Pharmacy Error Injury Lawyer Blog

A panel at the U.S. Food and Drug Administration (FDA) recommended that the labels for certain popular birth control pills, including the pill marketed as Yaz, should be updated to include new data that suggest an elevated risk of blood clots. The affected drugs are manufactured by Bayer. A panel of experts met for over nine hours on Thursday, December 8, to discuss data regarding blood clot risks with contraceptives containing the synthetic hormone drospirenone. It ultimately voted 21-5 to urge Bayer to update its labels. The panel had earlier voted 15-11 in support of keeping drospirenone-containing drugs on the market, a vote of confidence that the drugs still offer a benefit to patients. A full third of the panel voted against that recommendation. The FDA did not set a timetable for Bayer to change its labeling.

Bayer first released Yaz in 2006, and within a year its annual sales had reached $2 billion. This was boosted by an aggressive advertising campaign targeting women in their 20’s and touting the overall health benefits of the drug. In addition to its contraceptive benefits, ads claimed that Yaz could provide relief from PMS and acne. Millions of women started taking the drug, but by 2008 the possible health risks were becoming clear. Five studies conducted since 2009 have suggested a higher risk of potentially fatal blood clots, with one finding a 75 percent higher chance of developing blood clots as compared to patients taking older contraceptive drugs.

ABC News reports on a 24 year-old woman in Madison, Wisconsin who started taking Yaz in 2007 after seeing its ads on television. Within three months, she began to feel pain in her legs, which she attributed to time spent on her feet in her job as a nurse. The pain quickly turned out to be blood clots that traveled to her lungs, where they caused a pulmonary embolism. She spent almost two weeks in a coma, and when she woke up she had lost her sight. Whether her blindness is in anyway related to the drug is not known, but her blood clots are consistent with the findings of numerous studies of drugs containing drospirenone.

The Associated Press has a report on a 20 year-old California woman who died on Christmas Eve 2008 of a blood clot that had traveled to her lung. She had started taking Yaz two months earlier.

In 2008, the FDA sent a letter to Bayer regarding their advertisements for Yaz. FDA studies had shown that Yaz was not an effective treatment for PMS, and that it was not very effective at treating acne. State health authorities also made allegations of false advertising regarding Yaz’s supposed health benefits. Bayer reached a settlement in which it agreed to launch an expensive series of “corrective” television ads. These ads stated that Yaz could treat premenstrual dysphonic disorder (PMDD), a severe form of PMS, but was not indicated for the treatment of regular PMS.

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The Delaware Secretary of State’s Office has suspended the Controlled Substance Registrations of two medical doctors and a nurse practitioner because of allegations that they overprescribed a number of controlled substances in unreasonable and excessive amounts. Complaints filed against the the three, who all worked in the pain management field, further allege that they disregarded evidence that some of the prescribed medications were being abused or even diverted. The suspension immediately halted their legal authority to write prescriptions. One physician and the nurse practitioner reportedly also surrendered their Drug Enforcement Agency (DEA) registrations to federal authorities. The doctors may face further disciplinary action beyond the Secretary of State’s investigation.

One of the physicians, Dr. Mohammed Niaz, worked with the nurse practitioner, Jean Binkley, as her supervisor. The Secretary of State alleges that Dr. Niaz wrote prescriptions for over 57,000 tablets of various controlled substances during the first seven months of 2011. This amount included 42,000 tablets of the Schedule II narcotic Oxycodone. Binkley is alleged to have separately written prescriptions for over 89,000 Oxycodone tablets.

The state further alleges that one patient, using prescriptions obtained from Niaz and Binkley, obtained 360 Oxycodone tablets and 90 tablets of Alprazolam within a two-week period earlier this year. This is considered an unreasonable amount for one person for such a brief period of time. Alprazolam is the generic name for the drug Xanax, a Schedule IV controlled substance used to treat anxiety, but also highly prone to abuse. Both types of drug can be highly addictive and dangerous if abused, and their distribution is strictly controlled. The state alleges that many of the drugs obtained through prescriptions written by Niaz and Binkley ended up in the hands of people who did not have a prescription and did not have guidance on how to use the drugs safely.

Dr. Patrick Titus allegedly wrote an even greater number of irregular prescriptions. One pharmacy’s records reportedly showed 3,941 prescriptions written by Dr. Titus between January and November 2011, accounting for almost 750,000 pills of seventeen Schedule II narcotic pain medications such as Oxycodone, Oxycontin, and Morphine.

The Secretary of State launched an investigation with the assistance of the Delaware Attorney General’s office and the Division of Professional Regulation. Delaware law empowers the Secretary of State to revoke a medical professional’s license to prescribe medicine if “continued registration would be inconsistent with the public interest.” The Secretary of State’s reasoning in this case seems to be that these three medical professionals have established a sufficiently questionable prescription history, and that they would constitute a threat to the public interest if allowed to continue writing prescriptions.

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For people over the age of 65, two-thirds of emergency room visits result from side effects of medications in two broad categories, according to the Boston Globe and the New England Journal of Medicine. The categories are medications used to treat heart disease and those taken for diabetes. The study specifically lists blood thinners and anti-platelet drugs in the heart disease category, and blood-sugar-lowering drugs and insulin in the other. Numerous emergency room visits happen because of dangerous, and preventable, interactions between these drugs and other common medications.

The Globe goes on to list a series of tips to help seniors educate themselves about their medical conditions, their treatments, and the most common dangers inherent in their prescribed medications. Many medications require frequent, often constant, adjustments in dosage, so close communication with your doctor is essential. Long-term use of some medications can often cause their own medical complications and side effects, such as hypoglycemia with blood-sugar-lowering medications. The author quotes five tips from the American Association of Family Practitioners:

1. Obtain both written and verbal instructions from your doctor about the proper use of your medication. Ask your doctor to repeat the instructions as many times as it takes until you understand them. Understanding exactly how and when to take your medication is perhaps the most important step in avoiding injury.

2. Read your prescription, then read the label of the drug once you get it from the pharmacy. Read both the label on the bag and on the bottle itself. Make sure your name appears on all labels, and make sure the name and dosage of the drug match the prescription. Incorrectly-filled prescriptions are a frequent cause of medication-related injuries.

3. Talk to the pharmacist about possible side effects. You have an opportunity to do this whenever you pick up a prescription. The pharmacist can explain possible side effects and common drug interactions to you. That is part of why the pharmacist is there.

4. Stay in contact with your doctor and show up when requested for further testing. Notify the doctor of any side effects you are experiencing, no matter how minor they may seem to you. Failure to follow up once a medication is prescribed can lead to negative side effects down the road if the doctor cannot make adjustments to your treatment based on new information or changing circumstances. The doctor may also need to adjust medication based on unforeseen side effects, drug allergies, or other drug interactions.

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The family of a south Florida man has filed a lawsuit against North Shore Medical Center in Miami. The man, 79 year-old Richard Smith, died in July 2010 when he went to the hospital complaining of shortness of breath and received the wrong medication. The nurse who administered the allegedly fatal dosage received disciplinary sanctions and paid a fine, which the family does not find satisfactory.

Smith told doctors he had shortness of breath and an upset stomach. His treating physician ordered Pepcid, an antacid available over the counter. The ICU nurse instead took a vial of Pancuronium from a locked cart and put it in Smith’s IV. Pancuronium is a muscle relaxant used by the ICU when intubating a patient. In larger doses, it is used by the Florida prison system in executions as part of a three-drug cocktail. The drug does not affect consciousness, but does significantly impair motor functions. At high enough doses, a person would not be able to breathe.

According to hospital records, no one noticed Smith’s condition for thirty minutes. When hospital staff finally recognized the problem, Smith’s heart had stopped. Resuscitation efforts did not succeed in reviving him. An investigation by the state found that the nurse on duty not only failed to read the label on the medication, but failed to scan both the drug label and Smith’s patient ID bracelet. These would have alerted the nurse to the problem. Another report indicated that the nurse did not follow safeguards established for the drug cart containing the Pancuronium. The state cited the hospital for this failure. The hospital has reportedly removed Pancuronium from most nursing areas in the hospital and created a new packaging system with clearer warnings.

According to local news covering the story, the nurse still works at North Shore. He reportedly received a reprimand, paid a $2,800 fine to the state, and attended remediation courses. The hospital described this as appropriate counseling and re-training. Smith’s family disagrees, saying through their attorney that the nurse should not still be permitted to work with patients. This Pharmacy Error Injury Lawyer Blog has previously reported on cases where medication errors causing death have led to criminal convictions for involuntary manslaughter. In this instance, the consequences apparently end at professional discipline.

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