The drug approved to treat lung and pancreatic cancers called Tarceva has been linked to serious side effects including potentially fatal digestive tract perforations, skin reactions and eye problems. The complications from this defective drug have prompted the Food & Drug Administration to announce new warnings for the drug’s label.

The drug Tarceva is one of a class of cancer drugs known as epidermal growth factor receptor (EGFR) trosine kinase inhibitors, which are treatments designed to block the EGFR protein. This protein is believed to play a role in cancer cell growth.

The risk for gastrointestinal perforations while undergoing Terceva therapy is greatest in patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease. According to the letter, some instances of perforation had been fatal.

In addition, some Tarceva patients had developed bullous, blistering and exfoliative skin conditions, even suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis. Some of the defective drug cases have resulted in deaths.

Once again, the blood-thinning drug heparin has been linked to fatalities in patients. Five patients at Beebe Medical Center in Delaware fell ill after being treated with heparin IV bags. Two of the patients have died.

The IV bags contained diluted heparin that has been approved for a number of blood-thinning purposes. All five bags came from the pharmaceutical company Baxter International. This is not the first time that Baxter has been linked to heparin fatalities. In 2008, they had to recall thousands of cheap, tainted heparin products.

These two recent deaths have prompted the Food and Drug Administration to launch an investigation into the incident. So far, the FDA has not accused Baxter of distributing tainted heparin, nor have they implied that heparin itself may be less safe than previously thought. They said that it was only  “unusual” circumstances in the Delaware deaths that made them decide to investigate.

An independent lab is currently testing the Baxter heparin used at Beebe.

The Food and Drug Administration has announced that the deaths of two patients treated with possibly contaminated heparin may have been an isolated incident.

Five patients recently fell ill in a Delaware medical center after being treated with heparin IV bags supplied by Baxter International. Two of the patients, a 71-year-old man and a 64-year-old woman, have died, and a third patient remains hospitalized. These three people all suffered cerebral hemorrhages.

However, the FDA has found no evidence of contamination, nor have they received additional reports of fatalities or other serious injuries linked to heparin use. The FDA has determined that this incident alone is not enough to make any decisions about the production of heparin. FDA representatives have issued statements that patients should not worry about being treated with heparin.

Anyone who has suffered a defective drug injury should contact an experienced lawyer immediately as they may be eligible to receive compensation through a defective drug lawsuit.

Representatives from several indigenous Arctic communities are attending the fourth meeting of the United Nations Environment Program’s Conference of the Parties of the Stockholm Convention on Persistent Organic Pollutants in Geneva, Switzerland. These UN conferences are devoted to limiting and eventually eliminating pollutant emissions of the most dangerous chemicals.

Arctic communities are key in this battle. It is they who are most affected by air and water pollution worldwide. The Arctic acts as a “cold trap” for both atmospheric and oceanic contaminants that drift to the region. Indigenous communities not only breathe the thin, polluted air but also rely heavily on contaminated sea creatures for sustenance.

Even in low doses, the chemicals the UN is addressing can have harmful health effects including suppression of the immune system, developmental disabilities, diabetes, impairment of reproductive health and cancer.

Chemicals in their air and food also harm unborn children in these areas. Last year, a study conducted by the Alaska State Department of Public Health revealed the highest rate of birth defects in the nation—double the national average. Scientists from the United Nations Arctic Monitoring and Assessment Program discovered in 2007 that there is a gender imbalance in the Arctic areas of Greenland, Canada and Russia caused by the chemicals there. Harmful chemicals are also secreted to young children through breast milk.

The United States has yet to ratify the Stockholm Convention.

The Food and Drug Administration has released warnings about the possibility of serious injuries and even death caused by the cancer-treatment drug Tarceva. Generically known as erlotinib, Tarceva is administered as a once-daily pill taken by the patient on an empty stomach. It is intended to block tumor growth in lung and pancreatic cancer patients.

Serious injuries now associated with Tarceva are fatal holes in the gastrointestinal tract, toxic epidermal necrolysis (blistering and separation of the top layer of skin), corneal perforations, and eye ulcerations.

Tarceva is manufactured by Genentech Inc. and OSI Pharmaceutical Inc. The FDA approved Tarceva in 2004 to treat locally advanced lung cancer and metastatic non-small cell lung cancer.  In 2005, Tarceva was approved to treat locally advanced pancreatic cancer when used in combination with gemcitabine.

Heparin is a drug given to patients to help prevent blood clots from becoming big and causing serious problems.  But now it is being investigated if heparin is the cause of sickening five patients at the Beebe Medical Center in Delaware.

Wallace Hudson, vice president for corporate affairs at the Lewes Hospital, said that two of the sick patients have recovered, and no further cases have been discovered.  It is not certain when samples that have been sent to be tested will come back he said.  “We hope it’s soon.  We don’t want this thing dragging on,” he stated.  “But we need to find out what went wrong and make sure it doesn’t happen again,” he concluded.

The three other patients have been transferred to the University of Maryland Medical Center and the Christiana Hospital.

Baxter Healthcare Corporation is the manufacturer of the heparin.  They recalled batches of the drug in 2008 when the Food and Drug Administration (FDA) found that it was contaminated.

The use of heparin has been suspended at Beebe.  Representatives from Baxter were said to be at Beebe to assist with an examination of the accident.

The ability of heparin to repress clotting and coagulation makes it suspect for serious side effects if given in too large doses.  In itself, heparin is not a defective drug but some shipments of the drug, which were made in China, were tainted.

Three of the sickened patients had internal bleeding according to Hudson.  Beebe has notified the FDA along with the Delaware Health Care Operations Center.

There is a new safety warning in Canada linked to pre-filled saline and heparin syringes.  MedXL Incorporated has received complaints about visible particles and solution discoloration of the syringes according to Health Canada.

Syringes with a lot number between 6892 and 8180 and catalog number 3704, 37043, 37043B, 37043BNC, 3705C, 3705NC, 3706, 3780, 3781, 3786, and 3787 have been subject to the complaints.

The probability of finding a defective syringe is very small, about 12 in a million.  Still, people are being warned to take safety precautions like using aseptic techniques, visually inspect the product for particulate matter and discoloration, and do not use if the solution is discolored or contains a precipitate.

There have been no reported cases of bad reactions linked to the syringes.  The agency has stated that they have implemented the necessary corrective actions to correct the problem.

The drug used for cosmetic purposes and some muscle spasms known as Botox has received criticism for inadequate warnings about off-label uses.

The FDA-approved drug uses a toxin known as botulinium toxin type-A to remove facial wrinkles, relief of excessive sweating, and treatment for cervical dystonia and other facial muscle spasms. The toxin paralyzes the targeted muscles or nerves for an average three to four months.

If improperly used, the toxin (which is essentially the same bacterium that causes botulism) can spread throughout the body, causing muscle weakness, difficulty breathing, blurry vision, bladder control, and even death.

Another concern is the use of Botox to control muscle spasticity in children, including those with cerebral palsy. The FDA has not approved the use of Botox for that purpose; several injuries have been reported as a result of this off-label use.

A May 1 release from the U.S. Food and Drug Administration warns consumers to immediately stop using Hydroxycut products.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant.

One death, of a 19 year-old due to liver failure, has been reported to the FDA.

Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

If you have been harmed by a dangerous or defective drug, you should consider seeking the professional advice of an attorney.

Botox and two other injections have been linked to rare botulism symptoms according to the Food and Drug Administration (FDA).  Botox and other drugs have been approved to treat certain types of muscle spasms, but health officials have warned doctors and patients about potentially deadly risks of using Botox and other drugs.

Although Botox is usually known for clearing the body of wrinkles by paralyzing facial muscles, it is also widely used for muscle-spasm conditions.  But in some cases, the drug can spread to areas outside of the target site and paralyze or weaken the muscles used for breathing and swallowing thus causing death.

Signs of botulism can appear just several hours after injection and include difficulty swallowing or breathing, slurred speech, and muscle weakness.

The FDA stated that it received reports of children being hospitalized and even dying after they were injected with the drugs to treat cerebral palsy.  Most adult cases came when they were treated for muscle spasms and neck contractions.  Some were hospitalized and had to be put on mechanical ventilation to breathe.

The FDA is now requiring manufacturers such as Allergan, Solstice Neurosciences, and Medicis to put additional warnings on their products and conduct safety studies.  The warnings urge physicians to tell their patients about the risks of the drugs and to seek medical help if they show any signs of botulism.  They also have to create pamphlets that tell the risks to patients.

Allergan said that they would cooperate but also stated that the cases of botulism are very rare.  “Botox has been marketed in the United States for nearly 20 years, its safety and efficacy profile are well understood, and reports of suspected distant spread have been rare,” the company said.