Long Beach Personal Injury Lawyer - Defective Drugs

Children's Cold Medicine Recalled Over Dosage Cup

Shannon Weidemann — Tue, 30 Oct 2007 14:32:39 GMT

Over the counter cough and cold medicine has been recalled by Wyeth due to a faulty dosage cup that came with the medicine. The recalled drugs include several Robitussin and Dimetapp brands. The recall comes after an advisory board advised the FDA that cold medications had not been tested on children under the age of six and may not be safe.

The products are being removed because they come with a dosing cup that does not mark the half-teaspoon level recommended for children aged 2 through 5 years old, according to Wyeth Consumer Healthcare, a division of the Madison, N.J.-based drugmaker.
"There's nothing wrong with the products," said Wyeth spokesman Doug Petkus.

The company is hoping to have new packaging and dosage cups out in a few months. Consumers are advised they do not need to return the product for a refund.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.

Originally posted at InjuryBoard by Shannon Weidemann

Avandia Increases Risk of Heart Attack

Shannon Weidemann — Wed, 12 Sep 2007 07:52:02 GMT

A new study being published by the Journal of American Medical Association has found the a patients risks of heart failure and heart attack is increased when taking the diabetes drug Avandia. The stude was done by researchers at Wake Forest University School of Medicine. Avandia was required by the FDA in August to begin carrying a strict "black box" warning label.

"The risk of heart failure was known but not the magnitude. A doubling of risk is substantial," Singh added. "One in 30 patients taking rosiglitazone (Avandia) over a year will have heart failure, that's very substantial. And one in 220 will have a heart attack. That's also very substantial." Patients should talk to their doctors about the potential risks and benefits of the drug, Singh said.

Avandia is made by GlaxoSmithKline and is used by over 3.5 Million Americans. The study was done by analyzing data from over 14,000 patients. Some doctors are calling for more studies of the drug and its effects.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Shannon Weidemann

Zyprexa Class Action Lawsuit to Proceed

Shannon Weidemann — Sun, 01 Jul 2007 12:15:44 GMT

A class action lawsuit was brought against Eli Lilly for marketing the drug Zyprexa for uses not approved by the Food and Drug Administration (FDA). A judge has ruled that the case is allowed to proceed. The plantiffs claim that the drug company was allowed to charge more for Zyprexa because of the marketing.

The lawsuit, brought by the New York-based Sergeants Benevolent Association Health and Welfare Fund and others, alleged that Eli Lilly illegally marketed Zyprexa for "off-label" purposes (i.e. for uses not approved by the FDA), as well as withholding information about Zyprexa's safety and efficacy. Doctors may prescribe prescription drugs for "off-label" uses but drug companies are prohibited from marketing or promoting drugs for such uses. A 2006 study in the Archives of Internal Medicine found that more than 1 in 7 prescriptions for commonly-used drugs were for off-label uses that lacked scientific support. A study released in January 2007 by the federal Agency for Healthcare Quality and Research found that there was little scientific evidence to support the off-label use of Zyprexa and other atypical antipsychotics.

The judge in his ruling argued that this case and others like it may have an effect on the cost of pharmaceuticals, but that it is important for them to proceed in a court of law.

Originally posted at InjuryBoard by Shannon Weidemann

Vaccines on Trial for Causing Autism

Shannon Weidemann — Thu, 14 Jun 2007 12:30:14 GMT

The U.S. Court of Federal Claims is now hearing a case trying to prove that routine vaccinations caused autism in a child. The family of a 12-year-old girl with autism is asking the court to rule in their favor so that they may receive compensation from a federal vaccine injury fund.

Theresa Cedillo and husband Michael allege thimerosal-containing vaccines weakened their daughter's immune system and prevented her body from clearing the measles virus after she was immunized. That theory is one of three alleged by the thousands of plaintiffs. The others claim either thimerosal or the measles vaccine alone caused their children's autism.
"We hope to find out what happened and hopefully get the help she needs," said Theresa Cedillo, who takes care of her daughter full time at home.

This is the first case to go before the court. There are eight more waiting to be heard. A ruling could take months while the court considers the case.

Originally posted at InjuryBoard by Shannon Weidemann

Recalled Contact Lens Solution May Cause Blindness

Shannon Weidemann — Wed, 30 May 2007 10:13:33 GMT

A contact lens solution has been recalled that may cause an infection that can lead to blindness. The recalled product is AMO Complete Moisture Plus Multi-Purpose Solution and is manufactured by Advanced Medical Optics. The solution may be infected with a parasite that causes Acanthamoeba keratitis.

Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.
Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment, according to the CDC.
The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing, but Acanthamoeba is more difficult to treat.

People using the contact solution are advised to throw it away along with your contact lens case. You may also get more information by contacting the company at 1-888-899-9183.

Originally posted at InjuryBoard by Shannon Weidemann

FDA Wants Warning Label Strengthened on Anemia Drugs

Shannon Weidemann — Thu, 10 May 2007 14:03:57 GMT

Amgen Inc. and Johnson & Johnson sell and market two very popular injectible anemia medicines. The FDA advisory panel has voted that Aranesp and Epogen, also known as Procrit, should have stronger warning labels.

ESAs are approved to treat chemotherapy-induced anemia and chronic kidney disease-related anemia. The agency committee was meeting to reassess the risks of using of ESAs in the cancer setting. Another agency committee will meet to discuss the safety profile of the drugs in relation to kidney patients in early fall, Riley said.
The panel also recommended that the drugs' labels should specifically state that ESAs aren't indicated for use in specific tumor types in which clinical studies have revealed safety concerns, but only after additional studies are conducted, said Riley. Specific tumor types weren't targeted.
Further, labels should define hemoglobin levels in asymptomatic patients; they should also recommend that the use of ESAs should be discontinued after a chemotherapy regimen is completed and the degree of anemia with a subsequent chemo regimen is re-evaluated, the panel recommended.

The panel's findings are non-binding but the FDA tends to follow them. The drugs are part of the class of erythropoiesis-stimulating agents (ESAs) that stimulate the body into producing more red blood cells to combat anemia.

Originally posted at InjuryBoard by Shannon Weidemann

FDA Promises Improved Drug Safety

IB Contributor — Mon, 05 Feb 2007 21:26:45 GMT

After years of criticism of its drug safety standards and the much-publicized Vioxx scandal, the Food and Drug Administration is now proposing steps to improve the safety of prescription medication.

According to an article on www.consumeraffairs.org, the new steps are designed to make sure concerns about potential drug safety are widely circulated within the agency before a drug is given the stamp of approval.

"Our ongoing assessment of the drug and medical product safety system has affirmed that it is essential that our processes and scientific methods keep pace with the rapid evolution of science, technology and the health care system," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The extensive input we have received from stakeholders has proven invaluable as we transform the drug and medical product safety system and continue to fulfill our mission to protect and promote the public health."

Consumer advocates have long criticized the federal agency saying that it has been partial to the needs of drug manufacturers rather than consumers. FDA officials have long denied that charge vigourously. However, as evidenced by the Vioxx debacle involving pharmaceutical company Merck, which has been the most serious case affecting hundreds of thousands of consumers nationwide, some drugs do receive approval and are used by millions of consumers before the problems are detected or uncovered.

Vioxx received FDA approval and became one of Merck's biggest moneymakers before the company voluntarily withdrew it from the market in September 2004. That action was prompted by the discovery that use of the drug increased the risk of heart attacks and strokes. Merck faces more than 1,000 lawsuits from consumers who claim the company knew of the problems for years before pulling Vioxx from the market. Bisnar|Chase is representing 50 of those consumers who are waiting for their trials.

In setting out new steps, the FDA said it is responding to a a set of recommendations made by the Institute of Medicine, released in September 2006. The agency said it carefully considered recent IOM recommendations, along with advice from other experts, for making needed advances in the system. FDA said it agrees with the IOM that FDA's mission requires the agency "to balance expeditious access to drugs with concerns for safety."

The FDA said it plans to strengthen the drug safety system with a number of actions in support of three key efforts: 1. Strengthening the science that supports the FDA's medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management 2. Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products 3. Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system.

Although it is a blessed relief that the FDA is doing something about tightening its approval process, it must be noted that the damage is done. Vioxx has already caused a quarter million deaths in our country. We can only hope that catastrophic debacles of this nature don't repeat and that the FDA learns to listen and show some empathy to consumers.

If you or a loved one has suffered the effects of Vioxx or other defective drugs, I can help.

Originally posted at InjuryBoard by IB Contributor

Paxil and the Risk of Birth Defects

Christina Cole — Sat, 03 Feb 2007 23:59:52 GMT

Early study results for Paxil (paroxetine) suggest the drug increases the risk of birth defects, in particular heart defects, when women take it during the first trimester of pregnancy. Paxil is approved to treat depression and several other various psychiatric conditions. The FDA is currently gathering additional data and waiting for the final results of the studies to understand further the higher risk of birth defects.

The FDA is advising health care professionals to discuss this potential risk with women who plan to become pregnant or that are in their first pregnancy trimester. Health car professionals should consider discontinuing Paxil and switching to another medicine for these patients.

"Stopping this medicine on your own will in most cases create more problems then it is solving," says Sandra Kweder, M.D., deputy director of the FDA's Office of New drugs. "Many of these medicines are associated with withdrawal syndromes, which can be problematic for many patients and stopping is something that needs monitoring by a doctor."

The FDA asked Paxil's manufacturer, GlaxoSmithKline (GSK) of Research Triangle Park, to change the drug's pregnancy category from C to D which is a stronger warning. Category D means the studies on pregnant women have demonstrated risk to the fetus.

In September 2005, GSK updated the drug's labeling to add data from one study. As additional data is available the label is being changed to reflect the latest reported data.

The FDA has asked Paxil's manufacturer, GlaxoSmithKline (GSK) of Research Triangle Park, N.C., to change the drug's pregnancy category from C to D, which is a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the fetus.

GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has been changed to reflect the latest data.

Originally posted at InjuryBoard by Christina Cole