Agency Investigating Dilantin Risks of SJS and TEN

FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found on the FDA’s website.

SOURCE: U.S. Food and Drug Administration (FDA)

Dilantin lawsuit information: Dilantin Lawsuits

Dilantin SJS information: Dilantin Stevens Johnson Syndrome Lawsuits

Dilantin TEN information: Dilantin Toxic Epidermal Necrolysis Lawsuits

See also: Dilantin Side Effects.

Speak to a Dilantin Lawyer

If you took Dilantin and suffered Stevens Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), we encourage you to contact a Dilantin attorney at our law firm immediately. An experienced product liability attorney can assist you in a legal action against the makers of Dilantin. Contact our law firm and learn more about your legal rights and the options available to you and your family.

Updated: July 23, 2010 — Patients taking Dilantin, or Dilantin XR, need to be aware of serious skin side effects. The FDA has warned of a potential increased risk of severe skin reactions including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) from phenytoin therapy. Epileptic patients taking Dilantin to control seizures should be aware of these health risks. Dilantin (phenytoin sodium) is an anti-epileptic drug, sometimes also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Doctors prescribe Dilantin (phenytoin sodium) to patients with certain forms of epilepsy to manage temporal lobe seizures (a type of seizure caused by disease in the cortex of the temporal [side] lobe of the brain affecting smell, taste, sight, hearing, memory, and movement) and grand mal seizures (a type of seizure in which the individual experiences a sudden loss of consciousness immediately followed by generalized convulsions). Dilantin may also be used to prevent and treat seizures that can occur during and after neurosurgery (surgery of the brain and spinal cord).

Dilantin Stevens Johnson Syndrome (SJS)

Stevens Johnson Syndrome is a rare and serious disease that affects the mucous membranes and the skin, eventually resulting in the epidermis (the outer layers of skin) separating from the dermis (inner layers of skin). SJS is closely related to TEN (Toxic Epidermal Necrolysis), which affects the skin in the same way but can lead to the separation of one hundred percent of the epidermis. SJS is said to be a milder form of TEN, affecting up to thirty percent or more of the epidermis. SJS has been linked to many prescription medications and a multitude of common over-the-counter treatments as well. Stevens Johnson Syndrome is similar to Lyell’s Syndrome.

For more Dilantin SJS information, see also: Dilantin Stevens Johnson Syndrome Lawsuits

Dilantin Toxic Epidermal Necrolysis (TEN)

Toxic Epidermal Necrolysis (TEN), also known as Lyell’s Syndrome, is said to be a more severe form of Stevens Johnson Syndrome with mortality and morbidity rates that are much higher than SJS. Like SJS, TEN & Lyell’s Syndrome are immune complex-mediated hypersensitivity complexs that are a severe expression of erythema multiforme and involve the skin and mucous membranes. Again, as with SJS, there is significant involvement of oral, nasal, eye, vaginal, urethral, GI, and lower respiratory tract mucous membranes in Toxic Epidermal Necrolysis (TEN).

For more Dilantin TEN information, see also: Dilantin Toxic Epidermal Necrolysis Lawsuits

FDA Investigates Dilantin Risks of SJS and TEN

The FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy. For more FDA Report information, read: FDA Dilantin Investigation

Speak to a Dilantin Lawyer

If you took Dilantin and suffered Stevens Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), we encourage you to contact a Dilantin attorney at our law firm immediately. An experienced product liability attorney can assist you in a legal action against the makers of Dilantin. Contact our law firm and learn more about your legal rights and the options available to you and your family.

The Yaz birth control pill could be putting millions of young women at risk of serious side effects, including stroke, heart attack and even death. Bayer USA, the maker of Yaz, has already been warned by the Food & Drug Administration (FDA) for running TV commercials that minimize the potential health consequences of Yaz.

In the summer of 2009 several lawsuits were filed by women who claimed Yaz made them ill. The lawsuits allege Bayer overstated the benefits of Yaz and failed to warn that it could put women at risk of serious injury. It is expected that similar Yaz lawsuits will be filed in the near future.

Yaz Birth Control Pill

Yaz is a combination birth control pill for women that contains both estrogen and progestin. Yaz is considered a low-dose pill because it contains no more than .035 milligrams of estrogen.

Yaz received FDA approval as an oral contraceptive in March 2006, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in October 2006. Finally, in January 2007, Yaz was approved to treat moderate acne in women who desire an oral contraceptive for birth control.

Yaz is one of the best-selling oral contraception pills in the United States, with sales of $616 million in 2007.

Yaz Side Effects

Evidence is growing that Yaz carries serious health risks. Yaz contains a synthetic type of progestin called drospirenone. According to the FDA, drospirenone can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood, in high risk patients. This condition may result in potentially serious heart and health problems.

Because of this risk, women with conditions that predispose them to hyperkalemia (such as renal insufficiency, hepatic dysfunction and adrenal insufficiency) should not take Yaz. Women taking Yaz must also be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives.

In order for Yaz users to avoid high potassium levels, blood tests should be drawn every few months. Most women who take Yaz don’t know about taking these blood tests because the instructions to take the tests are given in a small package insert with the birth control – something few people ever read.

Women involved in Yaz lawsuits have claimed that they suffered from a variety of serious ailments. These Yaz side effects include deep vein thrombosis, pulmonary embolism, and stroke. Yaz has also allegedly been associated with heart attacks and deaths in young women.

Finally, the FDA’s Adverse Event Reporting System (AERS) lists a variety of other side effects reported by Yaz users. These include severe allergic reactions, rash, hives, itching, difficulty breathing, chest tightening, fainting, irregular heartbeat, liver problems, unusual or severe vaginal bleeding, unusual tiredness or weakness, vaginal irritation or discharge, and vision changes.

In this case-control study, data was collected by midwives during the first antenatal visit, which usually occurred prior to week 12 of gestation. Information on maternal drug use was obtained at the first antenatal visit. Information on drug exposure late in pregnancy was not available, unless the drug was prescribed by the antenatal clinic itself. (If the drugs were prescribed by a psychiatrist after the initial antenatal visit, this information would not have been recorded.) Identification of infants with PPHN was made from neonatal discharge diagnoses recorded using the modified ICD-10 (International Statistical Classification of Diseases and Related Health Problems). The study included a total of 831,324 infants born between the years of 1997 and 2005.

At the initial visit, mothers of 7587 infants reported the use of SSRI drugs in early pregnancy: citalopram (39%), sertraline (31%), fluoxetine (15%), paroxetine (13%), fluvoxamine (2%), or escitalopram (2%). A total of 506 infants were identified with a discharge diagnosis of PPHN among the 831,324 infants born. When all cases were analyzed, an increased risk for PPHN was observed among the SSRI-exposed infants (risk ratio 2.01) and it was marginally statistically significant. Controlling for other risk factors, including maternal body mass index, smoking, or diabetes, did not affect the association.

This study is consistent with the previous study from Chambers and colleagues which demonstrated an association between maternal use of SSRIs and PPHN. One of the major advantages of this study is that exposure information was collected prospectively and not based on retrospective inquiries which could be affected by recall bias and incomplete data. However, one of the major shortcomings is that, while the Swedish Medical Birth Register provides rich data on maternal drug use early in pregnancy, this database lacks detailed information regarding exposures occurring after the first antenatal visit.

The previous study from Chambers and colleagues suggested that late, but not early (before 20 weeks), exposure to SSRIs was associated with an increased risk of PPHN. The current study is based on the premise that early exposure to SSRIs is a proxy for late exposure; however, we know that some women taking antidepressants at the first antenatal visit may later elect to discontinue treatment. In addition, a significant number of women may elect to initiate treatment later in pregnancy.

The estimate of risk in the present study is lower than that reported in the Chambers study. Using the data from the Swedish Medial Birth Register, the risk ratio was calculated to be 2.01 and was slightly higher (2.36) if infants born earlier than 37 weeks were excluded. This translates into about 1.5 cases per thousand SSRI-exposed infants in this cohort. This lower estimate of risk could reflect the methodological differences between the two studies. In the Chambers study, risk may have been overestimated due to recall bias. However, the risk estimate in this study may have been underestimated if cases of late exposure were underreported.

While the current report may signal a link between SSRI exposure and risk for PPHN, the various studies taken together are inconsistent and, if this association does in fact exist, it is difficult to accurately quantify the magnitude of the risk. Women considering the use of antidepressants during pregnancy must be made aware of this risk but it must be weighed against the risks of untreated illness in the mother. To avoid or withhold antidepressants during pregnancy may place these women – and their children – at risk. Depression in the mother is not a benign event and, when left untreated during pregnancy, has been associated with poor neonatal outcomes, including preterm birth, low birth weight, and lower Apgar scores.

Speak to an SSRI Lawyer about an SSRI Birth Defect Lawsuit

If you took Prozac, fluoxetine, Zoloft, sertraline or any other SSRI antidepressant during pregnancy and your child was born with a birth defect, we encourage you to contact an SSRI litigation attorney at our law firm immediately. It may be too late to recover from the devastating effects of SSRI antidepressants, but an experienced products liability attorney at the Willis Law Firm can assist you in a legal action against the makers of the SSRI prescribed. You are not alone. Join other birth defect victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

Class A Recall – Polar Care – Medical & Radiation Emitting Device Recalls 

Abstract

PMID: 18314924 [PubMed - indexed for MEDLINE]

Speak to an SSRI Lawyer about an SSRI Birth Defect Lawsuit

If you took Prozac, fluoxetine, Zoloft, sertraline or any other SSRI antidepressant during pregnancy and your child was born with a birth defect, we encourage you to contact an SSRI litigation attorney at our law firm immediately. It may be too late to recover from the devastating effects of SSRI antidepressants, but an experienced products liability attorney at the Willis Law Firm can assist you in a legal action against the makers of the SSRI prescribed. You are not alone. Join other birth defect victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

PRESS RELEASE

The risk of PML with Tysabri is known and is kept under close monitoring by the EMEA. The product information advises healthcare professionals that the medicine must not be used in patients who have PML and that patients taking Tysabri should be regularly monitored for signs and symptoms suggestive of PML.

The two cases are currently being assessed by the EMEA’s scientific Committee for Medicinal Products for Human Use (CHMP). Elan, the marketing authorisation holder for Tysabri, has also been asked to provide any additional information they may have. Following assessment of all available data, the CHMP will determine whether any changes to the currently approved product information or the existing risk minimisation measures, including the ‘Physician Information and Management Guidelines for Multiple Sclerosis Patients on Tysabri’ are necessary.

– ENDS –

Notes:

1. Tysabri is used to treat relapsing-remitting MS in patients with high disease activity despite treatment with a beta-interferon or whose disease is severe and progressing rapidly.
2. More information about Tysabri is available on the EMEA website: http://www.emea.europa.eu/humandocs/Humans/EPAR/tysabri/tysabri.htm
3. The ‘Physician Information and Management Guidelines for Multiple Sclerosis Patients on Tysabri’ are part of the agreed risk management plan for Tysabri. In accordance with this plan, the marketing authorisation holder for Tysabri committed to provide an information pack to all physicians who intend to prescribe Tysabri. The pack contains, among other elements, also information about the diagnosis and management of PML. For more information see: http://www.emea.europa.eu/humandocs/PDFs/EPAR/tysabri/H-603-Annex-en.pdf
4. This press release, together with other information on the work of the EMEA, can be found on the EMEA website: www.emea.europa.eu

Media enquiries only to:

Martin Harvey Allchurch or Monika Benstetter

Tel. (44-20) 74 18 84 27, E-mail press@emea.europa.eu

European Medicines Agency update on progressive multifocal leukoencephalopathy (PML) and Tysabri

By Charlene Laino – Reviewed by Louise Chang, MD (Washington)

Taking antidepressants in pregnancy may raise the risk of giving birth prematurely, researchers report. But left untreated, depression may also increase the chance of preterm birth, says researcher Katherine Wisner, MD, professor of psychiatry, ob-gyn, and women’s studies at the University of Pittsburgh Medical Center.

Each pregnant woman has to work with her doctor to weigh the benefits and risks of treatment with antidepressants known as selective serotonin reuptake inhibitors (SSRIs), she says. Premature birth has been linked to a host of health consequences, including learning disabilities, mental retardation, and cerebral palsy.

SSRIs include Prozac, Paxil, Lexapro, Celexa, and Zoloft.

The new study, presented at the annual meeting of the American Psychiatric Association, involved about 200 pregnant women. About half of them suffered from depression, and half of those women took SSRIs throughout pregnancy.

Results showed that 23% of those who took SSRIs throughout pregnancy gave birth to preterm babies. But so did 21% of those with depression who didn’t take SSRIs — a difference so small it could be due to chance.

In contrast, only 6% of women who did not have depression and didn’t take SSRIs had preterm babies.

According to Wisner, other research had shown that both depression and SSRIs can raise the risk for miscarriage. But taking antidepressants during pregnancy doesn’t greatly increase the overall risk of most birth defects, she says.

At this time our law firm is no longer accepting new cases involving this drug. This does not mean that you do not have a case; please seek a second opinion with local legal counsel to discuss your options.

The drug manufacturer Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The defective drug is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a serious risk of digitalis toxicity in patients with renal failure. Symptoms of digitalis toxicity include: nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported to the FDA. Patients should contact their healthcare professional with questions regarding this medication.

Evidence is emerging to suggest that patients need to be alert to the fact that combining nonsteroidal anti-inflammatory pain medications (NSAIDs) such as ibuprofen (ADVIL) and naproxen (ALEVE) with a class of osteoporosis drugs called bisphosphonates, such as alendronate (FOSAMAX), etidronate (DIDR¬ONEL), ibandronate (BONIVA) and risedronate (ACTONEL) may result in an increased risk of ulcers and other gastrointestinal side effects and complications.

In the article, “Preserving Bones with Bisphosphonates: Should You Avoid NSAIDs?”- Worst Pills Best Pills, one randomized study of 26 healthy subjects looked for stomach ulcers in people who were given three short-term (10-day) treatments with alendronate, naproxen, and both together. Subjects were given all treatments with a one-to four-week washout between each. Eight percent of the people who took alendronate alone developed a stomach ulcer, and 12 percent of patients who took naproxen alone also developed a stomach ulcer. The study found that 38 percent of patients who took the two drugs together developed a stomach ulcer. There was a dramatic increase in the risk of stomach ulcers, demonstrating what is called synergism between the two drugs.

A larger study also examined the medical records of 242 patients who had received NSAID therapy for rheumatoid arthritis over a three-month period and found that over 30 percent of the patients receiving bisphosphonates along with their NSAID therapy had developed gastrointestinal ulcers, compared to 17 percent in those who received NSAIDs alone.