PharmaLawyer Blawg

Avandia has significantly higher risk of heart failure than Actos

2009-08-20T10:37:00.002-05:00

August 19, 2009 - An article published yesterday concluded that Avandia is associated with a significantly higher risk of heart failure and death than Actos. According to the authors, older patients with diabetes should not be prescribed Avandia because it lacks a distinct clinical advantage over Actos.

This is the most recent article exposing the serious health risks of Avandia. Thousands of individuals are currently pursuing legal claims against the makers of Avandia. The claims allege that the Avandia-users developed congestive heart failure or suffered a heart attack or death after taking the drug.

First Fosamax Trial Begins Tomorrow

2009-08-10T14:31:00.005-05:00

The first "bellwether" trial in the Fosamax litigation begins tomorrow. Merck & Co. currently faces more than 900 lawsuits that claim its osteoporosis drug Fosamax causes jawbone-tissue death. The trial is presided over by U.S. District Judge John Keenan in the U.S. District Court for the Southern District of New York.

"In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but also because it's the first information about how jurors respond to the evidence," said Howard Erichson, a law professor at Fordham University in New York, on Bloomberg.com. The verdict reached in the first "bellwether" trial often guides future out-of-court settlements. Accordingly, all plaintiffs and attorneys involved in the Fosamax litigation will be watching this cases closely in the coming days and weeks to determine the potential value of their lawsuits.

Legislators Take Aim at Direct To Consumer Advertising

2009-07-28T17:18:00.004-05:00

According to the New York Times, several bills have been introduced in the House to restrict or ban TV advertising for pharmaceuticals. However, restricting or banning these ads often runs afoul of free speech rights.

According to the NYT, Henry Waxman, Democrat from California, favors giving the FDA the power to bar consumer advertising for new drugs for an initial period after approval. Given that many drugs are approved before any real-world experience with the drugs has taken place many of the risks of a certain drug are not known. It is not until the drug has been on the market for several years that the risks are better understood. So, it makes sense to limit new drugs to patients who have not seen them on T.V., but have been prescribed to them by physicians who know them, their histories and medical conditions, not too mention the other prescriptions they take.

Delaying the availability of direct to consumer T.V. advertising may well have prevented numerous individuals from being injured by such "blockbuster" drugs as Vioxx, Lipitor, Yaz/Yasmin, and Ortho Evra just to name a few. Such limitations are not likely to be enacted any time soon because the broadcasters, newspaper and pharmaceutical lobbies are just too powerful to allow a law that would protect consumers, but hurt big business' bottom line.

Lawsuits Filed Nationwide Claiming Injuries from Yaz and Yasmin

2009-07-23T13:56:00.006-05:00

Women across the country are filing lawsuits claiming they suffered serious side effects from Yaz. The injuries these women suffered include blood clots, deep vein thrombosis, pulmonary embolism and stroke.

The lawsuits claim Bayer failed to warn of the serious injuries that could occur from the use of Yaz. The serious side effects appear to be caused by hyperkalemia, a condition caused by excessive amounts of potassium in the blood. According to the FDA the progestin used in Yaz and Yasmin called drospirenone or drsp can cause hyperkalemia.

In October 2008 the FDA cited Bayer's Yaz commercials for deceptive claims. The FDA's warning letter said the television commercials minimized the risks posed by the birth control pills. Bayer was forced to pull the ads and agreed to run new TV spots correcting the misinformation disseminated by its previous marketing campaigns.

Lawsuits Filed Over Yaz and Yasmin Birth Control Pills

2009-07-21T15:57:00.005-05:00

July 17, 2009 - Bayer Pharmaceuticals, maker of Yaz and Yasmin oral contraceptives is facing lawsuits regarding the safety of these drugs. The lawsuits allege that the FDA has received more adverse event reports for Yaz and Yasmin than other birth control pills.

Last year, Bayer Pharmaceuticals, the third largest pharmaceutical company in the world, agreed to run a $20million ad campaign correcting misstatements in a previous ad campaign, which downplayed risks and overstated benefits. Bayer agreed to run the ads following a warning letter from the FDA.

FDA Alerts Healthcare Professionals of Black Box Warning for Chantix and Wellbutrin/Zyban

2009-07-01T11:58:00.002-05:00

July 1, 2009 - The FDA alerted healthcare providers today that the manufacturers of varenicline (Chantix) and bupropion (Zyban, Wellbutrin and generics) must add new "Black Box" warnings highlighting the risk of serious neuropsychiatric symptoms in patients using these products. Symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.

The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease. Some of these cases may have been confounded by symptoms typically seen in people who have stopped smoking and are experiencing withdrawal from nicotine.

Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior. If varenicline or bupropion is stopped due to neuropsychiatric symptoms, patients should be monitored until the symptoms resolve.

The possible risks of serious adverse events occurring while using varenicline or bupropion should always be weighed against the significant health benefits of quitting smoking.

Lantus linked to cancer

2009-06-29T11:57:00.004-05:00

European studies released last weekend suggest a link between Sonofi-Aventis' diabetes drug Lantus and cancer. Two database analyses found an increase in cancer risk, especially breast cancer, amont Lantus patients compared to people using other forms of insulin. The data is not conclusive, but does arouse suspicion that should not be ignored when treating patients.

Lantus has the second largest share of the diabetic drug treatment market. The drug was approved by FDA for diabetes in 2000.

Risperdal Causing Breast Growth in Boys

2009-06-25T21:58:00.005-05:00

Risperdal, an atypical anti-psychotic drug, has been linked to breast growth, and even lactation, in boys under 18. The condition is known as gynecomastia (male breast growth), and is usually permanent.

Risperdal's approved uses were expanded after it's original FDA approval for treatment of schizophrenia, to include irritability associated with autistic disorders in children from 5 to 16 years of age, treatment of schizophrenia in adolescents aged from 13 to 17, and the short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17. It is prescribed "off-label" as a treatment for Attention Deficit Disorder (ADHD).

Risperdal causes a release of prolactin from the pituitary gland. Prolactin is a hormone that stimulates breast development and lactation. According to a recent CBS report, a four-year old boy, began developing a breast on one side of his body after he began taking Risperdal. At that young age, his breast had even begun producing milk. The child has undergone mastectomies to correct the problem.

Another boy began developing breasts as a result of Risperdal when he was 14, and still suffers psychological affects at age 19 even though he underwent a double mastectomy.

In 2008, Duke University psychiatrist P. Murali Doraiswamy told The Wall Street Journal that Risperdal had the strongest link with gynecomastia in children and adolescents of any of the newer antipsychotic drugs–accounting for 70% of the cases analyzed. He has also found that some girls taking Risperdal begin to lactate before they reach puberty.

Some children who have suffered from breast growth and have undergone masectomies are filing lawsuits against Risperdal's maker, Janssen. The lawsuits claim Janssen marketed Risperdal for unapproved uses in children, and downplayed serious side effects.

Lawsuits Filed in Arizona Against Makers of Zicam

2009-06-23T13:36:00.002-05:00

On Monday, June 22, 2009 more than 100 people filed claims against the makers of Zicam. The lawsuits seek compensation for loss of smell after using Zicam Nasal Gel Sprays and Zicam Nasal swabs. The lawsuits were filed in Maricopa County, Arizona.

The FDA warned consumers last week to stop using Zicam nasal cold remedies because they may cause anosmia (loss of smell). Since the warning was issued, hundreds of Plaintiffs have sought legal representation against Matrixx Initiatives, the Scottsdale, Arizona based company that makes Zicam products.

Matrixx Withheld Hundreds of Complaints About Zicam

2009-06-19T09:37:00.003-05:00

As has been widely reported, the FDA urged consumers to stop using Zicam nasal cold remedies and warned the company to stop marketing them as well. William Hemelt, Matrixx's acting president, cheif financial and chief operating officer, said Tuesday's warning from the FDA came as a "complete surprise" to the company. Matrixx was surprised by the warning eventhough in May FDA inspectors drew attention to more than 800 complaints to the company that had not been reported to the FDA. The approximatley 800 complaints related to Zicam nasal cold remedies. Broader reporting requirements were made mandatory by new laws passed in 2007. Mr. Hemelt acknowledged the reporting requirements, but said the company did not forward the reports to the FDA based on its lawyers recommendation.

Given the serious side effects of the drug, namely loss of smell and often taste, it seems unlikely the public would have chosen to use a product whose benefits are unproven had they known of the risks. According to Reuters, it is estimated that the recall of these products could cost the company as much as $10 million. By concealing about 800 complaints about the product, it appears the makers of Zicam made a conscious choice to profits over people.

Zicam Recall Sheds Light on other Homeopathic treatments

2009-06-18T13:25:00.004-05:00

Zicam, sold since 1999 as a cold remedy, was never tested by the FDA for safety like most drugs. Because Zicam is homeopathic, the FDA did not test the drug before it hit the market. However, after more than 130 Adverse Events Reports, the FDA could no longer ignore the problem. On June 16, 2009 the FDA warned customers to stop using Zicam Nasal Swabs and Nasal Gel Spray. The reason: too many reports of anosmia or loss of smell. On the same day as the consumer warning, the FDA sent a warning letter to Matrixx Initiatives, makers of Zicam, to stop marketing the nasal cold remedy products. The letter also stated that Zicam would have to be tested for safety and efficacy, just like other drugs before it is available again to consumers.

More than 1 billion doses of Zicam have been sold since 1999 according to the associated press. In 2006, Matrixx settled about 340 Zicam cases for $12 million dollars. The company claims it settled the cases to limit its legal exposure, but the settlements beg the question, just when did Matrixx know of the dangers of its products?

Many consumers were shocked to learn that products like Zicam don't have to pass any tests for safety before hitting store shelves. The protection for homeopathic medicines is almost the dirty little secret of the industry. In fact, Albert Lambert, retired deputy director of the FDA's unit overseeing drug labels, calls it "a big fraud" on the consumer.

According to an Associated Press article, homeopathic remedies have seen a resurgence in the last decade, with the market for these medicines growing by 89% since 2002. By 2007, homeopathic remedies were taken by almost 4 million Americans the article reported. In 2008, homeopathic medicine was an $830 million dollar industry according to the article. Hopefully the wide spread news coverage of the serious side effects from Zicam will force regulators and lawmakers to consider testing homeopathic medicines before they can be marketed. In the meantime, Matrixx can expect a new wave of claims from its customers who have lost the sense of smell.

Matrixx Maker of Zicam Warned by FDA

2009-06-17T14:31:00.006-05:00

In a letter from the FDA on Tuesday, June 16, 2009, Matrixx Initiatives, Inc. was ordered to file a New Drug Application with the FDA for its Zicam Cold Remedy products. The warning letter was prompted by more than 130 Adverse Event Reports to the FDA. The FDAs warning letter to Matrixx also indicates that the FDA is aware of over 800 reports of loss of smell or Anosmia made directly to Matrixx.

Those numbers are frightening considering that only a very small number of adverse events are usually reported to drug manufacturers and the FDA. Given that close to 1,000 people have already reported loss of smell, there are probably thousands, if not tens of thousands of people, who have suffered some loss of smell due to Zicam products.

According to the New York Times, Dr. Margaret Hamburg, FDA commissioner, said the incidence of anosmia associated with Zicam 'strikes us as a fairly large problem.' The company "paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell" in 2006, and "hundreds more such suits have since been filed."

In conjunction with the warning letter to Matrixx, the FDA warned consumers to stop using Zicam products immediately. You may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting Program by phone at 1-800-FDA-1088 or online at http://www.fda.gov/Safety/MedWatch/default.htm

Reglan Use in Infants

2009-06-16T15:35:00.002-05:00

Reglan and Infants
Gastroesophageal reflux (GER) effects approximately two-thirds of all infants. Some of the symptoms of GER in infants include regurgitating, spitting up and difficulty feeding. GER typically resolves between six and twelve months of age.

Gastroesophageal reflux disease (GERD), on the otherhand, is usually due to a poorly coordinated gastrointestinal tract and therefore may affect the child for a longer period of time. Symptoms of GERD include frequent vomiting, frequent or persistent cough, and/or colicky behavior. GERD is also associated with more serious symptoms including feeding problems, poor growth, breathing problems and recurrent pneumonia.

Reglan should only be used in infants after conservative treatments have failed. Examples of conservative treatment include, elevating the head of the baby's crib, holding the baby upright for 30 minutes after a feeding, and/or changing the infant's feeding schedule. If the conservative treatments fail, your pediatrician may recommend a drug like Reglan.

Be sure to discuss the risk of serious side effects including Tardive Dyskinesia with your doctor before starting your infant on Reglan. It is also important to use Reglan only for short-term treatment (4-12weeks) to decrease the likelihood of developing serious side effects.

FDA Warning on Zicam - Linked to Loss of Smell

2009-06-16T13:17:00.000-05:00

On June 16, 2009, the FDA warned consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kid Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia).

FDA notified consumers and healthcare providers to discontinue use of the Zicam products sold over-the-counter as cold remedies because the are associated with the loss of sense of smell. FDA recommends that consumers stop using these products and throw them away. Because Zicam Cold Remedies are homeopathic treatments, the FDA is limited in its capacity to regulate it, making a forced Zicam recall unlikely. In lieu of a Zicam recall, the three Zicam Nasal Cold Remedies have been discontinued.

The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam Products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or other signs of danger in the environment. Also, loss of the sense of smell is often linked with a loss of the sense of taste. People who cannot taste could unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating. The loss of the sense of smell can adversely affect a person's quality of life.

FDA recommends that consumers contact their healthcare provider if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products.