesterday that all supplies of heparin currently sold in the United States are safe.

Earlier this month, the FDA said that medical devices made with heparin had been implicated in 11 additional deaths, and 86 more adverse reactions. Most of the cases involved heparin used to clean intravenous lines. The heparin associated with two of the 11 deaths wasn’t contaminated and the FDA is unable to conclusively say how many of the deaths and side effects involved the tainted heparin. The FDA also did not identify which companies’ products were associated with the adverse reactions and deaths. (more…)

The Food & Drug Administration (FDA) says that illnesses from Salmonella tainted tomatoes now number 277, but the source of the outbreak still is not known.  Since the end of last week, 49 more cases of Salmonella linked to tomatoes have been identified in 5 more states and the District of Columbia. Forty-three victims have been hospitalized. No deaths have officially been attributed to the outbreak, but the infection may have been a factor in the death of a Texas man in his 60s who also had cancer, the Centers for Disease Control and Prevention said.  The FDA says it still considers the tomato Salmonella outbreak to be ongoing, as reports of illnesses are still being made.

In a conference call with news reporters yesterday, David Acheson, the FDA’s associate commissioner of foods, said that the discovery of a cluster of illnesses linked to one source is a helpful development because it allows investigators to better trace the source of the tomatoes, from foodservice facilities to distributors and possibly to the farm. Acheson declined to name the geographic region or where the people consumed the tainted tomatoes. (more…)