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.
Monday, June 29, 2009
Thursday, June 25, 2009
Risperdal Causing Breast Growth in Boys
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.
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.
Tuesday, June 23, 2009
Lawsuits Filed in Arizona Against Makers of Zicam
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.
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.
Friday, June 19, 2009
Matrixx Withheld Hundreds of Complaints About Zicam
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.
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.
Thursday, June 18, 2009
Zicam Recall Sheds Light on other Homeopathic treatments
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.
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.
Wednesday, June 17, 2009
Matrixx Maker of Zicam Warned by FDA
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
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
Tuesday, June 16, 2009
Reglan Use in Infants
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.
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
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.
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.
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