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Chantix Side Effects Blamed for Musician Carter Albrecht’s Violent Death

There is quit a bit of speculation that the side effects of the ant-smoking drug Chantix might have been responsible for ending Carter Albrecht’s life. Carter Albrecht, a prominent Dallas musician died a violent death earlier this month. In the week leading up to the tragedy, Albrecht had been reportedly suffering from vivid, hallucinatory dreams; a Chantix side effect.

Albrecht, a member of rock group Edie Brickell and the New Bohemians, was on the verge of promising solo music career. He had started taking Chantix a week before he died. The drug Chantix, approved by the Food & Drug Administration (FDA) just last year, is meant to assist people who want to stop smoking. Albrecht was reportedly desperate to quit, as a doctor had told him smoking would damage his singing voice.

According to the Dallas Morning News, Albrecht began complaining of vivid dreams as soon as he started using Chantix. While the Chantix labels list “changes in dreaming” as a possible side effect of the drug, Albrecht’s girlfriend told the newspaper that what happened to him went far beyond that. She said Albrecht would awaken in the middle of the night, not sure that what he had experienced was real or a dream.

One evening, after Albrecht had a few cocktails, he started lashing out violently towards his girlfriend – something she said had never occurred before. Albrecht’s girlfriend told the Morning News that he seemed confused and terrified, and looked at her as though he did not recognize her. Somehow, Albrecht ended up at the home of a neighbor, banging violently on the back door. A call was made to 911, but before the police arrived the terrified neighbor had fired a warning shot from his rifle, which accidentally hit and killed Albrecht.

Albrecht’s girlfriend told the Morning News that she is convinced that Chantix played a roll in his death. And since the drug was approved last year, evidence is emerging that it could very well cause side effects similar to what Albrecht suffered. Since the drug was approved, reports of users suffering from suicidal thoughts and bizarre violent behavior have been cropping up in media outlets. One Chantix user told the Morning News about feeling as though he wanted die after having had a couple of drinks. Once this man stopped using alcohol when he took Chantix, he said the suicidal thoughts ended.

Side effects like nausea, changes in dreaming, constipation, gas and vomiting are prominently listed on the patient handout that pharmacies include with Chantix prescriptions. But only in small print in the original box insert is there mention of rare episodes of psychotic and suicidal behavior.

Chantix affects the central nervous system, as does alcohol. One addiction expert told the Morning News that it would not be unusual for a drug like Chantix to react poorly with alcohol. And such an adverse reaction might not be discovered during clinical trials of a drug, as ethical considerations prevent researchers from studying a drug’s interaction with alcohol.

Pfizer, the maker of Chantix, claims that there is no link between the drug and violent behavior, but the FDA said it would be investigating the role it might have played in Albrecht’s death. Anecdotal evidence that this drug does causes serious behavioral changes in some users is starting to pile up. Until more studies are done to determine the safety of Chantix, caution should be used when taking it. And at the very least, users should avoid all alcoholic drinks while they are taking Chantix.

Gadolinium Based Contrast Agents Used in MRIs Get New FDA Black Box Warning

Today, the Food & Drug Administration (FDA) issued a “Dear Healthcare Professional” letter to inform practitioners of recent changes to the prescribing information for gadolinium based contrast agents used during Magnetic Resonance Imaging (MRI). The letter informs healthcare professionals that a blackbox warning, the FDA’s most serious type of warning, had been added to the product labels. The blackbox warns of the association between the use of gadolinium contrast agents and a rare disorder called Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD).

NSF/NSD is a debilitating disease that affects people with pre-existing kidney disease. The first case of NSF/NSD was reported in 1997, and it wasn’t mentioned in medical literature until 2000. NSF/NSD leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF/NSD can progress to the point of causing severe stiffness in joints, and it can lead to death. It can take some time after gadolinium exposure for NSF/NSD symptoms to appear, and the disease often progresses very slowly. At this time, there is no treatment or cure for NSF/NSD. However, improved kidney function does seem to slow the development of the disease. Unfortunately, for many patients with NSF/NSD, the only way to improve their kidney function is with a transplant.

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Latest Toy Recall Involves Nearly 600,000 Lead-Tainted Toys

American consumers have not seen the end of lead-tainted toy recalls. This week, the Consumer Products Safety (CPSC) commission issued 7 separate recall notices for toys made with toxic lead paint and children’s jewelry that contain unlawful levels of lead. So far this year, the CPSC has issued 50 separate recalls for children products that contained dangerous levels of lead, more than any other previous year. What’s worse, it is unlikely that these massive recalls will be the last for toys made with illegal amounts of lead.

Toy recalls have become an almost constant occurrence in the past several months, and have hit even the country’s largest toy maker. Since August 1, the CPSC has issued three separate recalls for hazardous, Chinese-made Mattel toys. The recalls involved toys with lead paint, and others that contained dangerous magnets that could cause intestinal injuries if swallowed by a child. Other products, including jewelry made for children, school supplies and clothing have all been recalled for high levels of lead.

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Topps Frozen Beef E. Coli Outbreak Spreads to 8 States, Sickens 21

E. coli contaminated Topps Meat Company frozen beef has already sickened 21 people around the country, leading federal officials to launch an investigation of the company’s plant and suppliers. Earlier this week, Topps recalled more than 300,000 pounds of frozen beef patties when six people in New York became sick after eating them. Tests of a package of Topps patties found in one victim’s freezer test positive for E. coli contamination.

According to the Centers for Disease Control, 21 people in 8 states may have become ill after eating E. coli-laced Topps frozen beef patties. Six people in Pennsylvania have been stricken with E. coli poisoning, and at least two are hospitalized. In New York, six people became ill, and three are hospitalized. Ohio and Maine have each reported one case of E. coli poisoning, and officials in Maine are investigating 4 other possible cases. Other victims of this E. coli strain have been reported in Connecticut, Indiana, Florida and New Jersey.

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Avandia Study Says Drug Increases Chance of Heart Failure

Yet another study has found that Avandia and Actos, popular diabetes drugs, raise a patient’s risk for heart failure. These new findings are just the latest to cast doubts on the safety of these medications, which have been under scrutiny for some time.

Actos and Avandia are drugs known as thiazolidinediones, or TZDs and are used to lower blood sugar. These drugs have been under scrutiny since May when a study of 42 clinical trials conducted by the Cleveland Clinic showed that patients taking Avandia had a 43% higher risk of having a heart attack, and a 64% higher chance of sudden cardiac death. The Cleveland Clinic study also found that Avandia nearly doubled the risk for heart failure. That study caused the Food & Drug Administration (FDA) to convene a hearing of an advisory panel to discuss Avandia’s heart attack risks. While the panel agreed that patients using Avandia do face a greater risk of heart attack, and the diabetes drug should bear the strictest FDA warnings, it stopped short of recommending that Avandia be pulled from the market entirely. Both Actos and Avandia already carry warnings that they may cause or worsen congestive heart failure, a condition in which the heart does not pump blood efficiently.

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Poor FDA Oversight of Clinical Trials Puts Patients in Danger

Lax oversight of clinical trials for drugs and medical devices by the Food & Drug Administration (FDA) is endangering the lives of millions of people who participate in such studies. A new report says that the FDA has too few inspectors, does not audit clinical trials often enough, and takes few corrective measurers on the rare occasions inspectors do spot problems with clinical trials. And more often than not, inspectors focus less on the safety of human trial subjects, and worry more about whether data is being collected accurately.

According to the New York Times, the report which was conducted by the inspector general of the Department of Health and Human Services, found that the FDA does not even known how many clinical trials are going on. The agency has only 200 inspectors, many of whom have other duties, to oversee an estimated 350,000 clinical studies. As a result, less than 1 percent of all clinical trials are audited, and the few audits that do take place can come months after a clinical trial has ended.

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FDA Promises Tougher Stance on Unapproved Drugs

More than forty years after a legal loophole allowed thousands of unapproved drugs to stay on the market, the Food & Drug Administration (FDA) is finally taking steps to crack down. But with even the FDA conceding that it cannot be certain of how many unapproved medications are on the market, it could be years before consumers are completely protected from this threat.

A recent investigation by cable network CNN revealed that the FDA estimates that around 2% of the prescription drugs now on the market never went through the agency’s approval process. Many are familiar drugs, like Phenobarbital, an anti-seizure medication, and most are listed in the Physicians Desk Reference. But many others are defective drugs that have been allowed to stay on the market because the law requiring FDA approval for prescription medications wasn’t in place until 1962. The FDA never took steps to insure that these older medications went through the approval process. And while it’s illegal to sell unapproved drugs, many companies’ that make these medications took the FDA’s lack of action as a sign of approval.

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Kolcraft Play Yard Kills Infant, Prompting Massive Recall

A Kolcraft Play Yard has been blamed for the death of a 10-month-old boy, prompting the Consumer Products Safety Commission (CPSC) to order a recall of 425,000 other defective play yards. The CPSC says that a restraint strap on the changing-table portion of the play yards poses a strangulation hazard to babies.

A dozen different Kolcraft play yards are included in this recall. The defective play yards were sold at retail stores across the country between January 2001 and September 2007, and ranged in price from $50 to $130. The recalled Kolcraft play yards can be identified by their model number that is printed on a white sticker located on one of the feet of the play yard.

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E. Coli Sickens Six Indiana School Children

Health officials in Indiana are frantically trying to pinpoint the source of E. coli contamination that has left at least six students at one elementary school sick. Four of the victims are known to have been infected with the deadly E. coli O157:H7 strain, and some are hospitalized.

All of the students attended Galena Elementary School in Floyd Knobs, Indiana. Authorities are also investigating four other suspected E. coli cases which involve other Galena students and their siblings. Despite the outbreak, the Floyd County medical examiner told local media outlets that he believed the school was safe.

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Fentora Side Effects Can Be Fatal, Warns FDA

Fentora, a powerful narcotic pain killer was the subject of a Food & Drug Administration (FDA) Public Health Advisory today. The advisory was issued because the FDA has received reports of deaths and other serious side effects related to Fentora. In the advisory, the FDA warns that Fentora should only be prescribed for approved conditions, and that dosage guidelines should be carefully followed. Earlier this month, Fentora’s maker, Cephalon, Inc., sent letters to physicians containing many of the same warnings.

Fentora was approved only for treating pain in cancer patients. It is intended for patients who experience breakthrough pain because they have developed tolerances to other opiate painkillers. Fentora contains fentanyl, a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

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