Questions are being raised as to the adequacy of the Food and Drug Administration’s handling of the contaminated blood thinner Heparin earlier this year. It is thought that the FDA misreported deaths tied to the product and didn’t thoroughly investigate the problem. It appears that the FDA released conflicting statements to the public and Congress about the number of deaths tied to contaminated Heparin.

The FDA said it linked three deaths to the defective drug in May, but last month claimed that only two of the deaths were possibly linked to Heparin when reporting to congressional staff.

Baxter International Inc., a company involved in the scandal, did its own investigation of the deaths and concluded that Heparin was not the likely cause in the three cases. Their investigation included obtaining medical records from patients, visiting a hospital where one of the patients had gone before dying, and interviewing pharmacists and nurses.

The FDA didn’t follow up with a clinical staff at the hospitals, talk with Baxter to find out further information about deaths, or access other medical databases it uses to evaluate drug safety problems.

In the past month, the FDA has issued an import alert detaining ALL milk products, milk derived ingredients and finished food products containing milk from China due to the presence of melamine.

These foods include both human foods (bakery products, cereals, cheese, ice cream, soft drinks, and candy) as well as several types of pet foods (pet cat foods, pet dog foods, pet fish foods, other pet foods, laboratory animal feeds, pet and laboratory animal foods, byproducts for animals, dairy byproducts for animals, and animal waste feed products) imported from China.

According to the FDA, the melamine milk contamination started in infant formula but “these contaminated milk components appear to have been dispersed throughout the Chinese food supply chain…Reports of contamination have come from more than thirteen countries in Asia, Europe, and Australia, in addition to the United States.”

Time magazine has reported that the Chinese government continues to downgrade the severity of the problem. Some believe that the contaminated foods are “one of the most important factors resulting in the soaring number of birth defects in China.”

According to a report published on Bloomberg.com, scientists and physicians at the Food & Drug Administration (FDA) have charged that the agency has corrupted the process by which new medical devices are approved.

The names of scientists who made the charges, as well as the devices to which they refer, have been redacted in the copy of a letter released to the public.

But the allegations in the letter are troubling. The scientists charge that misconduct by managers at the FDA Center for Devices and Radiological Health (CDRH) “is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans.”

The letter was sent to members of the House Energy and Commerce Committee, the Congressional arm that provides oversight of the FDA.

Labels on the antipsychotic drug Zyprexa don’t warn patients of all its potential side effects.

That’s according to the FDA which says it is looking into requiring the drugs’s manufacturer, Eli Lilly,  to include information about some of the drug’s more recently publicized risks and adverse effects such as weight gain, in children, hyperglycemia, and other metabolic effects.

While Zyprexa—a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania—is only approved for the treatment of schizophrenia and bipolar disorder, it was marketed for use in milder cases of bi-polar disorder and for dementia.

Also, internal Lilly documents and e-mail messages confirm Lilly marketed Zyprexa off-label. It was later found that Zyprexa can cause severe weight gain and an increase in blood sugar in many patients.  According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.

Last month, Lilly, in its ongoing Zyprexa scandal, agreed to pay $62 million to 32 states and Washington, D.C. to settle claims it improperly marketed Zyprexa.  CNN reported in an earlier release that, since 2005, Lilly has paid out over $1 billion in liability claims connected to Zyprexa.  CNN also pointed out that Lilly faces more problems, including a civil and criminal investigation led by federal prosecutors in Philadelphia.

The dangerous diet drug fenfluramine, an ingredient in Fen-Phen, may continue to damage the heart years after a patient stops taking it, according to a study published in BMC Medicine.  The study has shown  that people who stopped using Fen-Phen 11 years ago had damaged heart valves up to seven years later.

The study, conducted by researchers at the Central Utah Clinic, involved both fenfluramine and dexfenfluramine, another diet drug that is closely related to fenfluramine.  The Food & Drug Administration (FDA)  ordered fenfluramine and dexfenfluramine off the market in September 1997 after those drugs were linked to heart valve problems. Since its withdrawal, tens of thousands of lawsuits have been filed against the maker of fenfluramine by people injured by the drug.

This is the largest study to examine duration of exposure to the drug and the first to estimate the incidence of heart valve surgery among prior users. The researchers looked at 5,743 former users of fenfluramine and/or dexfenfluramine.

The patients were seen by doctors at the Central Utah Clinic between July 1997 and February 2004.  Each patient got an echocardiogram and 1,020 patients got two or more echocardiograms 30 months apart, on average.

When the study started, nearly 20% of the women and almost 12% of the men had at least mild regurgitation through the aortic valve or moderate regurgitation through the mitral valve.  Women, and people  who used the drugs the longest were most likely to have such problems.

Follow-up echocardiograms showed that aortic and mitral regurgitation usually stayed about the same or worsened, but improved in some cases. Thirty-eight patients — less than 1% — got heart valve surgery. Such surgery wasn’t common, but it was more common than in the general public, and in 25 cases, heart valve damage was linked to the drugs.

“We found clear evidence for a strong, graded association between duration of exposure to fenfluramines and prevalence of aortic regurgitation and for mild or greater mitral and tricuspid regurgitation,” lead researcher Charles Dahl, told Science Daily.

Chantix has been linked to 10 suicides in the United Kingdom, according to that country’s health regulators.

This is the first time officials at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have revealed the link between Chantix and suicide in that country.  Earlier this year, the U.S. Food & Drug Administration (FDA) said it had linked 37 suicides to Chantix.

Chantix, approved in both the US and Britain in 2006, works by blocking nicotine receptors to the brain. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

But the drug has been the subject of disturbing side effect reports.  In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning – the agency’s highest safety alert.

In the UK, where Pfizer sells Chantix under the name Champix, the MHRA website says a total of 24 people taking the medication have died, and of those, 10 were suicides. A further 213 claimed they had experienced suicidal thoughts and 407 said they were suffering depression.

The MHRA also says the number of users reporting adverse side effects while using Chantix  has doubled in the past seven months – up from 1,811 in February to 3,541 in September.  The British health watchdog is now  warning doctors and nurses to monitor the effects of the drug on smokers over the New Year, when many will try to kick the habit.

Last December, the European Medicines Agency ruled that the  inserts in boxes of Chantix be updated to include warnings about suicide and depression.

The Associated Press (AP) is reporting that Minnesota has joined many states seeking compensation from Lilly over the way it has marketed its popular anti-psychotic drug, Zyprexa.

Minnesota has joined several other states insurers, pension funds and unions accusing Lilly of concealing Zyprexa’s tendency to cause weight gain and diabetes and of marketing the drug for off-label uses.

The AP report notes Minnesota spent over $175 million through public health programs on Zyprexa prescriptions between 2000 and 2007.  The lawsuit helps the state learn more about the drug’s impact on Minnesota through the discovery process.  Lilly just recorded a third-quarter loss largely due to a $1.4 billion charge related to the investigation of Zyprexa marketing practices.

Zyprexa is a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania; however, internal Lilly documents and e-mail messages indicate Lilly marketed Zyprexa off-label.  Zyprexa can cause severe weight gain and an increase in blood sugar in many patients.  According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.

The people who manufacture a machine touted as a way to increase “inner-connectively to your DNA,” has been ordered to recall the device because it doesn’t do anything it claims to.

The Food & Drug Administration (FDA) has issued a Class I recall for the Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator sold by VIBE Technologies of Colorado.

The FDA says that that the VIBE Machine is not approved, and that the company’s claims that it can be used to treat or cure medical conditions and diseases such as cancer, depression, infection, and pain are unproven.

The company had further claimed that the machine “is a technological breakthrough that enhances the human body by helping it reach its optimum vibrational energy level.”

According to the FDA, it does no such thing.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Watchers of the U.S. Supreme Court seem to agree that the high court will likely rule in favor of a drug manufacturer in a case that saw a Vermont woman loose her arm to gangrene.

However, consumer advocates appeared relieved that the case will affect only situations where there were no allegations that drug companies tried to hide information about potential risks and where the FDA rejected stronger label warnings.

The case, Wyeth v. Levine, has been billed as a major milestone in an effort by the pharmaceutical and other industries to free themselves of unpredictable state court personal injury litigation by embracing instead a single federal regulatory regime — in short, federal pre-emption of state courts.

In 2000, Vermont guitarist Diana Levine went to a clinic seeking relief for her migraine. She was injected with the Wyeth drug Phenergan by means of an intravenous method that was discouraged but not forbidden by the labeling, which had been approved by the Food and Drug Administration.

But based on arguments before the high court Monday, the case could be decided narrowly, giving little guidance about broader pre-emption issues beyond the area of drug labeling.

If you’re driving and you black out or have a seizure, you’ll likely have a car wreck.

That makes sense, of course, but you might not be aware that one of the side effects of the smoking cessation drug Chantix is patients could unexpectedly have a seizure and black out.

Since the drug was approved for use in early 2006, Chantix users reported more than 1,000 seizure incidents. Of those, 52 caused the individual to black out momentarily.

Other side effects of Chantix include suicidal thoughts and tendencies and, allegedly, 40 suicides, though there have been no conclusive link discovered. However, the FDA is considering modifying the drug’s label to include the risk of developing seizures.

Patients who have suffered from either of the drug’s side effects should not only discontinue use of Chantix, but may also wish to speak with their doctor as well as an experienced Chantix attorney on the development of litigation.