The FDA recently added black box warnings to the $10 billion a year anemia drugs Procrit, Epogen and Aransep, citing an increased risk of death, stroke, heart attack and blood clots. The strong new warnings were added after studies showed a higher risk of death and life-threatening side effects in some patients.

These drugs are genetically engineered versions of a natural protein, erythropoietin that increases the number of red blood cells. They are generally prescribed to patients with kidney disease or cancer in the event that they become anemic. However, patients with chronic kidney failure are sometimes more likely to suffer increased risk of death, blood clots, strokes and heart attacks if prescribed too high a dosage of the drugs. In other studies, patients with head and neck cancer had more rapid tumor growth if they used higher-than-recommended doses. Additionally some studies showed an increased blood clot risk among cancer patients who were not receiving chemotherapy and in patients following orthopedic surgery.

The new boxed warning states that Erythropoiesis-stimulating agents (ESAs) increased the risk of death and serious cardiovascular problems when given at higher than recommended doses. The FDA also suggested that higher doses of the dangerous drug could lead to blood clots.

Director of the FDA’s Center for Drug Evaluation and Research, Steven Galson said “The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies. The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting.”

The recent stern warnings will advise physicians to prescribe the lowest possible doses of the EPAs that prevent blood transfusions. Previously, in dialysis patients, doctors would aim for a near normal level of hemoglobin. That required greater amounts of drugs, but it has now been shown to also cause a greater incidence of side effects.

J&J, the world’s biggest maker of health-care products, recalled more than 40 types of medicines this year because of contamination and incorrect labeling.

A group of Johnson & Johnson shareholders accused the company’s directors of ignoring “red flags” foreshadowing product recalls and government probes of manufacturing defects and marketing practices.

The shareholders asked a judge to find that directors and top executives mismanaged J&J and order them to pay damages. They also want J&J to “improve its corporate governance and internal procedures,” according to a complaint filed Dec. 17 in federal court in Trenton, New Jersey. Any money recovered would go to the company and not investors individually.

J&J, the world’s biggest maker of health-care products, recalled more than 40 types of medicines this year because of contamination and incorrect labeling. U.S. lawmakers began investigating J&J after a recall of batches of children’s Tylenol in April forced the company to suspend operations at a Pennsylvania plant. The probe uncovered the use of contractors to buy defective Motrin painkiller.

J&J also faces government investigations into whether it illegally marketed drugs and devices for uses not approved by the Food and Drug Administration and paid kickbacks. On Dec. 17, shareholders amended their so-called derivative lawsuits that seek to force directors and officers to pay the company.

While J&J once set “the gold standard for integrity and excellence,” the directors’ “utter disregard for their fiduciary duties, including permitting and fostering a culture of systemic, calculated and widespread legal violations has destroyed J&J’s hard-earned reputation,” shareholders claim.

Carol Goodrich, a spokeswoman for New Brunswick, New Jersey-based J&J, said the company is reviewing the complaint and has no comment.

Source: By David Voreacos and Alex Nussbaum of Bloomberg News

Agency working with trade associations to increase company vigilance and protect public

In a letter sent to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

The FDA has noted the three most common categories of these illegal products:

* Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
* Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
* Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration in September announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications.

These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
 
Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.
 
Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly. 
 
“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

If you or a loved one has been injured as the result of taking a dangerous drug, seek out an experienced defective drug attorney for professional insight.
 
Source: U.S. Food & Drug Administration

Pfizer Inc. says it is pulling its blood pressure drug Thelin off the market and stopping all clinical trials because the drug can cause fatal liver damage.

Thelin is sold in the European Union, Canada, and Australia as a treatment for pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. Pfizer says a review of clinical trial data and other reports showed a new link to liver injury. Liver toxicity was a known side effect of the drug, the company says.

Since there are other treatment options, Pfizer says the benefits of Thelin don’t outweigh the risks. It is stopping all studies of the oral drug, which Pfizer acquired in 2008 when it bought Encysive Pharmaceuticals Inc.

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

An article in the January 2011 issue of “Vanity Fair” details the globalization of our nation’s pharmaceutical trials.

As recently as 1990, the vast majority of drug trials were conducted in the U.S. or Europe. Today, pharmaceutical companies conduct most of their human testing in India, Africa and China.

It’s a lot cheaper and there are fewer regulations these companies much follow — in fact, in many of these countries, nothing regulates drug experiments on humans.

Further, there is absolutely nothing that demands transparency for these trials which lets drug makers pick and choose which trials they use to apply to the U.S. Food and Drug Administration for permission to market drugs in this country.

The FDA depends heavily on these trials. Because our enforcement mechanisms are so dangerously thing — as demonstrated in the heparin scandal — the FDA has precious little ability to oversee drug trials in this country, much less the more than 6,485 trials conducted overseas (in 2008).

Many of the drugs that are currently facing harsh criticism are the very drugs that relied heavily on these overseas trials. Studies for drugs like Celebrex, Ketek, Seroquel, Avandia and Paxil were conducted overseas, and the results of those trials — usually only the trials that showed the drug in the most positive light — used to gain FDA approval.

Often, these drug companies test drugs on children, even when their own researchers insist that the drug will have a limited benefit. Western countries have rigid regulations about testing on children but these regulations do not exists in most third world countries. Parents of these children — who are often illiterate and quite poor — are paid $350 per child enrolled in these studies but seldom told that they were taking part in an experiment.

The article makes the point that drug makers really do put profit first, and have only passing regard for the lives affected by the dangerous and defective drugs they make.

The article cites on study which revealed that, in 2009, 19,551 people died as a direct result of the prescription drugs they took, and that is just the reported number; only about 10 percent of such deaths are reported.

This puts the number of deaths due to FDA-approved drugs near 200,000 — dwarfing the number of people who die every year in car wrecks.

If you or someone you love has been harmed from using a dangerous or defective drug, please contact an experienced defective drug attorney for professional insight.

Paxil is a popular antidepressant that has a several dangerous side effects, birth defects, pregnancy risks, birth injuries and may even cause death.

Persistent primary hypertension, also called PPHN, is another danger to newborns whose mothers are prescribed the drug during pregnancy

Although Paxil is used primarily to treat depression, many doctors use it to also treat panic disorders, anxiety, and post traumatic stress disorder in millions of people around the world. The Food and Drug Administration advised doctors that prescribing Paxil to children and teenagers could significantly increase the likelihood of violence and suicidal tendencies.

Furthermore, Paxil may also cause a number of serious birth defects. Recent studies have shown that Paxil significantly increased the number of congenital heart defects such as primary pulmonary hypertension in developing fetuses. Two independent studies revealed that among women who took the during their first three months of pregnancy had babies with Paxil heart birth defects at 1.5 to 2 times the rate of normal births.

If you or someone you love has been injured after being prescribed Paxil, or any other defective drug or prescription medication, please contact an experienced defective drug attorney for professional insight.

According to a recent study, DES (diethylstilbestrol) may increase breast cancer risks for DES Daughters, as well as their mothers.

DES, a synthetic form of estrogen, was widely prescribed to prevent premature delivery and miscarriage. However, when given during the first five months of a pregnancy, DES could interfere with the development of the reproductive system in a an unborn child.

Between 5 and 10 million pregnant women were treated with the drug from 1938 to 1971. Studies conducted in the 1950s showed the drug was not all that effective in preventing complications of pregnancy so its use declined — but did not completely stop — until 1971.

A recent study provides initial results linking exposure to DES before birth with increased rates of breast cancer.  The study found that among participants, DES Daughters were more likely to experience breast cancer than were unexposed women.

Further, the study did find that, in women over 40 years old, DES Daughters were two-and-a-half times more likely than unexposed women to be diagnosed with breast cancer.

According to the National Cancer Institute, 16 percent of women prescribed DES during pregnancy developed breast cancer, in comparison with 13 percent of women not prescribed DES. Therefore, it is estimated that one in six women who were prescribed DES will develop breast cancer, whereas one in eight women in the general population will develop the disease.

In a year that’s been dominated by the recall of popular and highly visible drugs, several defective medical devices have also prompted government action.

In addition to last summer’s voluntary recall of DePuy hip replacement systems, Sigma International just announced a voluntary recall of its Spectrum model 35700 infusion pumps manufactured from October 2006 to March 2008.

This recall is being conducted because of the pump’s tendency to fail suddenly without issuing an alarm, the US Food and Drug Administration (FDA) announced today.

The class 1 recall, the most serious kind issued, is the latest in a series of recalls after the launch of an agency campaign in April to address what one FDA official called “rampant problems” with infusion pump technology. Earlier this month, a company called WalkMed Infusion announced it was voluntarily recalling roughly 2000 Triton Pole Mount infusion pumps.

The workhorse model 35700 Spectrum pumps are used to deliver medically necessary fluids like drugs, electrolytes, blood and blood products. The sudden failure of these pumps can cause inaccurate and potentially fatal flow conditions that range from backflow to overinfusion and free flow. Most troubling is the fact that no alarm sounds when these inaccurate flow conditions ensue.

The recalled units bear serial numbers ranging from 706497 to 724065 and Sigma is instructing customers to return the pumps for servicing or replacement.

More information about the announcement is available on the Web sites of the FDA and Sigma International.

If you or someone you love has suffered injury after using one of these pumps, please contact an attorney with experience dealing with defective medical devices.

Source: www.medscape.com

A German newspaper recently reported that letters written by scientists in the UK and Germany indicate that concern was being raised about the pregnancy test drug Duogynon in 1967 – yet it was still being prescribed until at least 1975.

André Sommer from Pfronten, Bavaria, is suing Bayer for the defects he suffered after his mother took the drug while pregnant with him in 1975. He was born with severe problems with his bladder and sexual organs.

His case will be heard soon by the Berlin District Court, and will include the documents which have recently come to light in which doctors wrote to each other about problems they had observed.

“The seeming relation between the increase in birth defects and the sale of the pregnancy test is pretty alarming,” one scientist wrote on November 1967.

“We have to be extremely careful,” when using the drug with pregnant women, another wrote.

Sommer, a teacher, says he is determined to force Bayer to open its files on the matter.

“Why were these gentlemen talking with each other about this internally, but were silent in public?” he asked.

A Bayer lawyer wrote to the court saying that all claims for information and compensation had run out of time – and that there was never any proof of a link between the use of Duogynon and birth defects.

Sources: Der Spiegel, The Local