Drug Recall Lawyer Blog

Tylenol and asthma: Is there a connection?

When I was in elementary school, my best friend has asthma. I know this because he told me he had it. I never saw any symptoms, he was a great athlete with good endurance.

Today, it seems like everyone and their brother has asthma. The street wisdom on why we have more asthma in 2011 than 1981: kids are not as tough as they used to be. Eventually, I think science will show that there are other factors that have actually increased asthma, nut allergies, and the like.

Cue the suspects. Today's suspect is Tylenol. It is one of those "everyone uses this at some point" products. Tylenol, known by its generic name acetaminophen, is a popular pain reliever and fever reducer. It is estimated that in any given week 23% of Americans use acetaminophen. Recent concerns regarding liver injury have been raised; however, other side effects such as asthma and eczema have also recently been gaining notice. The potential risk for asthma when administered to children and use during pregnancy is a concern that was first raised over 10 years ago.

Several studies have suggested that acetaminophen use in pregnancy, infancy, later childhood and adulthood may be associated with an increased prevalence of asthma. Two large observational studies have demonstrated that increased use of acetaminophen in children has occurred due to concerns of Reye's Syndrome and allergy/asthma to aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs).

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Tylenol is one of the most commonly used drugs in the United States. The active ingredient in Tylenol is a drug called acetaminophen. Acetaminophen-containing products such as Tylenol are used by more than 50 million Americans weekly to treat conditions such as pain, fever and the aches and pains associated with the common cold and flu. If taken at recommended doses, Tylenol (acetaminophen) causes very few side effects; however, taking more than the recommended dose can result in serious liver damage, acute liver failure and even death. Overdoses can result when patients accidentally take more than the recommended dose of Tylenol (or another acetaminophen product), or by taking more than one acetaminophen-containing product at the same time.

Liver Failure

Numerous studies have demonstrated that acetaminophen overdose is a leading cause of liver damage and liver failure in the United States, and the FDA notes that “the extent of liver failure cases reported in the medical literature provides an important signal of concern.” The Agency also concedes that ingesting even a small amount of Tylenol (acetaminophen) over the recommended total daily dose may lead to liver injury and even acknowledges that “currently recommended doses and tablet strengths of acetaminophen leave little room for error…”.

Widespread Use

In addition to Tylenol, acetaminophen is an active ingredient in over 600 over-the-counter and prescription medications. As such, individuals may inadvertently use more than one acetaminophen-containing product at the same time. For example, acetaminophen is a common ingredient in many multiple-ingredient medications, such as Sudafed Triple Action™ and NyQuil. Someone who takes Tylenol for a headache and who subsequently takes one of these combination medications to treat the aches and pains associated with the flu may unknowingly consume more than the recommended daily dose of acetaminophen.

Unclear Labeling

Further complicating the picture for consumers is the fact that acetaminophen may be difficult to identify as an ingredient. Some prescription medications that contain acetaminophen label the ingredient simply as “APAP.” The lack of clear labeling may also lead consumers to accidentally ingest more than one product that contains acetaminophen.

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Pregnancy and Topamax Birth Defects

In September, Topamax lawsuits pending in federal courts throughout the county, were consolidated in Pennsylvania. The lawsuits allege birth defects in children whose mothers took Topamax. This blog post discusses these suits. If you have an interest in discussing a potential Topamax lawsuit, call 800-553-8082 or get a free on-line consultation.

Topamax is an antiepileptic medication. It is often prescribed, off label, as a mood stabilizer for patients with bi-polar disorder. Topamax lawsuits claim that birth defects such as cleft lip, cleft palate, genital malformations and other birth defects in children were caused by their mothers taking Topamax (topiramate).

Topamax and topiramate (generic) are manufactured by several companies. The lawsuits allege that manufacturers failed to warn both the public and regulatory agencies about the potential for birth defects if used during pregnancy. To give you some idea of who the bad guys are in this story, consider this: Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals agreed to pay more than $81 million dollars in fines in 2010 for illegal promotion of Topamax related to off-label psychiatric use. The history is replete with the choice of profits over patients.

Earlier this year, the FDA issued a warning and required label changes to list oral clefts as a possible side effect of its use during pregnancy. Risk is highest if used during the first trimester of pregnancy. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry show that infants exposed to antiepileptic drugs have a 0.38 to 0.55% prevalence of oral clefts, however, those exposed to topiramate have a 1.4% prevalence of oral clefts, nearly 3-4 times higher than other anticonvulsants.

Cleft palate is a condition in which the infant has a gap on the roof of the mouth which interferes with the normal functioning of the mouth including chewing and talking. To correct the birth defect, surgery is required. Surgery is generally required between 6 and 12 months of age and can take several surgeries, and years, to correct.

Continue reading " Topamax Birth Defect Suits: Why Parents are Filing Topamax Lawsuits Around the Country " »