Archive for the ‘ FDA ’ Category

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.

You don’t want egg in your beer


That good old World War II phrase – meaning you’ve got it good without the extras – could be used to describe the American breakfast today: Eat your bacon and biscuits but skip the eggs. Since May, eggs contaminated with salmonella have sickened more than 1,500 people in the United States, leading to the largest egg recall in American history.

It was bound to happen. The U.S. egg industry has escaped federal regulation for decades. It’s a $4.4 billion industry that’s had little if any oversight despite pleas from consumers, public health experts and economists. The lack of supervision stems from what The Washington Post calls the “Balkanization” of federal agencies that are supposed to regulate food production in the U.S.

According to the newspaper, more than 15 federal agencies and 71 interagency agreements are involved in monitoring food in America. The proliferation of agencies results in serious safety gaps that expose the public to potentially deadly salmonella infections and other ailments that threaten health and waste tax dollars.

Since the May recall, a congressional investigation, a federal criminal investigation and several lawsuits have been filed over eggs contaminated with salmonella at two huge Iowa egg farms said to have caused the latest outbreak. Federal investigators found the farms had chicken coops piled high with manure and other contaminants.

Twenty years ago, experts warned that salmonella in eggs could be a public health threat. In July, the first federal regulations of egg production in the United States took effect.

Is Yaz really the jazziest thing ever?

Doesn’t look like it, these days. Anyone using Yaz or Yasmin for birth control or any other reason had best check this out: More than 1,000 lawsuits now claim that the drugs have life-threatening side effects, including blood clots in deep veins, strokes, heart attacks and gallbladder disease.  The April 19, 2010 issue of The Los Angeles Times had an in-depth story about charges against the drugs. Suspicion centers on drospirenone, a synthetic progestin that some studies say is causing the danger. They show that it has a six-fold greater risk of blood clots even in healthy young women. Other studies say it poses no greater risk.

Meanwhile, Bayer HealthCare had to change its advertising campaign for the drugs after the Food and Drug Administration charged it with overstating the drugs’ beneficial effect on premenstrual dysphoric disorder (severe depression, anxiety, headaches and other symptoms) while downplaying its risks. More studies that focus on its risks are underway. Public Citizen, a Washington, D.C. based non-profit watchdog, has the drug on its Do Not Take list.

Medicines that can injure and kill

Medicines that can injure and kill

Medicines that can injure and kill

The makers of Paxil, Reglan and the Duragesic Pain Patch – all prescription drugs – are facing lawsuits across the country. Paxil can cause fatal birth defects. Reglan can cause permanent, jerky body movements. The Duragesic patch can deliver a fatal overdose of a powerful narcotic. Anyone experiencing these side effects or who has lost a loved after taking these drugs should consult an attorney.

Paxil: If pregnant women take Paxil their babies can be born with fatal heart and lung defects. Paxil is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post traumatic stress disorder and premenstrual dysphoric disorder – conditions that cry out for relief. But it is highly addictive and can cause dangerous withdrawal symptoms, including suicide.

Reglan: If this drug is taken for an extended period (three months) it can cause permanent involuntary movements: lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking and pursing of the lips. Reglan is used to treat heartburn and acid reflux that does not respond to other drugs.

The Duragesic Patch: If these pain-killing patches leak, they deliver an overdose of Fentanyl, a narcotic that is 80 times stronger than morphine. Even after a patch with a crack has been removed, the overdose remains in the system for up to 72 hours. Duragesic patches are prescribed for cancer patients and others with chronic pain who have been taking prescription pain killers for some time. The patches never should be prescribed for anyone who has not previously been on pain medication.

“Bad Drug” Warning For Reglan

Imagine being unable to stop smacking your lips, making faces or sticking out your tongue. How about constant blinking or moving your eyes, arms, legs or fingers? If you’ve taken Reglan and this happened to you, you could have Tardive Dyskinesia. It’s a side effect that is rarely reversible. Although there is no known cure, some symptoms may diminish once victims are off the drug.

In February 2009, the U.S. Food and Drug Administration (FDA) slapped a “Black Box Warning” on Reglan, the strongest alert it can put on a medication. It also ordered Reglan’s manufacturer, Wyeth, to display the Black Box warning on prescriptions for Reglan and develop a medication guide for patients that discusses the risk. The federal agency also warned that Reglan should not be taken in large doses or for more than three months.

Reglan is the brand name of metoclopramide, a drug used to treat GERD (gastroesophageal reflux disease), a severe form of heartburn and related conditions, including heartburn in diabetics (diabetic gastro paresis). Metoclopramide prevents nausea and vomiting by moving food faster through the digestive tract. Teva Pharmaceuticals, Pliva, Pharma and Baxter Healthcare sell generic equivalents of Reglan.

Reglan has also been prescribed for infants with symptoms of vomiting or esophageal reflux and  pregnant women. But seniors, especially elderly women, seem to be the most vulnerable to Tardive Dyskinesia when taking Reglan.

It’s estimated that 60 million Americans have heartburn. For 25 million in the United States, heartburn is an everyday event. Attorney Jim Alder advises anyone taking Reglan, or one of its generic equivalents to contact their doctor immediately and then seek legal advice. Tardive Dyskenisia is a drug-induced disability that can cause life-long suffering.

You can give Big Tobacco a big hit

Thanks to a Dec. 15 ruling by the U.S. Supreme Court, consumers can use state consumer protection laws to sue tobacco companies for deceptive marketing practices for “light” or “low tar” cigarettes. Plaintiffs must prove that such cigarettes’ marketing violates state anti-fraud laws, by virtue of the cigarettes not being as healthy as advertised.

It’s believed that smokers of “light” or “low tar” cigarettes take longer puffs or otherwise compensate, thus offsetting any health benefits. It’s also believed that tobacco companies are well aware of this propensity, yet market their cigarettes as being healthier anyway.

Speaking of the FDA…

It still says Gardasil is okay. So does the Centers for Disease Control (CDC). The vaccine “prevents four viruses that account for about 70 percent of cervical cancers” according to its manufacturer, Merck. But this summer complaints from parents of girls who suffered serious side effects after taking the drug trained a national spotlight on the vaccine. CBS News reported in July that there were “more than a dozen deaths and 8,000 adverse reactions” to the vaccine. But the FDA says it has detected no common pattern in the deaths indicating that the vaccine caused them. The federal agency says the vaccine is an important preventive. More than 4,000 women in the United States die every year from cervical cancers that are caused by the sexually transmitted viruses Gardasil prevents. The FDA says benefits of the vaccine outweigh any risks. To be effective, it must be administered to young girls before sexual activity begins.

Beauty knows no pain,” the old saying goes. But it does have a price. Illegal Botox scammers are paying with fines and prison sentences. Victims are paying with facial paralysis. What the beauty-seekers hoped would eliminate forehead wrinkles put some in the hospital. Botox is made from the toxin of a bacterium that causes botulism, a severe form of food poisoning. The scammers knowingly used a cheaper version of it that is not approved by the FDA. Twenty-nine people, including several doctors, were convicted of knowingly injecting the unapproved Botox into nearly 1,000 victims. The FDA’s Office of Criminal Investigations (OCI) handled the case after four victims were hospitalized. There were no deaths and the paralysis was temporary. But the OCI uncovered instances of illegal Botox use across the United States, resulting in 68 arrests. Botox Cosmetic is the only FDA approved version of Botox. It is made from highly purified botulinum toxin. Small amounts of it injected between the eyes, affect the muscles ability to contract, smoothing out facial wrinkles for several months.