Results tagged “Dangerous Drugs” from New Mexico Injury Lawyer Blog

December 9, 2011

Yaz Required To Provide New Information On Warning Labels

The Food and Drug Administration (FDA) has recently issued documents recommending that birth control pills such as Yaz should contain additional warnings concerning the risk of blood clots. The FDA noted that patients and doctors should be informed about the risks. A statement from FDA scientists provides, "We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility."

A predecessor to Yaz, Yasmin, was the first birth control pill using drospirenone, a new form of progestin. In 2006 Yasmin was reformulated and sold as Yaz. Although it was originally thought to have fewer side effects than older contraceptives, Yaz has now been shown to have a higher risk of blood clots than earlier types of birth control pills.

If you or a loved one has taken Yaz or other birth control pill containing drospirenone it is important to speak to a New Mexico Yaz attorney to determine your next steps. Birth control pills such as Yaz, Yasmin or Ocella have been associated with several side effects in addition to blood clots including:

• stroke
• heart attack
• gallbladder disease

The FDA will also ask a panel of experts to provide advice whether the drug is too dangerous for some women to take.

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May 8, 2011

Topamax May Alter Effectiveness Of Birth Control Pills

Recent reports indicate that in addition to problems such as cleft palates and cleft lip from taking Topamax, Topamax may cause oral contraceptives to loose their effectiveness.

Topamax (topiramate) is a popular migraine and seizure medication that has been recently revised by the FDA as a "Class D" pregnancy drug - i.e. one where significant evidence exists that the drug may cause harm to a fetus during pregnancy. Now, combined with evidence that Topamax may render certain birth control ineffective, physicians are urged to inform patients of the danger of Topamax and oral contraceptive interactions.

In addition to the potential for birth defects, patients taking Topamax have developed eye disorders such as glaucoma and acute myopia.

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April 19, 2011

Topamax Recall After Reports Of Unusual Odors

Johnson & Johnson has issued a Topamax recall after receiving complaints about an unusual odor linked to a byproduct from a chemical used in treating wood. Sources believe the contamination may have occurred as a result of the way medication is shipped and stored.

Topamax has recently come under fire after the FDA issued warnings of an increased risk of cleft lips and cleft palates in infants of mothers who take Topamax (topiramate) during pregnancy.

The FDA has given the Topamax a pregnancy risk rating of D, indicating positive evidence of human fetal risk and birth defects.

Topamax has also been linked to eye disorders such as blurred vision, acute myopia and secondary angle closure glaucoma.

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March 18, 2011

FDA Removes 500 Unapproved Prescription Drugs From The Market

The FDA has announced that it will be seeking to remove nearly 500 unapproved prescription drugs from the market. In a statement, the director of compliance at the Center for Drug Evaluation and Research notes that they "don't know what's in them, whether they work properly, or how they are made."

If believe you may have suffered a seriously or harmful side effect after taking a prescription drug, contact a New Mexico pharmaceutical malpractice lawyer for more information.

Often, a drug's potential for injury is unknown until patients begin reporting harmful side effects. It was only after years of studies and lawsuits that dangerous drugs such as Avandia and Vioxx received adequate warnings. Recent cases involving dangerous drugs such as Baycol, Bextra and Reglan have all brought to light the potential for debilitating side-effects and in some cases an increased chance of life-threatening effects from taking these harmful prescription drugs.

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December 13, 2010

Supreme Court Agrees To Hear Generic Reglan Drug Label Suit

The U.S. Supreme Court has agreed to hear argument over whether generic drug makers can be sued for the failure to warn about dangerous side effects on their drug label even when they follow federal rules.

In PLIVA, Inc. v. Mensing a woman took metoclopramide - the generic equivalent of Reglan - for four years to fight diabetic gastroparesis. She claims that the drug caused a severe neurological movement disorder - tardive dyskinesia - not warned about by the drug's manufacturers and distributors.

The 8th U.S. Circuit Court of Appeals found in favor of the woman, noting that more should have been done to warn consumers about possible risks. The court reasoned, "If they realized their label was insufficient but did not believe they could propose a label change, they could have simply stopped selling the product. Instead they ...placed a drug with inadequate labeling on the market and profited from its sale."

The FDA has now required Reglan to add warnings about tardive dyskinesia in February 2009.

The Supreme Court will hear argument in the spring.

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November 29, 2010

Darvon/Darvocet Pulled From The Market

Last week, the FDA finally pulled propoxyphene - sold as Darvon and Darvocet - from the U.S. market. For nearly 50 years concerns have been raised over the side effects of Darvon/Darvocet usage, including its toxicity even at low levels and its highly addictive properties. Additionally, it has not been shown to be very effective as a painkiller - its intended use.

According to reports, its toxicity and risk of causing abnormal heart rhythms have caused thousands of deaths in patients who took these medications.

As recently reported, the FDA now concludes, even the recommended dose caused "significant changes to the electrical activity of the heart" which can "increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death."

Although last week's FDA actions in removing the drug, as well as its generic equivalents, is a positive step, it comes several decades too late, after thousands of consumers may have died as a result.

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