December 28, 2010

Pfizer recalls more bottles of Lipitor over odor

Pfizer announced this week that it is “recalling a lot of 19,000 bottles of the blockbuster cholesterol drug Lipitor, citing a consumer complaint about an "uncharacteristic" odor.” (NY AP, 12/21). This recall is the fourth recall since August.

The drug maker asserts that an outside manufacturer supplied the bottles, though it declined to identify the manufacturer. Pfizer also says that the health consequences are minimal. After the issue was pinpointed, Pfizer made changes back in August to address the problem. The current recall affects bottles shipped before the changes were made. The drug maker cautions that additional recalls may be necessary.

As a Chicago medical malpractice lawyer, I am hopeful that Pfizer quickly determines if any other recalls will be necessary. All patients taking Lipitor should ensure that the product is not a recalled batch before using.

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December 20, 2010

Eli Lilly suspends cancer study on safety concerns

Eli Lilly says it “suspended a late-stage study of tasisulam as a potential skin cancer treatment because of safety concerns, but the company will continue studying the drug candidate in other cancer studies.” (Indianapolis AP, 12/13).

Although Lilly did not disclose any details of specific safety issues, the researchers were studying the drug’s ability to treat metastatic melanoma patients. Melanoma is the most common form of skin cancer.

Nonetheless, the company says it plans to continue to develop the drug “as a potential treatment for breast, ovarian and other cancers, citing different dosing.”

As a Chicago medical malpractice attorney, I am hopeful that this drug will be, first and foremost, safe for use as a potential cancer treatment.

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December 12, 2010

Pfizer pulls Thelin from consumer markets, citing Liver damage.

Pfizer, Inc. says “it is pulling its blood pressure drug Thelin off the market and stopping all clinical trials because the drug can cause fatal liver damage.” (NY AP, 12/10).

The drug, Thelin has been sold in Europe, Canada, and Australia as treatment for “pulmonary arterial hypertension” – high blood pressure in the pulmonary artery.
Although Liver toxicity was known to be a side effect of Thelin, a new review of clinical trial data lead to the discovery of a new link to severe livery injury. This link led to the drug being pulled from consumer markets.

Because other treatment options are available, Pfizer says “the benefits of Thelin don't outweigh the risks…[so] It is stopping all studies of the oral drug.” As a Chicago products liability attorney, with medical malpractice experience, I am pleased to see Pfizer taking the necessary steps to remove unsafe drugs from the market.

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December 6, 2010

ANATOMY OF A BIRTH INJURY CASE

Parents who come to Hurley McKenna & Mertz seeking consultation regarding a potential birth injury case often have a common history. The mother usually has experienced a difficult delivery of her child, the family has a sense that the mother and child received negligent medical care from their obstetricians and nurses, and they have a child with severe deficits, a brain injury and often a diagnosis of cerebral palsy. Our firm must then decide which cases have merit and thus deserve an in-depth evaluation by my firm and its medical experts.
Birth injury cases often need two main elements: 1) clear and easily understandable negligence—i.e., evidence of a preventable mistake by the physicians or nurses caring for the laboring mother, and 2) strong evidence of fetal hypoxia or asphyxia at or near the time of birth.

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December 5, 2010

FDA questions effectiveness of weight loss pill

The Food and Drug Administration says “a pill to treat obesity from Orexigen Therapeutics Inc. helped patients lose weight, though it didn't meet all the criterion set forth by the agency.” (Washington AP, 12/3). As obesity is becoming an epidemic in America, the drug must be both effective and safe.

The drug, Contrave, is the third weight loss pill to be studied by the FDA this year, and the two others were rejected by the agency due to safety concerns. The potential issue with Contrave is that although patients taking the pill showed an average loss of 4.2% more weight than a placebo, the FDA has guidelines stating there should be at least a 5 percent difference between the drug and the placebo. The FDA will now ask a group of experts to evaluate the date and vote on the safety and efficacy of Contrave.

As a medical malpractice lawyer in Chicago, I am hopeful that the FDA considers all possible safety issues before approving a drug.

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