Injuryboard Commentary - Defective Drugs

NIH Halts Viagra Trial In Sickle Cell Patients

Chrissie Cole — Tue, 28 Jul 2009 22:11:00 GMT

A trial of sildenafil intended to determine if the drug could be used to treat pulmonary hypertension in some patients with sickle cell disease has been halted a year early by the National Institutes of Health (NIH).

The trial involved sildenafil -- marketed as Viagra when it is used to treat erectile dysfunction and Revatio when used for pulmonary arterial hypertension, or high blood pressure in the lungs. The NIH was sponsoring a study at nine U.S. hospitals and one in London.

The researchers found that 38 percent of patients taking Revatio had serious adverse effects, compared to 8 percent of patients getting a placebo.

Most episodes involved severe pain called sickle cell crises requiring hospitalization. No deaths have been linked with the drug.

Dr. Elizabeth Nabel, chief of NIH’s National Heart, Lung and Blood Institute (NHLBI) stresses that the side effects are specific to sickle cell patients and advises patients to talk to their doctors.

Sildenafil treats pulmonary hypertension by relaxing blood vessels in the lungs to allow blood to flow easier.

Nearly 30 percent of people with sickle cell disease are affected by pulmonary hypertension.

Originally posted at InjuryBoard by Chrissie Cole

Certain Zicam OTC Products Recalled

Chrissie Cole — Wed, 17 Jun 2009 20:33:00 GMT

The U.S. Food and Drug Administration (FDA) is warning consumers to avoid using certain over-the-counter Zicam products, after receiving 130 reports of loss of sense of smell associated with use.

Many Zicam users who experienced loss of sense of smell, also known as anosmia, said the condition occurred with the first dose; while others reported a loss of smell after multiple uses.

The affected Zicam products are:

--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

Anosmia, can adversely affect a person’s safety by limiting their ability to detect the smell of gas, spoiled food or smoke and other dangers in the environment.

“We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).

In a letter to Matrixx Initiatives, the maker of Zicam products, the agency said the company must cease marketing the products because they are misbranded and fail to warn users of the risks associated with use.

Zicam users that have experienced loss of smell or other problems associated with these products are advised to contact their health care professional.

Originally posted at InjuryBoard by Chrissie Cole

Stalled suits against drugmakers proceeding after Supreme Court preemption decision.

Wayne Parsons — Thu, 30 Apr 2009 12:16:10 GMT

Bloomberg News (4/30, Fisk, Feeley) reports, "Just two months after the U.S. Supreme Court decided patients can sue drugmakers over injuries from medicines approved by the government, long-stalled lawsuits against GlaxoSmithKline Plc and Bristol-Myers Squibb Co. are again moving toward trials." On March 4, the Supreme Court ruled that "federal regulatory approval of a medicine and information about side effects doesn't shield drugmakers from claims that patients and doctors weren't adequately warned." Justice John Paul Stevens, writing for the majority, stated that "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." The ruling has "already affected more than 250 lawsuits involving at least 10 companies that were in limbo before the ruling." Glaxo has "settled two cases on claims its antidepressant Paxil can make patients suicidal, after judges set trials citing the Wyeth decision." Meanwhile, "a group of Bristol-Myers lawsuits over the blood-thinner Plavix may now proceed to trial in federal court."

Originally posted at InjuryBoard by Wayne Parsons

FDA - Raptiva Withdrawn From U.S. Market

Chrissie Cole — Fri, 10 Apr 2009 12:22:00 GMT

Genentech, Inc., the maker of the psoriasis drug Raptiva (generic name efalizumab) recently announced a phased voluntary withdrawal of the prescription only drug from the U.S. market.

The decision is based on Raptiva's link to an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.

PML is a progressive neurological disease with no available treatment. Patients with a severely compromised immune system are at risk of suffering from an irreversible brain function and possibly death.

In February, the FDA issued a Public Health Advisory warning patients about the associated risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died.

The labeling for Raptiva was updated in October 2008 to include a Boxed Warning highlighting the risks of serious infections, including PML.

Approximately 2,000 patients in the U.S. are currently taking Raptiva for chronic plaque psoriasis. Approved by the FDA in 2003, about 46,000 patients worldwide have been treated with Raptiva.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online.

Originally posted at InjuryBoard by Chrissie Cole

FDA - Raptiva Linked To Three Deaths

Chrissie Cole — Sun, 01 Mar 2009 18:51:00 GMT

A Public Health Advisory, recently issued by the FDA confirms three deaths, and possibly a fourth from progressive multifocal leukoencephalopthy (PML), a rare brain infection, in patients using the drug, efalizumab (Raptiva) made by Genentech, Inc.

The labeling for Raptiva was updated in October 2008 to include a Boxed Warning, highlighting the risks of life-threatening infections, including PML.

Genetech was also directed Genentech, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to include a medication guide intended to educate patients about the drug’s associated risks.

PML is a rare and often-fatal brain infection, where there is inflammation of the brain's white matter. Patients with a severely compromised immune system are at risk of suffering from an irreversible brain function and possibly death. No treatment exists for PML.

The FDA is reviewing the latest information and will take appropriate measures to ensure that the risks of Raptiva do not outweigh its benefits, and that patients prescribed Raptiva are fully aware of the signs and symptoms of PML.

Originally posted at InjuryBoard by Chrissie Cole

Three Deaths Linked To Psoriasis Drug Raptiva

Chrissie Cole — Fri, 20 Feb 2009 12:05:00 GMT

The FDA has confirmed three reports of death from progressive multifocal leukoencephalopathy (PML) associated with the Psoriasis drug, Raptiva. A fourth case is being looked at as well.

Psoriasis is a chronic and painful skin disorder characterized by inflamed, red, scaly lesions, caused when affected skin cells reproduce faster than normal. Certain forms of psoriasis may be fatal.

Raptiva’s product labeling was revised in October 2008 to include a boxed warning about the risks of life-threatening infections associated with the drug, including PML.

Genentech, the manufacturer, was directed by the agency at that time to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide intended to educate patients about the drug’s associated risks.

The agency advises health care professionals to carefully monitor patients taking Raptiva for any sign of neurologic disease.

In September 2008, the drug Rituxan, also manufactured by Genentech, revised its labeling after a woman who was treated with it died from PML, according to the U.S. Food and Drug Administration (FDA).

Originally posted at InjuryBoard by Chrissie Cole

Genetech Updating Rituxan Label After Patient Death

Chrissie Cole — Mon, 15 Sep 2008 14:24:00 GMT

Genetech notified healthcare professionals of revisions to the prescribing information on the drug Rituxan after a woman who was treated with it died from a brain infection, according to the Food and Drug Administration (FDA).

Progressive multifocal leukoencephalopathy (PML) is a rare and often-fatal brain infection, where there is inflammation of the brain's white matter.

The drug was first approved by the FDA in 1997 to treat non-Hodgkin’s lymphoma and in 2006 for the treatment of rheumatoid arthritis.

According to the FDA, this is the first reported case of infection in a patient taking Rituxan for the treatment of arthritis. PML cases have been linked to patients taking Rixutan for unapproved uses in the past, including blood cancer.

Biogen Idec first reported the fatal case of PML in July.

Originally posted at InjuryBoard by Chrissie Cole

Paxil Preemption Ruling Overturned

Scott Kappes — Thu, 24 Jul 2008 16:17:55 GMT

A federal judge in Indiana has vacated his previous ruling that wrongful death claims brought against the makers of Paxil were preempted by federal regulations. This reversal will now allow the claims to be heard. The judge, David Hamilton, said that in the previous ruling the “court failed to appreciate the significance of the fact” that a drug manufacturers can modify the label of a medication without FDA approval, if they have reasonable evidence of serious harm that could be inflicted on patients. In the case of Paxil, SmithKline Beecham Corp. (now GlaxoSmithKline), failed to revise the label when they were well aware potential harm to recipients of the drug.

In the next term the Supreme Court will address the issue of preemption related to pharmaceuticals in the case Wyeth v Levine. The basic question that the court will have the duty of answering is whether the FDA’s approval of a medication should preempt state product liability lawsuits brought over injuries incurred by recipients but not specifically warned of on the label of a drug.

This is a very serious and intricate question that court must address in the coming months. If the court were to decide that lawsuits would be preempted by FDA approval, as they did for certain medical devices in Riegel v Medtronic, it would be a catastrophic blow to the plaintiffs’ rights. Hopefully the court will not be influenced by big pharma’s attempt to demonize the trail lawyers and product liability lawsuits.

While it is true that some trial attorneys have brought forth frivolous lawsuits that have given the entire industry a bad name, they are very much in the minority. Most plaintiffs’ attorneys truly do care for their clients and have chosen to work in the field that they do out of compassion for victims.

Pharmaceutical companies are amongst the richest companies in the world. Their greed and desire for profit transcends all barriers. On numerous occasions pharmaceutical companies have concealed evidence of adverse effects from their products, all in an effort to make more profit off of a medication that they knew was placing innocent victims in harm’s way.

These business giants must be held accountable for the injuries incurred from the medications that they make. If the tens of millions spent on lobbying each and a small portion of the multi-billion dollar profits seen by some companies each and every year were to go into making safer more effective drugs and better research, maybe there would not be a great need for plaintiffs’ law in this area. But as it stands now, the victims of defective medications need help more than ever.

Originally posted at InjuryBoard by Scott Kappes

Prescriptions Killed More Floridians Than Street Drugs In 2007

Eddie Farah — Sat, 14 Jun 2008 22:24:44 GMT

Prescriptions Killed More Than Street Drugs In 2007

By Eddie Farah on June 14, 2008

A report released this week by the Florida Department of Law Enforcement and the Florida Medical Examiner’s Commission, concludes that prescription drugs killed more Floridians in 2007 than illegal drugs.

In fact, the death rate is reported to be over three times higher than that of all illegal drugs combined.

Oxycodone, and methadone are at the top of the list. Cocaine, alcohol, and heroin use also increased, according to the report.

Stopping the taking of legally prescribed drugs, whether they were intended for the user or not, should be the focus of educating Florida’s families about the dangers of abusing prescription drugs, the report says. Meanwhile, law enforcement must focus on illegal street drugs.

Bill Janes, Director of the Office of Drug Control, says doctors and pharmacists must get involved to help stop doctor shopping.

“Only through a comprehensive, coordinated strategy will we be able to reverse this tragic, unacceptable trend,” he says.

Originally posted at InjuryBoard by Eddie Farah

You've been exposed to Cadmium - now what?

Megan Roth — Mon, 05 May 2008 00:00:15 GMT

Cadmium poisoning and how to effectively treat it is a conundrum.

Alright, let's say you've done everything we recommended in order to prevent cadmium poisoning. You've altered your diet to include a well-balanced mix of all major food groups, you've replaced your rusty, out-dated pipes, and you've stopped smoking (cold turkey, of course). So now there's no risk of cadmium exposure, right? Wishful thinking. Though you've decreased your risk, there's no way to completely eliminate it. Let's pretend that, one way or another; you've been exposed to the toxin. How do you know you've been exposed and how should you react?

First and foremost, you should know the symptoms of cadmium poisoning, which adversely affects respiratory and kidney functions. Anytime cadmium exposure is suspected or symptoms resemble those of cadmium poisoning, seek medical attention; there's no effective treatment for the poison, so it's important to diagnose it and begin work against it right away.

If you've been exposed to the toxin, immediately remove yourself from the environment in which exposure has occurred and administer oxygen. If exposure occurred through the ingestion of cadmium salts, induce vomiting ASAP; as happens when any toxin is ingested, our bodies react naturally as a means of warding off the harmful substance. The easiest way to eliminate this is to rid the body of the toxin, through whatever means necessary.

It's important to note that, to date, no treatment has been proven effective for cadmium poisoning. As a result, exposure to the toxin must be treated symptomatically. For example, cadmium poisoning often causes headaches, chest pains, muscle aches, coughing and fevers; though they may not be cured, each of these symptoms can be lessened with the use of over-the-counter medications.

Similarly, one who's experiencing the common symptoms of dizziness and fatigue will no doubt benefit from the ever-popular doctors' recommendation to get a little R&R - yup, you guessed it: rest and relaxation. While having an excuse to curl up on the couch without feeling guilty may seem nice, it'll undoubtedly get old when you have to do it day after day because your symptoms aren't going away.

This is the major problem: there may be means of providing temporary relief from symptoms of cadmium poisoning, but they are just that: temporary. The effects of cadmium poisoning will not go away and, in the long-term, they will not get better. Thus, it is essential to avoid exposure to the harmful element at all costs (regardless of how expensive they may be).

Originally posted at InjuryBoard by Megan Roth