Accutane has millions of victims — people who believed the acne drug would forever cure the nasty pustules scarring their faces. And it did. But thousands ended up with life-changing diseases of the intestines. When Accutane came on the market in 1982, it was hailed as the long-awaited miracle cure for the scourge of acne. Millions clamored for prescriptions from doctors, even those with mild cases of acne. Unknowingly, many were opening the door to a lifetime of pain and disability caused by Crohn’s Disease, ulcerative colitis and inflammatory bowel disease.

During much of Accutane’s 27 years on the market, its maker knew of its potential to cause these devastating diseases of the gut, but kept it a secret. Accutane’s manufacturer made billions at the expense of its victims. One victim, who had to have his colon replaced after taking Accutane, won a $25 million settlement. Other victims have filed suit as well.

Watch out for these two antidepressants. Some want Paxil and Zoloft banned for causing the most serious birth defects that newborns can have. Neither drug has received enough publicity to make sure that newly pregnant women, or those thinking of having a baby, are aware of their impacts on developing fetuses. And that can lead to the tragedy of a severe birth defect, or defects, for a newborn and its parents.

The Mayo Clinic’s website says that clinically depressed women who stop taking these drugs during pregnancy may neglect their own health. That could hurt the fetus too. But its website does not endorse the drugs. Rather, the federal government urges extreme caution when it comes to taking these drugs during pregnancy.

In 2005, the Food and Drug Administration (FDA) strengthened its warning about Paxil, citing new studies proving that women who took that drug during the first three months of pregnancy were 1.5 to 2 times more likely to have a baby with serious heart defects compared to women who took other anti-depressants or those who took none. In 2009, the FDA issued an even stronger warning citing cases in which newborns died within hours of being born due to serious birth defects of the lungs caused by Paxil.

Zoloft can cause holes in the heart, partially developed hearts, malformation of the heart’s valves, PPHN (a condition in which the lungs do not get enough oxygen), spina bifida (a condition in which the spine does not close), cleft palates and intestines or other organs that stick out of the navel, called omphaceles.

Many mothers who took this drug for depression while they were pregnant found out too late that it can cause serious, even life-threatening birth defects.

This is yet another case in which a big pharmaceutical company should have warned the public about the side effects of a drug it was selling, but didn’t. Instead, GlaxoSmithKline hid evidence that Paxil could cause birth defects. In a secret 1997 memo, five years after Paxil went on the market, a Glaxo executive wrote about about the need to “bury” evidence linking Paxil to birth defects.

Contents of the memo were revealed in a 2009 trial by lawyers for parents whose son was born with three serious heart defects. Glaxo lost the case and had to pay the family $2.5 million in compensatory damages. According to Bloomberg News, evidence at the trial showed that Glaxo “purchased….Paxil from a Danish company that had done animal studies showing that young rats died after taking low doses of the drug.”

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Warning for pregnant moms: Avoid anti-depressant Paxil at all costs

Depression, not joy, often arrives with pregnancy. Doctors point to fluctuating hormones as the cause. But beware of using Paxil for the “new mommy” blues. This prescription drug can cause serious life threatening birth defects of the heart, lungs and other vital organs.

The U. S. Food and Drug Administration (FDA) approved Paxil in 1992. The government came back six years ago with a serious warning about it that said: “…The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about two and a half times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population.”

Thousands of prescriptions for Paxil were written in the 13 years that it was on the market before the public knew it could cause potentially fatal birth defects. In 2009, a family won $2.5 million from a jury after their baby was born with three heart defects. Their lawsuit revealed that GlaxoSmithKline (GSK) knew as early as 1980 — from animal studies it conducted — that Paxil could cause birth defects. Since then, hundreds of lawsuits have been filed against Paxil’s manufacturer.

Given the company’s record of putting profits before safety, women who took Paxil while they were pregnant and had a child with serious heart and lung defects should contact a personal injury lawyer for assistance. Read the rest of this entry

You’ve been to the doctor and you have a prescription for what ails you. Now you know you will get better.

Don’t count on it. The drug you are taking might have been tested in a foreign country or manufactured there. Who knows if the drugs are reliable? The federal government doesn’t. The fact is, 200,000 Americans die every year from drugs that have been approved for sale in the United States after being tested or made abroad under conditions that are hard to investigate.

What’s causing this appalling situation? In a word, globalization. More and more big drug companies are testing their new drugs overseas where the Food and Drug Administration has no control over the clinical trials the companies conduct to convince the federal agency that the drugs are safe.

In 2008, “…80 percent of the applications submitted to the FDA for new drugs contained data from foreign clinical trials,” according to an investigative report in the January 2011 issue of Vanity Fair.

Big drug companies are visiting small towns in Romania, Estonia, northeastern China, India, Malawi, Latvia and other little known corners of the world looking for foreign citizens willing to test their new drugs in clinical trials. The “drug naive,” as the article calls them, are cheap to recruit in places where people only make a few dollars a day. Some of those who take the drugs think they are getting help for a disease when they are only getting a placebo. Others may never have taken medicine of any kind so test results can look better than they might if the drugs were tested in the United States. Vanity Fair ‘s investigative reporting found these and other shocking facts about foreign testing of new drugs that it details in its January 2011 magazine.

Celebrex, as Americans belatedly learned after a significant number of deaths, can cause strokes and heart attacks. The drug underwent 290 studies before it went on the market in the United States. But only 183 of those tests took place in the U.S. Millions took the drug. At the peak of its popularity in 2004, sales of Celebrex reached $3.3 billion.

In 2008, The Washington Post reported that Heparin, a blood thinner made from the intestines of Chinese pigs, caused “hundreds of serious adverse reactions and scores of deaths” when it was contaminated during a production process in that country. Ketek, an antibiotic that can cause liver and kidney disease, is another example of a drug tested in a foreign country and then sold in the U. S. Unfortunately, the problem is growing.

Clearly, the FDA hasn’t kept up with the drug industry’s deadly push for profits. The United States has no “chain of command in modern American drug testing,” according to Vanity Fair. That leaves average Americans facing a potentially deadly problem that‘s hard to avoid.

Even the most conscientious parents and caregivers can inadvertently harm children with liquid medicines for colds, coughs, allergies and stomach aches these days. A new study in the Journal of the American Medical Association says that dosing instructions, measuring cups and even droppers packaged in these over-the-counter remedies are confusing. Consequently, children can be under-dosed or over-dosed. The study examined 200 popular medicines for children 12 and under.

According to the Los Angeles Times “….more than one-quarter of these products failed to include a measuring device in the package.” Others had instructions that were at odds with the device that was included. Some of the measuring devices were not properly marked: The instructions called for a teaspoon while the device was marked in milliliters.

While many of the differences don’t cause serious health consequences, some do have that potential. As the Times report noted, “…several days of overdosing with products that contain acetaminophen can cause serious damage to the liver.” Under-doses of liquid medicines for pediatric cold, cough, allergy and stomach medications can leave a child in pain.

The study called the problem widespread given the popularity of the 200 top-selling products it tested for measuring discrepancies that could lead to under- or over-doses of these medications. It was conducted at the New York University School of Medicine and Bellevue Hospital Center.

Women who took Paxil during the first trimester of their pregnancy and gave birth to a baby with serious heart or lung defects now have more potential evidence to use in court against GlaxoSmithKline. The international drug manufacturer was hit with a record breaking $750 million fine last month for knowingly making and selling prescription drugs that were “adulterated.” Paxil was one of the drugs. Now there is more reason to doubt the company’s claims that Paxil was not responsible for their children’s birth defects.

GSK must pay a $150 million fine to the U.S. Justice Department plus $600 million in civil penalties to federal and state authorities. The drugs were made at a plant in Puerto Rico between 2001 and 2005. They include Kytril, Bactroban, Paxil CR and Avadament. The drugs are used to treat infection, nausea, depression and Type II diabetes.

Prosecutors said the drugs did not conform to American manufacturing standards designed to ensure the purity and safety of prescriptions. They also said the fines show that the
Federal Government will come down hard on any drug company that sells substandard drugs in the United States.

In 2009, the family of a child born with three holes in his heart after his mother took Paxil while she was pregnant was awarded $2.5 million. A jury in Philadelphia ruled that GSK failed to test Paxil properly and did not reveal information about its potentially devastating effects on developing fetuses, especially in the first three months of pregnancy. According to the Food and Drug Administration, women who took Paxil during their early pregnancies “were about one and a half times as likely to have a baby born with a heart defect” as women who took other anti-depressants or women in the general population.

Scientists now say that severe, nodular acne can cause a depression so deep, it can lead to suicide. Acne’s pustules and facial scars destroy self-confidence and limit social life because others may avoid sufferers for fear of being infected even though acne is not spread by physical contact.

Even mild acne is emotionally disturbing. So, it’s no wonder that millions of people took Accutane to get rid of the condition, putting them at risk of developing two devastating diseases of the gut. As we know now, Accutane can cause ulcerative colitis and Crohn’s Disease – lifelong, life-threatening intestinal ailments. It was on the market for 27 years from 1982 to 2009. Anyone who developed either disease within five years of taking Accutane should contact a personal injury lawyer. One Accutane victim was awarded $25 million by a Jury in New Jersey after having his colon removed as a result of taking Accutane. Accutane’s manufacturer, Hoffmann-La Roche took the drug off the market in 2009. The company is now defending itself against a flood of lawsuits.

There’s no surprise here. Accutane was the go-to drug for serious cases of acne for nearly 30 years before it was taken off the market in 2009 by its manufacturer, Hoffman-La Roche. While Accutane stopped acne dead in its tracks in almost 95% of cases – patients called it miraculous – a llittle publicized side effect was creating thousands of victims. Accutane was connected to serious diseases of the intestines in some patients. Information about Accutane’s link to ulcerative colitis and Crohn’s Disease exploded into the news this past February when a New Jersey jury awarded an Alabama man $25 million. Andrew McCarrel had to have his colon removed after taking Accutane. The drug’s maker, Hoffman-LaRoche, is based in New Jersey. Thousands of law suits against Acutane’s maker have now been filed. More are on the way.
Ulcerative colitis causes inflammation and ulcers in the intestine. It’s a serious disease that causes pain, fever, chills and profuse diarrhea. It’s been linked to colon cancer. Life-threatening complications include hemorrhage and colon rupture. Crohn’s Disease is also a serious inflammatory disease. It can cause lesions anywhere from the mouth through the entire intestinal tract. While both can be treated, there is no cure.

Anyone who developed these diseases within five years after they stopped taking Accutane should investigate their legal rights at www.accutane-lawsuit-lawyer.com.