Pharmaceutical Lawsuit and Recall Information

FDA Speeds Up Drug Review

RX Recall — Thu, 17 May 2012 17:35:35 +0000

United States Drug Review Process Faster Than Europe or Canada

In a study from the New England Journal of Medicine, researchers from Yale and the Mayo Clinic have found that the US is faster than both Europe and Canada in approving more medicines in less time. This is significant news since the FDA has long been criticized for falling behind other peers in approving new important drugs. The study states, ”between 2001 and 2010, the FDA’s typical review of a new drug was about 15 percent faster than those by the European Medicines Agency and Health Canada.”

The approval process time decrease seems to have improved since the passing of the 1992 Prescription Drug User Fee Act. The FDA website explains the act as authorizing “FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.”

Harlan Krumholz, MD writes in a Forbes article (5/17), ”we found that the FDA was almost two months faster than the European Medicines Agency and Health Canada. Moreover, the majority of the agents that we evaluated were approved first in the United States.” Krumholz goes on to argue that there should now be more regulations for market studies.

Whooping Cough Epidemic in Washington State

RX Recall — Tue, 15 May 2012 21:07:59 +0000

Washington State Declares Whooping Cough Epidemic

The Associated Press reports that the Center of Disease Control has been contacted for help by concerned health care officials in Seattle, Washington.

This is one of the state’s worst break outs of whooping cough in decades. The amount of cases has soared so high and rapidly that it has prompted the outbreak to be declared an epidemic.

State health officials are looking for federal help in controlling the epidemic, they are also urging residents to get vaccinated as quickly as possible as whooping cough is highly contagious.

Washington has had 10 times the amount of cases this year as they had reported in all of 2011. It is the first state to declare a whooping cough epidemic since the state of California in 2010.

The Center of Disease Control spokeswomen, Alison Patti, reminds adults and teens to get booster shots so the disease will not spread to the babies in their lives.

Sunburn Prevalent in Young Adults

RX Recall — Mon, 14 May 2012 21:39:48 +0000

In spite of the growing sun protection products market, sunburn continues to be prevalent in young white adults, says a study from the US Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Melanoma is deadlier than the top two most common cancers, basal cell carcinoma and squamous cell carcinoma. Sunburn, heat lamps and tanning beds may increase your risk of melanoma. ”Although protective behaviors such as sunscreen , shade use and wearing long clothing to the ankles have increased in recent years, sunburn prevalence remains high,” write the study’s authors.

The most common methods of protection from the sun by women were using sunscreen and staying in the shade. Wide brimmed hats and wearing long sleeves were least common behaviors.

For men, covering up with pants and staying in the shade were most common and wearing hats and long sleeves were also least common behaviors.

The use of sunscreen in men and women has increased in the past decade.

“These results suggest that additional efforts are needed to identify and implement effective strategies targeting younger adults to improve their sun protective behaviors and prevent sunburn and ultimately skin cancer,” the authors write.

Anti-Osteoporosis Drugs Found To Be Dangerous

RX Recall — Fri, 11 May 2012 17:28:45 +0000

Fosamax, Actonel, and Reclast Under Fire

A recent government study has found that taking anti-osteoporosis drugs such as Fosamax, Actonel and Reclast for 3 to 5 years may actually do more harm than good reports The New England Journal of Medicine.

These medications may be particularly harmful to people with only mild bone loss and it is suggested that younger people with mild bone loss should probably not even be on these medications. However, post-menopausal women with significant bone loss benefit greatly from the medications.

Any women on anti-osteoporosis drugs for more than three years are strongly advised to consult their doctor.

CCSVI Treatment On FDA Alert List As Potentially Deadly

RX Recall — Thu, 10 May 2012 19:24:56 +0000

FDA Alert on Liberation Therapy For CCSVI

Experimental procedure referred to as “liberation therapy” or “liberation procedure” used in the treatment of chronic cerebrospinal venous insufficiency (CCSVI) is on the U.S. Food and Drug Administration alert list. Health care professionals and patients are being warned about injuries and deaths linked to the use of the procedure.

CCSVI, which causes the veins in the neck and chest to narrow, some researchers believe, may cause multiple sclerosis (MS) or add to the increase chance of getting MS by adversely influencing the blood drainage from the brain and the spinal cord. Studies investigating the connection between CCSVI and MS have been obscure and even the criteria used in diagnosing CCSVI have been questionable and not clearly established.

MS is an immune-mediated disorder of the spinal cord and brain and progresses over time. With MS nerve fibers are damaged in the brain and spinal cord which result in significant disabling neurological symptoms, however the cause of this is unknown.

“Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health. “Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes.”

Liberation therapy is an experimental procedure that uses balloon angioplasty devices and stents to try to widen the narrowed veins of the neck and chest. This procedure has been found by the FDA to cause death, stroke blood clots, abdominal bleeding, damage to the treated veins and cranial nerve damage. Also, the FDA has never even approved balloon angioplasty devices and stents as treatment for CCSVI.

The FDA alert notifies investigators and doctors who are planning on running clinical trials on the use of medical devices and stents to treat CCSVI that they must first have FDA approval and comply with all FDA regulations.

Prozac and Pregnancy

RX Recall — Mon, 07 May 2012 20:08:03 +0000

Prozac Update

Prozac and breastfeeding

A recent study by researchers at University of Arizona found a link with women who take antidepressants, such as Prozac, and a decrease in breastfeeding.

It is suggested that depressive disorders and/or taking antidepressants while pregnant may cause a decline in the number of women choosing to breastfeed.

In fact,the study showed that women exposed to antidepressants like Zolofty, Celexa, Paxil, Lexapro and Prozac were 60% less likely to breastfeed than women who had not taken any type of antidepressant.

The reason for the significant decline is inconclusive. It could be due to the mother being fearful that the medication in the breast milk could harm the child or the mother’s depression itself could play a role.

“While the benefits of breastfeeding an infant are very clear, this study suggests that women who are taking antidepressants in pregnancy are not engaging in this behavior as often as we would like to see,” said Christina Chambers, professor of pediatrics at University of California San Diego, and co-author of the study.

Prozac Side Effects

Prozac (fluoxetine hydrochloride) is a prescription medication used to treat depression, obsessive-compulsive disorder (OCD) bulimia nervosa, and panic disorder. Prozac is made by Eli Lilly and Company and was approved by the Food and Drug Administration (FDA) in 1987.

Since its release, studies have linked Prozac to several serious side effects. Although still available on the market, the FDA has issued three alerts warning of potential Prozac dangers. Prozac use may cause serotonin syndrome, persistent pulmonary hypertension in newborns (PPHN), and may incidence of depression and suicide.

Prozac Health Risks and Side Effects

Since October of 2004, the FDA has issued three separate alerts regarding possible Prozac side effects.

Serotonin Syndrome

In 2006, the FDA issued an alert stating that a life-threatening condition called serotonin syndrome can occur when medicines called Serotonin and Noreponeprine Reuptake Inhibitors (SNRIs, such as Prozac) and migraine headache medicines known as 5-hydroxtryptamine receptor agonists (triptans), are taken together.

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SNRI or a triptan. If you take migraine medicines, ask your healthcare professional if your medicine is a triptan.

Persistent Pulmonary Hypertension in Newborns

Also in 2006, an FDA alert announced the results of a study linking the use of antidepressant medicines like Prozac during pregnancy to babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies. Babies with PPHN can become very sick, even die. Results from the study also showed that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies were six times more likely to develop PPHN than babies born to mothers who did not take antidepressants during pregnancy.

Increased Risk of Suicide

In October of 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare provides to an increased risk of suicidality. Since the alert, Prozac has carried a black box warning.

In 2005, the FDA announced that several scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, including Prozac. The FDA advised that all Prozac patients should be watched closely for worsening depression.

Other Prozac Side Effects

Other side effects associated with Prozac use include nausea, difficulty sleeping, anxiety, nervousness, and sleepiness.

Zoloft Update

RX Recall — Fri, 04 May 2012 18:31:21 +0000

Zoloft Update:

Research reported in the online edition the journal Frontiers in Evolutionary Psychology (4/27/12) questions the effectiveness and safety of well known antidepressant medications. The study states that the benefits of these drugs are overshadowed by the potential risks they pose. In short, the study concludes that antidepressants such as Zoloft, do more harm than good.

Zoloft:

Approved by the U.S. Food and Drug Administration in 1991, Zoloft (sertraline) is manufactured by Pfizer Pharmaceuticals. It’s used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), premenstrual stress disorder, and social anxiety disorder (SAD).

The use of Zoloft has been linked to serious side effects, including birth defects in children, serotonin syndrome, and an increased risk of suicide.

Zoloft and Birth Defects:

Zoloft use may cause the following birth defects:

Heart defects
Transposition of the great arteries
Pulmonary hypertension
Craniosyntosis
Omphalocele
Club foot
Limb defects
Lung defects
Asthma/breathing issues

Actos Cancer Warning Update

RX Recall — Wed, 02 May 2012 20:09:21 +0000

Canada Adds Bladder Cancer Warning to Actos Label

Canada Health warns public of bladder cancer risks and heart failure when using the diabetic drug Actos.

In June of 2011 both France and Germany issued a recall on Takeda Pharmaceutical’s Actos. At that time Canada opted to wait and do a safety review on the diabetes drug. Now, however, Canada concludes that action is necessary. The new Actos label will warn of the high risks of bladder cancer and heart failure. Also, Health Canada is recommending that people with family history of bladder cancer or blood in their urine not take Actos at all.

Patients taking Actos at this time are advised to speak to their health care professional before stopping the drug.

In the U.S., many federal Actos lawsuits are being consolidated so that rulings will be consistent and resources and costs will be kept to a minimum. A class action lawsuit against Actos was filed in Canada in December 2011.

Side Effects Of Celexa

RX Recall — Mon, 30 Apr 2012 22:02:44 +0000

Celexa Dosage Changes

FDA announces that Celexa, a widely used antidepressant, should not be used in doses larger than 40 mg per day.

Exceeding the recommended dosage could lead to fatal changes in the electrical activity in the heart.

Side effects of Celexa may be more severe in patients that have low levels of potassium and magnesium in the blood.

The FDA is calling for a revised label for Celexa and any generic versions of the drug.

Celexa has been a blockbuster treatment for Forest Pharmaceuticals in the treatment of depression in adults.

Celexa is not recommended for children. Last year, Forest Pharmaceuticals had to pay out $313 million dollars in a lawsuit claiming they had paid peiatricians kickbacks to endorse Ceexa and Lexapro (Forest’s derivative of Celexa).

Pradaxa Side Effects Under FDA Investigation

RX Recall — Fri, 27 Apr 2012 02:40:18 +0000

Pradaxa Side Effects – FDA Update

In December of 2011 the FDA conducted an investigation of reports of patients using Pradaxa in order to see if the rate of serious side effects is greater than first projected by the manufacturer.

Pradaxa, a blood thinner, became available in the U.S. in October 2010. It is used to reduce the risk of stroke in patients with non-valvular atrial fibrillation. It is marketed as being safer than traditional blood thinners, like warfarin (brand names Coumadin, Marfarin and Jantoven). It also does not react with certain foods the way warfarin does, which reduces the likelyhood of bleeding events. Since Pradaxa thins blood, bleeding events can be extremely dangerous to patients.

In November of 2011 Pradaxa manufacturer, Boehringer Ingelheim, reported 260 cases of fatal bleeding cases that had been attributed to using Pradaxa. They were clear to state that the rate was still below the projected rate in their clinical trial. However, there have been enough reports that the FDA put Pradaxa on their FDA MedWatch email alert in early December 2011.

Boehringer Ingelheim and the FDA are working together to analyze the post-market reports. It is complicated with the many factors that influence the reports, such as the length of time the drug has been on the market, whether or not the adverse side effect is detailed on the drug label, and the rate at which adverse effects are reported. The FDA is also examining the reports looking for evidence of inappropriate dosing, use of interacting drugs, and other clinical factors that may lead to bleeding.

Pradaxa Has No Antidote for Traumatic Bleeding

Traumatic hemorrhaging from Pradaxa is potentially deadly. Unlike traditional blood thinners that Pradaxa was meant to replace, serious bleeding can not be stopped by the administration of vitamin K. There is no simple antidote for Pradaxa bleeding.

The elderly are much more vulnerable to hemorrhaging from Pradaxa. There are a couple reasons for this. First, they are more likely to suffer from balance problems, arthritis and other disorders that put them at a greater risk of a fall which results in bleeding. Also, older people’s kidneys may not filter as efficiently and the drug may stay in their system longer. Dialysis can clear the drug from their system and may be prescribed for patients needing to stop serious bleeding.

In March 2012, a case study in the Journal of Neurosurgery showcased the deadly dangers of Pradaxa traumatic hemorrhaging in an elderly patient. The report detailed the ultimate death, of an 83-year-old man at the University of Utah Medical Center. In the begining, the patient’s case appeared to be that of a minor fall. Initially the patient was awake and alert, and his neurological exam produced no concerns. CT scans revealed only small, superficial areas of hemorrhaging in his brain.

Unfortunately, within a few hours of arriving at the hospital, new scans showed extensive intracranial hemorrhaging. Doctors administered IV fluids and a protein called recombinant factor VIIa to stop his brain bleeding, but nothing worked. Dialysis was also considered to clear the Pradaxa from his system, but his condition deteriorated too quickly. The man went into a deep coma, and passed away shortly after.

FDA Advises Pradaxa Users

Patients with AF are advised not to stop taking Pradaxa without discussing it with their healthcare professional. The risk of stroke is greatly increased with the abrupt stopping of blood thinners. Strokes can cause serious and permanent disability and even death.

The FDA will continue to communicate any drug safety information concerning Pradaxa when it becomes available.

Pradaxa Sales Skyrocket

On a side note Pradaxa is reported to have made Boehringe Ingelheim $831 million from February 2011 to February 2012. Board member Hubertus von Baumbach said in a statement. ”The launch of Pradaxa is among the most successful market introductions in the pharmaceutical industry in the past few years.”