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.

See also: Dilantin Side Effects.

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

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.

Patients with constant pain after hip implant surgery may need to speak with their doctor to see if the hip implant has failed. Failed hip implants include any hip implant that has broken, come loose or caused other hip surgery related problems. According to most experts, temporary pain or discomfort after a hip implant surgery is normal and not suggestive of a broken hip implant, femoral head or socket. However, a sudden pain in the implanted hip joint, sometimes preceded by an audible “pop” from the hip just before the onset of pain, is a signal of a hip implant fracture or failure.

Zimmer Durom Cup Hip Implant Failures

Problems with the Durom cup became known in April when a Los Angeles surgeon, Dr. Lawrence Dorr, publicly warned other orthopedists about Durom cup failures he was hearing about from his patients. At that time, Zimmer said it would initiate an investigation but that it saw no reason to take other action, such as halting sales. Zimmer cited European data that indicated that the Durom cup was doing well there; however, the version of the Durom cup used outside the U.S. is a bit different from the one used in the United States. Additionally, while U.S. doctors use the Durom cup in traditional hip replacement surgeries, surgeons in other countries use the device in a relatively new kind of hip surgery known as resurfacing, which involves different surgical techniques.

Hip Implant Fractures and Defective Hip Implants

If a hip implant fractures, surgery to replace it will be necessary. Currently, no tests exist that can predict which patients will experience failure of their hip implants. Patients with recalled hip implants should be closely monitored by their doctors.
Some Zimmer hip implant patients are suffering from what has been described as Zimmer hip pain. Pain in the area of where a hip replacement has been done may indicate a faulty hip implant, loose hip implant, broken hip implant or defective hip implant. Zimmer hip implant patients who are concerned that they may have received a defective artificial hip are urged to contact their orthopedic surgeons or the hospital where their Zimmer hip replacement surgery took place. Concerned patients should request their surgery records from the hospital ’s medical records department to find out if a Zimmer Durom cup hip implant was used in their hip replacement surgery.

NOTE: If you are required to have replacement surgery, tell your Doctors that you want the hip implant to be preserved as evidence and NOT shipped or returned to the manufacturer, as it is critical evidence in a potential product liability lawsuit against Zimmer.

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 patents 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.

PriCara Recalls 25 mcg/hr Duragesic (Fentanyl Transdermal System) CII Pain Patches

PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) Duragesic (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.

Fentanyl Gel Leaks

Duragesic 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. As per the approved product labeling for Duragesic, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately safe-guard affected patches with cut edges by storing them in a plastic container in a safe place, using caution not to handle them directly. Keep defective fentanyl patches away from children and animals and do not dispose of them until you have spoken to an attorney or healthcare professional. Patches with a cut edge that have leaked gel will not provide effective pain relief.

Anyone who has 25 mcg/hr Duragesic or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

Duragesic Fentanyl Patches

Duragesic patches are used to manage persistent moderate to severe chronic pain that needs to be treated around the clock and which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products. It should only be used by people who are receiving or have developed a tolerance to pain therapy with opioids. Duragesic should not be used if patients have pain that will go away in a few days, such as pain from surgery, medical or dental procedures, or short-lasting conditions. Any adverse reactions experienced with the use of fentanyl patches should be reported to your health-care providers. Duragesic brand and other fentanyl patches are available by prescription only, through pharmacies, and should be used only under the supervision of a physician.

Duragesic patches sold in Europe, Latin America and Asia are not affected by this recall.