Use of sertraline contraindicated with Tourette's syndrome drug Orap
Johnson & Johnson Has Released Another "Dear Doctor" Letter About Eprex
Thioridazine Connected to Unexplained Deaths of Psychiatric In-patients
AstraZeneca's Cancer Therapy Drug Nolvadex Receives Boxed Warning
Medtronic's Intrathecal Baclofen for Severe Spasticity Receives Boxed Warning
Vioxx Label to Include New Warnings of Heart Risks, Merck Says
Etanercept, infliximab may be associated with lymphoma development
Johnson & Johnson Warns of Rare Blood Disorder Risk From Eprex
GlaxoSmithKline Issues Warning About Antiretroviral Drug Label Switch
Doctors Alerted to Adverse-event Reports for Danco's Mifeprex/Misoprostol Regimen
FDA Investigating Bayer's Recall of Gamimune N Lots Due to Tampering
December 24, 2002
ST. LOUIS (MD Consult) - The tumor necrosis factor (TNF) antagonists etanercept and infliximab may be associated with lymphoproliferative disorders, according to MedWatch reports.
Between May 1999 and December 2000, Dr. M. Miles Braun and colleagues, from the US Food and Drug Administration and the National Cancer Institute in Rockville, Maryland, identified 26 reports of lymphoma subsequent to initiation of anti-TNF therapy. Between November 2001 and September 2002, another 68 cases reported to the FDA's passive postmarket adverse event reporting system were classified as having a probable or possible association with etanercept and infliximab.
In the December issue of Arthritis and Rheumatism, the researchers reviewed data from the earlier cohort. The indication for TNF antagonist use was rheumatoid arthritis in 18 of the 26 cases, psoriatic arthritis for 2, and Crohn's disease for 5 cases. For one case the indication was unspecified.
Among the 18 patients given etanercept, lymphoma was diagnosed a median of 8 weeks (range 2 to 52 weeks) after starting therapy. The median duration of treatment with infliximab before diagnosis was 6 weeks (range 2 to 44 weeks) for 7 of the 8 cases.
Current data don't facilitate drawing conclusions about whether these TNF antagonists were the cause of the reported lymphomas, whether these neoplasms developed naturally as part of the underlying medical conditions, or whether they occurred as a complication related to other immunosuppressive medications these patients were exposed to, the investigators said.
Further implicating the antagonists, was the observation that the latent period was quite similar to that associated with lymphomas which develop following immunosuppressive therapy for patients who have organ transplants, the investigators said.
Dr. Braun's group identified two patients previously treated for lymphoma who relapsed very quickly after starting anti-TNF therapy. Therefore, they suggest such patients be considered ineligible for such treatment, at least until this concern is resolved.
In two patients, one treated with etanercept and one with infliximab, there was lymphoma regression once treatment was discontinued, investigators report. Patients should be monitored for spontaneous remission after withdrawal of the medication to see if cytotoxic chemotherapy can be avoided if the patient's clinical condition permits, they said.
Dr. Braun's group asks clinicians to report similar cases to MedWatch in great detail.
November 21, 2002
ST. LOUIS (MD Consult) - Pfizer Inc. has sent a letter to healthcare professionals warning that the prescribing information for its antidepressant sertraline (Zoloft) has been changed to contraindicate its use with the Tourette's syndrome treatment pimozide (Orap).
The change was made at the request of the US Food and Drug Administration (FDA).
According to the Pfizer letter, a study examining a single 2-mg dose of Orap co-administered with a 200-mg dose of Zoloft caused an increased concentration of Orap of about 40 percent.
"Due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of Zoloft and pimozide should be contraindicated," the letter said.
Zoloft is approved for depression, panic disorder, obsessive-compulsive disorder, premenstrual dysphoric disorder, and post-traumatic stress disorder.
Orap is made by Gate Pharmaceuticals, a unit of Israel's Teva Pharmaceutical Industries Ltd.
November 19, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has issued a nationwide alert to warn about using injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance the products are sterile.
Urgent Care recalled all lots of its injectable steroid September 16, 2002. The recall was based on reports of four patients who developed a rare fungal infection of the lining of the brain and spinal cord. The patients tested positive for a fungus consistent with one later found in an Urgent Care product. One patient died.
The nationwide alert was initiated by Urgent Care's refusal to voluntarily recall any other injectable product and provide the FDA with a complete list of products that were distributed, the FDA said. The inspection of Urgent Care's facility revealed the firm failed to ensure sterility or test for potency and sterility prior to distribution, the FDA said.
The FDA said it was working to identify recipients of the products along with the US Centers for Disease Control and Prevention (CDC) and officials from North Carolina and South Carolina and said it would take whatever additional action is needed.
The South Carolina Board of Pharmacy has issued a Cease and Desist order to halt the sale of Urgent Care products, the FDA said.
The pharmacy couldn't be reached for comment.
Based on available information, the FDA said it believes Urgent Care distributed the majority of its injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia.
The FDA said among the products distributed were baclofen, betamethasone, Bimix 30:1 (phentolamine mesylate/papaverine), clonidine, estradiol, hydromorphone HCl, fentanyl, methylprednisolone acetate, morphine sulfate/bupivacaine, papaverine HCl, super Trimix (papaverine HCl/phentolamine mesylate/prostaglandin) testosterone cypionate, and testosterone/estradiol.
These products are labeled as URGENT CARE PHARMACY 2500 WINCHESTER PLACE, STE. 106, SPARTANBURG, SC 29301, 800-692-8982, the FDA said.
The FDA asks consumers, physicians and healthcare workers to notify the FDA's voluntary reporting program, MedWatch, about any complaints or problems associated with these products. Reports to MedWatch can be made by calling 1-800-FDA-1088 or online on the FDA Web site.
November 18, 2002
ST. LOUIS (MD Consult) - Drugmaker Pharmacia and the US Food and Drug Administration (FDA) are telling doctors the firm's Cox-2 inhibitor valdecoxib (Bextra) has been associated with serious allergic reactions and shouldn't be given to patients allergic to sulfa.
In a notice, the FDA said it has received post-marketing reports regarding various allergic events, including skin and anaphylactoid reactions. The events were rare, but some patients were hospitalized, the FDA said.
The Bextra label has been updated to reflect the new case reports and contraindication, the FDA said.
Pharmacia sent similar letters to healthcare professionals November 13, the FDA said, announcing the post-marketing reports and new warnings that will be included on the updated label.
In a copy of the letter on the FDA's Web site, Pharmacia said these cases occurred in patients with and without a history of allergic-type reactions to sulfonamides and included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme.
The label will be updated to carry two separate warnings for the skin and anaphylactoid reactions, Pharmacia said, and a section to outline the post-marketing experience. An estimate of the frequency was not possible because the reactions were voluntarily reported from a population of uncertain size, according to the label included in the Pharmacia letter.
The FDA first approved Bextra in November 2001 for treating osteoarthritis, rheumatoid arthritis and menstrual pain.
November 5, 2002
ST. LOUIS (MD Consult) - Roche Holding AG has changed the US label of Roaccutane to mention an association with violent behavior, Roche said. Roaccutane is used to treat severe acne.
The change followed discussions with the US Food and Drug Administration, which requested the warning for the drug.
This isn't the first change to Roaccutane's label to address the risk of aggressive behavior.
July 17, 2002
ST. LOUIS (MD Consult) - Johnson & Johnson has issued another "dear doctor" letter updating European doctors about the rare but serious adverse reactions reported in renal patients taking the anemia drug Eprex (epoetin alfa).
The letter provides the European healthcare community "with current information about the worldwide reported cases of pure red cell aplasia (PRCA) in chronic renal failure (CRF) patients," the company said.
It is "largely consistent" with earlier warnings that Eprex should be given intravenously in chronic renal failure patients and if this wasn't possible, the risk/benefit of subcutaneous administration should be considered for individual patients.
The letter and an update to the prescribing information have been issued by Ortho Biotech, a division of Janssen-Cilag.
The number of reports of pure red cell aplasia in renal patients taking J&J's Eprex is continuing to rise, the company said.
The company said 141 suspected cases had been reported through the end of May, 17 more than the 124 reported through April.
Only seven of the 17 additional cases had occurred this year. The rate of reporting remained rare at 1.14 per 10,000 patient years.
July 12, 2002
ST. LOUIS (MD Consult) - Thioridazine-induced arrhythmia appears to have caused some sudden unexplained deaths among psychiatric in-patients, researchers report in the June British Journal of Psychiatry.
The University of Newcastle's Dr. Simon H. L. Thomas and colleagues conducted a case-control study comparing psychiatric in-patients who died suddenly with matched controls in five hospitals in northeast England.
The researchers identified 69 case-control clusters. Sudden unexplained deaths were associated with hypertension, ischemic heart disease and treatment with the antipsychotic drug thioridazine (adjusted odds ratio for thioridazine 5.3, p=0.004), Dr. Thomas's team discovered.
The main cause of thioridazine-related death appears to be torsades de pointes induced by the thioridazine, the researchers said. Other antipsychotics weren't significantly associated with sudden unexplained death, they said.
Br J Psychiatry 2002;180:515-522.
July 1, 2002
ST. LOUIS (MD Consult) - The number of patients who have developed a rare blood disorder when treated with Johnson & Johnson's anemia drug Eprex (erythropoietin) has risen to 124 worldwide, and one of those patients died, the firm said.
Johnson & Johnson is investigating possible triggers of pure red-blood cell aplasia, the company said in a letter to Canadian physicians.
Eprex, which has been available for 15 years, is marketed in the United States as Procrit, a treatment primarily for cancer patients who develop anemia after chemotherapy.
Johnson & Johnson said it hasn't identified what is causing some patients' immune systems to attack the protein-based drug. They said subcutaneous delivery appears to play a role, and all of the cases to date have been in patients with kidney disease.
As a result, Johnson & Johnson said its drug should be administered intravenously to patients with chronic kidney failure.
Amgen Inc. holds domestic rights to the drug, under the brand name Epogen, for kidney dialysis patients. Amgen said earlier this year there has been one reported case of aplasia in the past 12 years among patients taking Epogen.
June 28, 2002
ST. LOUIS (MD Consult) - AstraZeneca has added a boxed warning to its cancer therapy Nolvadex (tamoxifen citrate) to emphasize a link with uterine malignancies, strokes and pulmonary embolisms, according to the US Food and Drug Administration.
The documents included a "Dear Doctor" letter, the revised label and a new patient insert, all dated mid-May.
The warning was developed as a way to urge physicians to use caution when deciding whether to use Nolvadex to reduce the risk of invasive breast cancer in patients with ductal carcinoma in situ and patients at high risk of developing breast cancer, according to the letter.
"While it has been known that Nolvadex treatment is associated with an increased risk of endometrial cancer, recent information indicates that there is also an increased risk of developing a rare and more aggressive uterine sarcoma," the letter said. "These data, and the previously reported increased risk of stroke and pulmonary embolism, have prompted changes to the Nolvadex label."
The new label says the benefits of tamoxifen outweigh its risks in women who already have breast cancer, but doctors should discuss the possible benefits versus the potential risks of serious events with patients receiving or considering Nolvadex to reduce the risk of developing breast cancer.
In the letter, AstraZeneca said it feels Nolvadex offers clear benefits for breast cancer risk reduction, but the risk-benefit considerations should be made on an individual basis.
June 13, 2002
ST. LOUIS (MD Consult) - "Dear Doctor" letters warning that additional counterfeit versions of the anemia therapy epoetin may be circulating in the US have been posted on the MedWatch division of the US Food and Drug Administration (FDA) web site.
The letters, from Johnson & Johnson subsidiary Ortho Biotech Products, say the UK-based company knows about at least two counterfeit lots of Procrit (epoetin alfa) being distributed in the US.
Counterfeit vials of a similar drug, Amgen Inc.'s Epogen, were discovered in May 2002. Epogen and Procrit are primarily used to treat anemia associated with chemotherapy and chronic kidney failure.
Ortho Biotech said it appeared the counterfeiters purchased 2,000 U/mL vials of Procrit and relabeled those vials with 40,000 U/mL labels. The lower than labeled strength of the counterfeit vials mean it's possible patients could be under-dosed, the company said.
In May, Amgen said it appeared the counterfeit Epogen vials had about a 20-times-lower concentration of the active ingredient than what the label indicated. Amgen didn't say how many patients might be affected, but said it was working with the FDA to investigate the matter and prevent further distribution of the counterfeit product.
Ortho Biotech said it became aware of the counterfeit vials because they contained two lot numbers that should have been used up by this time. In the letter, the firm said it's cooperating with the FDA to investigate this matter and prevent further distribution of counterfeit Procrit.
The genuine lots, with the numbers P002641 and P002384, were last shipped on February 2002 and September 2001, respectively, the company said.
Healthcare professionals who have received possible counterfeit lots should contact the FDA at 1-800-835-4709 to report the event, the company said. Additional updates will be posted on the company's Web site at www.procrit.com. Healthcare professionals seeking a refund should contact their wholesale supplier, the firm said.
June 3, 2002
ST. LOUIS (MD Consult) - Eli Lilly & Co. has confirmed six instances in which the company's antipsychotic Zyprexa (olanzapine) was replaced with aspirin tablets.
In May, Lilly said it confirmed the tampering in three cases. The first, in Minnesota, was brought to Lilly's attention in January, and an investigation was launched by the company and the US Food and Drug Administration (FDA). The next two were discovered in late April, both in Wisconsin, Lilly said.
In 225,000 letters dated May 4, Lilly warned pharmacists and physicians nationwide that in certain bottles of Zyprexa, the schizophrenia drug was replaced with aspirin.
During this time, Lilly received reports about other cases of Zyprexa tampering, but was uncertain if they were the same three cases or different ones, Lilly said. The three new cases occurred in Florida, California, and Wisconsin. In five of the six cases, the tampered product reached pharmacists. In the sixth case, the product was returned to the company by the wholesalers.
Since none of the tampered Zyprexa bottles reached consumers, there have been no cases of adverse events reported, Lilly said.
The FDA is now investigating the tampering.
May 28, 2002
ST. LOUIS (MD Consult) - Medtronic Inc.'s intrathecal baclofen therapy (ITB) has added a boxed warning to highlight rare cases of high fever, altered mental status and other potentially life-threatening sequelae during withdrawal of therapy, according to the US Food and Drug Administration (FDA).
Intrathecal baclofen therapy is used to treat severe spasticity that doesn't respond to oral medications. The adverse events associated with the withdrawal also included muscle rigidity that in rare cases advanced to rhabdomyolysis, multiple organ-system failure and death, the FDA said.
Medtronic notified healthcare professionals of adverse events in an April "Dear Doctor" letter. The FDA notice was issued by its MedWatch Program and included a copy of the "Dear Doctor" letter posted on the agency's Web site. Further details were added to the Warning section of the prescribing information to outline the clinical cases. In that section, Medtronic said 27 cases have been reported over the last nine years, including six deaths.
Warning signs of advanced intrathecal baclofen withdrawal syndrome include autonomic dysreflexia, sepsis, malignant hyperthermia, neuroleptic-malignant syndrome or other conditions associated with hypermetabolic state or widespread rhabdomyolysis, Medtronic said. Rapid, accurate diagnosis and treatment are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal, the company added.
Suggested treatment involves restoring the intrathecal baclofen at or near the same dosage as before therapy was interrupted, but treatment with GABA-ergic agonist drugs could also be used if restoration could not be performed immediately, Medtronic said.
May 14, 2002
ST. LOUIS (MD Consult) - GlaxoSmithKline said that two bottles of Ziagen (abacavir), an antiretroviral drug for HIV infection that can cause a life-threatening allergic reaction in some patients, had been tampered with and falsely labelled Combivir (lamivudine plus zidovudine), a more expensive antiretroviral combination drug.
The incident appeared to be confined to the United States, a company spokesman said. The motive for the tampering appeared to be financial and could lead to a criminal prosecution.
The British drug maker said it received reports of possible criminal tampering after four bottles of two HIV drugs aroused the suspicions of patients, pharmacists and doctors in California, Connecticut, Maryland and Florida. The apparent tampering comes just days after Indianapolis drugmaker Eli Lilly and Co. said its schizophrenia drug Zyprexa (olanzapine) was replaced with aspirin in three bottles sent to US pharmacies.
False labels of Combivir, which retails for $515 a month, were placed on two bottles containing Ziagen, which sells for $320 per month, Glaxo said. The risk to patients is primarily from to a potentially life-threatening hypersensitivity reaction to Ziagen that affects approximately 5% of patients.
Phony Combivir labels were also found on two bottles that did contain Combivir. Glaxo said original labels have lot numbers allowing authorities to trace where a bottle of medicine is made and which wholesalers and retailers take possession of it before it is sold.
Removing a label and replacing it with a counterfeit label, even for the correct drug, erases all such information and could allow criminals to disguise their identities, a company spokesperson said. There was no evidence of tampering before the product left Glaxo's manufacturing plant.
The incidents appear isolated and no injuries or adverse reactions have been reported, the company said. Company tests indicate no problems with the medicine itself.
Glaxo said it was not issuing a recall on the drugs, but was asking patients and health professionals to be alert and examine the contents of each Combivir bottle. The pills are easy to tell apart.
Combivir is a white capsule-shaped tablet engraved with "GX FC3" on one side and has a plain opposite side. The Combivir label shows a color photo of the tablet. Ziagen is a yellow capsule-shaped tablet engraved with "GX 623" on one face, while the other side is plain.
May 10, 2002
ST. LOUIS (MD Consult) - Some tablets of Eli Lilly and Company's antipsychotic olanzapine (Zyprexa) were recently replaced with aspirin, according to documents on the US Food and Drug Administration's (FDA) web site.
The documents included two letters sent to healthcare professionals by Indianapolis, Indiana-based Lilly, telling them about the suspected tampering. One letter was addressed to doctors, and the other was sent to pharmacists. Both were dated May 4, 2002.
In the letters, Lilly said it has learned about incidents in which US pharmacists found the tablets in certain 10 mg and 15 mg 60-count bottles were replaced with what appeared to be aspirin.
Lilly said the incidents seem isolated and limited in scope. Although no injuries or adverse effects have been reported to date, Lilly said it considers the situation a safety issue.
The Zyprexa 10 mg tablets are round and white, which is similar to aspirin, Lilly said. Pharmacists can differentiate between the two tablets by looking for the "Lilly" brand name and the number "4117" on the side of each 10 mg tablet, the company said.
The 15 mg tablets are blue, oval shaped and embossed with a similar "Lilly" brand mark plus the number "4415," Lilly said.
Pharmacists were instructed to inform the company of any suspicious bottles, and healthcare professionals were asked to direct concerned patients to the pharmacy to return the pills.
Lilly said it was investigating the reports with the FDA.
News of the tampering follows recent reports that Lilly's top-selling anti-psychotic has been associated with a higher rate of diabetes among patients in Europe.
May 9, 2002
ST. LOUIS (MD Consult) - 3M Pharmaceuticals has started a voluntary US recall of its Maxair press-and-breathe metered-dose inhalers because the products may occasionally stick, thereby failing to deliver the appropriate dose of asthma medication pirbuterol acetate.
The recall doesn't affect 3M's Maxair Autohaler, a breath-actuated metered-dose inhaler using the same medication, and only includes the US. The problem was discovered during routine testing, 3M said.
Patients should return the recalled inhalers to their pharmacies, where the products will be replaced with the Maxair Autohaler free of charge, 3M said. A prescription from a physician is required to obtain the replacement.
3M has sent recall alert letters to distributors, physicians and pharmacies. The recall involves about 700,000 inhalers.
The affected lots were shipped between September 2000 and April 2002 and were numbered 000644, 000756, 000947, 001009, 001110, 001111, 010025, 010195, 010283, 010413, 010414, 010482, 010580, 010708, 010709 and 011210.
April 23, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration announced that Baxter Healthcare Corp. and the American Red Cross are warning of a possible link between immune globulin intravenous (IGIV) and serious thrombotic events including chest pain, heart attack and congestive heart failure.
The exact cause of the thrombotic events is unknown, but rapid infusion of IGIV is considered a possible risk factor, according to Baxter, which makes Gammagard S/D, and the Red Cross, which distributes Polygam S/D.
Statements advising caution in giving IGIV to patients with cardiovascular disease or previous thrombotic events have been added to the labels of both products, the FDA said. Pharmacists, nurses and other healthcare professionals who administer immune globulin intravenous should read and follow the package insert.
For patients with risk factors, Baxter and the Red Cross recommend an infusion concentration of no more than 5% and an infusion rate of no faster than 0.5 milliliters per kilogram body weight per hour. The infusion rate should be advanced slowly, if well tolerated, to a maximum rate of 4 milliliter per kilogram body weight per hour.
Patients with risk factors such as coronary artery disease, hypertension, cerebrovascular disease and diabetes should be carefully evaluated, the Red Cross said.
April 19, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration said Danco Laboratories, which markets early-abortion pill Mifeprex (mifepristone), has issued an alert to healthcare providers concerning new adverse-event reports, including several reports of ruptured ectopic pregnancies.
The FDA said the adverse events occurred in women given misoprostol vaginally as part of medical abortions. The agency said the regimen it approved in 2000 included oral administration of misoprostol and it hasn't reviewed the safety and efficacy of vaginally-administered misoprostol.
Misoprostal has been given vaginally as part of certain published studies at doses higher than the oral dose in Mifeprex's approved labeling, the agency said.
New York City-based Danco warned in its "Dear Healthcare Provider" letter that it has received "a small number of reports" of ruptured ectopic pregnancies in women given Mifeprex and misoprostol. Those reports included one death from a resulting hemorrhage, Danco said.
The letter said, in part, "Confirmed or suspected ectopic pregnancy is a contraindication for the use of Mifeprex and should be ruled out prior to initiating Mifeprex treatment. Because ectopic pregnancy may be present despite your best efforts to rule it out ... you should be mindful of the possibility of an ectopic pregnancy throughout the treatment period and have a plan for its management."
The letter also said Danco has received two reports of serious systemic bacterial infection in women given Mifeprex and misoprostol, including one fatal case. Danco said the drugs don't appear to present "a special risk of infection" above and beyond the risks normally associated with menstruation, childbirth and abortion.
Finally, the company said it had received a report of a 21-year-old woman who suffered a heart attack several days after taking Mifeprex and misoprostol. No causal relationship between any of these events and use of Mifeprex and misoprostol has been established, Danco said.
The product's label has not been changed as a result of the reports. The FDA did not rule out asking for new warnings later.
April 12, 2002
ST. LOUIS (MD Consult) - The label of osteoarthritis drug Vioxx (rofecoxib) will be changed to include language warning the medicine poses higher cardiovascular risks than a standard arthritic treatment, but no greater risk than placebo, manufacturer Merck & Co. Inc. said.
US regulators have also approved the medicine for rheumatoid arthritis, the New Jersey-based drugmaker said.
The cardiovascular warning wasn't previously on the Vioxx label, but is being required by the US Food and Drug Administration (FDA) following a major head-to-head trial of the drug against the drug naproxen, a popular older, less expensive arthritis treatment. The FDA also approved language in the label that says patients taking Vioxx suffered fewer serious gastrointestinal problems than those taking naproxen, Merck said.
The new precautionary language says twice as many people taking Vioxx in an 8,000-person trial suffered heart attacks and other cardiovascular problems as those taking naproxen. The label will also include data from two other studies showing that patients taking Vioxx suffered fewer serious cardiovascular events than those taking placebo.
Merck said it remains confident Vioxx is safe
April 11, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has warned three pharmacies to stop selling illegal nicotine lollipops and lip balms as aids to quit smoking.
The lollipops and lip balms are unapproved drugs and need to pass extensive tests to determine if they are safe and effective, the FDA said.
Pharmacists were selling the products at stores and over the Internet under federal rules that allow them to make medicines easier to take, a practice known as compounding. The FDA said the lollipops and lip balms violated those rules because some were being sold without a physician's prescription. Also, the type of nicotine typically used, nicotine salicylate, isn't allowed in compounding.
The products also lacked proper directions for use and failed to carry adequate warnings against use by children, the FDA said. The FDA sent warning letters to Bird's Hill Pharmacy based in Needham, Massachusetts; Ashland Drug of Ashland, Mississippi; and The Compounding Pharmacy of Aurora, Illinois. All three pharmacies were selling the nicotine products over the Internet, the FDA said.
The FDA letters asked the pharacies to respond within 15 days. Failure to stop selling the products could lead to additional action, such as seizure or an injunction.
The lollipops are promoted as a way to give up cigarettes, or a way for smokers to get a nicotine fix when they can't smoke a cigarette.
April 5, 2002
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) said Pfizer Inc. has revised the label of its atypical schizophrenia drug Geodon (ziprasidone) to clarify the warning against using it with drugs which prolong the QT interval.
In a letter to healthcare providers, Pfizer said the labeling changes were made in consultation with the FDA to provide better understanding. The previous label -- which listed seven contraindicated drugs and said the list was incomplete -- was sometimes misinterpreted, Pfizer said.
The label also includes a new paragraph in the warnings section saying use with drugs known to prolong the QTc interval should be avoided and Geodon shouldn't be used in patients with congenital long QT syndrome or a history of cardiac arrhythmias.
In 2001, Geodon was approved in the US to treat schizophrenia. Approval was expected in 1998, but was delayed because the FDA was concerned about possible QT prolongation. Pfizer subsequently submitted safety data from more than 4,000 patients showing that the mortality rate for Geodon was similar to the rate for placebo.
Since approval, 156,000 patients have received Geodon and the postmarketing results are consistent with the clinical database, Pfizer said.
March 19, 2002
ST. LOUIS (MD Consult) - Bayer Corp. said it has recalled two lots of its Gamimune N, 10%, Solvent/Detergent Treated immune globulin intravenous product after discovering the immune serum had been tampered with.
The firm also said the US Food and Drug Administration has started an investigation.
The two lots of Gamimune N, 10%, numbers 648X078 and 648X062, were recalled from the US market on February 1 and March 14, respectively, according to Bayer, a unit of Germany's Bayer AG. An analysis of the recalled materials indicates tampering with the overseals of 13 vials.
Bayer has also determined that the returned vials with the damaged overseals have an unexpectedly low protein concentration, elevated chloride level, and are contaminated with bacteria.
The firm hasn't received reports of adverse events related to the recalled product, and several hundred Gamimune N, 10% vials have been returned, the company said.
Both recalled lots of Gamimune N came from a single distributor, the company said.
March 4, 2002
ST. LOUIS (MD Consult) - Roche Laboratories Inc. has recalled two lots of its Versed Syrup (midazolam) muscle relaxant because potential precipitation inside the bottle could result in a serious health hazard, the US Food and Drug Administration (FDA) said.
Versed Syrup is most commonly used in hospitals and clinics to help patients relax before medical tests or surgery. It is also used in doctors' offices and by dentists.
Roche is enacting a voluntary class I recall of the 118 mL (2mg/mL) bottles because they might contain a complex of the active ingredient and saccharine that failed to mix, the FDA said. The recall involved the lots numbered U0009-50 and U0010-50, the FDA said.
A class I recall involves a health hazard situation, with reasonable probability of an adverse health consequence such as death. The FDA said this precipitate could cause a lack of uniformity in the product, resulting in the administration of a sub-optimal or overdose.
The alert was issued by the FDA's MedWatch program, which monitors safety issues.
February 21, 2002
ST. LOUIS (MD Consult) - Hospitals and pharmacies are being asked to avoid confusion between two drug products that could result in morphine overdose.
The confusion involves opium tincture and paregoric (camphorated opium tincture), both used to control diarrhea but containing vastly different amounts of morphine.
The warning, from the Institute for Safe Medication Practices (ISMP), follows a newspaper report that a 51-year-old woman with chronic diarrhea had died from morphine intoxication after receiving a teaspoonful of opium tincture -- about 50 mg of morphine -- instead of paregoric.
The nonprofit ISMP, an independent reviewer of medication errors, said the patient's physician had prescribed camphorated tincture of opium, but a recent pharmacy graduate allegedly confused it with opium tincture.
While paregoric has been used for many years to control diarrhea, it is often "dangerously referred to by its synonym, camphorated tincture of opium," ISMP said. That has caused confusion with opium tincture, a preparation that contains 25 times the amount of morphine as paregoric, the ISMP said.
This is a potentially dangerous situation that invites serious medication errors, the ISMP said. The Institute has issued four previous warnings dating to June 1996 describing the potential for such errors.
To reduce the confusion and error possibilities, the ISMP suggests the pharmacy and therapeutics committees consider whether the two products are necessary.
Other recommended steps include making clinicians aware that it is dangerous to refer to paregoric as "camphorated tincture of opium," placing warnings on containers of opium tincture, and building alerts into computer systems.
The complete safety alert can be found at the Institute's Web site: www.ismp.org.
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