Orange County Personal Injury Lawyer - FDA & Prescription Drugs

Study Reveals High Levels of Lead In Lipstick

Chrissie Cole — Tue, 01 Sep 2009 00:19:00 GMT

Lead levels in lipstick are higher than previously reported according to a new study by the U.S. Food and Drug Administration (FDA).

The agency tested 20 (unidentified brands) lipsticks and found the amount of lead is up to four times higher than a study found two years ago, by the Campaign for Safe Cosmetics.

The main problem with the findings is that cosmetic companies are not required to list lead as an ingredient.

“No safe blood lead level has been identified,” said the U.S. Centers for Disease Control and Prevention.

The agency suggests avoiding all sources of lead exposure, including lipstick. Lead can build up in the body with exposure over time, especially if it's exposed to it every day. Pregnant women are particularly vulnerable to lead exposure, because lead can cross the placenta and affect fetal brain development.

The take home message is simple, avoid lipsticks containing lead. Here is a list of 11 lipsticks that were lead-free in 2007.

Originally posted at InjuryBoard by Chrissie Cole

Study to Analyze ADHD Medications and Heart Attack Risks

Chrissie Cole — Mon, 17 Sep 2007 19:06:29 GMT

A comprehensive new study is underway by two U.S. Department of Health and Human Services agencies, to determine if prescription medications used to treat attention deficit hyperactivity disorder (ADHD) increases the risk of heart attack, cardiovascular problems or stroke.

Research supported by the U.S. Food and Drug Administration (FDA) and the Agency for Healthcare Research and Quality (AHRQ) will study the clinical data of approximately 500,000 adults and children who have taken prescription medication to treat ADHD to determine if the drugs increase heart attack risks.

Medications prescribed for the treatment of ADHD are known to increase blood pressure and heart rate, therefore experts are concerned about the drugs potential to increase cardiac risk. Additionally, researchers believe the risks may be different between adults and children, but more evidence is required about the long term affects of taking ADHD medication.

The planned analysis follows an FDA-sponsored preliminary study that compiled information from large health care databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes, including death. Based on that effort, researchers identified people who took ADHD drugs during a seven-year period ending in 2005. AHRQ, which sponsors research on clinical effectiveness and safety, will team with FDA to complete the analysis of the data.

"This study highlights one of AHRQ's most important missions: to collect and analyze, scientific evidence that will help patients, policymakers, and clinicians make the best possible decisions," said AHRQ Director Carolyn M. Clancy, M.D. "This partnership with the FDA is a great way to move closer to answering important clinical questions that affect children and adults who have ADHD."

Originally posted at InjuryBoard by Chrissie Cole

Reports of Adverse Drug Effects on the Rise

Chrissie Cole — Sat, 15 Sep 2007 13:57:52 GMT

According to a new study, reports of adverse drug affects reported to the Food and Drug Administration has doubled over the past decade. Deaths associated with serious adverse drug effects also doubled.

"A change of this magnitude ought to be cause for alarm," says Thomas J. Moore, senior scientist, drug safety and policy, for the Institute for Safe Medication Practices in Huntingdon Valley, Pa., and the lead author of the study.

The study was based on analysis of serious adverse drug events voluntarily reported to the FDA through the Adverse Events Reporting System (AERS), also known as "MedWatch" reports, from 1998 to 2005. A serious adverse drug event is a scenario that results in a birth defect, disability, death, hospitalization, life threatening and lastly needed intervention to avoid harm or further illness associated with certain drugs.

The list of drugs most commonly associated with adverse side effects include: Tylenol (acetaminophen), Paxil (anti-depressant and Celebrex (anti-inflammatory) along with Fentanyl (pain killer.)

The study was released in the September 10th issue of Archives of Internal Medicine.

The Drug List
On the list of drugs most commonly identified in fatal events:
Oxycodone (OxyContin and others)
Fentanyl (Duragesic and others)
Clozapine (Clozaril)
Morphine
Acetaminophen (Tylenol)
Methadone
Infliximab (Remicade)
Interferon beta (Rebif, Betaseron, Avonex)
Risperidone (Risperdal)
Etanercept (Enbrel)
Paclitaxel (Taxol)
Acetaminophen-hydrocodone (Vicodin, Lortab, and others)
Olanzapine (Zyprexa)
Rofecoxib (Vioxx)*
Paroxetine (Paxil)

Drugs on the list of those most commonly identified in disability or serious outcomes:
Estrogens

Insulin

Infliximab (Remicade)

Interferon beta (Rebif, Betaseron, Avonex)

Paroxetine (Paxil)

Rofecoxib (Vioxx)*

Warfarin (Coumadin)

Atorvastatin (Lipitor)

Etanercept (Enbrel)

Celecoxib (Celebrex)

Phentermine (Pro-Fast)

Clozapine (Clozaril)

Interferon alfa (Alferon N, Infergen, Intron A, Roferon-A)

Simvastatin (Zocor)

Venlafaxine (Effexor)
* This drug is no longer available in the U.S.

For more information on this subject, please visit or section on Defective Drug and Product Lawsuits.

Originally posted at InjuryBoard by Chrissie Cole

Avandia Under Fire Again

Chrissie Cole — Wed, 12 Sep 2007 14:41:31 GMT

GlaxoSmithKline's (GSK) type2 diabetes drug Avandia, is once again the center of controversy after new research claims that using the drug increases the risk of heart attack.

A research paper published in the Journal of the American Medical Association (JAMA) discovered that patient's who take Avandia, were 42 percent more likely to suffer a heart attack then those that were in the control group, according to the Wall Street Journal.

Research compiled from four different clinical trials of Avandia, over the duration of a year, confirms earlier studies and suggests the use of Avandia increases cardiological risk.

A separate paper, also published by JAMA, concluded that Actos (a rival diabetes drug from Takeda Pharmaceuticals) appeared to reduce the risk of heart attack. However, the studies did not directly compare Avandia and Actos.

In July, an advisory committee to the US Food and Drug Administration (FDA) found that Avandia was tied to a risk of heart attacks but did not recommend the drug be withdrawn.

However, the FDA approved new "black box" warning labels for the drug to emphasis that it may trigger congestive heart failure and that patients should be monitored closely by their doctor.

For more information on this subject, please visit our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Chrissie Cole

Certain Diabetes Drug Manufacturers to Heighten Label Warnings on Heart Failure Risk

Chrissie Cole — Wed, 15 Aug 2007 21:13:51 GMT

Manufacturers of certain drugs approved for treating Type 2 diabetes have agreed to add stronger warnings on the risk of heart failure, announced the U.S. Food and Drug Administration (FDA). The information will be included in a "boxed" warning - the FDA's strongest warning.

The updated warning label will highlight that certain drugs may cause or worsen heart failure in some patients.

The FDA determined an updated label with a boxed warning on the risks of heart failure was required for the thiazolidinedione class of antidabetic drugs after a review of adverse reports. Included in this class are Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). The FDA has requested that the manufacturers of these drugs, GlaxoSmithKline and Takeda, address these concerns.

While reviewing the adverse event reports, the FDA discovered cases of significant weight gain and edema - both warning signs of heart failure. In some reports, continued use was association with poor health outcomes, some including death.

The updated warnings will advise health care officials to carefully observe patients for signs and symptoms of heart failure. The warning will also state that these drugs should not be used by those people who have serious or severe heart failure.

For more information on this subject matter, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Chrissie Cole

Data Shows Avandia Increases the Risk of Heart Attack

Christina Cole — Mon, 28 May 2007 18:36:39 GMT

Safety data from controlled clinical trials has shown a significant increase in the risk of heart attack and heart-related deaths in patients that are taking Avandia (rosiglitazone) for type 2 diabetes.

However, there is other published and non published data from long term clinical trials that contradict the evidence about the risk of heart attack in patients currently taking Avandia.

While the FDA is not recommending patients stop taking Avandia, they are suggesting they contact their doctor to discuss their current treatment.

The FDA is unsure whether the other approved medications in the same class for treating type 2 diabetes has less, the same or even greater risks. Switching to other therapies also confers its own risks. For this reason, the FDA is providing this safety alert to prescribers so they can make informed treatment decisions.

Originally posted at InjuryBoard by Christina Cole

FDA Says No to Vioxx Successor

IB Contributor — Sat, 05 May 2007 19:31:06 GMT

The U.S. Food and Drug Administration last week turned down pharmaceutical giant, Merck & Co.'s request to market Arcoxia, a successor to its banned arthritis drug Vioxx, according to an article posted on HealthDay's Web site. The decision came as little surprise, since an FDA advisory panel of medical experts had already voted 20-1 on April 12 against the approval of Arcoxia, a drug very similar to Vioxx.

Arcoxia (etoricoxib) is a cox-2 inhibitor, the same class of drugs that includes Vioxx, Bextra and Celebrex. Vioxx was withdrawn from the market in September 2004, after studies showed it doubled the risk for heart attack and stroke. Bextra was withdrawn for similar reasons early in 2005. Celebrex remains on drug store shelves, albeit with a strong warning label highlighting potential heart risk. Merck is still reeling under lawsuits filed by thousands of plaintiffs across the nation, several of whom are still awaiting their day in court.

The FDA decision was preceded by a barrage of criticism over Arcoxia's potential risk for increasing heart attacks and strokes, particularly among people with existing heart disease. Arcoxia is designed to treat the pain of osteoarthritis without the harsh stomach effects associated with painkillers such as aspirin. But in his testimony before the agency's advisory panel, FDA scientist Dr. David Graham said drug safety studies performed on Arcoxia were neither adequate nor reasonable to support its approval, the article said.

"What you're talking about is a potential public health disaster" Graham said of Arcoxia. "We could have a replay of what we had with Vioxx."

The fact that Merck faces more than 10,000 lawsuits related to Vioxx and is still pushing a drug that critics call "the offspring of Vioxx" is simply amazing. Their track record proves time and again that they like to put drugs in the market without proper testing. The FDA should be commended for disapproving this new drug, which if approved, could have caused a similar travesty as its predecessor, Vioxx. At Bisnar|Chase, we still have about 50 clients who are awaiting their trials on Vioxx cases.

For more information on heart disease and cox-2 inhibitors, visit the American Heart Association's Web site, www.americanheart.org. If you have suffered the adverse effects of Vioxx or other defective drugs, call me for a free consultation.

Originally posted at InjuryBoard by IB Contributor

FDA Proposes Suicide Warnings on Antidepressants

Christina Cole — Wed, 02 May 2007 20:52:10 GMT

The FDA has requested that the makers of antidepressant drugs expand their warning labels to include adults age 18-24. The labels currently have similar warnings for adolescents and children.

The maker of Prozac - Eli Lily Co and Pfizer Inc - Zoloft manufacturer and many other drug companies, said they will comply with the FDA's request.

"We believe this step will help ensure that the millions of people with depression who are young adults age 24 and under and their families can make informed treatment decisions while minimizing the fear and stigma associated with depression," Eli Lilly said in a statement.

The new labels would note that studies have not shown an increased risk in adults older than 24 and adults 65 and older taking antidepressants that have decreased risks of suicidal behavior and thoughts.

The expanded warnings will emphasize that depression and other disorders themselves are usually the most important cause of suicide.

The proposed changes came with the endorsement of FDA expert advisers. Some experts have argued that the changes are overdue while others maintain they could keep drugs from those who need them.

Last month, a comprehensive analysis of antidepressants for children and teenagers found the benefits of treatment trump the small risk of increasing suicidal thoughts and behaviors in some patients.

Originally posted at InjuryBoard by Christina Cole

Permax (Pergolide) Withdrawn from Market

Christina Cole — Mon, 30 Apr 2007 07:25:56 GMT

The FDA in cooperation with the manufacturers that distribute Permax (pergolide), have agreed to withdraw the drug from the market due to potential heart valve damage.

Two new studies showed that patients with Parkinson's disease that were treated using Permax (Pergolide) had an increased chance of serious damage to their heart valve. Permax is a member of a class of drugs that are known as dopamine agonists and is used to help manage the symptoms and signs (tremors) of Parkinson's disease.

Patients that suffer from Parkinson's disease who are taking Permax should:

â€¢ Contact their healthcare professional to discuss alternate treatment options.

â€¢ NOT stop taking Pergolide without consulting their healthcare professional, since stopping pergolide too quickly can be dangerous and several other effective treatments are available.

Read the full Permax Recall.

Originally posted at InjuryBoard by Christina Cole

Dietary Supplement Joy of Love Recalled

Christina Cole — Thu, 19 Apr 2007 12:46:27 GMT

Jen-On Herbal Science International Inc. is voluntarily recalling one of their supplements sold under the name HS Joy of Love. The recall was announced after they were informed by the Food and Drug Administration (FDA) that lab analysis completed by the FDA, found the product contained Piperadion Vardenafil, an analog of Vardenafil, an FDA approved drug that is used for the treatment of male Erectile Dysfunction (ED).

Piperadion Vardenafil is similar to Vardenafil and is supposed to have a similar pharmacological and adverse event profile. This can pose a threat to consumers because the analogue can interact with nitrates found in some prescription drugs (like that of nitroglycerin) and can dangerously lower blood pressure levels.

Consumers that have high cholesterol, diabetes, high blood pressure or heart disease are known to take nitrates. ED is a common problem in men that have such conditions and therefore consumers may seek this type of product to help with sexual performance.

Consumers who have H S Joy of Love in their possession should stop using it immediately. In the event of any adverse side effects due to its consumption, consumers should contact a physician right away. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Jen-On Herbal Science International, Inc. for a full purchase price refund by calling (626) 333-9998 for instructions on the return and refund process.

Originally posted at InjuryBoard by Christina Cole