Older antipsychotic drugs – known as “conventional” antipsychotics – pose an increased risk of death when used to treat dementia in elderly patients, prompting the Food & Drug Administration (FDA) to ask the makers of these drugs to add a black box warning to their labels. In 2005, newer antipsychotic drugs, including Abilify and Risperdal, received a similar warning. The conventional antipsychotics subject to the new black box warning include:

Compazine (prochlorperazine)
Haldol (haloperidol)
Loxitane (loxapine)
Mellaril (thioridazine)
Moban (molindrone)
Navane (thithixene)
Orap (pimozide)
Prolixin (fluphenazine)
Stelazine (trifluoperazine)
Thorazine (chlorpromazine)
Tilafon (perphenazine) (more…)

Food & Drug Administration (FDA) scientists are concerned about Enbrel’s link to fatal infections in kids, and have recommended stronger warnings for the medication. Their findings also make it less likely that the agency will approve the Amgen and Wyeth drug to treat severe psoriasis in children. Enbrel is already approved to treat psoriasis and rheumatoid arthritis in adults and juvenile arthritis in children, and an FDA advisory panel is set to consider expanding its approved uses to include severe psoriasis in children on Wednesday.

Enbrel is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body’s immune system called TNF. Today, FDA scientists expressed concern about broadening the drug’s approval, citing reports of dangerous side effects in children who have already taken the drug. Reports submitted to the agency linked to infections that sometimes led to hospitalization and death. Of the 14 deaths recorded by the FDA, more than half were in children taking Enbrel for arthritis, while the others were among children taking the drug for unapproved uses. The FDA scientists also recommended that stronger warnings about the possibly-fatal infections be added to Enbrel’s label. (more…)

A doctor who is an expert in smoking cessation says federal regulators ignored his concerns about Chantix when he raised them last year. Dr. John Spangler, director of Tobacco Intervention Programs at the Wake Forest University School of Medicine in Winston-Salem, N.C., says that a safety study by researchers employed by Pfizer and published in a relatively obscure medical journal looked at far too few subjects — a total of only 251 taking the drug — to determine whether or not the drug is safe when used over that duration. Yet, the researchers concluded that Chantix could be safely administered for up to one year.

Dr. Spangler also did his own analysis of the Chantix study, and told ABC News that the authors failed to mention that study subjects who took the drug were 2.5 times as likely to experience a serious adverse event – mostly heart and vision problems. Dr. Spangler said the small size of the study made it impossible to determine if the adverse events were the results of chance, or were caused by Chantix. It is Dr. Spangler’s contention that a bigger study must be conducted to determine the safety of Chantix. Until it is done, doctors who prescribed the drug must consider the possibility that an increased risk exists. Though he brought his concerns to the Food & Drug Administration (FDA) in May 2007, the FDA has not asked Pfizer to conduct such a long-term study. (more…)

Ethex is expanding last week’s recall of potentially over-sized morphine tablets that could contain as much as twice the amount of active ingredient than is safe.

Ethex is characterizing the additional morphine tablet recall as a precaution, and says that no additional oversized tablets have been identified in the affected lots. No report of unexpected side effects or injury has been received. However, opioids such as morphine, have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure, apnea, and hypotension. (more…)

The Food & Drug Administration (FDA) now says the number of people sickened by Salmonella tainted tomatoes has grown to 228, and is warning that contaminated tomatoes might still be on the market. The tomato Salmonella outbreak has sent 25 victims to the hospital. Officials from the Centers for Disease Control (CDC) also acknowledged for the first time yesterday that Salmonella from contaminated tomatoes played a role in the death of a cancer patient in Texas.

The tomato Salmonella outbreak began in mid-April, and at that time was centered mostly in New Mexico and Texas. Earlier this week, the FDA warned consumers nationwide 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. (more…)

Senator Charles Grassley (R-Iowa) has written to the Food & Drug Administration (FDA), asking the agency to investigate whether GlaxoSmithKline covered up data on Paxil’s suicide risk.

In September 2004, the FDA issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. The warning followed a report issued by Britain’s Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil. (more…)

Two young women in Europe have died after receiving Gardasil, bringing the total number of known deaths following administration of the HPV vaccine to 5. In the U.S., three young women have reportedly died after receiving Gardasil. However, there could be more such incidents, as health officials believe that adverse effects of medication are widely underreported.

Though no cause of death has yet been listed, the European Medicines Agency (EMEA) says the young women died shortly after receiving Gardasil. The EMEA is characterizing their deaths as “sudden and unexpected.”

(more…)

Officials from the Food & Drug Administration (FDA) and Centers for Disease Control (CDC) say they are still investigating whether tomatoes from Mexico and a few Florida counties are to blame for a Salmonella outbreak that has sickened 167 people across the U.S. While tomatoes from 19 Florida counties have been cleared in the outbreak, several in central Florida, as well as Dade and Collier in the southern part of the state, are still being investigated. Dade County tomatoes account for about 10 percent of the total Florida tomato crop.

Mexican tomatoes are prime suspects in the outbreak. Mexico, the largest exporter of fresh tomatoes to the U.S., supplies most of its tomatoes to the U.S. in the winter months, supplementing Florida’s output. The bulk of Salmonella cases linked to the tomatoes are located in the southwest United States, and there have been no reported illnesses in Florida. (more…)

The Food & Drug Administration (FDA) says it is making progress in tracing the source of a tomato Salmonella outbreak that has sickened 167 people. “We are getting closer to identifying the source or sources,” Julie Zawisza, a spokeswoman for the FDA said late Tuesday. The agency has confirmed the same strain of Salmonella – St. Paul – in 17 states. Twenty-three outbreak victims have been hospitalized, and Salmonella has been listed as contributing to the death of a cancer patient in Texas. The man apparently contracted Salmonella from pico de gallo he ate at a Mexican restaurant.

Since the outbreak began in mid-April, the FDA has been trying to pinpoint exactly where the Salmonella-tainted tomatoes came from. One of the things making the tomato Salmonella investigation so difficult is logistics. Fresh produce increasingly comes from far-away states and even far-away countries, which is why contaminations increasingly crop up across the country. Before the advent of globalization, food poisoning outbreaks from fruits and vegetable were usually isolated to geographic areas near were the tainted food was grown. (more…)

Disturbed by the blinding eye infections caused by tainted ReNu with MoistureLoc and Advanced Medical Optics (AMO) Complete MoisturePlus, a Food & Drug Administration (FDA) advisory panel has called for tougher testing and warnings for contact lens solutions. Critics of contact lens solution makers have long contended that current testing methods are not enough to insure the products’ safety. The FDA is not bound to follow recommendations of advisory panels, but in most cases, it does so.

In 2006, Bausch & Lomb issued a worldwide recall of ReNu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. Following an investigation, the Centers for Disease Control determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. (more…)