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

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.

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

The Food and Drug Administration (FDA) has issued a public health advisory stating that the use of Zicam Cold Remedy nasal products should be stopped.  The nasal products are used to help with cold symptoms.  They contain zinc and have been found to cause anosmia.

Anosmia is a condition where the victim loses their sense of smell and partial sense of taste.  The FDA has received more than 130 reports linking the loss of smell to Zicam since 1999.  They are recommending that these products be thrown away immediately.

The products manufactured by Matrixx Initiatives that have been targeted include:
•    Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
•    Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
•    Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

About three years ago, ReNu with MoistureLoc contact lens solution was linked to a medical condition called Fusarium Keratitis.  It is an infection in the eye that is very serious and potentially blinding.

The contact lens solution was recalled from the U.S. in April of 2006 after about 180 cases of Fusarium Keratitis were confirmed.

Other contact contact lens solutions have also been recalled in the past.  Advanced Medical Optics (AMO) sold Complete MoisturePlus solution in 2007.  The solution was linked to 21 cases of infections and the company recalled the product.

Now, the Food and Drug Administration ( FDA) is trying to make the public more aware of the safety precautions that should be taken when dealing with contact lenses.  Earlier this year, they hosted a workshop called “Microbiological Testing of Contact Lens Care Products,” to make a method to test contact lenses and solutions.

There was also a meeting in June 2008 where recommendations were made for the labeling of contact products.  In addition to the expiration date, companies had to also put a discard date on the bottles of solution.  This date is when the bottle should be thrown away after being opened.

The FDA sent out letters to solution manufacturers who added an option of cleaning lenses without rubbing.  The letter stated that there is an improvement in safety when the lenses are rubbed and rinsed instead of just rinsing alone.

Along with the letter, the FDA has made a new video on contact lens safety.  The video can be seen of the FDA website.  Some main points in the video are completely emptying the contact lens case after each use, using the rub and rinse method, use a contact lens solution to clean, rinse, and then air dry contact lens cases after each use, and do not expose contact lenses or lens storage cases to any type of water of non-sterile solution.

Several lawsuits from around the country involving defective Chinese drywall have been moved to a single federal court in New Orleans, Louisiana where they will be presided over by a panel of seven judges.

United States District Judge Eldon Fallon will be in charge of pre-trial procedures. The panel chose Fallon because he has had previous experience in overseeing litigation that started in multiple courts.

The biggest source of lawsuits against home builders, suppliers and manufacturers of the defective Chinese drywall is in New Orleans from Katrina survivors. Unfortunately, many of the houses built and paid for by the victims’ insurance companies contained drywall that secreted sulfuric smells, eroded appliances, and was accused of causing a variety of health problems.

Ten cases from Florida, Louisiana, and Ohio have been consolidated into this one court. In doing this, the government hopes to avoid inconsistent rulings that might occur if similar cases were dealt with by separate judges.

Margaret Hamburg, the new commissioner of the US Food and Drug Administration, has said that her first priority is to reinvigorate the troubled agency. Doing so, she said, will restore its credibility with the public and policy makers.

In an interview with The Wall Street Journal, the commissioner said that she is taking a “hard look” at the medical device division and a “fresh look” at the abbreviated framework it uses to approve many riskier and implantable products. “This is a high priority,” she said.

Scientists at the FDA’s Center for Devices and Radiological Health have sent letter to Congress and the White House alleging that political and corporate influence have trumped science at the division. The device industry is concerned that the FDA or Congress might toughen standards in applying the abbreviated approval process, called 510(k), to devices that would otherwise go through a lengthy review involving more clinical trials and safety data.

A government report in January said that the 510(k) process has been overused.

Dr. Hamburg said that a new transparency task force at the FDA is weighing the need to transmit emerging data about potential drug side effects against claims by corporations that want to keep commercial information confidential.

A recall has been announced on hand sanitizers made by Clarcon Biological Chemistry Laboratory.  The Food and Drug Administration (FDA) reported that the products being recalled contain high levels of disease-causing bacteria.

“Serious deviations” were found in recent tests dealing with government required practices.  According to the statement the analysis, “revealed high levels of various bacteria, including some associated with unsanitary conditions.  Some of these bacteria can cause opportunistic infections of the skin and underlying tissues.  Such infections may need medical or surgical attention, and may result in permanent damage.”

Some of the products recalled include: Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty, and Total Skin Care Work.

The company located in Roy, Utah, has voluntarily recalled the products.  The FDA advises that anybody with these defective products should throw them away immediately.