Sarasota Personal Injury Lawyer - FDA & Prescription Drugs

Alli and Xenical Receive FDA Review After Reports of Liver Injury

Joe Saunders — Tue, 25 Aug 2009 08:49:15 GMT

The FDA is reviewing diet drugs Alli and Xenical after 32 adverse event reports associated the drugs with liver injury. Alli is manufactured and marketed by GlaxoSmithKline and is available as an over-the-counter weight loss supplement. Xenical, which contains twice the dose of orlistat, is a prescription drug that's manufactured by Roche and marketed by GlaxoSmithKline.

All of the reported liver injuries occured outside of the United States and 27 of the patients were hospitalized with six reports of liver failure. All but two of the adverse event reports concerned the stronger prescription drug Xenical.

Originally posted at InjuryBoard by Joe Saunders

Acetaminophen Safety and the FDA

Joe Saunders — Tue, 07 Jul 2009 11:39:50 GMT

Last week's FDA panel decision to ban painkillers Vicodin and Percocet as well as limit acetaminophen has a long and complicated backstory. The call for banning Vicodin and Percocet was in part a reaction to the chemical composition of the two painkillers which combine a narcotic with the ubiquitous acetaminophen.

Yet, acetaminophen's detractors have been around for years in spite of a successful pharmaceutical marketing program that's convinced the general public that the drug is completely safe. The acetaminophen marketing campaign may be best illustrated in the brand Tylenol. The makers of Tylenol launched an aggressive campaign in the 1980's after it was discovered that the over the counter drug had been tainted. This campaign, which led to new and effective safety measures also carried with it a side effect. Consumers became convinced that there was nothing wrong with popping a few Tylenol for every ache and pain without regard for the amount of acetaminophen ingested. In some cases, this has led to liver failure.

Finally, last week, the FDA decided it was time to issue a statement about proper dosage and use of acetaminophen. At this point, it's too early to tell what if anything the FDA plans to do with the popular acetaminophen but the statement should serve as a reminder to all consumers that overuse can have potentially lethal consequences.

Originally posted at InjuryBoard by Joe Saunders

Tarceva Receives New Warnings from FDA

Joe Saunders — Mon, 11 May 2009 13:08:00 GMT

Cancer drug Tarceva will have to add new warning labels because of serious side effects associated with the drug manufactured by Genentech and OSI Pharmaceutical, Inc. The side effects include skin problems, eye reactions, and punctures in the digestive tract. According to the FDA, some of the skin problems resemble those associated with Stevens Johnson Syndrome. Eye problems include corneal perforations and ulcers.

Tarceva has been approved to treat certain forms of lung and and pancreatic cancer.

Originally posted at InjuryBoard by Joe Saunders

Raptiva-Genentech's Psoriasis Drug is Recalled

Joe Saunders — Fri, 10 Apr 2009 10:04:17 GMT

Genentech's psoriasis drug, Raptiva has been voluntarily recalled due to several deaths related to use of the drug. Raptiva has been linked to a potentially fatal brain infection, progressive multifocal leukoencephalopathy (PML). Raptiva is designed to lower the body's natural immune system in order to treat psoriasis. However, it also makes patients more susceptible to a virus that attacks the central nervous system once the body's T cells have been suppressed. Besides PML, the drug may lead to viral meningitis and invasive fungal disease.

The FDA reacted to Genentech's Raptiva recall by stating that healthcare professionals should no longer prescribe Raptiva to new patients. Current Raptiva patients should consult their doctor in order to determine an alternative method of treatment for psoriasis. The FDA had issued a black box warning in October 2008, months before it was known that 3 patients had died after using Raptiva for the past 3 years.

Since the recall is very recent, it is not known when Genentech officials knew of the link between the psoriasis drug and PML. What is known is 3 people are dead because of another harmful drug. In announcing the Raptiva recall, Genentech officals noted that the risks outweighed the benefits of the drug which prompted the recall. What an understatement! Three people have died, that's quite a risk.

Originally posted at InjuryBoard by Joe Saunders

Zyprexa Settles Lawsuits with 33 States

Joe Saunders — Mon, 13 Oct 2008 11:13:12 GMT

Eli Lilly, the manufacturer of the schizophrenia and bipolar disorder drug, Zyprexa, has settled lawsuits with 33 states that sued the drug company for falsely marketing its drug to patients with neither scizophrenia or bipolar disorder. Those are the only two illnesses for which Zyprexa has been approved. However, in Lilly's never-ending quest for more revenues, it marketed the drug for dementia and milder forms of bipolar disorder, a violation of federal law. The $62 million settlement eclipses the $58 million settlement Merck recently paid for illegally marketing Vioxx.

Eli Lilly is not out of legal trouble just yet. The NY Times has reported that, "the agreement may also be a sign that a much larger deal is near in a separate but related civil and criminal investigation led by federal prosecutors in Philadelphia. In that case, Lilly is expected to pay more than $1 billion in fines and restitution to states and the federal government and may also plead guilty to a misdemeanor criminal charge related to off-label marketing of Zyprexa."

Zyprexa is a dangerous drug that can cause severe weight gain and is more likely than other schizophrenia or bipolar disorder drugs to lead to the onset of diabetes. These harmful Zyrpexa effects make Eli Lilly's marketing behavior even more heinous.

Originally posted at InjuryBoard by Joe Saunders

Diabetes' Drugs Avandia and Actos

Joe Saunders — Tue, 24 Jun 2008 17:45:45 GMT

A panel of outside FDA advisers will be asked what types of studies should be conducted in order to evaluate the safety of diabetes' drugs Avandia and Actos, both of which have been linked to cardiac problems. Just last year, the FDA suggested the drugs should carry the highest possible warning labels.

``Questions have been raised as to whether long-term cardiovascular trials should be part of the approval process for pharmacological therapies developed for the treatment of diabetes,'' according to the FDA briefing document, prepared for the panel's meeting. "

Originally posted at InjuryBoard by Joe Saunders

Glaxo AIDS Drug Doubles Heart Attack Risk

Joe Saunders — Fri, 11 Apr 2008 10:44:39 GMT

In a study published in the Lancet medical journal, Glaxo SmithKline's AIDS drug Ziagen doubles the risk of heart attack. In the wake of the published study, AIDS doctors are urging caution before abandoning the drug. These antiretrovirals are wonderful and lifesaving, but they do have toxicity problems," said Charlie Gilks, director of AIDS treatment and prevention at the World Health Organization.

Not surprisingly, Glaxo's spokesperson argued that internal company research does not support the Lancet findings.

Originally posted at InjuryBoard by Joe Saunders

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