Yourlawyer.com (Dilantin News)

Dilantin Injection Reportedly Causing Purple Glove Syndrome, FDA Says

Tue, 09 Sep 2008 00:00:00 -0700

According to a quarterly report it released last week, the Food & Drug Administration (FDA) is investigating instances were Dilantin (phenytoin) injections led to a disorder known as Purple Glove Syndrome. This condition, which was named for the discoloration that often accompanies it, can lead to the need for emergency surgery, and even limb amputation, if it becomes serious.

Phenytoin is an antiepileptic drug. Aside from seizures, it is an option in the treatment of trigeminal neuralgia as well as certain cardiac arrhythmias. In the US, phenytoin is marketed as Phenytek and Dilantin (including Dilantin Kapseals, Dilantin-125 and Dilantin Infatabs).

Phenytoin has been administered intravenously since 1956. But occasionally, this treatment can lead to a complication called Purple Glove Syndrome. Purple Glove Syndrome starts as a pale blue or dark purple discoloration which appears around the intravenous insertion site 2 to 12 hours after the administration of the drug. Progression occurs during the next 12 to 16 hours as developing edema and continued discoloration spread around all sides of the affected limb.

If a patient is fortunate, the discoloration and edema will gradually fade, and the affected limb will heal within 2 to 4 weeks. However, Purple Glove Syndrome can sometimes turn quite serious, resulting in the death of affected tissue. When such necrosis occurs, a patient may require surgery to restore blood flow to the affected tissue. The most severe cases of Purple Glove Syndrome can lead to amputation of the injured limb.

In its report, the FDA did not say how many cases of phenytoin-related Purple Glove Syndrome it was investigating. But a 1998 study conducted by researchers at the Mayo Clinic found that of 152 patients receiving intravenous Dilantin (phenytoin), 9 (about 5.9%) developed Purple Glove Syndrome. The study also found that the disorder was more likely to affect the elderly, and people who received more than one dose of phenytoin.

No one yet understands why intravenous Dilantin can cause Purple Glove Syndrome. The disorder does occur when Dilantin - which has highly alkaline PH - leaks into the interstitial tissue. But Purple Glove Syndrome is also seen in patients were such phenytoin leakage has not occurred. Some health practitioners believe this could have something to do with the exact formulation of the phenytoin injection.

Suit Over Phenytoin Names 10 Defendants in Womans Death

Fri, 15 Aug 2008 00:00:00 -0700

According to court papers, Agnes Davis was prescribed phenytoin and then suffered a severe adverse reaction- Stevens-Johnson Syndrome - that allegedly led to her death. Phenytoin is a generic version of Dilantin. The lawsuit, filed by Willie Davis Jr. and Alice Washington—Davis’s family members—on August. 8, 2008, names 10 companies that make, label, test, market, or distribute phenytoin. Among other issues, the defendents allege that the defendants misled and failed to adequately warn users of life-threatening side effects caused by taking phenytoin.

The complaint’s causes of action include strict product liability-failure to warn and defect in design or manufacture, fraud, breach of implied and express warranties, negligence and gross negligence. The 10 companies named as defendants are: Mylan Inc., Mylan Bertek Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Actavis Mid Atlantic, Morton Grove Pharmaceutical Inc., Taro Pharmaceuticals USA Inc., VistaPharm Inc., Barr Pharmaceuticals Inc., Ivax Pharmaceuticals Inc., Elkins-Sinn Inc., Hospira Inc., Hospria Worldwide Inc., and Baxter Healthcare Corporation.

The suit also states that Davis began taking phenytoin in June 2006. Sometime later, Davis broke out with a high fever and skin rash that resulted in blisters on her face and body. Davis was then hospitalized for several weeks at the Medical Center of Southeast Texas where she was diagnosed with Stevens-Johnson Syndrome. According to MayoClinic.com, Stevens-Johnson syndrome is a rare, serious disorder of the skin and mucous membranes and often presents with several days of flu-like symptoms, followed by inflammation of the mucous membranes, and a painful red or purplish rash that spreads and blisters, eventually causing the top layer of the skin to die and shed. The syndrome is usually a specific type of allergic reaction in response to medication or infection, according to the Mayo Cinic’s Website.

The plaintiffs allege that the defendants violated the applicable code of federal regulations by failing to include a warning that Stevens-Johnson Syndrome is a potential side effect of phenytoin. "Accordingly, Ms. Davis' prescribing physician was deprived of the ability to fully assess the risks when making the decision to prescribe the drugs due to the defendants deficient and inadequate warning," the complaint states. The plaintiffs also claim that Davis would not have taken phenytoin had the risks and dangers been disclosed, and "would not have suffered her adverse reaction and its subsequent complications."

The complaint states that because the drug hazards were hidden, the drug makers “have reaped huge profits"; that the defendants failed to perform adequate testing that would have shown that phenytoin possessed serious side effects; that the defendants should have taken appropriate measures to ensure that its defectively designed product would not be placed into the stream of commerce; that prior to manufacturing and distributing the drug, the companies "had knowledge from several sources" that the product presented substantial and unreasonable risks to the consumer; that the drug makers knowingly and deliberately failed to remedy the known defects "for the purpose of increasing sales and enhancing its profits"; and that “Defendants' conduct was wanton and willful, and displayed a conscious disregard for the safety of the public and particularly of Ms. Davis, entitling her to exemplary damages."

Dilantin Linked to Osteoporosis

Wed, 30 Apr 2008 00:00:00 -0700

A recent study revealed that the popular epilepsy drug Dilantin might be placing young women who take it for a year or more at higher risk for osteoporosis. The April 29 issue of Neurology states the bone loss described in the research was actually eight times higher than that experienced by pre-menopausal women not taking epilepsy drugs. "That suggests that if these women remain on this medication and have ongoing significant or accelerated bone loss that over time, they will be entering the peri-menopausal period with lower bone density and therefore a greater risk for low bone mineral density over time and therefore a higher risk of fractures," said study lead author Dr. Alison M. Pack, assistant professor of clinical neurology at Columbia University in New York City. Pack received funding from GlaxoSmithKline and other pharmaceutical companies for the study.

According to Dr. R. Eugene Ramsay, director of the International Center for Epilepsy at the University of Miami Miller School of Medicine, 90 percent of older people who have seizures are put on Dilantin, generally because of its low cost. "It's particularly important, because the older population has the highest incidence of epilepsy. There are more new-onset seizures occurring there and yet they are getting the cheapest and worst treatment," he said.

This study—partially supported by GlaxoSmithKline, which makes Lamictal—involved 93 pre-menopausal women from the ages of 18 to 40 with epilepsy. Each woman either took Dilantin (phenytoin), Tegretol (carbamazepine), Lamictal (lamotrigine), or Depokote (valproate). All women took 1,000 milligrams of calcium daily and were physically active. After one year, women taking Dilantin lost 2.6 percent of their bone density in the femoral neck of the hip while bone mineral density stayed about the same in the other three groups; bone mineral density stayed the same at the spine and the total hip. The speed—one year—at which Dilantin affected bone health was surprising, said Dr. Steven V. Pacia, director of the division of neurology at Lenox Hill Hospital in New York City.

Women who require epilepsy drugs can either switch to a medication other than Dilantin or they can increase their calcium intake, said Pack; however, according to Pacia, calcium supplementation may not be sufficient to offset Dilantin’s bone-depleting effects. "There may be a direct affect on bone absorption of calcium," Pacia said. "If the mechanism is damaged, the bone is not going to be able to take up calcium. An alternate drug that doesn't cause the same problem is preferable. In the rare cases we had to use Dilantin, drugs like Fosamax and Boniva can be used to try to counteract the effect, and that does happen."

Earlier research revealed an adverse effect on anti-epileptic drug treatment—including Dilantin and other drugs—on bone and mineral metabolism. And one previous study revealed anti-seizure medications had the same effect on the incidence of osteoporosis in older men as it did in older women, Ramsay said. "We're just beginning to recognize that we need to look at the long-term health care issues of anti-convulsants," Ramsay said.

Without Warning

Thu, 10 Apr 2003 00:00:00 -0700

A rare but debilitating and potentially deadly allergic reaction to some drugs, may be on the rise. But you won't read about it on drug labels.

KAITLYN LANGSTAFF'S catastrophic injuries are the stuff of nightmares. In 12 months, this 9-year-old girl from Saratoga has gone from being active and healthy to wheelchair-bound, blind and unable to eat or speak. With massive scarring in her lungs and airways, she breathes bottled oxygen through a tube inserted in her neck. She relies on a feeding tube in her stomach. She mouths words with the aid of an electronic larynx. She will need countless surgeries to reclaim what's left of her health.

Langstaff's story, her courage, the poems she's written (one of which was recorded as a rock song by the band Miggs) and her family's resilience has made national news. So has her incredible survival, against all odds, after she was diagnosed in April 2002 with toxic epidermal necrolysis, a relatively rare and often lethal form of Stevens-Johnson syndrome, a frightening blistering and burning disease brought on by a severe, systemic allergic reaction to certain drugs.

But what many people haven't heard are claims of an alarming rise in case reports of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), according to some observers. Support groups for the disease's survivors have popped up. Complaints to the FDA's MedWatch database are reportedly mounting, accompanied by a surge of lawsuits filed against doctors, hospitals and drug manufacturers.

The medications that most often provoke this extreme allergic reaction are widely used by both adults and children. They include antibiotics such as penicillin and bactrim; anti-convulsants such as phenobarbital and Dilantin; and prescription pain relievers called nonsteroidal anti-inflammatory drugs (NSAIDs)such as Bextra and Daypro. And perhaps even more worrisome, over-the-counter NSAIDs such as ibuprofen, including Children's Motrin and Children's Advil are also triggering the reaction.

Growing List

No accurate count exists of how may people have been stricken with TEN or SJS, or its milder version, erythema multiforme. Once a drug is approved, physicians are not legally required to report adverse reactions to the FDA. (Less than 1 percent of drug reactions are reported to the federal government.) Some estimate that there have been 200,000 SJS and TEN cases worldwide, but that's only a rough guess.

At least 50 percent of known SJS cases are drug related, experts say; other cases may have viral or bacterial origins. (TEN, however, is predominantly caused by drug reactions.) Children in particular seem to be more susceptible to SJS, and some say women are as well. SJS and TEN often cause blindness, and in 10 percent to 30 percent of cases, death. More than half of the patients who have TEN die.

While stressing that the reaction is rare, some of those who track SJS and TEN say the number of cases is climbing, although the evidence remains anecdotal. Jean McCawley of Denver, Colo., president and founder of the Stevens Johnson Syndrome Foundation, says her group now has 1,500 members. (Her daughter had SJS.) The website posts wrenching personal testimonials from people who have lived through the disease. McCawley says she has also seen a steady rise during the last two years of children getting SJS after using Children's Motrin, about one new case each month.

Paula Fillari, a veteran registered nurse with the Bothin Burn Center at St. Francis Memorial Hospital in San Francisco, which treats only the most dire cases of TEN--says the hospital now sees five patients a year, more than double the previous number of admissions. (Fillari presented a pilot study on new protocols for treatment of the disease at an international burn conference last year.)

"As more medications, antibiotics and anti-inflammatories get onto the market, there's potential for more medications causing this," Fillari says. "The list is getting longer."

But other experts caution that there is no evidence that more people are getting the allergic reaction. With no mechanism in place to monitor the incidence of the disease, it's just impossible to tell, says Dr. Bernard Cohen, director of pediatric dermatology at Johns Hopkins Children's Center in Baltimore, Md. The overall incidence is thought to be 1 to 6 per million patients, he notes.

"The bottom line is, any time you use a drug you can have an adverse reaction; you're always taking a risk," Cohen says. SJS and TEN are uncommon, he adds, "but when it happens, it can be devastating. With TEN, it's a disaster."

"I think it's a bigger problem than people realize," says Valerie Chereskin, a San Diego PR consultant who had SJS in 1990. "When you talk to someone, you quickly discover other people who've also had [SJS]; they just come out of the woodwork."

Both Chereskin and Cohen agree, however, that doctors are often unfamiliar with the disease, its symptoms and its debilitating effects, and can misdiagnose it. "When you get SJS, [many] doctors don't even recognize it," Chereskin says. "So they give you more of the drug that caused it--doing you more harm, which could end up killing you."

Like Swallowing Lye

This is precisely what Brad and Kerry Langstaff think happened to their daughter Kaitlyn. On April 6 of last year, while on a family trip, Kaitlyn, then 8 years old, was given Children's Motrin by her parents for fever and a sore throat. (She had no known drug allergies and was given the correct dosage.)

The next day, Kaitlyn broke out in a severe rash and high fever. She continued taking the drug every four to six hours when she was taken to Fresno's Children's Hospital, where she was diagnosed with TEN and admitted to the pediatric intensive-care unit. It wasn't until the third or fourth night in the PICU that a doctor at the hospital recommended that she stop taking the drug.

In the meantime, Kaitlyn rapidly developed blisters and lesions resembling second-degree burns throughout her body. With SJS and, especially, the more severe TEN, the immune system attacks the body inside and out--in particular, the skin and mucous membranes. Kaitlyn's skin sloughed off, and with all her nerve endings exposed, she was in excruciating pain. Blisters on the inside of her eyelids fused her eyes shut, and scarring on her corneas left her unable to see. Her tongue stuck to her palate and had to be surgically separated.

Filled with scar tissue, her lungs and airways closed down, forcing doctors to give her a permanent tracheostomy. She suffered severe kidney damage and loss of hearing. She endured multiple blood transfusions and operations to remove vast amounts of dead and damaged skin, among other treatments. She had to be heavily sedated and tied to her bed.

In all, Kaitlyn was hospitalized for 110 days at four different hospitals, and she was close to death several times. On April 15, she was airlifted to Los Angeles' Children's Hospital because it appeared she might need a heart-lung machine. On May 28 she was transferred to Lucile Salter Packard Children's Hospital at Stanford for more treatment, later to be moved to the Santa Clara Valley Medical Center. Kaitlyn will have to wait years before surgery is attempted to open her airways or to try corneal transplants to have her vision restored.

Kaitlyn's mother, Kerry Langstaff, has said that doctors likened the condition of Kaitlyn's throat to a patient who has swallowed lye, and her lungs to someone who has cystic fibrosis. (Because they were accompanying Kaitlyn, who was receiving a medical procedure last week, Kerry and Brad Langstaff were unavailable for comment.)

Another parent describes a similar set of circumstances. Melanie Eden's 7-year-old son, Sam, also got SJS last year after taking Children's Motrin. "In my gut, I feel like it was the Children's Motrin, but no one can prove that," says Eden, who lives near Phoenix, Ariz. Five days after he was given the drug for a cold, Sam couldn't go to the bathroom or swallow, and he had bright red eyes and blisters on his tongue. The doctors at the hospital misdiagnosed his symptoms, which got worse. But doctors at another hospital quickly realized that he had SJS and put him in the ICU for 10 days, the entire time on morphine.

"I was in shock," Eden says. "I couldn't leave his side. I kept my hands on him; I felt if I could touch him, he wouldn't go away." Because of the burning and blistering, Sam now has asthma; his eyes won't tear; and his nose is painfully dry.

"It breaks my heart, but he can see; many kids come away blind," she says. "There's a reason why hospitals give children Tylenol," she adds. "It doesn't react with the body's systems the way NSAIDs do. People need to know what the risks are."

Jean McCawley's daughter. Julie, then only 11 months old, reacted violently after she was given both phenobarbital and Children's Motrin.

"There, right in front of my eyes, I watched the blisters erupting," McCawley says. The doctors thought the infant had chickenpox; it was only later that she was correctly diagnosed with SJS. "She looked liked she was deep-fried. I was terrified," McCawley recalls. Julie is now blind and has scarring in her nose, mouth, esophagus and lungs. "No amount of money will be enough to compensate for what this child has suffered," McCawley says from a hotel room in Boston, where Julie was undergoing a medical procedure to help restore her eyesight. (McCawley sued her doctor and lost.)

But it's not just children who have been diagnosed with the disease after taking medication. Valerie Chereskin was 35 when she was given Septra, a sulfa-based antibiotic, which precipitated her severe case of SJS in 1990.

"I looked like I was from another planet. I was in agony," she says. Her skin melted away; a minister was called in to perform last rites. She has since recovered. However, it was two years until she could go out in the sun, and now has an artificial tear duct to regulate moisture in her eyes. "People take drugs without even thinking about it, but drugs are not candy; they contain strong chemicals," she says. (She also sued her doctor, unsuccessfully.)

Marlene Kerber, a 48-year-old Los Angeles resident, contracted a severe case of TEN in 2000 after she was prescribed an anti-convulsant medication. She was in a drug-induced coma for 2 1/2 months and was burned over her entire body. "I had none of my own skin left," she says. Kerber regained her sight after numerous surgeries. "I count my blessings every day, believe me," she says. She sued her doctor for medical malpractice and won.

Rash Decisions

On March 12, 2003, Kaitlyn's parents sued the manufacturer of Children's Motrin: McNeil Consumer & Specialty Pharmaceuticals (a subsidiary of Johnson & Johnson). The suit, filed in U.S. District Court in San Jose, claims that the drug caused Kaitlyn's extreme allergic reaction. The suit alleges that the company failed to adequately test the drug for over-the-counter use with children and did not fully report its clinical trials on the drug. (Ibuprofen was approved for nonprescription use in children in 1996.)

Kaitlyn's parents also claim that the company failed to warn consumers in any of its materials or package inserts or on the drug box that the drug could cause SJS or TEN and, furthermore, what to do if a rash or mucosal lesions develop.

"We're aware of a report of a 9-year-old girl who was diagnosed with [TEN] allegedly associated with the use of Children's Motrin," says a company spokesperson. "As the manufacturer of Motrin/ibuprofen products, we're deeply concerned about all matters relating to our products and are investigating the incident."

"You have to be cautious about giving adult drugs to children," says James C. Barber, the Langstaffs' lead attorney, who is based in Dallas, Texas. "It wasn't until the last few years that drugs were even tested separately on children."

Barber adds, "The [drug's] warning says nothing about SJS and nothing about stopping and calling a doctor if a child develops a rash." (The drug's label does warn of severe allergic reactions including hives, facial swelling, asthma and shock, and advises that the drug be stopped and to consult a doctor if pain or fever gets worse, or if an allergic reaction or any new symptoms appear, among other signs.)

Barber's firm successfully sued Pharmacia and G.D. Searle, the manufacturers of Daypro, a prescription NSAID, on behalf of an adult woman who came down with a severe case of TEN after taking the drug. (The suit settled in 2002.) Barber is about to file two new suits on behalf of two children who contracted SJS, one after taking Children's Motrin and another after taking Children's Advil. (The anti-inflammatory Bextra now includes warnings about the risk of serious skin problems, including SJS, after a recent legal settlement.)

"If suing is going to make drug manufacturers more conscientious about warnings on drug labels, then that's good," says Lisamaria Martinez, a senior at UC-Berkeley who was blinded from a childhood bout of SJS. "It's really important to know what's in these drugs."

Dr. Cohen is skeptical that warnings about SJS will make a difference. "There's no test to predict who will get [SJS or TEN]," he says. "Even if a drug has a warning, with one in a million people getting [the illness], it won't stop people from using the medication."

Meanwhile, Kaitlyn battles on. "She is a brave, courageous little girl that represents everything good about the human spirit," says Mark Mills, legal assistant for Barber's firm. "She's an impressive child, and she has an impressive family. They have been devastated by this disease."

Dilantin Stevens Johnson Syndrome Side Effect Lawyers

Thu, 10 Apr 2003 00:00:00 -0700

DOWNLOAD OUR DILANTIN INFORMATION PACKAGE

Injured by Dilantin?

Dilantin (Generic: Phenytoin) is an antiepileptic drug prescribed to manage temporal lobe seizures and grand mal seizures. The FDA approved Dilantin, manufactured by Pfizer, on November 20, 2001. A major side effect of Dilantin is a severe skin reaction called Stevens Johnson Syndrome (SJS), a severe allergic reaction to a drug. SJS is a potentially life threatening skin disease that causes rashes, skin peeling, sores on the mucous membranes and death.

With Stevens Johnson Syndrome (SJS), a person often encounters blistering of mucous membranes, typically in the mouth, eyes, and genitals. Nearly all cases are caused by a reaction to a drug, most often sulfa antibiotics, barbiturates, and anticonvulsants such as Dilantin. Stevens Johnson Syndrome (SJS) generally starts with a fever, headache, cough, and body aches, symptoms which may last from 1 to 14 days. Then a flat red rash breaks out on the face and trunk of the body, often spreading later to other parts of the body in an irregular pattern. The areas of rash enlarge and spread, often forming blisters. The skin of the blisters becomes very loose and easy to rub off. In addition, the damage to the lining of the mouth makes eating difficult. Closing of the mouth may be painful, so the person may drool. A person’s eyes may swell and become so filled with pus that they seal shut. The corneas can become scarred. The opening through which urine passes (urethra) may also be affected, making urination difficult and painful. Sometimes the mucous membranes of the digestive and respiratory tracts are involved, resulting in diarrhea and difficulty breathing.

Other side effects associated with Dilantin include: confusion, constipation, discolored urine (pink, red, or brown), fatigue, slurred speech, agitation, anemia, bone marrow depression, chest discomfort, difficulty learning (children), dizziness, fever and chills, frequent bone fractures or breaks, headache, joint pain, light gray stools, low thyroid function, malformed bones, numbness or tingling in extremities (long-term use), painful erection, restlessness, severe stomach pain, severe skin reaction, shallow or troubled breathing, uncontrolled jerking of limbs, uncontrolled facial movements, unusual bleeding or bruising, weight loss, and yellow eyes or skin.

If you or a loved one took Dilantin and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.