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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According to the FDA Propylthiouracil (PTU) can cause serious liver injury, including liver failure and death.

PTU is used to manage hyperthyroidism associated with Grave’s disease. It is also used to decrease symptoms of hyperthyroidism in preparation for surgically removing the thyroid gland or before inactivating the thyroid gland with radioactive iodine therapy

Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared with methimazole (MMI).

The FDA has identified 32 AERS cases (22 adult and 10 paediatric) of serious liver injury associated with PTU use. Of the adult cases, 12 deaths and 5 liver transplants occurred. Among the paediatric patients, 1 case resulted in death and 6 in liver transplants.

In contrast, for MMI only 5 AERS cases of serious liver injury were identified. All five cases were in adult patients and 3 resulted in death.

Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. PTU may also be used when it is not advisable to remove the thyroid gland.

Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first 6 months after initiation of therapy (fatigue, weakness, vague abdominal pain, loss of appetite, itching, easy bruising or yellowing of the eyes or skin).

In general, PTU is considered second-line drug therapy except in patients who are allergic to or intolerant of methimazole. Rare cases of embryopathy, including aplasia cutis, have been reported with use of MMI during pregnancy, while no such cases have been reported with PTU use. Thus, PTU may be more appropriate for patients with Graves’ disease who are in their first trimester of pregnancy.

Agranulocytosis is potentially the most serious side effect of Propylthiouracil therapy. Patients should be instructed to report any symptoms of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. The drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, interstitial pneumonitis, fever, or exfoliative dermatitis. The patient’s bone marrow function should be monitored. Propylthiouracil can cause fetal harm when administered to a pregnant woman.

Because the drug readily crosses placental membranes and can induce goiter and even cretinism in the developing fetus, it is important that a sufficient, but not excessive, dose be given. In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently a reduction of dosage may be possible. In some instances, Propylthiouracil can be withdrawn 2 or 3 weeks before delivery.

On April 18, 2009, the FDA held a public workshop with the American Thyroid Association (ATA) to discuss PTU-related hepatotoxicity. The FDA is continuing to monitor these serious reported adverse events and working to make changes to the PTU prescribing information, particularly for use in paediatric patients. Also, the ATA plans to update its treatment guidelines for Graves’ disease in the upcoming months.

Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole (MMI). Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy. PTU and MMI were approved in 1947 and 1950, respectively.

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.

Psoriasis is a chronic disease, for which a number of effective therapeutic options are available, including four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate.

Generally, treatment for psoriasis patients involves a rotation of therapies.

More information about Psoriasis

The FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva.

In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Raptiva is prescribed for Psoriasis which is a skin disease that is caused, in part, by an overactive immune system.

Raptiva is administered once a week, as an injection under the skin (also called a subcutaneous injection). If you will be giving the injection to yourself or another person, the doctor will instruct you on how to prepare and inject the medication.

The usual sites for injection are the upper leg, upper arm, abdomen, or buttocks. The injection site should be rotated each week. Do not change the dose or stop taking Raptiva without first talking to your doctor.

Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug.

Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

People who took Spiriva or Boehringer’s older medication, Atrovent, for at least a month were 58 percent more likely to experience heart attack, stroke or cardiovascular death than those taking other drugs, the U.S. researchers wrote in the Journal of the American Medical Association.

Germany’s privately held Boehringer Ingelheim and Pfizer said they strongly disagreed with the study’s conclusions.

Via -(Reuters)

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.

July 10th the U.S. Consumer Product Safety Commission in agreement with Wal-Mart Stores Inc. of Bentonville, Arkansas announced a voluntary recall on the “Faded Glory” Lip Gloss, Locket, and Bracelet Sets sold exclusively at Wal-Mart across the nation.

High levels of lead were found in the lobster claw clasp located on the charm bracelet included in this set. The lobster claw clasp is used to close the bracelet around the wrist. If the clasp is ingested, it can cause serious health injuries and/or illnesses. No injuries or incidents have been reported at this time.

This “Faded Glory” set was manufactured in China and sold in Wal-Mart from May 2008 through June 2008 selling for about $6 each. If you are in possession of this item, discontinue any use of this item immediately and return it to Wal-Mart for a full refund.

If you have experienced any adverse side effects after using this product, contact an attorney from our firm that has knowledge of product liability and personal injury.

According to a study published in the Journal of Clinical Psychiatry, isotretinoin, the active ingredient of Accutane, doubles the risk of depression.CHU Sainte-Justine Research Centre scientists say while depression is a rare side effect of isotretinoin therapy, close monitoring of isotretinoin users is necessary due to the serious consequences of depression.

They concluded that psychiatric assessments of patients prior to and during isotretinoin therapy are crucial.

Accutane, a form of vitamin A (isotretinoin), reduces the amount of oil released by the skin and helps the skin renew itself more quickly. The drug is an effective choice in treating severe nodular acne.

Press TV – Acne drug raises depression risk

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During the probe investigators discovered that in some fraternities most members were aware of “organized drug dealing occurring from the fraternity houses by its members,” the U.S. Drug Enforcement Administration said in a statement.

“Undercover agents purchased cocaine from fraternity members and confirmed that a hierarchy existed for the purpose of selling drugs for money,” the DEA said.

Authorities said they found drugs being moved in resale quantities.

“We’re talking about trafficking,” Stephen Weber, SDSU president, told a news conference.

The district attorney’s office said search warrants were served in San Diego and suburban La Mesa, including the Theta Chi fraternity house and several apartments.

A member of Theta Chi sent out a mass text message to his “faithful customers” stating that he and his “associates” would be unable to sell cocaine while they were in Las Vegas over one weekend, according to the DEA. The text promoted a cocaine “sale” and listed the reduced prices.

Dale Taylor, national executive director of Theta Chi, said he was “obviously shocked and saddened” by the allegations.

Theta Chi has prohibited the San Diego chapter from group activities like parties or sports activities and will investigate additional disciplinary measures, up to expulsion of members or the entire chapter.

The San Diego chapter was founded 61 years ago and has 65 members. It recently purchased two small pieces of land where raided Tuesday and planned to build a new house there.

“There were on the upswing,” Taylor said. “They had improved their recruitment. They were trying to raise money for a new house.”

Kerry Steigerwalt, senior managing partner of Kerry Steigerwalt’s Pacific Law Center in La Jolla, a large firm of criminal defense attorneys, said the fraternity members arrested Tuesday could face prosecution for gang crimes both because of their association with the fraternities and because one of the non-students arrested in the sting is a documented Los Angeles gang member.

Steigerwalt said if prosecutors can show that some of the individuals arrested were associated with that gang member, Omar Castaneda, those individuals could find themselves charged with gang crimes.

“Under the gang statute, they don’t have to be members of the gang. All they have to do is be in close association with a gang member who is participating in activity to ultimately benefit the gang,” Steigerwalt said. “I gotta tell you, it would not surprise me if gang enhancements are charged.”

If you’ve been injured in any way, shape or form, you’ll need to act quickly to make sure your legal rights are protected.  A personal injury lawsuit has approximately four elements that a jury must consider before a case goes to trial.  In most cases, there is duty, breach, causation and damages.  There are several different types of injury cases that can occur.  Many people may not even consider certain situations, so it’s important to learn what qualifies as personal injury. 

Bodily injury is a classic example of a situation where a person suffers injury to his or her brain, skeletal system, spine, organs or even suffered from a disease.  This type of case is pretty straightforward and damages can be awarded by the proof of pain and suffering.  Of course, the monetary damages awarded will depend on the severity of the injuries that were suffered.

Economic injury is a bit more complicated.  Certain acts can lead to damages where a person might not actually suffer physical injury.  For instance, if someone’s negligence leads to the devaluation of personal property, this might be considered an economic injury.

Injury to reputation is an area of personal injury law where certain individuals slander another person.  Sometimes these cases are considered economic injury cases, but the inherent breach of duty present is different.  The plaintiff actually needs to show harm to his or her reputation that has led to physical or economic damages in order for this type of claim to be sustained.

Intentional injury is an area of personal injury law where the negligence standard doesn’t need to apply because the defendant has done something wrong with the intention of doing so.  Examples of this type of personal injury could include assault and battery.

So, as you can tell, there are many types of personal injury cases, and these examples above are just the tip of the iceberg.  If you or a loved one has suffered any type of personal injury or damages as a result of negligence, failure to act or intentional damage, then you need to contact an attorney immediately.

Learn more about hiring a personal injury attorney, types of personal injury or filing a personal injury lawsuit or for California and San Diego personal injury lawyer resources visit our legal resource website www.kerrysteigerwalt.com.

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