Atlanta Personal Injury Lawyer - prescription drugs

New Labeling Added By FDA from Infections Linked to Transplant Drugs

Jessica Smagacz — Sun, 19 Jul 2009 16:00:58 GMT

According to MSNBC, this past Tuesday, Federal health regulators said they were going to add new labels regarding the risks of infection to organ transplant drugs made by several drugmakers. Some of those drugmakers include Roche and Novartis.

This move is a result of FDA receiving reports of dangerous viral infections in patients who took these drugs, “which are typically used to avoid rejection following kidney transplant.”

The drugs that will have these new labels include: Roche’s CellCept, Novartis’ Myfortic, Wyeth’s Rapamune, Neoral, and Sandimmune.

FDA is continuing to monitor any reports of safety problems with these medications. FDA has also said that “physicians should carefully monitor patients for signs of viral infection, which can sometimes lead to kidney failure.”

Originally posted at InjuryBoard by Jessica Smagacz

FDA on the Option to Reduce Painkiller Overdoses

Jessica Smagacz — Wed, 01 Jul 2009 00:57:55 GMT

This past Monday, AP reported that the makers of Tylenol, Excedrin and other medications attempted to dissuade regulators from placing new restrictions on painkillers, including the possibility of removing some of them from store shelves.

35 experts were organized by the FDA to attend a two-day meeting in order to discuss ways to prevent overdose with acetaminophen.

Acetaminophen is the pain-relieving, fever-reducing ingredient in Tylenol and some other prescriptions and over-the-counter medications.

Currently, acetaminophen is “the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.”

Please see our past post: FDA will Discuss Liver Risks with Tylenol & other Painkillers.

FDA asked its experts to consider a range of options:

-Adding a “black box” warning label to the products

-Lowering the drug dosage in some products or

-Pulling certain types of medications off the market

Companies such as the industry group that represents Johnson & Johnson defended the products “saying they pose a relatively small risk to patients.”

“Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.”

Although the FDA is not required to follow the advice of its panels, it usually does. This panel vote was supposed to occur earlier today.

According to AP, FDA is making it clear that it “will not play king-maker in the market for over-the-counter medications.”

Originally posted at InjuryBoard by Jessica Smagacz

FDA will Discuss Liver Risks with Tylenol & other Painkillers

Jessica Smagacz — Sat, 27 Jun 2009 02:13:12 GMT

Federal regulators and medical experts will debate next week on how to limit liver injury in patients who take painkillers such as Tylenol, according to CNN.com.

The main issue under the “microscope” is with the ingredient called acetaminophen. This is a drug found in over-the-counter painkillers (such as Excedrin, NyQuil and Theraflu). All of these drugs can cause liver damage, acetaminophen being the most widely used drug in America.

Around 100 people die yearly from accidently overdosing on this common drug, acetaminophen. Apparently, this drug is safe if you take the recommended dosage on the label.

However, FDA does say that “the drug’s prevalence in a variety of pain relievers, fever reducers and cough medicines means patients don’t realize they are taking several drugs that contain the same ingredient, often leading to an overdose of acetaminophen.”

Since 1977 when an agency committee recommended labels for pain relievers to contain a warning about the possibility that they can damage a patient’s liver, FDA has been “struggling with [this] issue.”

Here are the current options that are being discussed:

-reduce recommended dosing levels

-Limit the number of pills or liquid in each drug containing acetaminophen

-and eliminate medicines that combine acetaminophen with other ingredients

Originally posted at InjuryBoard by Jessica Smagacz

Woman with Stevens-Johnson Syndrome May be Able to See Again after Eye Surgery

Jessica Smagacz — Wed, 10 Jun 2009 13:56:40 GMT

Cynthia Dicks, a 51 year old Sumter native, hasn’t been able to see for twelve years. According to The Item, she is scheduled for surgery in Boston at a Harvard University-affiliated hospital in order to transplant a cornea in her right eye. If this procedure is successful, her vision will be restored.

About twelve years ago, Cynthia had an pneumonia. She had it so bad that she was given Septra (combination of two antibiotics that typically treat urinary tract infections). Then she had a rare allergic reaction known as Stevens-Johnson Syndrome, with symptoms such as rashes and burns, a fever, and swelling of her eyelids.

Cynthia said, “My whole body had peeled in 24 hours. The medicine had burned me all through my veins and everywhere.” Because of this rash, she had third-degree burns over her body. She then lost her left eye and was blinded.

Because of Stevens-Johnson Syndrome, she hasn’t shed a tear in 12 years. It dried out her tear ducts, saliva glands and sweat glands.

Cynthia has hope that she will be able to see again if this surgery is successful.

For more information on Stevens-Johnson Syndrome, check out our past blog here.

Stevens-Johnson Syndrome can result in anxiety, serious pain and suffering. If you or anyone you know has Stevens-Johnson Syndrome, you may want to contact the attorneys at Childers & Schlueter, LLP to see how they can help protect your legal rights.

Originally posted at InjuryBoard by Jessica Smagacz

Possibility of Risks—More than 20 Drugs Under FDA Monitoring

Jessica Smagacz — Sun, 07 Jun 2009 18:08:21 GMT

According to Red Orbit, FDA released a list of over twenty drugs that are being tested for potential safety issues.

The list that was released this past Thursday had two-dozen different drugs, ranging from treatment of sleep disorder to weight-loss.

Sally Beatty, spokeswoman for Pfizer, said, “As with all our medicines, we work with the FDA to ensure our labeling reflects the latest safety information.” Pfizer Inc has a drug called Chantix that is on this list. This drug helps people quit smoking. FDA regulators are trying to see if the drug has any possible risk of accidental injury or vision impairment to patients.

Investigations began on the drug Chantix in 2007 after reports of psychiatric problems. Apparently a nonprofit group reported 1,001 cases of accidental injuries and blackouts from people who used Chantix.

The Federal Aviation Administration has banned the smoking cessation drug for use among air traffic controllers and pilots.

Some other drugs on the list are Pfizer’s bladder control Detrol—there have been reports of Stevens-Johnson syndrome (a serious skin reaction). Caphalon Inc’s sleep disorder drugs (Provigil and Nuvigil) are on the list because of serious skin reactions that were reported.

Originally posted at InjuryBoard by Jessica Smagacz

Acetaminophen Liver Warnings Recommended by FDA group

Jessica Smagacz — Thu, 28 May 2009 23:55:31 GMT

AP reported that an FDA group released a report this past Wednesday recommending stronger warnings and dose limits on drugs that have the painkiller acetaminophen because of an increased risk of liver injury.

Acetaminophen is available as a generic over-the-counter drug and is also available in prescription drugs. The most well-known over-the-counter drug acetaminophen is found in Johnson & Johnson’s Tylenol.

The working group report said, “There is extensive evidence that hepatotoxicity (liver toxicity) caused by acetaminophen use may result from lack of consumer awareness that acetaminophen can cause severe liver injury.”

The FDA group recommended better public information efforts, stronger labels warning of these liver side effects, and does limitations.

The report also said, “"Consumers may not be aware that acetaminophen is present in many over-the-counter combination products, so they may unknowingly exceed the recommended acetaminophen dose if they take more than one acetaminophen product without knowing that both contain acetaminophen."

Meetings and discussions on these recommendations will be occurring soon.

Originally posted at InjuryBoard by Jessica Smagacz

Problems & Risks Associated with Antipsychotic Drug Seroquel

Jessica Smagacz — Thu, 21 May 2009 11:11:14 GMT

Many patients have brought a lawsuit against a British drugmaker AstraZeneca PLC “alleging they were harmed by the blockbuster drug for schizophrenia and bipolar disorder,” according to the Washington Post.

Apparently the marketing team (executives) for the company attempted to block the efforts by company scientists to raise their concerns about the antipsychotic drug Seroquel.

Problems that may be associated with this drug include weight gain.

Patients bringing this suit claim that they have evidence of internal documents released Wednesday that back their claim. The Associated Press received some of the internal e-mails and other documents which the Washington Post says “show efforts to keep public information about Seroquel positive amid a spirited debate between the company’s scientists and its marketing executives.”

Tony Jewell, the AstraZeneca spokesman, said that Seroquel was approved in 1997. The label insert said that diabetes, high blood sugar and weight gain have been observed in patients in clinical studies that have been conducted. Jewell also said that FDA approved Seroquel for treatment in patients with bipolar mania, then bipolar depression and then an extended-release version.

“Doctors are allowed to prescribe drugs for unapproved uses, but drugmakers can’t promote them for those uses.”

AstraZeneca’s drug, Seroquel has brought in $4.5 billion in revenue last year, making Seroquel its number two drug. The company is facing about 15,000 lawsuits over Seroquel.

Originally posted at InjuryBoard by Jessica Smagacz

Additional Study shows Eye Risks Linked to Flomax

Jessica Smagacz — Wed, 20 May 2009 11:26:07 GMT

A new Canadian study showed that with men taking Flomax to treat an enlarged prostate face, according to U.S. News & World Report, a more than double the risk for serious complications if they need cataract surgery.

Flomax has previously been linked to cataract complications. Several studies have been conducted on Flomax. One study, conducted in 2005, found that men taking Flomax or other alpha-blockers before they went through cataract surgery experienced complications during and immediately after the procedure took place.

After this study came out, FDA strove to impose stronger warnings about the drug. When FDA urged stronger warnings, Boehringer Ingelheim Pharmaceuticals (makes Flomax) sent letters to doctors warning them about the potential problems.

In this new study, it compared men who took Flomax before surgery and those who have not taken Flomax before surgery.

These were the results: 7.5 percent of the men who took Flomax in the two weeks before cataract surgery had serious complications. Only 2.7 percent of those who did not take Flomax had serious complications, making it a 2.3 times greater risk if the men had taken Flomax before surgery.

Dr. Chaim M. Bell, a scientist at the Keenan Research Center at St. Michael’s Hospital in Toronto said, “The problems were not found to the same extent among men taking other alpha-blockers. Patients that were prescribed tamsulosin had an over twofold increase in their risk of adverse events after cataract surgery.”

All of these findings can be found in the May 20^th issue of the Journal of the American Medical Association.

People should know about the risks before going through with cataract surgery, especially if they are taking Flomax.

Originally posted at InjuryBoard by Jessica Smagacz

Georgia Settles with Eli Lilly and Co. for $6 million

Jessica Smagacz — Wed, 29 Apr 2009 19:44:25 GMT

According to AJC, while other states are seeking more with lawsuits over potential side effects of Zyprexa, Georgia made the decision to enter into a multimillion-dollar settlement with Eli Lilly and Co.

Georgia will get more than six million dollars from this settlement. Even with this amount, some are questioning if Georgia is making the right decision.

Many of the lawsuits filed against Eli Lilly and Co. contend the company has misled patients and physicians about Zyprexa’s potential side effects. These side effects include diabetes, hyperglycemia and excessive weight gain. The company has denied any wrongdoing in these civil cases.

Apparently, Thurbert Baker, State Attorney General, believes this provides a good deal for state taxpayers. “The attorney general’s office looked at the anticipated Medicaid losses and calculated the payout would be about double what Georgia’s claims would have been.,” said Russ Willard, a Baker spokesman.

FDA approved Zyprexa for the treatment of schizophrenia and bipolar disorder. However, some of the lawsuits, attorneys are claiming the company targeted patients with dementia when FDA did not approve this.

Lilly did plead guilty to illegally marketing Zyprexa in January and agreed to pay $1.42 billion to resolve the lawsuits and to end the criminal investigation.

Originally posted at InjuryBoard by Jessica Smagacz

Experimental J & J anticlotting Drug Backed by FDA

Jessica Smagacz — Sun, 29 Mar 2009 23:05:31 GMT

AP reported that FDA advisers said the benefits of an experimental anticlotting drug from Johnson & Johnson outweigh its risks which include bleeding and incomplete data about liver side effects.

The FDA panel included cardiology experts who voted 15 to 2 in favor of the J & J’s rivaroxaban. If this is approved, it will be “the first new pill-based anticlotting drug in a half-century.”

“J & J and partner Bayer have asked the FDA to clear their once-daily pill to stop blood clots in the legs of patients who have undergone hip or knee replacement surgery.”

This is great news if this new drug can help. However, see our past post: Proposed Drug Rivaroxaban has Bleeding Risk.

Over 800,000 patients in the U.S. undergo the procedures each year. Blood clots are a common side effect and can be deadly if they get loose and travel to the lungs.

FDA is not required to follow the advice these experts and panelists voted on, but “it usually does.”

Rivaroxaban cut the risk of blood clots or death in half in four studies of knee and hip replacement patients as compared with patients taking Sanofi-Aventis’ Lovenox (top selling drug used by orthopedic patients now).

Dr. Peter DiBattiste (J & J’s head of cardiology) said “I think we’re very pleased with the discussion and outcome and look forward to an ongoing dialogue with the agency.”

Originally posted at InjuryBoard by Jessica Smagacz