Posted On: May 29, 2009

Analysis Shows Risk of Perforated Stomach or Bowels Rises Sharply With Use of Cancer Drug

In a meta-analysis of 17 studies, researchers have found that the cancer drug Avastin substantially increases the risk of developing holes in the stomach and intestines, U.S. News & World Report said May 25. Researchers looked at 17 studies of Avastin, none of which have proven a significant association between the drug and perforations in the gastrointestinal tract. However, in their analysis, the researchers at Stony Brook University Cancer Center in New York found that patients were twice as likely to develop perforations when they took Avastin, and that the rate of perforations went up as the dosage did.

Avastin (bevacizumab) is approved in the United States to treat several types of cancer. In fact, the FDA in early May approved the drug for treatment of brain cancer. It attacks cancerous tumors by preventing new blood vessels, which keep cancer tissue alive, from forming. In the Stony Brook study, researchers looked at 17 studies involving nearly 13,000 patients who received Avastin along with chemotherapy. Those who received 2.5 milligrams of Avastin were 61% more likely to develop perforations than those not taking Avastin. At twice that dose, 5 milligrams, patients were 167% more likely to develop a perforation. The risk was highest in patients with coleorectal and renal cancer and lowest in those with pancreatic cancer.

Perforations in the stomach and bowels are a serious and potentially life-threatening medical emergency. When these holes develop, they allow stomach acids, food and feces to leak from the organs where they belong into the abdomen. This leads to a bacterial infection of the abdomen called peritonitis. Patients feel abdominal pain that gets worse when they move, nausea, vomiting and sometimes fever. Doctors generally must perform surgery to close the hole and wash away the matter that leaked.

As a Missouri prescription drug injury attorney, I am disappointed to learn that there’s accuracy to reports of Avastin’s dangers. This is the first strong evidence connecting Avastin to stomach and bowel perforations, but other studies have turned up evidence for the association. In fact, the drug was approved for use in breast cancer patients over the objections of the FDA’s own panel of experts. Avastin didn’t seem to prolong lives, they argued, so those and other side effects may not be worthwhile. Nonetheless, it was approved and now carries a black box warning, the strongest available, about its potential to cause gastrointestinal problems.

If you are taking Avastin and you believe it’s responsible for holes in your digestive tract that led to a medical emergency, you should call The Lowe Law Offices as soon as possible. People should never be injured or killed by prescription drugs that are supposed to help. If the drug’s manufacturer failed to warn patients and the public about this risk, patients who were harmed have the right to sue the drug manufacturer for all of their physical, financial and emotional injuries. That includes the cost of more medical care and all other costs related to the injury, as well as the physical pain, emotional trauma and any death or disability caused by the defective drug.

Based in St. Louis, the Lowe Law Offices is a national law firm specializing in representing people who were hurt by dangerous prescription drugs or lost a loved one. Our Illinois defective drug lawyers represent people in the Midwest and around the United States. And we offer free, confidential consultations, so you risk nothing to learn more about your rights and any potential case. To set up an appointment with an experienced dangerous prescription drug attorney, please contact us online or call toll-free at 1-877-678-3400 today.

Posted On: May 19, 2009

Watchdog Group Asks FDA to Add Warning on Label of Constipation Drug That May Cause Miscarriage

Consumer advocacy group Public Citizen has asked federal regulators to require a black box warning on the label of a drug it says may induce miscarriage or premature labor, the Associated Press reported May 6. Amitiza (lubiprostone) is prescribed to people who suffer from chronic constipation, but it is chemically similar to misoprostol, which can induce labor and miscarriage in pregnant women. Amitiza’s label currently warns that the drug has not been tested in pregnant women and that they should use it only if the benefits outweigh the risk to the fetus, but Public Citizen wants a stronger label. Neither the FDA nor the drug’s maker, Sucampo Pharmaceuticals, commented for the story.

Amitzia, which is considered less addictive and easier to tolerate than older laxatives, was prescribed more than a million times in 2008. Its chemical cousin, misoprostol, is approved for treatment of gastric ulcers in the United States. However, misoprostol also causes uterine contractions and thins the cervix, which is why it is widely used off-label, and approved in other countries, to induce labor and end pregnancies. In fact, it may be prescribed with the abortion drug RU-486. It is also used when a natural miscarriage or other obstetric problem leaves tissues in the uterus.

It is unclear whether Amitzia has similar effects. No studies have been done examining the drug’s effect on human pregnancies, but studies with Guinea pigs have shown a 4% miscarriage rate. For that reason, it is still available to pregnant women, although its label suggests that they weigh the risks of using Amitzia against its benefits. A spokesman for Public Citizen called that label “grossly inadequate” and lacking in useful information.

As a defective prescription drug attorney, I agree. While I am sure most patients will do what’s best for their unborn children, they must be armed with good information to do so. As things currently stand, they must rely on a doctor or their own self-directed research to find that information. History has shown over and over again that pharmaceutical companies cannot be trusted to disclose information that might hurt their drugs’ sales. Pregnant women taking Amitzia could run extremely serious risks -- inducing a miscarriage or giving birth prematurely, which can cause death and serious birth defects in the baby and is also extremely expensive. Until quality studies in humans establish that Amitzia is safe, women should at least be clearly warned of the risks.

The dangerous pharmaceutical lawyers at The Lowe Law Firm represent victims of just this kind of oversight -- people who were hurt by a drug that was supposed to help. Based in St. Louis, we handle defective medication lawsuits for victims in Missouri, the Midwest and around the United States. If you’ve been seriously harmed or lost a loved one to a defective prescription drug, we would like to help. To learn more, please contact us online today or call toll-free at 1-877-678-3400.

Posted On: May 13, 2009

Heparin-Linked Deaths Spur Fears About Repeat of 2008 Contaminated Prescription Drug Recall

Federal regulators and pharmaceutical company Baxter International are investigating the cause of two deaths linked to blood-thinning drug heparin, the Wall Street Journal reported May 11. Two patients at a hospital in Lewes, Delaware died after using the heparin, and a third suffered unspecified medical problems; a spokeswoman for Baxter said their symptoms include intracranial bleeding. A hospital administrator told the newspaper that the problem had not yet been identified, but the use of heparin was the only thing they found tying the three cases together.

This is the second serious safety problem in two years for heparin and Baxter. Heparin is a blood thinner, used to treat dangerous blood clots, certain heart problems and people on life support. Contaminated heparin imported from China killed 81 people and sickened 785 more in 2008, sending them into shock and dangerously lowering blood pressure. The culprit was oversulfated chondroitin sulfate -- a supplement that is cheaper than heparin but mimics its effects, suggesting that it was used intentionally to cut costs. In response, Baxter and other manufacturers were forced to recall their versions of the drug. However, the article noted, the drug in the current outbreak comes from a North American source and patients’ symptoms are different.

As a dangerous prescription drug attorney, I hope regulators can find the problem and recall any tainted medication before more patients fall ill. The symptom mentioned in the article, intracranial bleeding, is the medical term for a hemorrhage inside the skull, including in the brain. This is considered a medical emergency because it can create pressure inside the skull that leads to brain damage -- and thanks to the heparin, the bleeding won’t be stopped by the body’s natural blood clotting ability. Patients with the serious medical problems treated with heparin are already weak, and they tend to be older -- those who died in Delaware were 64 and 71. A drug that causes severe pressure on the brains of these patients could kill them or leave them with permanent brain damage.

Based in St. Louis, The Lowe Law Firm represents clients throughout the Midwest and the United States who have been seriously harmed by a defective pharmaceutical product. Our defective medication lawyers help people who fell ill or lost a loved one to a dangerous drug hold pharmaceutical companies legally responsible for their actions. In a drug injury lawsuit, you can claim compensation for a death, serious illness or permanent disability, as well as compensation for all of the medical costs caused by the drug’s flaws. To learn more about how you can take action at a free, confidential consultation, please contact The Lowe Law Firm online today or call us toll-free at 1-877-678-3400 from anywhere in the United States.

Posted On: May 7, 2009

FDA Announces Safety Recall of Diet Aid Hydroxycut Following Cases of Liver Damage and Death

The U.S. Food and Drug Administration has warned consumers that they should immediately stop using an over-the-counter diet aid called Hydroxycut, the Associated Press reported May 1. The dietary supplement is associated with serious liver problems, the article said, including the death of a teenaged boy. Its maker, Iovate Health Sciences, has agreed to recall all 14 Hydroxycut products. Consumers who have any of those products should return them to the store where they were purchased, an FDA press release said, and report any negative effects of using the supplement to their doctors and the FDA. More information from Iovate can be found at HydroxycutInformation.com.

Hydroxycut is one of the most popular weight-loss supplements on the market, selling 9 million packages last year according to the Associated Press. The FDA recalled it after receiving 23 reports of serious liver problems in otherwise healthy people, including the death of a 19-year-old young man from liver failure. (Iovate disputes that Hydroxycut was responsible for the death.) Patients using the recommended amount of the supplement have reported jaundice (a yellowing of the skin), seizures, heart problems and a form of muscle damage called rhabdomyolysis, which can lead to kidney failure. Symptoms of serious liver problems include jaundice, brown urine, excessive tiredness, nausea and vomiting, itching and loss of appetite.

It is unclear which ingredient in Hydroxycut is behind the liver problems, the Associated Press said. The FDA does not have the power to review or test supplements before they go on the market, and Iovate has changed the supplement’s formula several times. However, a safety researcher interviewed by the Associated Press said the problem may be a fruit enzyme called hydroxycitric acid, which has been linked to liver problems in a scientific study.

As a Missouri dangerous drug attorney, I fear that this may only be the beginning of larger problems with this supplement. Hydroxycut is one of the most popular weight-loss supplements on the market, selling tens of millions of units over seven years. With so many users, it’s possible that far more than 23 users have encountered problems, but not connected them to using the supplement. Unfortunately, this is especially likely because the FDA has little regulatory power over dietary supplements. Instead, it must rely on post-consumption reports of problems from users of the supplements, and many consumers -- or their doctors -- don’t think to report their problems right away. In fact, the death believed to be related to Hydroxycut took place in 2007, but was reported only in March.

If you are one of the thousands of Americans who has used Hydroxycut and you now believe it’s responsible for serious health problems, you have legal rights. In a dangerous drug injury lawsuit, you can claim payment for all the medical treatment related to the supplement’s defects, as well as lost wages and compensation for your injuries. The Lowe Law Firm can help. Based in St. Louis, Missouri, our pharmaceutical liability lawyers represent clients around the nation who have been hurt by defective medications and dietary supplements.

If you would like to learn more about your rights and your options at a free, confidential consultation, please contact the Lowe Law Firm online or call toll-free at 1-877-678-3400 today.