Mississippi Personal Injury Blog - FDA & Prescription Drugs

A special place in Hell for tobacco executives

Gerry McGill — Thu, 11 Jun 2009 13:20:11 GMT

I hope there is reserved a special place in Hell for tobacco company executives. First there were flavored cigarettes. Guess what age group they were aimed at? Then I have been receiving junk emails for "Electronic Cigarettes", whatever they are, being pimped by shock jock Howard Stern. But today the Associated Press reports that R.J. Reynolds Tobacco Company is test marketing disolvable tobacco products and says they are designed for adults. The trouble is, the little tablets look an awful lot like the Pez candies my grandsons consume.

Some members of the U.S. Senate call the product "tobacco candy" and say the are designed with one thing in mind: to get kids hooked on nicotine.

"Tobacco candies are clearly designed to appeal to children through both packaging and taste," said Sen. Jeff Merkley, D-Ore. "This is not a safe product. This is not safe tobacco. It is a product that, like cigarettes, causes cancer and kills."

Merkely and Sen Sherrod Brown, D-Ohio have co-sponsored a provision in the Senate tobacco bill requiring the government to study health effects of dissolvable tobacco. The Food and Drug Administration (FDA) would be given authority to restrict how the products are marketed and sold.(somehow that doesn't make me feel any better about it)

A spokesperson for North Carolina based R.J. Reynolds accused Merkley and others of intentionally distorting the nature of the dissolvable tobacco products. "It's not tobacco candy. That terminology is their terminology," says David Howard , a spokesman for Reynolds.

I wonder how the two Senators from North Carolina will vote on Senators Merkely and Brown's provision?

Originally posted at InjuryBoard by Gerry McGill

Drug Manufacturers Sued Over Marketing of Cholesterol Drugs Vytorin and Zetia

Gerry McGill — Tue, 29 Jan 2008 13:22:58 GMT

The Associated Press has reported that drug manufacturers Merck & Company and Schering-Plough Corporation, the makers of the popular cholesterol drugs Vytorin and Zetia, are being sued in states across the country, including Mississippi, over allegations that the two companies misled consumers into thinking the drugs were more effective than generic cholesterol drugs.

Originally posted at InjuryBoard by Gerry McGill

Merck Recalls Unsterilized Vaccine; 1.2 million Doses Pulled

Courtney Mills — Thu, 13 Dec 2007 09:30:23 GMT

Pharmaceutical giant Merck & Co. recalled some 1.2 million doses of Hib vaccine, after it was revealed through quality control that the vaccines had not undergone proper sterilization techniques. Production equipment used to manufacture the vaccines had not been properly sterilized, so these lots had to be recalled.

The vaccine, known as Haemophilus influenza type b, prevents the spread of bacterial meningitis. 11 lots of the vaccine were recalled by Merck, as well as two lots of Merck's hepatitis B vaccine.

According to the CDC, any children who already received the vaccine already do not need to be vaccinated again, as the vaccine's efficacy was not minimized in any way. If children do not exhibit any problem signs after about one week, then there should not be any reason for concern of contamination.

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

Originally posted at InjuryBoard by Courtney Mills

Bayer Halts Sales of Trasylol Globally

Gerry McGill — Tue, 06 Nov 2007 15:27:58 GMT

Bayer AG halted worldwide sales Monday of its anti-bleeding drug Trasylol at the request of U. S. and foreign health officials pending further analysis of a Canadian study that suggests it's linked to a 50 percent higher risk of death than the other drugs in the clinical trial. The Food and Drug Administration asked the company to stop selling the drug, used to prevent excessive bleeding during heart bypass surgery, until it could receive and review further results from the study.

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

Originally posted at InjuryBoard by Gerry McGill

Jury Awards $7 Million in Accutane Trial

Gerry McGill — Fri, 12 Oct 2007 14:00:53 GMT

A Pensacola, Florida jury yesterday awarded $7 million to a Pensacola man who said that the manufacturer of Accutane failed to warn him that the use of the controversial acne drug could cause a gastrointestinal disease. The Pensacola jury deliberated for two days before finding that Swiss drug-maker Hoffman-La Roche failed to warn that use of Accutane could potentially lead to a condition known as inflammatory bowel disease.

Adam Mason, 31, had his colon removed after he developed the disease. The surgery, he said, made it impossible for him to return to work as a welder.

In May, a New Jersey jury awarded $2.6 million to 36-year-old Andy McCarrell of Alabama, who filed a lawsuit citing claims similar to Mason's.

To read the complete article see the October 12, 2007 edition of The Pensacola News Journal.

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

Originally posted at InjuryBoard by Gerry McGill

FDA Issues Health Advisory On Codeine, Nursing Mothers

Courtney Mills — Fri, 17 Aug 2007 14:33:26 GMT

The FDA issued new important information about the use of codeine in mothers who are nursing children.

Because of the way certain individuals metabolize codeine, which breaks down into morphine in the liver, there runs the risk of having extremely high levels of morphine excreted into breast milk. Some women metabolize morphine at a very rapid rate, causing the blood level of morphine to spike. The FDA reported that these women would also have higher morphine levels in their breast milk, which in turn could lead to life-threatening or fatal side effects in nursing babies.

As a result, doctors are encouraged to prescribe lower doses of codeine to nursing mothers to relieve pain or to ward off a cough.

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

Originally posted at InjuryBoard by Courtney Mills

First Accutane Trial Yields $2.6 Million Verdict

Gerry McGill — Mon, 09 Jul 2007 15:58:00 GMT

A New Jersey jury awarded $2.619 million to a man who claimed the acne drug Accutane caused his inflammatory bowel disease. The man claimed that the drug's manufacturer failed to warn customers of the serious side effects that caused him to have multiple surgeries, including the removal of his colon.

Introduced in 1982, Accutane has been prescribed to more than 13 million patients internationally. In addition to claims that the drug caused inflammatory bowel disease, there are also cases in litigation over the company's failure to adequately warn about birth defects, suicide, and depression.

In a statement, the company said it plans to appeal, adding that "there is no reliable scientific evidence that Accutane causes inflammatory bowel disease." However, at trial the defense relied upon Accutane's warning label, arguing that the company had warned of inflammatory bowel disease for 20 years.

Curiously, the company also argued at trial that Accutane does not cause inflammatory bowel disease.

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

Originally posted at InjuryBoard by Gerry McGill

Diabetes Drug Avandia Increases Heart Risks

Gerry McGill — Mon, 25 Jun 2007 14:56:36 GMT

A study by Dr. Steven Nissen, a well-known cardiologist from the Cleveland Clinic, which was published in the New England Journal of Medicine on May 21, concluded that Avandia increases a patient's risk of a heart attack by 43% and the risk of death from cardiovascular causes by 64%.

The study confirms that 60,000 to 100,000 reported heart attacks from Avandia users may be linked to the drug which has been on the market for 8 years.

Avandia's manufacturer, GlaxoSmithKlein, PLC, a British company, has sold Avandia to more than 1 million Americans, and 6 million people worldwide, to treat Type II Diabetes which is the most common form of diabetes. Sales in the U.S. reportedly exceeded $2.2 billion last year.

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

Originally posted at InjuryBoard by Gerry McGill

Heart Stent Fails Test and Pulled From Market

Shannon Weidemann — Wed, 09 May 2007 07:59:46 GMT

A heart stent that is used in Europe, Asia, and Latin America has failed testing in the United States and will be pulled from the market. The CoStar drug coated stent did not work as well as another already in use in the United States. The maker of the stent, Conor Medsystems will not seek FDA approval for the defective medical device.

The clinical trial showed that, after eight months, CoStar was inferior to Taxus in reducing major adverse cardiac events. While rates of heart attack and death were similar between the two stents, J&J spokeswoman Susan Odenthal explained, CoStar had higher rates of target vessel revascularization, or when symptoms recur somewhere in the treated blood vessel.
Conor said the dose of the drug used to coat the stent, the cancer drug paclitaxel, was not effective. Taxus also uses paclitaxel as a stent coating. The CoStar differs from other drug-coated stents in that it uses tiny reservoirs built into the stent to release the drug.

The company is owned by Johnson and Johnson. They plan to rework the stent using a different drug as the coating on the stent.

Originally posted at InjuryBoard by Shannon Weidemann