When 15-year-old Alex Koehne died a year ago at Stony Brook University Medical Center, his parents donated his organs; and although Alex was diagnosed with bacterial meningitis, his organs were deemed healthy for transplantation.  A month later, the Koehne’s were told by Stony Brook that Alex had actually died of a rare lymphoma, a diagnosis in which his organs would not have been transplanted given the disease’s transmission strength.  The Koehne’s recently learned two patients who received Alex’s organs died last year of the same rare lymphoma and two other’s were undergoing chemotherapy.

The specialized medical teams involved in transplant procedures must move quickly to assess the suitability of organs for transplants and speed is even more critical given the growing organ waiting lists.  In the months after their son’s death, the Koehne’s remained in constant contact with the group that coordinates organ donations in the metropolitan area, the New York Organ Donor Network and hoped one day to be in touch with the recipients of their son’s organs. They only learned of the recipients’ deaths when they called the group themselves in January after they heard a reporter was making inquiries and wanted to understand why these deaths were kept from them for so long. (more…)

Two cases of Salmonella poisoning in Minnesota have been linked to Milford Valley Farms Chicken Cordon Bleu raw frozen chicken entrees. While no recall was issued, consumers are being warned to cook the raw, frozen chicken dinners thoroughly, and to avoid preparing them in microwave ovens.

According to the Centers for Disease Control, Salmonella bacteria sicken 40,000 people every year. Although the true number could be much higher, because it is estimated that for every case of Salmonella poisoning reported, two others are unreported.  Salmonella causes 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. In rare cases, Salmonella can cause a disease called Reiter’s Syndrome, a difficult- to- treat condition that causes severe joint pain, irritation of the eyes, and painful urination. (more…)

According to a study in The Journal of Clinical Pharmacology this past January, ibuprofen may lessen the benefit of daily aspirin therapy.  Other pain relievers are preferable for those who need aspirin therapy; however, complete clinical relevance of this effect remains unclear.  Those patients who are taking both ibuprofen for pain and aspirin to reduce their chances of a second stroke may not be receiving the full benefit of their stroke prevention efforts

Researchers assessed the combined effect of both drugs on a group comprised of 10 healthy volunteers and 18 others who were using both medications for pain relief and stroke risk reduction. The blood-thinning effect of the aspirin was blunted in the healthy participants, while those who were attempting to prevent a stroke appeared to be resistant to the effects of aspirin until ibuprofen was discontinued. Also, 13 people in the latter group experienced a stroke while taking these two drugs together over a 27-month period.  “Those strokes were preventable,” said Francis M. Gengo, PharmD, lead author and associate professor of pharmacy practice and neurology at University at Buffalo in New York. (more…)

Last week, there was not much the residents of Alamosa, Colorado could do in the way of water other than flushing their toilets since the municipal water system was off-limits for every other use.  Schools and restaurants were closed and the National Guard was handing out bottled water.  But, the people of Alamosa are receiving a reprieve following the outbreak of salmonella bacteria contaminating the tap water there.  Now, some residents in northern Alamosa are able to use tap water for brief showers.  Since March 19th Alamosa residents have been unable to use water straight from the tap for brushing teeth, washing dishes, drinking, and cooking and crews are flushing the water system to purge salmonella bacteria.

It is not known how the water became contaminated and, to date, 315 people have become ill, with 85 cases of salmonella confirmed and 12 people hospitalized. (more…)

The US Food and Drug Administration (FDA) just named 25 drugs and biologic products, including some well-known and popular medications, whose makers will be required to submit safety plans later this year.  The product list as published in the Federal Register and includes the multiple myeloma medication thalidomide (Thalomid), the anti-psychotic medication clozapine (Clozaril), and the abortifacient drug mifepristone (Mifeprex).  The plans, called Risk Evaluation and Mitigation Strategy—or REMS—plan must be submitted to the FDA no later than September 21 on pain of “enforcement action,” which includes monetary penalties, the FDA said.

The move comes under amendments to the Food, Drug, and Cosmetic Act, which was passed last year and which also gave the FDA authority to require a REMS plan when a drug first goes to market or when the FDA is made aware of new safety data.  The goal of REMS is to ensure the safe use of medications that have risks if used improperly, according to Jane Axelrad of the FDA’s Center for Drug Evaluation and Research.  “These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,” Axelrad said.  “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS,” she added. (more…)

Advanced Bionics, LLC, a maker of cochlear implant hearing aids, could face a stiff fine from the Food & Drug Administration  (FDA) for manufacturing violations that may have resulted in dangerously defective hearing aids.  The FDA has alleged that Advanced Bionics failed to follow manufacturing standards and wants to fine the California medical device manufacturer $2.2 million.

Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator in 2007.  The cochlear implant hearing aid is surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The hearing aid is considered a Class III device by the FDA—the most stringent regulatory category for devices. The FDA says the hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss. (more…)

Covidien Ltd., is the latest company to recall a heparin product over concerns that the drug may contain a contaminant that could be responsible for causing hundreds of adverse reactions in patients in the US.    Covidien said on Friday that its supplier, Scientific Protein Laboratories of Wisconsin, said two lots of Heparin Sodium USP active pharmaceutical ingredient it received might contain a heparin-like contaminant. As a result, Covidien said that it was recalling its prefilled syringes that contain heparin as a precaution, although the company’s products have not been implicated in any of the reported adverse reactions.

Scientific Protein Laboratories also supplied contaminated ingredients to Baxter Healthcare, the company whose heparin has been linked to more than 700 serious reactions and possibly 19 deaths among patient in the US.  In the US, Baxter first recalled 9 lots of heparin in January, after the drug was linked to serious, and sometimes fatal reactions in some patients.  Those reported reactions to Baxter heparin included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening. In February, Baxter expanded the heparin recall to include all of its heparin products, and suspended sales of its drug. (more…)

Vytorin should only be used as a last resort because there is no evidence that the cholesterol-lowering medication provides any more benefits than cheaper statins alone.  That was the conclusion reached by a panel of four prominent cardiologists after the results of the much-delayed ENHANCE study were released at the American College of Cardiology meeting over the weekend.  The study looked at whether Vytorin, which is a combination of Merck & Co.’s  Zocor and Schering-Plough Corp.’s  Zetia, was better at reducing clogged arteries in the neck than Zocor, a statin drug, alone.

The ENHANCE study, which was funded by Merck and Schering-Plough, focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin, Zetia or a high dose of simvastatin, the generic form of Zocor.  While both Vytorin and Zetia were found to have significantly reduced cholesterol in these patients, neither drug provided any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries.  Overall, the study failed to meet its primary goal, which was to show whether Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck. (more…)

Simply Fresh Fruit of Los Angeles, California has announced a nationwide recall of select fresh cut fruit products that contain cantaloupe that may be have been contaminated with salmonella.  The week, Simply Fresh was requested by its supplier, Tropifresh, Inc. to recall products produced with cantaloupe from Agropecuaria Montelibano.  Simply Fresh began to recover this product earlier, on March 24, based on a notice published by the US Food and Drug Administration (FDA).

Recalled products include:  Simply Fresh Fruit Brand food service Fruit Mix in Syrup products dated “sell by 4 – 18 08” or earlier, food service Cantaloupe Chunks in Syrup products dated “sell by 4 – 08 8” or earlier, and retail and club store Simply Fresh, Fresh  Cut Fruit Brand containing cantaloupe dated “sell by 3 – 29 8”or earlier.  The retail and club store products involved were removed from sale prior to March 24.  Also, foodservice distributors who sell their own brand, have been notified, and are recalling all involved products.  Foodservice products are packed in plastic pails or jars, and retail products are packed in plastic trays.  Food Service establishments who have any of the products involved in the recall should contact their supplier for disposition instructions.  Consumers with questions may contact Simply Fresh Fruit at (323) 586-0000. (more…)

Cough and cold medicines for children under the age of two are being pulled from Great Britain shelves immediately.  At least 100 products will be put under the counter while parents are warned about the danger of giving toddlers potentially fatal overdoses.  This means that many popular medicines will be banned for children under the age of two and parents of children up to the age of six will have to ask for the products specifically.  Some feel the move could signal a return to old-fashioned remedies such as honey and lemon drinks.

Some of the best-selling brands affected include Tixylix, Robitussin, Benylin, and Calpol and the alert involves 12 ingredients in the medicines, many of which have been used by drug firms for years.  At least five deaths of British children under two have been linked to cough and cold medications and over 100 serious cases of suspected adverse reactions have been reported.  A similar warning was issued in here in the US earlier this year following the US government’s first national estimate of the problem wherein about 7,000 children are sent to hospital emergency rooms every year with about two-thirds of the children taking medicines without supervision and one-quarter falling ill when their parents dosed them properly.  In those cases, children developed an allergic reaction or some other problem according to a study conducted by the U.S. Centers for Disease Control and Prevention (CDC).  The CDC studied both over-the-counter (OTC) and prescription medications. (more…)