March 29, 2011

FDA warns of risks with Soladek vitamin solution

Federal health officials are “warning consumers not to use Soladek vitamin solution because it may contain dangerously high levels of vitamins.” (Washington AP, 3/28). As a Chicago personal injury lawyer with expertise in products liability cases, I too urge consumers to stop using Soladek immediately.

The Food and Drug Administration says “it has received seven reports of serious health problem among people who used the product, including vomiting, diarrhea and kidney malfunction.” Upon evaluation, the FDA says it has received information concluding the Soladek contains levels of vitamins A and D that are unsafely high. Soladek is “marketed by Indo Pharma, a company based in the Dominican Republic. The solution comes in a vial and is labeled in Spanish.”

The FDA further stated, “the product violates U.S. law because it claims to treat various medical conditions, including rickets and infection, but has not undergone regulatory review.” Consumers should avoid this product and chose vitamins in consultation with their health care professionals.

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March 21, 2011

FDA cracks down on J&J plants linked to recalls

Federal officials said “that the consumer health unit of Johnson & Johnson will be barred from resuming operations at a Pennsylvania manufacturing plant linked to millions of bottles of defective medicines until it meets quality standards.” (M. Perrone, AP Health Writer, 3/10).

The Food and Drug Administration has executed a formal consent decree with the Johnson and Johnson that is designed to improve operations at three manufacturing plants linked to last year’s recalls. J&J has issued 20 recalls since September 2009.

The agreement requires J&J “to destroy all recalled drugs that have been returned to the company within 30 days. The decree also sets strict deadlines for arranging third-party contractors to inspect the plants and recommend improvements.”

As a products liability lawyer in Chicago, I am pleased to see the proactive actions taken by the FDA. I am hopeful that J&J will act quickly to fix any and all issues with its product.

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March 14, 2011

FDA warns of birth defects with Topamax

The Food and Drug Administration has issued an incredibly important warning to female consumers. The FDA is “warning women of child-bearing age that the epilepsy drug Topamax can increase the risk of birth defects around the mouth.” (Washington AP, 3/4). The drug, which is marketed by Johnson & Johnson “to control seizures cause by epilepsy…[and] is also used to relieve migraine headaches.” Consumers should also remember there is a generic drug known as topiramate has the same risks as Topomax.

The warning follows data collected from a registry of pregnant women, which suggests that a baby is more likely to have cleft lip and cleft palate if their mother took Topamax during the first trimester.

Women taking any form of the drug should consult with her doctor immediately regarding pregnancy. As a Chicago area Medical Malpractice attorney, I urge all women who are pregnant are who are planning to become pregnant to consult with their doctors about the risks associated with Topamax or its generic.

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March 4, 2011

NRC sanctions Pa. doc in flawed cancer treatments

The Nuclear Regulatory Commission “has sanctioned a doctor who performed nearly 100 botched prostate cancer procedures at Philadelphia's VA Medical Center.” (Philadelphia AP, 2/24). Previous blogs discuss the concerning pattern of medical care provided by Dr. Gary Kao, and as a personal injury and medical malpractice attorney in Chicago, I am pleased that some form of justice has been served on the doctor.

The NRC says “Dr. Gary Kao cannot take part in agency-related activities without undergoing more training,” after finding that Dr. Kao was responsible for 91 botches procedures in which veterans received incorrect dosages of radioactive seeds implanted to kill cancer cells in the prostate. Many patients received doses that were insufficient, but had seeds implanted carelessly in nearby organs and surrounding tissues.

Last year, the NRC fined the VA hospital $227,500 and now are imposing sanctions on Dr. Kao. Although this is certainly a step, Dr. Kao’s carelessness should not be forgotten and he should be monitored further to ensure patient safety.

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