Doctors have been flooded lately by concerned patients taking the Type 2 diabetes pill Avandia. Stephen Clement, an endocrinologist at Georgetown University, says his office has received about 30 calls from people taking Avandia. Avandia works by increasing the body's sensitivity to insulin, consequently helping to control blood sugar levels. Clement says that patients who are on the drug probably should continue to take it. However, if they are concerned, they can switch to Actos, "an alternative drug that has a similar onset of action and similar efficacy. We're leaving that up to them as an option if they want to change over."

More Questions Than Answers

Clement and other experts say that it is too soon for all patients to be stopped from taking Avandia. Their advice remains the same even after U.S. Senator Charles Grassley said that the Food and Drug Administration was aware of the potential heart dangers of Avandia and did not take action. GlaxoSmithKline, who manufacturers Avandia, says that "stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks."

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Posted by Patricia Bowling at 01:13 PM | Permalink

Advanced Medical Optics plans to remove Complete MoisurePlus from the market because reports of acanthamoeba keratitis have been linked to the solution. Complete MoisturePlus is used as a cleanser for soft contact lenses and also as a solution in which to store them. Acanthamoeba keratitis is caused by a parasite and can cause blindness in those who do not treat the condition.

Contact Lens Solution Yanked

The Centers for Disease Control and Prevention say that the solution has been linked to infections in at least 138 patients since January 2005. Those who wear soft contact lenses and use the solution should get rid of all bottles of the solution in their possession and replace their lenses and their storage containers. Symptoms of acanthamoeba keratitis include eye pain, redness, blurry vision, and light sensitivity.

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Posted by Patricia Bowling at 12:56 PM | Permalink

Beverly Rockwell plans to seek compensatory and punitive damages on behalf of her son, Trevor A. Drake, who died after an injection of Magnevist. Rockwell claims that Magnevist, made by Bayer, was responsible for her son's death. The lawsuit alleges that the drug caused a skin and joint disease known as Nephrogenic System Fibrosis or Nephrogenic Fibrosing Dermopathy and these diseases proved fatal to Drake.

Norwalk, Ohio Mother Sues Bayer Healthcare Pharmaceuticals for the Death of Her 24-Year-Old Son

This is the first lawsuit against Bayer over the effects of Magnevist. In 2006, the U.S. Food and Drug Administration said that there were 200 cases worldwide of NSF/NFD and the cases developed following patient exposure to gadolinium-based contrast agents, such as Magnevist.

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Posted by Patricia Bowling at 11:33 AM | Permalink

The U.S. Food and Drug Administration plans to stop companies that sell unapproved drug products in time-release dosage form that contain guaifenesin. Guaifenesin is a substance usually used to relieve cough and cold symptoms by causing removal of mucus from the lungs. About 20 companies currently make timed-release products that contain guaifensin that have not been reviewed by the FDA.

Action Taken to Stop Marketing of Unapproved Timed-Release Guifenesin Drug Products

Steven K. Glason, the director of the FDA's Center for Drug Evaluation and Research, says that "today's action is another example of our commitment to ensure all drugs marketed in the United States that require FDA approval have that approval. This benefits consumers because drugs that skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured."

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Posted by Patricia Bowling at 11:06 AM | Permalink

China is working to cut back on corruption in its government. Case in point: China has sentenced its 62-year-old former head of the food and drug administration to death for allegedly taking bribes. Zheng Xiaoyu will be the first senior Chinese official to face the death penalty in seven years.

Death Penalty for Chinese Executive

Zheng is believed to have taken up to $850,000 in bribes during his tenure at the food and drug administration, from 1998 to 2005. Under Zheng's watch, dozens of people in China died from fake or bad drugs and food products. Citizens in Beijing said of Zheng's conviction: 'The damage that his corruption has brought is much worse than that caused by a dealer who sells fake drugs. The harm he has caused affects more people and brings more damage... Fake drugs can't cure diseases, instead they make things worse. Young people may be strong enough to recover, but I am afraid it could be fatal to old people."

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Posted by Patricia Bowling at 10:49 AM | Permalink

Lybrel, Wyeth's new oral contraceptive that eliminates the monthly bleeding associated with the menstruation cycle, has been approved by the Food and Drug Administration. The FDA says that no excessive risks have been seen in those taking Lybrel: "The risks of using Lybrel are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attacks and strokes."

Wyeth Contraceptive Approved

Wyeth plans to conduct a post-marketing survey to see if Lybrel causes any other side effects that are more severe than those caused by other contraceptives. However, Dr. Daniel Shames, a deputy director at the FDA's office of drug evaluation, says that "we don't expect any surprises." The main concern for women on Lybrel is that, because the drug eliminates regular periods, women may have trouble recognizing if they are pregnant. Lybrel will become available in July.

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Posted by Patricia Bowling at 11:42 AM | Permalink