Sarasota Personal Injury Lawyer - Drug Products

Congress Starts Asking Questions About Dr. Jarvik

Joe Saunders — Tue, 08 Jan 2008 11:36:11 GMT

Dr. Robert Jarvik became known as the maker of the world's first artificial heart in the 1980's. Most recently, his face and name are splashed in tv and print media ads pitching Pfizer's cholesterol drug Lipitor. The marketing campaign is so often used that Congress has started asking Pfizer questions about Dr. Jarvik's qualifications to pitch a cholesterol drug. The Wall St. Journal published an article about the inquiry and stated that Jarvik doesn't hold a license to practice medicine. When NBC's Robert Bazell did an investigative piece last year, he reported that Jarvik has never done a medical internship and has never practiced medicine! Yet, he's pitching a cholesterol drug that millions of patients are using. Congressman John Dingell has stated that Jarvik appears to be giving medical advice in the marketing pieces. Pfizer has made millions of dollars with the drug using Jarvik as the celebrity endorsee. That doesn't seem accurate marketing to me!

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

Originally posted at InjuryBoard by Joe Saunders

Older Patients Who Take Avandia Have Higher Risk of Heart Attacks

Joe Saunders — Thu, 13 Dec 2007 11:33:53 GMT

According to an article published in the Journal of the American Medical Association older people who suffer from diabetes and take Avandia as part of their treatment regimen are 60% increased risk of heart failure, a 40% increased risk of heart attack, and a 30% increased risk of death. This is obviously not good news for Glaxo Smith Kline, the manufacturer of Avandia. Avandia is a controversial drug designed to treat Type II diabetes but has faced stiff criticism concerning its links to cardiac issues.

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

Originally posted at InjuryBoard by Joe Saunders

Genentech's Move to Restrict Use of Cheaper Avastin Leads to Probe

Joe Saunders — Mon, 03 Dec 2007 09:30:23 GMT

Genentech, the maker of Avastin, has sought to restrict access to its cheaper drug Avastin so that health officials will use a more expensive brand has lead to Congressional criticism. The restriction on the eye disease drug has led one US senator to write letters to the Centers for Medicare and Medicaid and the FDA inquiring as to the propriety of Genentech's actions. Senator Kohl of Wisconsin also sent a letter to Genentech informing them that he will investigate these restrictions.
This seems to be another instance where pharmaceutical companies are seeking higher profits at the expense of the consumer. While every company has a right and a duty to make a profit for its shareholders, it crosses the line when that company restricts access to cheaper drugs that work.

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

Originally posted at InjuryBoard by Joe Saunders

Dietary Supplement Recall

Joe Saunders — Tue, 27 Nov 2007 15:38:33 GMT

Bodee LLC has issued a voluntary recall of all its Encore dietary supplements after the FDA determined that a chemical analyis of the supplement contained harmful, undeclared ingredients. The FDA analysis showed that Encore Tabs contained aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

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

Originally posted at InjuryBoard by Joe Saunders

Senate Bill Would Allow FDA Monitoring of Over the Counter Drug Ads

Joe Saunders — Tue, 13 Nov 2007 08:18:43 GMT

A bill introduced by Senators Henry Waxman of California and Ted Kennedy of Massachusetts would give the FDA regulatory authority concerning ads for over the counter drugs. The bill comes in the wake of an FDA advisory about banning cold medicines for children under the age of 6. The new bill would give the federal agency power to impose monetary fines on advertisers. Presently, over the counter drugs fall under the authority of the Federal Trade Commission.

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

Originally posted at InjuryBoard by Joe Saunders

Novartis Chief Executive Says FDA Succumbing to Political Pressure in its Attempt to Increase Drug Safety

Joe Saunders — Tue, 09 Oct 2007 05:09:39 GMT

During the three day Clinton Global Initiative, Novartis Chief Executive Dan Vasella said that the FDA was buckling under political pressure to monitor the safety and efficacy of new pharmaceuticals. HIs comments were made in the wake of rising awareness of overly aggressive marketing tacticts by pharmaceutical companies at the expense of consumer safety. Two Novartis drugs, Prexige and Galvus have met significant regulatory delays in the US in spite of being approved in other parts of the world. Vasella didn't comment on the number of drugs including Merck, Zyprexa, and Avandia, to name a few. Big pharma has been playing money politics with consumer safety for years now. It's about time the FDA increased its monitoring of drug safety.

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

Originally posted at InjuryBoard by Joe Saunders

FDA Cites Cold Medicine Dangers for Children

Joe Saunders — Sat, 29 Sep 2007 09:26:51 GMT

Cold and cough medicines purchased over the counter for children under six years of age can cause serious side effects, including death, concluded an FDA analysis of the safety of children's cold and cough medicines. The FDA has had 54 reports of children's death as a result of using decongesants containing pseudoephedrine, phenylephrine and ephedrine. The FDA has told companies marketing children's hydrocodone products that they must end their distribution prior to October 31.

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

Originally posted at InjuryBoard by Joe Saunders

FDA Warning Issued for Pain Drug Fentora

Joe Saunders — Thu, 27 Sep 2007 10:45:13 GMT

Fentora, used to treat pain in cancer patients, has drawn an FDA warning as a result of deaths in patients who were given the improper dosage or Fentora was incorrectly substituted as a pain management pharmaceutical. The FDA warning stated that Fentora should not be used in cancer patients who are unable to tolerate other opioid
drugs. Fentora was approved by the FDA last year for cancer patients to treat severe pain and who were already taking morphine or other fentanyl drugs.

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

Originally posted at InjuryBoard by Joe Saunders

Congress Gives FDA More Power to Monitor Drug Safety

Joe Saunders — Fri, 21 Sep 2007 08:18:12 GMT

Congress has passed legislation giving the FDA new powers of oversight concerning the pharmaceutical industry including more authority to require changes to drug labels, demand additional safety studies and limit the distribution of medications when safety concerns arise. The new legislation includes an interesting twist in that it may limit protection of pharmaceutical companies for drugs that have the FDA stamp of approval. The Bush Administration sided with the drug companies a year ago when it successfully argued that FDA approval of a drug absolves them from legal liability. This new legislation calls this Bush pre-emption into question, a good thing for consumers.

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

Originally posted at InjuryBoard by Joe Saunders

Ketek Significantly Increases Risk of Liver Disease

Joe Saunders — Thu, 13 Sep 2007 05:43:08 GMT

Ketek, an antibiotic used for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, tonsillitis, or pharyngitis, has been shown to cause severe liver injury. Health Canada, in its September 2007 edition, has documented the risk of liver damage for users of the drug. The FDA should recall Ketek as a dangerous drug. Its risks significantly outweigh its benefits.

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

Originally posted at InjuryBoard by Joe Saunders