Diseases & Conditions Blog

Women Should be Warned About Birth Defects - Wednesday, September 26, 2007

A new study suggests that doctors are not doing a good job of warning young women to avoid getting pregnant while they are taking prescription drugs that can cause birth defects. University of Pittsburgh Medical Center researchers found that nearly half of the women taking medicines that can cause birth defects were not counseled by their doctor about using contraceptives or other birth control measures to prevent pregnancy.

There are several drugs that may cause birth defects including some antibiotics, acne meds, cholesterol reducers, anti-seizure drugs, sleep aids and blood thinners.

The Food and Drug Administration (FDA) classifies drugs into categories of whether they are safe or potentially harmful to developing fetuses. But, often, busy physicians do not consult the FDA listings for these drugs.

Researchers did find that women on the acne drug Accutane (generic isotretinoin) got more pregnancy prevention counseling than anyone else. Anyone taking Accutane is required to use birth control, pass a pregnancy test before each monthly refill and enroll in a national registry. Women taking statins for cholesterol got the least amount of counseling.

Vioxx Maker Being Sued by State of New York - Tuesday, September 25, 2007

New York State Attorney General Andrew Cuomo and New York City Mayor Michael Bloomberg have filed a lawsuit against Merck & Co. Inc. accusing the drug manufacturer of hiding risks posed by the pain reliever Vioxx and thereby defrauding Medicaid of the money paid out for the prescriptions.

Vioxx was taken off the market in 2004 because it significantly increased the risk of heart attack and stroke. The drug was approved for the treatment of osteoarthritis, dysmenorrhea, rheumatoid arthritis, migraine headaches and juvenile rheumatoid arthritis.

The action papers state that before they stopped selling the drug, Merck carried out a "concerted and tenacious campaign of false and fraudulent statements" to minimize the strength of the link between Vioxx and heart problems. This campaign continued up to one month before Merck stopped selling the drug. During that month, doctors in New York continued to prescribe Vioxx. Had those doctors been aware of the risks, they would not have prescribed the drug to their patients.

Woman Sues After Husband Dies of Cancer - Tuesday, September 18, 2007

A Kentucky woman, Verona Beasley, has filed a lawsuit against 10 defendants claiming her husband died from pancreatic cancer after being exposed to benzene and butadiene. Beasley claims her husband, Donald, was diagnosed with cancer in early 2006 and was told by doctors that his cancer was related to exposure to benzene and butadiene. Donald Beasley was a tire builder at General Tire and Rubber Company in Mayfield, KY for 26 years.

Mrs. Beasley claims that during the course of her husband's employment there, he was exposed to and inhaled, ingested or otherwise absorbed benzene and butadiene, which were designed, manufactured, sold or distributed by the defendants. Those defendants include BP Amoco, Chevron, Continental Tire, Shell Oil and ConocoPhillips.

Benzene is a hydrocarbon that is produced by the burning of natural products, is found in gasoline and other fuels, and is used to make some types of dyes, rubbers, lubricants, drugs, detergents and pesticides.

Butadiene is an industrial chemical used in the production of synthetic rubber.

The suit claims the defendants had a duty to exercise reasonable care and caution for the safety, health and welfare of her husband but failed by including those chemicals in their products even though they would have a toxic and dangerous effect on the health of anyone handling them.

The suit further claims the defendants failed to provide adequate warning and instructions, failed to recommend use of protective equipments, and failed to recall or cease using benzene and butadiene.

Mrs. Beasley claims that her husband's cancer disfigured and disabled him, caused pain and suffering, medical expenses and lost wages. She is seeking damages in excess of $150,000.

FDA Recommends Medical Device User Fee Program - Monday, September 17, 2007

The FDA has proposed a recommendation to Congress for reauthorizing the Medical Device User Fee and Modernization ACT (MDUFMA), which would help to ensure that safe and effective medical devices get to patients in a timely fashion. Under this program, industry covers a portion of the costs of the FDA's pre-market review program through a variety of fees. The additional revenues generated from the fees paid by the medical device industry would continue to be used to ensure patients have timely access to safe and effective medical devices.

This proposal, if adopted, would foster the development of innovative in vitro diagnostic tests by issuing new industry guidance on emerging issues and reviewing some low-risk devices to determine whether any of them could be exempted from the need for product review.

The Medical Device User Fee and Modernization Act of 2002, which expires on September 30, 2007, amended the federal Food, Drug and Cosmetic Act to provide the FDA with new responsibilities and resources to keep with the rapidly growing device industry and advancing medical device technology.

Ketek Being Linked to Burn-like Blisters - Wednesday, September 12, 2007

The side effect most often associated with the antibiotic drug Ketek is liver failure; however, at least one person has had a different, life-threatening reaction to Ketek. Now people who have taken the drug are investigating the possibility of filing lawsuits against the manufacturer Sanofi-Aventis for the side effect toxic epidermal necrolysis (TEN).

Ketek is an antibiotic that has been under scrutiny for years due to its link to liver failure in patients taking the drug. But now, TEN is a much more serious side effect linked to Ketek. Most recently, a young woman in Canada spent four weeks in a burn unit after taking Ketek for a sinus infection. The woman allegedly had a serious reaction to the drug, which resulted in burn-like blisters all over her body.

The condition was diagnosed as TEN; TEN often leaves patients with permanent scars and other serious health problems. The woman's skin peeled over her entire body, inside her mouth, and she lost her eyelashes. She was treated with intravenous antibiotics to prevent infection, and lotions were applied to keep her skin lubricated.

In the United States, Ketek has been linked to 53 cases of liver damage and four deaths; the FDA reports that Ketek has been linked to nine deaths worldwide.

The FDA voted to keep Ketek on the market to treat mild to moderate pneumonia last year. However, the FDA warned that Ketek should only be used as a secondary alternative to other medications. The FDA panel also recommended that Ketek should have a black box warning about its serious side effects.

Many wonder why Ketek has not been taken off the market yet and point out that there are other drugs available that can treat infections without the risk of liver failure.

Funding to Research Carcinogens Awarded - Monday, September 10, 2007

The National Institutes of Health (NIH) has awarded a group of UC Berkeley scientists a $4.7 million grant yesterday to develop new methods for detecting lymphoma and other diseases caused by environmental exposure to contaminants.

Researchers from several departments are teaming up to form the Center for Exposure Biology and work on three interdisciplinary projects developing sensors that could detect blood cancer risks on a large, cost-efficient scale.

The grant is part of the institutes' Genes, Environment and Health Initiative, whose aim it is to understand interactions between environmental exposure to contaminants and genetic variations on human disease.

One project from the center focuses on mapping out adducts, compounds produced by the body when proteins react with chemical carcinogens, to determine what chemicals cause cancer and how the disease can better be diagnosed.

According to Stephen Rappaport, adjunct professor of environmental health sciences and director of the program, the researchers will examine adducts produced by exposure to chemicals such as benzene, found in gasoline and cigarettes. An additional part of the project focuses on using microchips to process fluid samples in small volumes, possibly allowing the detection of early signs of leukemia and lymphoma based on a single cell rather than thousands or even millions.

This technology could be useful in remote locations, for over-the-counter tests, or during major emergencies.

FDA Warns Consumers About Counterfeit Drugs Sold on Internet - Wednesday, September 5, 2007

In the past few years, more and more people have been buying prescription drugs over the Internet; however, the FDA is cautioning consumers about the dangers associated with buying drugs online. The FDA alert is based on information it received indicating that 24 apparently related Web sites may be distributing counterfeit prescription drugs.

Xenical, an FDA-approved drug prescribed to help obese individuals lose weight, is one of the drugs that consumers thought they were buying but actually got a counterfeit version instead. Three different consumers in three states in recent months bought what they thought was Xenical, but instead, they received a counterfeit version in the mail.

The FDA investigation is on-going, but at this point, it appears that the Web sites selling the counterfeit Xenical are operated from outside the United States. We have a partial list here of the Web sites being investigated, but a full list of the 24 sites that may be involved in the distribution of counterfeit drugs is available on the FDA web page www.fda.gov/buyonline/:

AllPills.net
Pharmacy-4U.net
DirectMedsMail.com
Brandpills.com
Emediline.com
RX-ed.com
RXePharm.com
PillsPharm.com

Pediatric Vaccines Containing Thimerosal Linked to Autism - Tuesday, September 4, 2007

In June 2007, the United States Federal Claims Court in Washington D.C. will begin hearings on 4,800 claims filed by parents who believe pediatric vaccinations caused their child's autism. The lawsuits claim that thimerosal, a preservative that contains mercury and is used in vaccines, causes autism. After an extensive three-year investigation led by the Committee on Government Reform, it was concluded that mercury does not belong in vaccines and that thimerosal poses a very serious risk to those subjected to its toxicity.

As far back as 1982, the Food and Drug Administration (FDA) called for the removal of thimerosal from all over-the-counter products. But it was not until July 1999 that the FDA asked manufacturers to remove thimerosal from pediatric vaccines. When researchers looked carefully at the vaccine schedule, they found that if the schedule were followed, American children had been exposed to 30 times the minimum acceptable level of mercury from vaccines.

The number of children affected by autism has been drastically growing in recent years. In 1970, autism affected 1 in 2,000 children. In the year 2000, 1 in 250 were affected. According to the Autism Society of America, in 2006, a staggering 1 in 150 children was diagnosed with autism. Autism is currently the fastest growing developmental disability in young people. Even though vaccines with mercury have been proven to contribute to autism, learning disabilities, Alzheimer's disease, and other neurological conditions, clinics still use thimerosal because other products containing mercury have been phased out.

Currently, lawsuits involving the makers of products containing thimerosal abound. These claims state the drug companies, for years, have failed to tell doctors how much mercury was contained in vaccines prior to the FDA being ordered by Congress to find out in 1997. Some of the large drug companies being sued are GlaxoSmithKline, Merck, Wyeth-Ayerst and Eli-Lilly.

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