Januvia side effects could include pancreatitis according to FDA

Diabetes treatment Januvia and Janumet ( sitagliptin / metformin ) could be linked to occurrences of acute pancreatitis, According to the FDA.

This is the same problem that sunk sales of Amylin Pharmaceuticals Inc.’s Byetta.

88 cases of acute pancreatitis were reported to the fda in Januvia patients between 10/06 and 02/09.

The agency is working with Merck to include new warning information on the drug’s label.
“It is recommended that health care professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases,” the agency said, in a statement.

Patients who take these drugs are advised by the FDA to discuss this news with thier doctor and advice that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin.

Still, the agency said it is unknown whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of the condition.

“Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert health care professionals to this potentially serious adverse drug event,” the agency said.

What is sitagliptin?

Sitagliptin is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.

Sitagliptin is for people with type 2 diabetes (non-insulin-dependent) diabetes. Sitagliptin is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.

Sitagliptin may also be used for other purposes not listed in this medication guide.

If you or someone you care about has taken a medication and suffered adverse side effects, we urge you to contact our law offices today. You may have actually injected or ingested a defective drug;  if so, you could be entitled to monetary compensation for any pain and suffering that resulted from your experiences with the product.

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Ocella Lawsuit Information

Ocella class action lawsuits starting with possible case settlements for Ocella victims.

Birth control pills have been around for quite some time and in fact are being used by thousands who try to prevent themselves from getting pregnant. A birth control pill is an oral contraceptive which contains hormones that try to stop ovulation so that the female will be unable to produce an egg for the male sperm to fertilize.

There are many types of birth control pills that are circulating in the market today although one has to be very careful in choosing which birth control pill to use and whether it is safe for your body or not.

One of these is Ocella.

The same brand of pill may cause side effects in most women but it may have only a slight adverse effect on others.  These side effects may generally depend on the overall health condition of the woman taking the contraceptives. But most of the times, however, the side effects caused by taking oral contraceptives or birth control pills may go unnoticed for a little while and the woman taking it would usually overlook the changes that is happening to her.

Some of the changes that may not be noticed for a short time would be mood changes, headaches and weight gain.

Mood changes are also one of the side effects that may go unnoticed by the woman taking birth control pills. This change can only be noticed by the people around her but not by the woman herself.

These things may only be considered as somewhat probably minor changes, but still, this should be a cause for concern already because it might lead to something serious since some of the more serious side effects of birth control pills are blood clots, heart diseases, breast and liver cancer.

Ocella Attorneys are interested in hearing from any women that has suffered the above side effects.

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Yasmin Lawsuit Information
Yasmin side effectsYasmin side effects

Yasmin Lawsuit Information

Law firms recently have started taking inquires from people who may have a potential  yasmin lawsuit due to injury from side effects.

The FDA issued a letter to Bayer AG and strongly suggested that they talk about the numerous side effects. The FDA felt that the ads were misleading These claims are misleading because they suggest that Yasmin’s “different kind of hormone” offers unique “chemistry” benefits and that this difference contributes to the high rate of drug efficacy.

Yasmin is a type of birth control pill marketed and manufactured by the German company Bayer Schering Pharma AG Yasmin first entered the American market in 2001 and has generated close to 500 million in sales to date.Yasmin is an oral contraceptive and is a synthetic spironolactone analogue known in the medical world as drospirenone.

Drospirenone binds to the progesterone receptor, the resulting complex becomes activated and binds to specific sites on DNA. This leads to an increased difficulty of sperm entry into the uterus and implantation.

When the Yasmin TV advertising started the FDA took issue with the television commercials which featured women discussing the benefits of the product. The ads had a music score and dialog between the actors.

While there has been no official Yasmin recall, the U.S. Food and Drug Administration (FDA) has warned Bayer AG that the advertising campaign for Yasmin and Yaz were misleading, namely that the ads suggested a broad useage of the medication, minimized potentially serious side effects, and overstated the efficacy of the pill.

Twice have letters been sent to Bayer AG, and once has Bayer AG been ordered to correct its ads, costing the company a total of $20 million. Bayer AG is also under obligation to submit future ad campaigns to the FDA for approval before it launches them in the U.S.

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Acetaminophen Liver Failure Side Effects

Acetaminophen Liver Failure

Research has shown that hundreds of Americans each year experience acute liver failure as a result of taking acetaminophen — widely known under the brand name Tylenol — and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.

Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.

History of  Acetaminophen Liver Failure

In the late 1990s, research began to show that acetaminophen was a major cause of acute liver failure in the United States, with up to half of the cases due to accidental overdose. Responding to these concerns, FDA took a number of steps to reduce the incidence of liver injury related to acetaminophen.

In 1998, FDA finalized a regulation that required all OTC acetaminophen products to include an alcohol warning in labeling.

The warning stated: Acetaminophen. ‘‘Alcohol Warning’’: ‘‘If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.’’

In 2002, FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen.7 The Advisory Committee recommended a specific liver toxicity warning and distinctive labeling on OTC packages so that products containing acetaminophen could be more easily identified. FDA and manufacturers were also advised to educate consumers and health professionals about the risk of liver injury from acetaminophen.

In early 2004, FDA launched a public education campaign to help consumers use acetaminophen more safely. By most standards, the campaign would be considered small, due to budgetary constraints. It was also limited by reluctance on the part of some commercial outlets to provide a venue for FDA’s message about acetaminophen toxicity as the product was sold or promoted in those outlets. Nonetheless, FDA has continued to expand efforts to improve public education about acetaminophen overdosing and liver injury and has recently updated the acetaminophen information on FDA’s Web site.

In 2004, FDA sent letters to every state board of pharmacy asking them to consider requiring labeling on the immediate container of Rx products containing acetaminophen that: (1) uses the term acetaminophen, not APAP, (2) instructs patients to avoid concurrent use of other acetaminophen containing drugs, (3) instructs patients not to exceed the maximum daily recommended acetaminophen dose, and (4) instructs patients to avoid drinking alcohol during prescription use.8 FDA was informed by the National Association of Boards of Pharmacy that, as of February 2008, no states had implemented regulations related to the request.

In December 2006, FDA issued proposed regulations for OTC labeling for acetaminophen containing products to require inclusion of new safety information and that the container and outer carton identify acetaminophen when it is an ingredient.9 The final version of the regulation is currently under review.

In 2007, the Director of FDA’s Center for Drug Evaluation and Research (CDER) convened a multidisciplinary working group in CDER to continue to evaluate the issues associated with acetaminophen-related liver injury and consider additional steps FDA could take to decrease the number of cases of acetaminophen-related liver injury. The working group considered detailed reviews of the issues from the Office of Nonprescription Products, the Office of Surveillance and Epidemiology and the Division of Anesthesia and Analgesic and Rheumatology Drug Products as part of its deliberations.

Source: FDA 2009 Meeting Materials web page

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Acetaminophen Black Box Warning by FDA

6-30-2009

Acetaminophen /Tylenol – Black Box Warning Recommended by the FDA

The FDA has recommends that the a black box warning is added to the labels of prescription pain and cold products that contain acetaminophen wich is widely known under the brand name Tylenol.

The FDA states that there is a signifigant health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products.

Because acetaminophen is important for the use of treating pain and fever they do not want to remove it from the market.

Acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.

Acetaminophen is the active ingredient in Tylenol.
It is also found in many other over-the-counter medications you can buy at the drug store and in prescription drugs your doctor prescribes:
Common names include:

• Actifed
• Alka-Seltzer Plus
• Benadryl, Butalbital
• Co-Gesic
• Contac
• Darvocet
• Excedrin
• Fioricet
• Lortab
• Midrin
• Norco
• Percocet
• Robitussin
• Sedapap
• Sinutab
• Sudafed
• TheraFlu
• Unisom With Pain
• Vick’s Nyquil
• Vick’s DayQuil
• Vicodin,
• Wygesic
• Zydone

Acetaminophen in overdose can seriously damage the liver. If the damage is severe, a liver transplant may be necessary in order to save a life.

Accordning to Research, hundreds of people each year are diagnosed with acute liver failure as a result of taking acetaminophen and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.

Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.

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Zicam Warning by FDA – Consumers Should Stop Taking

Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.

The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions againstdrug companies than the Bush administration did.

The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”

The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.

“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the release said. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”

Matrixx had $101 million in sales last year, of which $40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.

The F.D.A. does not have the power to order product recalls but must rely on manufacturers to do so voluntarily. Bills now moving through Congress would give the agency that power. Bush administration appointees said the F.D.A. did not need mandatory recall authority because companies always withdrew unsafe products when asked.

But the government sometimes negotiated for days or weeks before companies agreed to recalls, leading many more consumers to be put at risk. And the Zicam case demonstrates that aggressive enforcement action can lead to disagreements.

An F.D.A. warning letter sent to Matrixx on Tuesday states that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.” Such language would normally describe a recall alert. The products have no proven benefits.

Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the F.D.A., said Deborah M. Autor, director of compliance in the agency’s drug center. The law requires producers of approved drugs to forward to the F.D.A. all reports of product-related injuries, but Ms. Autor declined to say whether this reporting requirement applied to Matrixx.

“This disabling loss of one of the five senses may be long lasting or even permanent in some people,” Ms. Autor said. “People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life.”

Dr. Charles E. Lee, a compliance officer in the agency’s drug center, said zinc could be toxic to nerve receptors in the nose. In the 1930s, intranasal zinc was tested as a polio preventative, and some patients suffered anosmia, Dr. Lee said.

Hydroxycut Recall Information – 5/2/2009

Products included in the Hydroxycut Recall

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut Hardcore Liquid Capsules
• Hydroxycut Max Liquid Capsules
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

Users of Hydroxycut should be aware of symptoms of possible liver damage from hydroxycut, including, jaundice, brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

Stomach Medicine Side Effects Require Box Warning by FDA

Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.

More about : Reglan and Tardive Dyskinesia

No Limit on Lawsuits against Drug Makers upheld by Supreme Court

In a win for consumers, the United States Supreme Court has upheld a law that would have limited the amount of money in lawsuits against drug makers.

The Supreme Court has upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea that it limit lawsuits against drug makers.

In a 6-3 decision Wednesday, the court rejected Wyeth Pharmaceuticals’ claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont.

The decision is the second this term that rejected business groups’ arguments that federal regulation effectively pre-empts consumer complaints under state law.

Raptiva Psoriasis Drug Side Effects FDA Warning

Raptiva Psoriasis Drug Side Effects warning issued by the FDA.

The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died.

All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.

The FDA is reviewing this latest information. The agency will take appropriate steps to:

• ensure that the risks of Raptiva do not outweigh its benefits;

• that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and

• that health care professionals carefully monitor patients for the possible development of PML.

The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system.

These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient’s susceptibility to infections.

Since the approval of Raptiva (efalizumab) in October 2003, the FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years of age who were using Raptiva for the treatment of moderate to severe plaque psoriasis.

Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years.  None of the patients were receiving other treatments that suppress the immune system while taking Raptiva.

PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.  When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML.

Raptiva works by affecting T-cells in the immune system.  The effects of Raptiva also decrease the function of the immune system and increase susceptibility to infections.

Raptiva was approved for the treatment of moderate to severe plaque psoriasis in 2003. There were no cases of PML seen in the clinical trials that supported the approval of Raptiva.  At the time of approval, a total of 2,764 patients had been treated with Raptiva.  Of those 2,764 patients, 2400 had been treated for three months, 904 for six months, and 218 for one year or more.

In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML.  In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.

The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML.

Healthcare providers should, in the interim, be aware of the following information and advice:

• Raptiva increases the risk of PML.  Longer, continuous use may further increase this risk.

• Inform patients using Raptiva of the potential risk of developing PML.

• There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.

• Monitor patients being treated with Raptiva for the onset of neurologic symptoms.  Discontinue Raptiva if PML is suspected.

• Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks.  Consideration should be given to use of other approved therapies to control the patients’ psoriasis.

• The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.

Patients using Raptiva should:

• Be aware that Raptiva increases the risk of developing PML.  PML is a disease that is fatal or causes severe disability.

• Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.

• Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.

• Contact their healthcare provider immediately if they experience these symptoms.

• Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML

In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.

According to Reuters,  Genentech Inc (DNA.N) is developing plans to minimize the risks of a deadly infection reported in patients who took the company’s Raptiva psoriasis drug, a company spokeswoman said on Thursday.
The European Medicines Agency recommended suspension of Raptiva’s marketing approval after three confirmed reports of progressive multifocal leukoencephalopathy, or PML. U.S. regulators said they were reviewing the cases.

“We are evaluating all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan,” Genentech spokeswoman Tara Cooper said.

Genentech markets Raptiva in the United States. Merck Serono, a unit of Merck KGaA (MRCG.DE), holds marketing rights to Raptiva in Europe. (Reporting by Lisa Richwine, editing by Lisa Von Ahn)

Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with RAPTIVA . These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with RAPTIVA. If a patient develops a serious infection, RAPTIVA should be discontinued and appropriate therapy instituted.

Progressive Multifocal Leukoencephalopathy PML) resulting from JC virus infection has occurred during therapy with RAPTIVA.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

The FDA asks health care providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html

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Byetta Diabetes Drug Information

Byetta  is a drug  used for Diabetes treatment .

In an August  2008  Byetta warning, the FDA  said it  would to strengthen warnings about life-threatening pancreas problems linked to the type 2 diabetes drug Byetta after getting two reports of deaths and four other hospitalizations in Byetta users.

Those patients had hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) or necrotizing pancreatitis (in which the inflamed pancreas destroys itself).

All six patients were hospitalized, and their Byetta treatment was stopped. The four survivors were still recovering at the time that the FDA learned of their illness.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected and not restarted if pancreatitis is confirmed, notes the FDA. Byetta, given by injection, was approved by the FDA in 2005.

BYETTA® (exenatide) is a synthetic peptide that has incretin-mimetic actions and was originally identified in the lizard Heloderma suspectum.  BYETTA enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.

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Yasmin Lawyer – Yasmin Birth Control under Scrutiny

Yasmin Birth control drug is the latest drug to come under scrutiny. Yasmin has been associated with several serious side effects including stroke, heart attack and even death.  Women a history involving cardiovascular problems should be especially careful.

Other severe side effects include:

• Severe allergic reactions including :rash, hives, itching, difficulty breathing.
• Tightness in the chest swelling of the mouth, face, lips, or tongue.
• Fainting
• Irregular heartbeat
• Symptoms of liver problems
• Unusual or severe vaginal bleeding
• Unusual tiredness or weakness
• vaginal irritation or discharge
• Vision changes (eg, sudden vision loss, double vision)

If you experience any of these Yasmin side effects you should seek medical attention immediatly.

Yasmin Lawyers are also investigating these reports and are looking for women who may have severe side effects from yasmin birth control.

For more information call our free legal hotline 1-866-242-0905

FDA Warning – Tarceva – Erlotinib Tablets

OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment.

Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN.

Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range.

New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tarceva

Epilepsy Drug may Cause Birth Defects

Topiramate, sold under the brand name Topamax by Johnson & Johnson, makes up about 20% of prescriptions issued to treat epilepsy. Epilepsy is a disorder that is most associated with powerful seizures.

A study was done whereby 203 pregnant women were given topiramate and other epileptic drugs.
The results were as follows:

“18 ended in spontaneous abortions, two in stillbirths and five in induced abortions. Of the 178 babies born, 16 had major birth defects. In three of those cases, the mothers had taken only topiramate, and in the other 13, the mothers had taken it in combination with other drugs. Four of the babies had cleft palates or lips. Four male babies had genital birth defects”

Many experts were not surprised about these findings since it was known that topiramate had caused similar defects in animals. However, experts caution people that this study was performed on a very low number of women so it cannot be fully determined whether or not topiramate is so detrimental to a growing fetus. Dr. Kimford J. Meador of the University of Florida in Gainesville was not part of the study and commented that “You can’t make any definitive statements from the data.”

Even if there is this risk to the fetus, it is essential that a pregnant woman continue to take the drug while pregnant if they are taking it to treat seizures. This is because seizures may actually cause more adverse affects to the fetus than the topiramate.

If you or your baby has suffered any medical injuries after using Topiramate or Topamax, contact our office immediately.

Carbatrol Lawsuit filed

Generic versus brand name drugs are always an issue for pharmaceutical companies. If there are drug companies producing generic versions of drugs illegally, then it should very well be an issue.

This is the case with Shire who has a track record of filing lawsuits against other drug companies. This time they are filing patent infringement lawsuits against Nostrum Pharmaceuticals and Apotex for attempting to apply to be able to market versions of its anti-seizure drug Carbatrol.

Carbatrol is used to treat patients who suffer seizures disorders and trigeminal neuralgia. Trigeminal neuralgia is described as episodes of “sudden, brief, recurrent, stabbing facial pain.”

There are rules and regulations that must be followed when producing generic drugs some of which are in place to protect consumers. If a company is not following these rules they can be detrimental to the public health.

This is the cause of some pharmaceutical drug recalls. Consumers use the recalled drug ignorant of its recall status and consequently suffer extreme adverse effects and sometimes death.

If you have taken a drug and have experienced any adverse side effects consult with one of our attorneys as well as visit our website at www.kerrysteigerwalt.com. (Always seek the medical attention you need first.)

Cipro Side Effects draw Black Box Warning by FDA

The (FDA) anounced to the makers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

Many people agree that the FDA is simply not doing enough about drugs like this.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

“Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations,” said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research.

“The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”

Morphine Sulfate Recall- Voluntarily Recall by Ethex Corp

ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall. The voluntary single-lot recall is due to a report that a tablet with as much as double the appropriate thickness was identified and the possibility therefore that there may be other similar oversized tablets that may have been commercially released in the affected lot. Such tablets may contain as much as twice the labeled level of active morphine ingredient. The product is a white oval tablet with “60″ on one side, and “E” on the reverse.

No report of unexpected side effects or injury has been received. However, opioids such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness. As such, they may be less likely to be able to determine that a tablet is overweight or oversized than an unimpaired individual.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation previously initiated the recall notification to wholesalers and retailers who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact the number above regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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