Pharmacy Error Injury Lawyer BlogPosted in: High Alert Drugs
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Drug Manufacturer Recalls Vaccine Due to Expired Ingredients
Voluntary Recall Announced for Certain Oral Contraceptives Due to Packaging Error
The U.S. Food and Drug Administration (FDA) announced on February 24 that Glenmark Generics USA, the North American division of Indian pharmaceutical company Glenmark Generics, Ltd., was voluntarily recalling seven lots of oral contraceptives at the consumer level. The recall is reportedly due to a packaging error, in which blisters were oriented incorrectly within the packaging for the tablets. This may cause the sequence of tablets to be incorrect, causing patients to take the tablets in the wrong order. This could therefore cause the overall treatment to be ineffective, leading to insufficient contraception and other health risks. The FDA recommends that anyone using oral contraceptives with the faulty packaging should immediately switch to a non-hormonal form of contraception.
Glenmark has not said how many total packages are affected by the recall, only the number of lots. It has said that a sufficient amount of the product is still available on the market, so the recall should not significantly impact the total supply. The tablets were reportedly manufactured by Glenmark in India and distributed by its North American division to retail pharmacies and wholesalers.
The affected products contain a mixture of Norgestimate and Ethinyl Estradiol in varying proportions. Both are hormones used in oral contraceptives, the treatment of menopause symptoms, and other conditions. Patients are instructed to take specific tablets at specific times during a 28-day period, and an interruption of the prescribed cycle can interrupt the contraceptives’ efficacy. The specific tablets covered by the recall, according to the FDA, contain tablets with doses of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg of the two compounds.
The FDA says that the packaging error does not pose any immediate health risks to women using the product. The principal risk, it says, is that unintended pregnancy could result from a lapse in contraceptive coverage resulting from the error. It could potentially pose health risks to people using oral contraceptives for non-contraceptive reasons, but that issue is not addressed by the FDA’s announcement.
Earlier in February, pharmaceutical company Pfizer also issued a recall of twenty-eight lots of similar generic tablets and brand-name Lo/Ovral-28 tablets. The tablets, manufactured by Pfizer and labeled under its Akrimax Pharmaceuticals brand, had similar packaging errors to the Glenmark product. Packaging on the Pfizer products might indicate the wrong sequence of tablets and contain inaccurate information on ingredients. Some tablets contain active ingredients and others only inert ingredients, and the sequence is critically important. The recall affected around 1 million packages.
Shortages of Important Drugs Give Rise to Concerns Over Safety of “Grey Market” Replacements
Shortages of certain prescription medications are nothing new to most pharmacists, hospitals, and doctors. According to the American Hospital Association, nearly 99.5 percent of U.S. hospitals reported some drug shortages in the first half of 2011, with 44 percent experiencing shortages of more than twenty drugs and 78 percent rationing drug supplies to deal with shortages. The Food and Drug Administration (FDA) reports that the number of drugs reported to be in short supply has increased from around 55 in 2006 to 178 in 2011, and the number could go as high as 350 for 2011 when statistics become available. Aside from basic problems of availability of medications to patients who might desperately need them, the situation also lends itself to unscrupulous behaviors like price gouging and hoarding. The nonprofit research and advocacy group CorpWatch recently issued a report on concern over “grey markets” that spring up for certain drugs that are in demand but also in short supply.
“Grey markets” can endanger patients not only by charging high prices for drugs, but also by removing key quality control procedures and the professional safeguards enjoyed when dealing with licensed doctors and pharmacists. The CorpWatch report describes how a New Hampshire woman found her routine appointments for cancer treatment cancelled when the hospital could no longer obtain her medication. Her particular medication, doxorubicin, trade name Doxil, is used to treat breast cancer and many other forms of cancer, and it is one of the few possible treatments for many people.
The CorpWatch report claims that Doxil’s manufacturer, Johnson & Johnson, actually subcontracts many of the stages of production, which has caused significant delays in production schedules for the drug. A single facility in Ohio manufactures Doxil, according to the Los Angeles Times, and it reportedly cannot keep up with demand. The plant closed temporarily due to concerns over product safety, which only made the shortage worse.
The FDA recently announced that it has approved the importation of shipments of substitutes for Doxil and another cancer drug, methotrexate, from foreign manufacturers. Lipodox, a drug manufactured by Indian company Sun Pharma Global, will temporarily replace Doxil. Australian company Hospira will send shipments of its version of methotrexate, a drug used to treat childhood leukemia. At best, these shipments will cover shortages for no more than a few months. Doctors interviewed by the New York Times stressed that this solution is extremely temporary.
Drug Confusion Causes Eye Injury, $1 Million Lawsuit
The U.S. Food and Drug Administration (FDA) issued an alert to pharmacists nationwide on December 28, 2011 regarding two drugs with similar-sounding names but very different uses, warning them of the risk of serious injury if one drug is accidentally substituted for the other. Durezol is an FDA-approved eye medicine that consists of a 0.05% solution of ophthalmic chemicals. Durasal, meanwhile, is a topical wart remover. It is not formally approved by the FDA, and it consists of a 26% solution of salicylic acid. Both drugs are available with a doctor’s prescription.
Ordinarily the FDA would screen trade names to see if they were substantially similar to an existing name in a way that might confuse consumers, but it never subjected Durasal to is formal approval process. Durasal reportedly went on the market shortly after the FDA approved Durezol.
Complaints about confusion between the two drugs began as early as 2009, with ophthalmic patients accidentally receiving the wart remover Durasal. Obviously a solution of more than a quarter acid is not ideal to place into one’s eye, and several patients have allegedly suffered severe eye injuries as a result. Durasal’s manufacturer, Elorac, Inc., has reportedly not responded to the FDA’s request to discuss a possible recall of the drug. The Philadelphia Inquirer reported that a company spokesperson at one time said the company planned to introduce a new product, also containing salicylic acid but with a different name. As of early January 2012, however, Durasal remains on the market.
A New York City patient filed a lawsuit against pharmacy chain Walgreens in early 2011 for mixing up the two medications. The man had just undergone minor eye surgery and went to fill a prescription for Durezol, the eye medicine. The pharmacy allegedly gave him Durasal instead, causing what he described as “grievous personal injury.”
The Consumerist reports that, despite packaging and warning labels, medicine mix-ups are a fairly common occurrence. They reference the story of an Arizona woman who mistook superglue for eyedrops in 2010 and needed emergency medical intervention. Eye drops may present a particular problem, since some patients may not able to immediately review the label and instructions due to impaired vision. The packaging for Durasal includes a clear warning that the product is “NOT FOR USE IN EYES,” but media reports do not indicate if pharmacies ordinarily dispense the medication in its original packaging, or if the warning was visible to the particular injured individuals.
FDA Wants More Warning Label Information for Yaz
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.
Study Shows Further Links between DES Exposure and Cancer in Women Exposed In Utero
A study recently published in the New England Journal of Medicine has expanded on the links between diethylstilbestrol (DES) and many forms of cancer. Researchers looked at 6,500 women, 4,600 of whom received exposure to DES while in the womb. They found substantially higher risk of cancer, including breast cancer and adenocarcinoma. They also found a higher risk of infertility and neonatal death. The study serves as a reminder of the risks posed during widespread use of DES decades ago, which led to a landmark court decision regarding liability for drugs that cause medical complications.
DES is a synthetic form of estrogen first developed in 1938 and used to treat breast and prostate cancers, among other uses. The U.S. Food and Drug Administration approved it in 1941 to treat menopausal symptoms, vaginitis, and to suppress lactation after childbirth. It was used from the 1940’s to the 1980’s in estrogen-replacement therapy. It was a standard treatment for prostate cancer for 40 years, until more effective treatments were approved in the 1980’s. DES was also a common treatment for breast cancer from 1960 to 1977.
For a period of about 30 years, doctors gave DES to pregnant women believing it could reduce the risk of complications or losses in pregnancy in women with a history of miscarriage. The FDA approved DES for this use in 1947, but withdrew it from use with pregnant women in 1971 after studies linked it to certain tumors in girls and women exposed to the drug in utero. Further study showed medical complications in people exposed after birth. Women exposed to DES in the womb have been encouraged by the National Cancer Institute to seek regular specialized medical examinations to look for complications due to the drug.
Women who took DES while pregnant have shown a slightly higher rate of breast cancer. Women exposed in the womb, known as “DES daughters,” have shown a wide array of health complications, including multiple types of cancer. In addition to its carcinogenic properties, DES is considered a teratogen, meaning it can cause malformations in children exposed in utero. Men exposed to DES in utero have shown elevated rates of testosterone deficiency and neurological issues.
Once negative publicity developed around DES, multiple lawsuits were filed against the drug’s manufacturers across the United States in the 1970’s. This led to the California Supreme Court’s 1980 decision in Sindell v. Abbott Laboratories, which demonstrated the legal doctrine of market share liability. The plaintiff had developed cancer because of her mother’s use of DES. Due to the number of years that had passed from the time the mother took the drug to the time the daughter learned of her injuries, she could not identify the specific manufacturer of the pills her mother took. The doctrine put forth by the California court made all manufacturers of the drug liable in proportion to their share of the drug’s market at the time of use. Since then, courts have only applied the market share doctrine to cases involving pharmaceutical products.
Fosamax Lawsuit in New York May Proceed, but With Limitations
A New York federal judge is allowing a lawsuit over the osteoporosis drug Fosamax to go forward, but with limitations. Judge John Keenan will allow plaintiff Linda Secrest to pursue her claim against Merck & Co., but she will not be able to claim punitive damages or to argue that Merck failed to warn her about potential risks in taking the drug. Secrest claims that a defect in Fosamax caused osteonecrosis of the jaw (“ONJ”), a condition in which the tissue in her jaw decayed. Secrest’s lawsuit is the fourth bellwether case against Merck over Fosamax, and the outcome will affect thousands of other Fosamax claims. Significantly, Judge Keenan stated in his decision that he found no evidence that any warning label would have caused Secrest’s prescribing physician to take her off the medication.
Fosamax, or its generic equivalent alendronate, treats and prevents osteoporosis, a condition in which the bones weaken and can easily break. It first came on the market in 1995. The drug works by inhibiting bone resorption, the process by which bones break down with age. Doctors often prescribe the drug for women who have gone through menopause.
The FDA began to collect reports of ONJ as far back as 2000, and other complaints such as broken legs began to come in as well. A 2008 finding from the FDA indicated a possible link between the drug and certain cases of esophageal cancer. A report from the American Dental Association followed soon after that suggested a connection between ONJ and medications in the same class as Fosamax. A 2010 press release from the FDA warned of a possible elevated risk of thigh bone fractures. These correlations led quickly to litigation.
Secrest’s lawsuit began in Florida, and in August 2006 it moved to the U.S. District Court for the Southern District of New York to be consolidated with other similar lawsuits. Secrest, along with dozens more plaintiffs around the country, filed suit against Merck, Novartis Pharmaceuticals, Procter & Gamble Pharmaceuticals, Aventis Pharmaceuticals, Sanofi-Aventis, Walgreen Co. and Mouhannad Budeir DDS. The lawsuit, styled In Re: Fosamax Products Liability Litigation, seeks tort damages for personal injury and products liability. Three bellwether cases preceded Secrest’s case. Merck one two of those cases at trial, and the third resulted in am $8 million jury verdict against Merck, which Judge Keenan reduced to $1.5 million.
Safety of Electronic Medical Records Questioned After Pharmacy Error Leads to Death of Infant
A recent Chicago Tribune article, that our Baltimore pharmacy misfill injury attorneys have been following, looks closely at electronic medical record safety, after a tragic medication error occurred, stemming from a computer mistake made at the Chicago-area Advocate Lutheran General Hospital, that caused the death of a newborn infant.
According to the article, Genesis Burkett, an infant born 16-weeks premature, was given a fatal overdose of sodium chloride last year, receiving over 60 times the dosage ordered by the physician. The hospital pharmacy error was reportedly made after a technician from the hospital pharmacy misread and inaccurately typed the doctor’s handwritten prescription orders into a hospital computer—a common source of pharmacy misfills and errors, as attorneys have discussed recently in a Baltimore pharmacy error injury blog.
The data entry mistake then caused a pharmacy misfill, as the automated machine prepared an intravenous solution containing a lethal overdose of sodium chloride that caused the infant’s heart to stop. Advocate Health Care’s chief medical officer, Dr. Lee Sacks stated that the pharmacy error could have been prevented by the automated alerts on the IV compounding machine, but at the time that the customized bag was prepared for the infant, the alerts were not activated and connected to the main pharmacy information systems at the hospital. The family’s attorney reportedly blamed the pharmacy error and wrongful death on a mislabeled IV bag.
After the medication error led to the infant’s tragic death, Advocate has since added electronic alerts to the IV compounders and initiated other medication safety measures to prevent this kind of pharmacy error from happening in the future.
Risperdal Recalled by Manufacturer Due to Drug Contamination
Our Talbot County, Maryland pharmacy error injury lawyer blog recently discussed a series of recalls drug maker Johnson & Johnson made last year, in an effort to maintain the health and safety of consumers—after complaints of an unusual smell causing nausea, vomiting, diarrhea and gastrointestinal pain were reported, due to trace amounts of 2, 4, and 6-tribomoanisole (TBA), a chemical used to preserve wood necessary in the construction of pallets used for transportation and shipping of the product packaging materials.
In related news, Ortho-McNeil-Janssen Pharmaceutical, the drug manufactures of Risperdal (risperidone), an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and irritability associated with autistic disorder in adolescents and children, recently voluntarily recalled 16,000 bottles of the brand name drug and 24,000 bottles of the generic drug—also because of an unusual odor.
The Risperdal drug manufacturers found that the unusual smell was also caused by trace amounts of TBA, used to preserve wood pallets for the transportation and storage of product materials. While not considered to be toxic, a small group of patients have reported gastrointestinal symptoms when taking products with this offensive odor. The drug maker claims that the presence of TBA has not caused any reported serious adverse events, but the company has instituted a series of actions to reduce the potential of TBA contamination in the future, to avoid personal injury or harm to any consumers.
This is the second medication error warning surrounding Risperdal this year. Last month our attorneys discussed another warning involving Risperdal in a Baltimore pharmacy error injury blog, issued by the U.S. Food and Drug Administration, discussing potentially dangerous medication errors associated with Risperdal and Requip, a drug used for the treatment of Parkinson’s disease and Restless Legs Syndrome, with 226 reports of patients receiving the incorrect medication.
FDA Warns of Confusion between Risperdal and Requip, Leading to Medication Error
The Food and Drug Administration recently issued a warning about the potentially dangerous medication errors occurring with the drugs Risperdal (risperidone) and Requip (ropinrole)—with 226 reports of patients accidentally receiving the wrong drug, causing sickness and at least one death.
Risperdal (risperidone) is an antipsychotic used for the treatment of schizophrenia, autism side effects and bipolar disorder, and is reportedly being confused with Requip (ropinirole), a drug used for the treatment of Parkinson’s disease and Restless Legs Syndrome, that acts in place of dopamine.
According to the Food and Drug Administration report, the medication errors are happening as a result of the drug name similarity as well as the similarity in generic drug labels and packaging, with overlapping drug characteristics such as the drug strengths, and dosing intervals. Other errors have reportedly stemmed from illegible handwriting on prescriptions.
Patients who were victims of the medication errors have reportedly experienced confusion, tiredness, hallucinations, and an altered or changed mental status, among others health problems.
The FDA warns patients who are taking the generic versions of Requip or Risperdal to notice the name and appearance of their medication, to know exactly why they are taking the drug, and to ask any questions and to report any difference in medication appearance to their pharmacists—to avoid pharmacy misfills or medication errors.