The vials affected by the recall were labeled with a concentration of 0.5 mg/3 mL. As such, doctors could prescribe that patients use the inhaler more often, thereby administering too much of the drug, perhaps even overdosing, inducing albuterol toxicity.

Albuterol toxicity brings on conditions and symptoms such as dizziness, headache, tremors, and nervousness. More serious symptoms include seizures, high blood pressure, angina (chest pain brought on by a lack of oxygen-rich blood in the heart), low potassium levels, and a rapid heart rate, possibly reaching 200 beats per minute.

If you, your child, or anyone in your family uses an albuterol inhaler, please check the drug vials in your possession to ensure they are not included in the recall. The FDA has published a list of lot numbers of the recalled asthma medication. If you find your medication is labeled with any of those lot numbers, return it immediately to where you purchased or received it, whether a pharmacy or doctor’s office.

If you notice any of the albuterol toxicity symptoms, contact your doctor immediately. Depending on how much damage is done, or how ill the patient becomes, you may also be entitled to compensation. We hope that doesn’t happen, but if it does, please contact Bachus & Schanker for a free consultation with a product liability lawyer.

That in itself is not new information. In 2007, the FDA put a black box warning on Avandia when it became apparent through drug trials that the drug increased the risk of heart attack. A black box warning is the strongest warning that can be included in prescription drug package inserts, so named for the bold, black border that surrounds the information. It is used when a drug is found to cause severe or life-threatening adverse effects.

What is new is that GSK may have tainted initial studies in order to control published results. It’s possible GSK knew Avandia was much more dangerous than those trial results showed three years ago.

While the FDA investigates, it has prohibited the drug maker from accepting new patients into current trials. Participants in current trials are not affected by this restriction. On July 14, a 33-member FDA panel reviewing scientific data about Avandia voted on what action should be taken. Twelve panel members voted for Avandia to be taken off the market completely. But others were in favor of simply enhancing the black-box warning, and adding restrictions to the drug’s prescribed use. In short, The FDA has not yet come to a consensus on how to handle the situation.

In the meantime, if you or a loved one is taking Avandia, do not stop taking the drug on your own. This can cause blood sugar levels to become unstable, causing other serious health problems. Talk to your doctor to address your concerns, and perform any drug changes under the supervision of a medical professional.

If the worst has occurred, and you or a family member taking Avandia has suffered a heart attack or other serious side effects related to the drug, you need representation from an Avandia lawyer in Colorado. An attorney can help you determine how to proceed when dealing with this large, possibly dishonest pharmaceutical company.

Fifteen-year old Cody Miller was prescribed Singulair by his doctor to relieve his allergy symptoms and immediately suffered from severe mood swings and after only 2 weeks of treatment, took his own life. Cody’s parents, Kate and David Miller met with FDA officials earlier this week to share their story and recommend that the drug maker Merck post stronger warnings on Singulair labels.

In just over a year Merck has updated Singulair’s warning labels to include: tremors in March 2007, depression in April 2007, suicidal tendencies in October 2007, and anxiousness in February 2008. Given that Singulair is one of its top selling products, with sales of $4.3 billion dollars in 2007, it’s no wonder Merck is dragging their feet.

The FDA is tasking Merck to evaluate their existing clinical data for any signs of suicidal behavior. Isn’t that kind of like asking the fox to guard the hen house? Additionally the FDA plans to review reports it has received which could take up to nine months. I find it difficult to believe the FDA is even considering the data provided by Merck as reliable after it was revealed that Merck had ghostwritten clinical studies for Vioxx.

In addition, the FDA is investigating Accolate, Zyflo, and Zyflo CR for incidents of behavior or mood changes and suicide and will assess whether further action is necessary.

You may report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR by using the FDA’s MedWatch Adverse Event Reporting program. See the following options:
1. On-line at www.fda.gov/medwatch/report.htm
2. By returning the postage-paid FDA form 3500 (available in PDF format at: www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
3. Fax the form to 1-800-FDA-0178
4. By phone at 1-800-332-1088

First introduced in 1982 by the drug maker Hoffman-La Roche, Acctutane became of their top sellers with an estimated 1.2 billion dollar in sales.Despite reports as early as 1984 of serious adverse reactions including miscarriages and birth defects, the FDA decided to allow the sale of Accutane relying on doctors’ discretion and wisdom to properly prescribe the drug. Other adverse effects include inflammatory bowel disease, Crohn’s Disease, suicide, loss of bone density and bone fractures, muscle weakness, chapped lips and nose bleeds, Hoffman-La Roche refused to recall their product.

The side effects related to Accutane are so severe that the FDA now requires all patients who take Accutane to sign a consent form. Since 1996, pharmacists are required to give patients a Medication Guide which details the risks. Thalidomide and Mifeprex are the only other drugs that have required a Medication Guide.

In 1997 European authorities placed strict controlling measures on Accutane because of reports of serious psychiatric disorders associated with the drug. But, it wasn’t until the death by suicide in May 2000 of Michigan Congressman Bart Stupak’s son, BJ while taking the drug, that public awareness of the dangerous link between Accutane and suicide emerged. In response, a spokesperson for Roche claims that it has been used safely by over 13 million patients and that severe acne in itself can cause depression.

So, you decide…is Accutane a miracle cure or deadly remedy?

In 16 of 20 papers that reported on clinical trials, a Merck employee was assigned as the author of the first draft of the manuscript. An outside academic scientist was then listed as the lead author when the study was published.

Researcher based their allegations on documents they discovered from Vioxx lawsuits detailing the industry wide practice of ghostwriting medical research studies that are published in academic journals. Vioxx, sold as a pain reliever, was pulled from the market by Merck in 2004, over evidence linking it to heart attacks and strokes. Late last year Merck agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread. “It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” continues Dr. Ross.

Merck has even acknowledged they hire medical writers or use in-house employees to draft research reports that a doctor will later assign his name as lead author. Merck defends this practice by claiming although they may have provided the draft, the doctor was a major contributor and the reports reflects his opinion. So we aren’t necessarily getting an unbiased opinion – essentially the doctor was told what the expected outcome should be.

Dr. Ross is concerned the issues go beyond the authorship of drug research studies, raising questions about the validity of the clinical trials on which the research is based. “Who designed the trial? Who did the trial? Who did the analysis? Who interpreted the analysis?” Dr. Ross asks.

Previous studies have shown drug makes spend almost twice as much marketing a drug as they do on research and development. Now it seems they aren’t really doing the unbiased, untainted research that they should be. The question we should be asking is…if Merck did it with Vioxx, what other research studies are the other drug companies fudging? Let’s get these foxes out of the hen house!

According to a new Women’s Health Initiative study published in the Journal of the National Cancer Institute, women who take conjugated equine estrogen are at double the risk of developing benign proliferative breast disease. Tom Rohan, MBBS, Ph.D. of Albert Einstein College of Medicine and his colleagues report benign proliferative breast disease is thought to be an early stage of in the development of breast cancer and may increase the risk of later carcinoma.

Researchers looked at than 10,000 women from a previous hormone replacement trial who were given the HRT drug Premarin manufactured by Wyeth. 155 cases of non-cancerous proliferative breast disease were documented in women participating in Hormone Replacement Therapy (HRT) compared to 77 in women taking placebos.

This latest news, in addition to previous reports of serious side effects including increased risk of breast, uterine and ovarian cancer, heart attack, stoke, blot clots, dementia, and gall bladder disease, indicates that it’s time for Wyeth to do the right thing and stop putting profit before safety and issue a recall on their golden goose, Premarin. As successful as Premarin may have been for millions of women, studies are proving the risks are beginning to outweight the benefits and drug manufacturers should begin putting serious research dollars into HRT alternatives.

Baxter’s initial partial recall occurred on January 17, 2008. On February 28, 2008, seven weeks later, after 400 cases of adverse reactions and four deaths, they announced a recall of all of their heparin products. Since the latest recall, there are now reports of additional deaths that may be attributed to heparin. Because 4 deaths aren’t enough.

One would hope that a pharmaceutical company would have all of the kinks worked out before they put their product on the market. That said, let’s give them the benefit of the doubt and say the drugs are as safe as they can make them, but something totally unforeseen comes up that proves to be a danger to the public. In a perfect world, that product would immediately be pulled from the market and there would be no deaths and minimal adverse reactions from a defective product. The FDA and Baxter don’t exist in our perfect world. History has shown that Corporate America won’t pull a defective product until it hurts them financially. Baxter and the FDA claimed the health benefits outweighed the health risks. Tell that to the 400 patients who suffered adverse reactions. Tell that to the families of the four people who died.

And now the Supreme Court is considering protecting companies like Baxter. Justice Stephen G. Breyer said the fundamental question is who should make the decisions that determine whether a drug is “on balance, going to save people or, on balance, going to hurt people? An expert agency on the one hand or 12 people pulled randomly for a jury role who see before them only the people who the drug hurt and don’t see those who need the drug to cure them?” he continues.

Seems to me, that is exactly the type of questions you and I should be answering. Justice Breyer contends the role of policing the medical market is exclusively the role of the Food and Drug Administration. The Institute of Medicine, the Government Accountability Office and the FDA’s own science board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food.

Justice Breyer’s logic interprets into the hard, cold fact that if a few people die or suffer serious side effects as a consequence of taking any drug, then that is okay. A small price to pay, for the benefit of the masses. Let’s hope that Justice Stephen G. Breyer or his family isn’t one of unlucky few that suffers serious side effects or dies. Because according to Justice Breyer’s logic, that’s okay, because there are many more people who benefited from this drug.

That’s not okay. The 400 patients who suffered from the adverse reactions don’t think it’s okay. The families of the 4 people who died don’t think it’s okay. If the drug companies think that is okay, then let’s hold them financially accountable.