What’s the Cause?

Tysabri is proven to cause progressive multifocal leukoencephalopathy (PML) due to a low autoimmune system. According to the Nation Institute of Health (NIH), PML is caused by the reactivation of a common virus in the central nervous system of immune-compromised individuals. Mortality is around 50% and those who do not die from the disease are generally left severely mentally impaired.

Problems From the Start

The FDA approved the drug in 2004, but Tysabri was pulled in 2005 due to those in the clinical trials coming down with PML. In the FDA report it said that the onset of PML became much higher after Tysabri, usually dispensed under supervised infusion, had been administered regularly for 12 months.

According to the Wall Street Journal, 66,000 people around the world take the drug. Only 1 in 1000 people contract PML. There have been 31 cases reported since it was reintroduced by Biogen in 2006. Biogen attributes the lower number to close monitoring of the patient during the infusion. Also, few patients have received more than 36 infusions.

Warning the Public

On the Tysabri website in the side effects section, it specifically states,

TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML).

The actions of the FDA today specifically require a change in the instructions on the bottle and with the packaging of the drug, warning the public of the chances and risks of PML.

The FDA further deemed that it would not reduce or restrict production because the occurrence of PML in patients is low enough not to outweigh the benefits over all to patients using the drug.

What To Do If You Contract PML from Tysabri

If you or a loved one contracts PML or shows symptoms of PML from taking Tysabri infusions please:

• Talk to your doctor.
• Request to be immediately taken off of the drug (as per Biogen’s instructions)
• Seek legal council by calling Phillips Webster to learn about your legal options.

We’ve been posting about the details of the issues involving Zicam lately, but some are wondering why anosmia is something to be concerned with, when other products have been known to cause cancer and death. However, basic research will tell anyone that the loss of the sense of smell, particularly if it’s permanent, can be a dangerous condition for several reasons.

When someone cannot smell, the most obvious danger it creates is that those people may not be able to sense dangers that include smoke from a fire or poisonous substances or gas leaks. However, there are other problems associated with anosmia, and they are directly correlated with the longer duration of this condition.

Those who cannot smell will often fall into a depression, as they understand that they are physically limited and are also concerned about their lack of ability to detect the dangers described above. Medical experts have also noted that those with anosmia will slowly lose weight as a result of a loss of appetite, and this can create many other medical problems that are high-risk in nature.

Ultimately, anosmia is a serious enough side effect that the FDA ordered the makers of Zicam to stop marketing the product and for Matrixx Initiatives, Inc., the manufacturer, to voluntarily pull the products from the shelves. If you or someone you love has been injured as a result of using Zicam, contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.

Today, Matrixx Initiatives, Inc. responded by voluntarily pulling the products in question from retail shelves across the United States until the matter is resolved. The three specific products within the overall product line that were pulled include:

• Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
• Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
• Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

To reiterate the warning issued by the FDA yesterday, you should immediately stop using these products if you have them in your home.

The reason this issue arose is because the FDA received at least 130 reports of consumers using the Zicam products listed above and developing ansomia, which is the loss of the sense of smell. Consumers reported the development of this side effect soon after use, and while no duration of the condition has been defined, some reported that it took several months for their sense of smell to return.

It’s believed that zinc, one of the ingredients in Zicam products, was the reason for this side effect, as it has been known to create similar problems in people who have been exposed to it in the past. If you or someone you love has been harmed as a result of using Zicam, contact the defective drugs attorneys at Phillips & Webster immediately to schedule a free initial consultation.

However, it recent news has been released that shows that Reglan continues to draw the ire of the US Food and Drug Administration (FDA), and after the FDA had earlier required that a ‘black box’ warning be placed clearly on the labels of all Reglan products, Baxter must now also complete a ‘REMS’ study, which stands for Risk Evaluation and Mitigation Strategy. The study is meant to define whether the risks of allowing Raglan products to remain on the market outweigh the benefits.

The products at issue include:

• Reglan® Tablets
• Reglan® Oral Disintegrating Tablets
• Reglan® Injection
• Metoclopramide Oral Solution

The side effects that were reported include problems that seem to stem from the central nervous system, including uncontrolled movement of the extremities, lip smacking, grimacing and rapid eye movements. If you or someone you love has been harmed as a result of using Reglan products, contact the defective drugs attorneys at Phillips & Webster immediately to schedule a free initial consultation.

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Capsules
• Hydroxycut Max Liquid Capsules
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

The products were recalled because of at least 23 reports of serious side effects developing in consumers who purchased more than 9 million containers of it within the past year. The side effects involved serious damage to consumers’ kidneys and livers, and one 19-year-old man died after using Hydroxycut.

Hydroxycut was a popular product line because it marketed itself as a ‘natural weight loss’ solution that used natural products. However, it has yet to be determined which ingredient or ingredients are responsible for these side effects, as the ingredients seem to have changed several times.

If you have been using any of these products, you need to stop using them immediately, as was stated by the FDA. If you’ve been injured as a result of using them, you need to contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.