Cherry Hill, New Jersey Personal Injury Lawyer - FDA

FDA Identifies 19 Potentially Dangerous Drugs on the Market

Mike Ferrara — Thu, 08 Oct 2009 21:52:19 GMT

As we know, drugs that are shown to be “safe” for public consumption through clinical trials sometimes prove dangerous when actually consumed by the public on a day-to-day basis. Expecting this, the FDA gathers adverse event reports on every approved drug on the market. When it spots a pattern of adverse events associated with a particular drug, it puts this drug under intense scrutiny. If the drug proves, after extensive testing, to be dangerous, the FDA may implement new regulations such as a change in labeling, use restrictions, or black box warnings. Occasionally, as was the case with Merck’s Vioxx, safety concerns will compel the FDA to remove the drug completely from the market.

Below is the most recent list of drugs currently under close scrutiny by the FDA.

Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008

Product Name: Active Ingredient (Trade)
or Product Class

Potential Signal of Serious Risk/New Safety Information

Additional Information

(as of September 24, 2009)

Apomorphine (Apokyn)

Psychiatric events

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Choriogonadotropin alfa (Ovidrel)

Anaphylactic reactions

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Clomiphene citrate (Clomid)

Visual disorders

FDA is evaluating this issue to determine if the labeling, which includes visual disorders in the Warnings and Adverse Reactions sections, is adequate.

Clozapine orally disintegrating tablet (FazaClo)

Deaths

This issue relates to a finding, based on AERS reports, that the proportion of death events versus all events is higher for FazaClo than for other clozapine products. The reported events in the death cases are similar for FazaClo and other clozapine products. FDA is continuing to evaluate this issue.

Darifenacin (Enablex) and Solifenacin (Vesicare)

Angioedema and other allergic reactions

FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Drospirenone/ethinyl estradiol (Yasmin)

Pancreatitis

FDA is evaluating this issue to determine if the labeling, which includes pancreatitis, is adequate.

Efavirenz (Sustiva)

Birth defects involving the eye and face

This issue stemmed from a case of anophthalmia in AERS that was originally reported to the Antiretroviral Pregnancy Registry (APR). The labeling was updated in March 2009 to include a description of this case.
Efavirenz (Sustiva) labeling

Fibrin sealant, human (Evicel)

Air embolism

FDA is evaluating this issue to determine if labeling is adequate.

Hydrochlorothiazide in combination products

Skin reactions

FDA is evaluating this issue to determine if labeling is adequate for the various hydrochlorothiazide-containing combination products.

Imiquimod cream (Aldara)

Dysuria due to severe local reactions during use in the genital area

This issue was identified during a review of imiquimod adverse events as required by the Best Pharmaceuticals for Children Act and was presented at the November 18, 2008 Pediatric Advisory Committee meeting: One Year Post-Exclusivity Adverse Event Review: Imiquimod Pediatric Advisory Committee Meeting November 18, 2008 (PDF - 83 KB) (refer to Slide 24).

The labeling will be updated to include this event.

Modafinil (Provigil) and Armodafinil (Nuvigil)

Serious skin reactions

This issue was originally identified from AERS reports and added to labeling in 2007. An FDA Drug Safety Newsletter article featured this issue in Fall 2007: Modafinil (marketed as Provigil): Serious Skin Reactions.

FDA is continuing to evaluate this issue to determine the need for any further regulatory action.

Orlistat (Xenical, Alli)

Hepatotoxicity

FDA issued an Early Communication about an Ongoing Safety Review on this issue in August 2009.

Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)

Polyethylene glycol oral laxative (various trade names)

Neuropsychiatric events

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Raltegravir (Isentress)

Psychiatric events

The Adverse Reactions section of labeling (postmarketing experience) was updated to include psychiatric events.
Raltegravir (Isentress) labeling

Selegiline (Emsam)

Hypertension

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Sumatriptan/naproxen (Treximet)

Myocardial infarction

FDA evaluated case reports in AERS and determined that the current labeling, which includes a Boxed Warning addressing myocardial infarction, is adequate.

Testosterone gel (Androgel, Testim)

Adverse events from accidental exposure

May 2009 FDA News Release, Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide, describes the addition of a Boxed Warning to the labeling addressing adverse events in children and women due to accidental exposure to testosterone gel.

Tolterodine tartrate (Detrol)

Stevens-Johnson syndrome

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Varenicline (Chantix)

Angioedema, serious skin reactions, visual impairment, accidental injury

In July 2009, FDA approved revised labeling (changes to Precautions and Adverse Reactions sections and changes to the Medication Guide) to include angioedema, serious skin reactions, and accidental injury.
Varenicline (Chantix) Labeling (PDF - 285KB)

-FDA website

If you are taking any of the above drugs and are concerned about its potential adverse effects, please contact your health care provider right away.

Originally posted at InjuryBoard by Mike Ferrara

Phenergan Gets Black Box Warning from the FDA

Camryn Hansen — Mon, 21 Sep 2009 20:09:37 GMT

One woman’s horrific experience with Phenergan, the migraine drug formerly sold by Wyeth, has finally ended in a black box label—the strongest warning offered by the FDA—on the drug.

When in April of 2000, violinist Diana Levine went to her local health center seeking migraine treatment, a physician’s assistant administered Phenergan intravenously via the IV push method. But because the syringe missed Levine’s vein, the arm became gangrenous in a couple of weeks, and ultimately had to be amputated.

Levine sued Wyeth in Vermont State court, but the case was taken all the way to the US Supreme Court. Ultimately, the question the Court had to decide was whether or not Wyeth should be liable for Levine’s gangrene and subsequent arm amputation because the company knew of the risks of gangrene from the IV push method (more than 50 patients have developed gangrene as a result of using this specific method with Phenergan), and nevertheless marketed the drug to be used this way.

The Supreme Court sided with Levine, rejecting Wyeth’s arguments in favor of federal preemption and awarding the plaintiff $6.7 million in damages. Until last week, however, the FDA didn’t respond by placing any more regulations on Phenergan, also known as promethazine.

Now, promethazine will carry a black box label warning physicians that the safest way to administer the drug is through intramuscular injection (not IV push).

While it would have been gratifying to see the FDA ban the IV push method altogether with this drug, as Levine has indicated herself, the black box warning is nevertheless a win for consumer protections.

Originally posted at InjuryBoard by Camryn Hansen

AstraZeneca’s Ongluza: Here to Treat Diabetes Caused by Seroquel.

Camryn Hansen — Fri, 07 Aug 2009 22:10:17 GMT

It’s beyond fishy that drug giant AstraZeneca has partnered with Bristol-Myers Squibb to create Ongluza, the new diabetes drug that, now armed with FDA approval, stands to become a billion dollar blockbuster, competing directly with Merck’s Januvia.

Just a few months ago, AstraZeneca was in a lot of trouble for burying company documents that linked its popular antipsychotic, Seroquel, to the development of diabetes in patients taking the drug.

Seroquel, which brought in a full 14% of drug maker AstraZeneca’s $31.6 billion in sales last year, is only FDA-approved to treat schizophrenia and bipolar disorder. In the past few years, however, illegal off-label marketing for uses such as depression, insomnia, and childhood ADHD has spread its use 22 million patients, making it one of the best-selling drugs in the world.

More than 15,000 of these 22 million have filed over 9,000 personal injury lawsuits alleging not only that Seroquel caused them to develop diabetes, weight gain and other health problems, but that AstraZeneca knew as early as 2000 of Seroquel’s health risks and deliberately withheld these risks from patients and doctors.

As of July 2009, AstraZeneca had spent nearly $600 million fighting Seroquel-related lawsuits, fully exhausting its insurance coverage for such expenses.

Given the Ongluza development, it appears that AstraZeneca’s strategy will be to continue to market Seroquel for off-label uses to as many Americans as possible, and when this drug gives them diabetes, pay for the lawsuits by selling them some Ongluza to treat it.

Originally posted at InjuryBoard by Camryn Hansen

FDA Advisers: Vicodin and Percocet Belong off the Market

Camryn Hansen — Wed, 01 Jul 2009 23:29:29 GMT

Yesterday, an FDA advisory panel voted to recommend that all drugs combining acetaminophen (commonly known as Tylenol) with narcotics be taken off the market due to their elevated risk for severe liver damage and overdose.

Combination drugs like these include Vicodin and Percocet—two prescription painkillers that can be addictive and are sometimes sold on the street. If the FDA does not remove these drugs from circulation, the panel said, it should reduce the amount of acetaminophen in them and make sure patients fully understand the risk of liver damage associated with taking them.

The group recommended that the FDA "send a clear message that there's a high likelihood of overdose from prescription narcotics and acetaminophen products," Dr. Sandra L. Kweder of the FDA's Office of New Drugs said at a news conference after Tuesday's meeting.

Although acetaminophen is one of the most commonly used drugs in the United States for treating pain and fever, overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s, according to the FDA, citing one study.

The agency cited another study, a 2007 Centers for Disease Control and Prevention population-based report, that estimated acetaminophen was the likely cause of most of the estimated 1,600 acute liver failures each year. -CNN

Following up on earlier recommendations, the panel also recommended that to prevent overdose and consequent liver damage, the FDA should lower the maximum daily dose of acetaminophen in OTC and prescription medications as well as pay more attention to doses of the drug in children’s medicines.

Though the FDA doesn’t have to follow advisory committee recommendations like these, it usually does.

As a consumer, please pay attention to the ingredients in your medications. Whenever you take an over-the-counter product containing acetaminophen, make sure that you are not taking more than the recommended dose, and supervise children’s dosages vigilantly. Just because you can get a drug over the counter does not mean that it’s safe.

Originally posted at InjuryBoard by Camryn Hansen

FDA Warns of Possible Salmonella in Pistachios

Camryn Hansen — Wed, 24 Jun 2009 21:58:37 GMT

According to the FDA, consumers should not eat two brands of pistachios that are associated with a salmonella-related recall because they may have been repackaged before being sold in airports and hotels.

The brands to avoid are California Prime Produce and Orange County Orchards, both of which were repackaged by Orca Distribution. (Anaheim, CA).

"The company (Orca) did not publicly announce its recall. We are warning consumers not to eat these brands of pistachio," FDA spokeswoman Stephanie Kwisnek said on Tuesday in a telephone interview. -Reuters

The salmonella pistachios originally came from Setton Pistachio (Terra Bella, CA), which recalled its products nationwide in March after the bacteria had been found in some of the nuts.

Symptoms of salmonella infection generally begin with nausea and vomiting, and progress to abdominal pains, cramps, and diarrhea which can last anywhere from two days to a week. Typically, patients can recover without treatment, but young children, seniors, and those with weakened immune systems can require hospitalization for dehydration and other complications.

Earlier this year, more than 500 people were sickened and at least seven died of food poisoning from salmonella-tainted peanut butter manufactured by the Peanut Corporation of America.

If you have been sickened by pistachios or any other contaminated consumer product, contact The Ferrara Law Firm to find out more about your right to compensation.

Originally posted at InjuryBoard by Camryn Hansen

Nestle Toll House Cookies May Contain E-Coli – Protect Your Kids

Mike Ferrara — Sun, 21 Jun 2009 20:21:40 GMT

After getting reports of food-borne illnesses in 28 states that seem to have been caused by its cookie dough, Nestle is recalling 300,000 cases of it as a precaution, suspecting that it may be contaminated with E-coli bacteria.

E. coli is a dangerous bacterium which can cause bloody diarrhea, dehydration, and kidney failure, especially in young children, the elderly, and those with weak immune systems. It was recently found in contaminated beef from Illinois producer Valley Meats. Hundreds of consumers became sick from the E-coli in these products.

The FDA and the Centers for Disease Control and Prevention are urging any consumers with pre-packaged, refrigerated Nestle Toll House cookie dough products to throw them away immediately. They are also asking that restaurants and retailers stop serving Nestle Toll House products, for the sake of their customers’ health.

According to the CDC, 66 people have become sick and twenty five have been hospitalized after eating raw cookie dough since March.

Nestle issued a statement saying, "While the E. coli strain implicated in this investigation has not been detected in our product, the health and safety of our consumers is paramount, so we are initiating this voluntary recall."

"We really want to remind consumers that raw cookie dough should not be eaten," she said. -CNN

Anyone who becomes sick after eating Nestle Toll House cookie dough should contact his or her doctor to check for the presence of E-coli.

If you have been sickened by these or other contaminated consumer products, contact The Ferrara Law Firm to find out more about your right to compensation.

Originally posted at InjuryBoard by Mike Ferrara

Something Smell Fishy? If You’re Taking Zicam, No Way to Tell

Mike Ferrara — Thu, 18 Jun 2009 23:05:48 GMT

Maddeningly, it has taken the FDA a full ten years to issue a warning about Zicam Cold Remedy, a homeopathic nasal gel manufactured by Matrixx Initiatives, letting us know that this drug can permanently damage our sense of smell.

According to the FDA website,

The products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these 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.

Despite having settled hundreds of lawsuits over the past few years over this same issue, Matrixx seems to be petulantly insisting that Zicam is safe, listing on its website no side effects apart from drowsiness and stinging.

Losing a sense of smell doesn’t just mean getting less pleasure out of coffee in the morning, either, though this certainly happens too. People without a sense of smell are often unable to detect smells that may signal a life-threatening situation, such as a gas leak or a fire in the house. Something as simple as being able to tell whether the food you’re about to eat is rotten can mean the difference between getting violently sick or not.

So why hasn’t Zicam been flat-out recalled if it poses such a threat to safety? Zicam is a homeopathic drug, which means that it doesn’t receive FDA approval to begin with; it’s possible that this is why the agency is laying relatively low. As of now, the FDA has only asked the company to stop marketing Zicam, and to submit data on its safety and effectiveness.

FDA non-regulation of homeopathic remedies in itself is a fact that needs to be questioned and dealt with, since homeopathic remedies are not only booming in this country—who can afford doctor-prescribed medicine these days?—but are often imported and sold over the internet with little attention to quality or contamination. Particularly disturbing findings have emerged concerning Ayurvedic herbal products sold on the internet, which have been shown to contain toxic levels of mercury, lead, and arsenic.

Originally posted at InjuryBoard by Mike Ferrara

Congress: the FDA Will Now Control Cigarettes

Mike Ferrara — Thu, 11 Jun 2009 21:15:36 GMT

The Senate voted today and the House is expected to vote tomorrow to pass The Family Smoking Prevention and Tobacco Control Act, a critical piece of legislation that will allow the FDA to regulate cigarettes and other forms of tobacco.

Currently, a full twenty percent of Americans smoke, and 400,000 die every year from diseases related to smoking.

The new legislation, which President Obama is expected to sign as soon as it reaches his desk (he co-sponsored the bill when he was in the Senate), will allow the FDA to regulate the chemicals in cigarette smoke, ban cigarette flavorings (which are said to entice children and teens into the deadly habit), and look into banning menthol (which has links to higher rates of lung cancer). There are about 60 cancer-causing chemicals and 4000 poisonous chemicals in cigarette smoke: these would all be reduced under the auspices of the FDA.

However, though the FDA may also be able to reduce the amount of addictive nicotine in cigarettes, this legislation expressly forbids the agency to ban it altogether. Researchers have suggested that doing so might force addicts to turn to the black market for their nic fixes.

The law would also further restrict marketing and advertising of tobacco products. Colorful advertising and store displays will be replaced by black-and-white-only text as part of restrictions aimed at reducing the appeal to youth to try smoking. Cigarette makers will be required to stop using terms like “light” and “low tar” by next year and to place large and graphic health warnings on their packages by 2012.

“This long-overdue grant of authority to F.D.A. to regulate tobacco products means that the agency can finally take the actions needed to protect our people from the most deadly of all consumer products,” Edward M. Kennedy, the Massachusetts Democrat who was chief sponsor of the legislation in the Senate, said in a statement from home, where he is receiving treatment for a brain tumor. -The New York Times

The wholly bipartisan legislation passed in the Senate by a 3:1 ratio; it has equally bipartisan support in the House.

Originally posted at InjuryBoard by Mike Ferrara

Anti-Thyroid Drug for Graves’ Disease Linked to Serious Liver Injury

Mike Ferrara — Wed, 03 Jun 2009 22:59:21 GMT

Today, the FDA warned doctors about risks of serious liver injury associated with the anti-thyroid drug propylthiouracil (PTU), used to treat Graves' disease. Graves’ disease is an autoimmune disorder that causes the thyroid gland, which controls hormones that regulate metabolism, to become overactive.

Since 1968, the FDA has tracked 32 cases of serious liver injury linked to PTU use. Of the 22 adult cases, 12 resulted in death and five required liver transplants; of the 10 child cases, one resulted in death and six in liver transplants.

"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy." -FDA

According to the FDA, PTU is used as a “second-line drug therapy,” except when patients are allergic to or contraindicated for methimazole, the preferred drug for treating Graves’ disease. Because methimazole has been shown to cause a rare birth defect not associated with PTU, PTU is often given to Graves’ disease patients during early pregnancy.

If you or a loved one has suffered liver injuries after using PTU, contact the Ferrara Law Firm to learn more about your right to compensation.

Originally posted at InjuryBoard by Mike Ferrara

FDA: We Need Stricter Liver Damage Warnings on Acetaminophen (Tylenol)!

Mike Ferrara — Thu, 28 May 2009 23:40:30 GMT

In late April, the FDA announced that many over-the-counter painkillers and fever reducers will now require warning labels about the risks of liver damage and stomach bleeding associated with taking them.

Now, FDA advisers plan to meet in late June to review a new FDA report calling for even stronger language in label warnings, better consumer education, and dosage limits for prescription as well as over-the-counter acetaminophen (most of us know it as Tynenol).

According to the report, released yesterday, consumers don’t know that acetaminophen can cause severe liver damage, and so aren’t careful enough when they use it. In general, many people take more than the recommended dose of over-the-counter pain medication, mistakenly thinking that more of the drug will equal more pain relief but without dangerous side effects. Many people are also unaware that acetaminophen is numerous OTC products (not just Tylenol) including cold remedies and headache and fever medicines, making it fairly easy to accidentally exceed recommended dosages.

Despite more than five years of FDA-sponsored consumer education campaigns, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity continue to occur," the report said.

The report also calls for limiting the maximum adult daily dose to no more than 3,250 milligrams, but with a lower daily maximum for patients consuming three or more alcoholic drinks every day while using acetaminophen products. It also recommends limiting the tablet strength for immediate-release formulations to a maximum of 325 milligrams, and the single adult dose to a maximum of 650 milligrams. -Steven Reinberg, HealthDay

Warnings will have to appear on all over-the-counter products containing acetaminophen as well as on all non-steroidal anti-inflammatory drugs (NSAIDs) drugs such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve) and Excedrin—which all pose risks of stomach bleeding.

Originally posted at InjuryBoard by Mike Ferrara

Product Name: Active Ingredient (Trade) or Product Class	Potential Signal of Serious Risk/New Safety Information	Additional Information (as of September 24, 2009)
Apomorphine (Apokyn)	Psychiatric events	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Choriogonadotropin alfa (Ovidrel)	Anaphylactic reactions	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Clomiphene citrate (Clomid)	Visual disorders	FDA is evaluating this issue to determine if the labeling, which includes visual disorders in the Warnings and Adverse Reactions sections, is adequate.
Clozapine orally disintegrating tablet (FazaClo)	Deaths	This issue relates to a finding, based on AERS reports, that the proportion of death events versus all events is higher for FazaClo than for other clozapine products. The reported events in the death cases are similar for FazaClo and other clozapine products. FDA is continuing to evaluate this issue.
Darifenacin (Enablex) and Solifenacin (Vesicare)	Angioedema and other allergic reactions	FDA is continuing to evaluate these issues to determine the need for any regulatory action.
Drospirenone/ethinyl estradiol (Yasmin)	Pancreatitis	FDA is evaluating this issue to determine if the labeling, which includes pancreatitis, is adequate.
Efavirenz (Sustiva)	Birth defects involving the eye and face	This issue stemmed from a case of anophthalmia in AERS that was originally reported to the Antiretroviral Pregnancy Registry (APR). The labeling was updated in March 2009 to include a description of this case. Efavirenz (Sustiva) labeling
Fibrin sealant, human (Evicel)	Air embolism	FDA is evaluating this issue to determine if labeling is adequate.
Hydrochlorothiazide in combination products	Skin reactions	FDA is evaluating this issue to determine if labeling is adequate for the various hydrochlorothiazide-containing combination products.
Imiquimod cream (Aldara)	Dysuria due to severe local reactions during use in the genital area	This issue was identified during a review of imiquimod adverse events as required by the Best Pharmaceuticals for Children Act and was presented at the November 18, 2008 Pediatric Advisory Committee meeting: One Year Post-Exclusivity Adverse Event Review: Imiquimod Pediatric Advisory Committee Meeting November 18, 2008 (PDF - 83 KB) (refer to Slide 24). The labeling will be updated to include this event.
Modafinil (Provigil) and Armodafinil (Nuvigil)	Serious skin reactions	This issue was originally identified from AERS reports and added to labeling in 2007. An FDA Drug Safety Newsletter article featured this issue in Fall 2007: Modafinil (marketed as Provigil): Serious Skin Reactions. FDA is continuing to evaluate this issue to determine the need for any further regulatory action.
Orlistat (Xenical, Alli)	Hepatotoxicity	FDA issued an Early Communication about an Ongoing Safety Review on this issue in August 2009. Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)
Polyethylene glycol oral laxative (various trade names)	Neuropsychiatric events	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Raltegravir (Isentress)	Psychiatric events	The Adverse Reactions section of labeling (postmarketing experience) was updated to include psychiatric events. Raltegravir (Isentress) labeling
Selegiline (Emsam)	Hypertension	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Sumatriptan/naproxen (Treximet)	Myocardial infarction	FDA evaluated case reports in AERS and determined that the current labeling, which includes a Boxed Warning addressing myocardial infarction, is adequate.
Testosterone gel (Androgel, Testim)	Adverse events from accidental exposure	May 2009 FDA News Release, Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide, describes the addition of a Boxed Warning to the labeling addressing adverse events in children and women due to accidental exposure to testosterone gel.
Tolterodine tartrate (Detrol)	Stevens-Johnson syndrome	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Varenicline (Chantix)	Angioedema, serious skin reactions, visual impairment, accidental injury	In July 2009, FDA approved revised labeling (changes to Precautions and Adverse Reactions sections and changes to the Medication Guide) to include angioedema, serious skin reactions, and accidental injury. Varenicline (Chantix) Labeling (PDF - 285KB)