Atlanta Personal Injury Lawyer - FDA

Pfizer Fined $2.3 Billion For Illegally Advertising Its Drugs

M. Brandon Smith — Thu, 03 Sep 2009 12:04:44 GMT

Pfizer and its subsidiary, Upjohn, are paying $2.3 billion in order to settle criminal and civil liability that arose from illegal promotion of the painkiller Bextra.

Bextra, according to the Wall Street Journal, was pulled from the market in 2005. It was commonly associated with a life threatening condition called Stevens Johnosn Syndrome and Toxic Epidermal Necrolysis.

Pfizer, as part of the settlement agreement, “agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud.”

Other drugs Pfizer has settled civil charges related to Bextra include schizophrenia drug Geodon, antibiotic Zyvox and anti-epilepsy drug Lyrica.

According to the Department of Justice (DOJ), Pfizer’s settlement agreement is the largest health-care fraud settlement in DOJ history.

Other settlements are among attorneys and Pfizer in 42 states and the District of Colombia to cover state civil consumer protection allegations related to Geodon which include paying $33 million.

What exactly did Pfizer do?

According to DOJ, the company allegedly paid kickbacks to health-care providers in order “to induce them to prescribe Bextra and other drugs.” The company promoted Bextra for off-label uses that have not been approved by the FDA. Pfizer denies the kickback charges but does concede “improper actions related to the promotion of Zyvox.”

Originally posted at InjuryBoard by M. Brandon Smith

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

Government Creating Legal Immunity for Swine Flu Vaccine Makers

Jessica Smagacz — Sat, 18 Jul 2009 22:55:53 GMT

According to the Atlanta Journal-Constitution, federal officials and vaccine makers are going to be immune from lawsuits that result from any new swine flu vaccines. This comes from a document signed by Secretary of Health and Human Services Kathleen Sebelius.

Think back to the last time the government went on a major vaccine campaign against a new swine flu. There were thousands filed where people claimed they suffered side effects from shots. Now, the government is getting a head start to prevent this. The government has protected vaccine makers against lawsuits when they were for the use of childhood vaccines since the 1980s.

According to Centers for Disease Control and Prevention, Swine Flu has caused about 263 deaths so far. “But those are people who sought health care. It’s likely that more than 1 million Americans have been sickened by the flu, many with mild cases.”

The regular winter flu vaccine has been approved by the FDA this past Friday. The government has not faced a new swine flu virus since 1976.

What are you feelings about this move to protect the makers of new vaccines for swine flu?

Originally posted at InjuryBoard by Jessica Smagacz

Eli Lilly’s Blood Thinner Approved by FDA

Jessica Smagacz — Sat, 11 Jul 2009 10:25:19 GMT

Associated Press reported that yesterday, FDA approved a blood thinner from Eli Lilly, even though this blood thinner has bleeding risks.

However, FDA has mandated that the drug must carry “the agency’s sternest warning because of its bleeding risks.”

Plavix is the world’s second best selling medication that will now have some competition with the approval of Lilly’s Effient. Plavix is made by Sanofi-Aventis and Bristol-Myers Squibb.

This decision to approve Effient has been delayed several times. FDA staffers reviewed Effient multiple times trying to weigh the drug’s risks versus its benefits.

Apparently, Effient has to carry a boxed warning to alert physicians of the risks of the bleeding and also is reserved for issues that may cause serious injury or death.

Lilly has conducted a study of over 13,000 patients with Effient. The results were that Effient prevents more heart attacks than Plavix; however, Effient causes more internal bleeding.

FDA said that Effient should not be taken by patients with a history of bleeding, stroke, or those patients who are undergoing surgery.

“Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire 2013.”

Do you think boxed warnings are effective?

Miller Tabak & Co. analyst Les Funtleyder says that “the boxed safety warning could curb sales, but not to a large extent. The FDA has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some meaning it had when it was rare.”

Originally posted at InjuryBoard by Jessica Smagacz

FDA Requires Manufacturers of Smoking Cessation Aids Add New Boxed Warnings

Jessica Smagacz — Sat, 04 Jul 2009 13:26:13 GMT

A recent FDA alert reported that FDA is requiring the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) add new Boxed Warnings.

In addition to adding new Boxed Warnings, the manufacturers are required to develop patient Medication Guides 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

These changes that are required to the prescribing information & Medication Guide for patients are also required for bupropion products (Wellbutrin and generics) that are for the treatment of depression and seasonal affective disorder.

FDA, as a result of receiving continued postmarketing adverse event reports for varenicline and bupropion, is requiring these added warnings.

“Healthcare professionals should advice 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.”

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

Stop Using Zicam Cold Remedy Nasal Gel- Possible Loss of Smell

Jessica Smagacz — Sat, 20 Jun 2009 15:27:23 GMT

This past Tuesday, FDA told consumers who are using Zicam Cold Remedy nasal gel and related products to stop use immediately. These products have the possibility of permanently damaging the sense of smell, according to CBS News.

These over-the-counter products contain Zinc. Zinc is an ingredient scientists are saying that can damage nerves in the nose—the nerves needed for smell.

Since 1999, about 130 consumers reported a loss of smell after using Matrixx Initiatives’ Zicam products.

Dr. Charles Lee, part of FDA’s compliance division, said, “Loss of the sense of smell is potentially life threatening and may be permanent. People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house.”

Currently, Matrixx is defending the safety of its products. However, they said that there is a possibility that they may remove them from the market.

Zicam Cold Remedy was NEVER formally approved because it is part of a group of remedies not required to go through federal review before launching. They are considered homeopathic treatments, something FDA has never fully regulated.

No formal recall has been announced. FDA sent the company a warning letter asking them to stop marketing its zinc-based products.

Surprisingly, “the global market for homeopathic drugs is about $200 million per year, according to the American Association of Homeopathic Pharmacists.”

If you are using these products, it’s highly recommended that you stop.

Originally posted at InjuryBoard by Jessica Smagacz

Medtronic Recall given FDA’s most Serious Score

Jessica Smagacz — Sun, 14 Jun 2009 14:59:05 GMT

This past Thursday, FDA said that thousands of Medtronic pacemakers may potentially cause serious injury or death, according to AP.

The pacemakers may have wiring defects that can cause them to malfunction. Medtronic is the world’s largest medical device company. There are 37,000 pacemakers that have this wiring defect.

FDA has classified this pacemaker as a Class I recall. This means that the device could “seriously or fatally injure patients.”

There are about 1.7 million of these pacemakers that have been implanted since 1997. “The defects affect a small subset of Kappa and Sigma pacemakers, causing them to not respond or run out of batter power.”

Over 95 percent of doctors were notified about this problem and have confirmed their receipt of the Medtronic’s letter.

“Patients should seek medical attention immediately if they experience fainting or lightheadedness, the company said in a statement.”

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