Latest Drug News

Recall expanded to include all lots of x-ray contrast agent August 10, 2006
ST. LOUIS (MD Consult) - Less than 2 weeks after recalling a single lot of its Ultravist (iopromide) Injection x-ray contrast agent, Berlex, Inc, announced on July 31, 2006, the recall of all lots worldwide. The recall, limited to the 370-mgI/mL concentration, is made on the basis of the potential that "particulate material in conjunction with crystallization may be present in the product," according to the company. This recall does not include other concentrations of Ultravist (ie, 150 mgI/mL, 240 mgI/mL, or 300 mgI/mL). Read more.

Antiepileptic drug may cause cleft lip or palate, manufacturer warns August 9, 2006
ST. LOUIS (MD Consult) - After discussions with Health Canada, GlaxoSmithKline Inc informed patients on August 8, 2006, of new safety information concerning the antiepileptic agent Lamictal (lamotrigine) tablets. New data from a pregnancy registry suggest an association between taking Lamictal in the first trimester of pregnancy and increased risk of cleft lip, cleft palate, or both in babies. Read more.

One lot of hydralazine hydrochloride injection may contain particulates, vials recalled August 9, 2006
ST. LOUIS (MD Consult) - On August 3, 2006, the US Food and Drug Administration (FDA) and Luitpold Pharmaceuticals, Inc, notified health care professionals of a voluntary recall of 1 lot of the antihypertensive agent hydralazine hydrochloride injection (20 mg/mL, 1-mL single-dose vials). Recall of this product, which is distributed by American Regent, Inc, was initiated because some vials may contain particulates. Read more.

FDA approves new liquid bowel-cleansing prep for colonoscopy August 8, 2006
ST. LOUIS (MD Consult) - Salix Pharmaceuticals, Ltd, announced on August 2, 2006, that the US Food and Drug Administration has granted marketing approval for prescription MoviPrep (polyethylene glycol [PEG] 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution). The agent is indicated for bowel cleansing before colonoscopy in adults aged 18 years or older. Read more.

Seizure medication approved in intravenous formulation August 3, 2006
ST. LOUIS (MD Consult) - On August 2, 2006, Belgian pharmaceutical company UCB announced that the US Food and Drug Administration has approved Keppra (levetiracetam) injection 500 mg/5 mL (100 mg/mL) for use as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Keppra injection is an alternative for patients when oral administration is temporarily not feasible. It must be diluted before use and administered as a 15-minute intravenous infusion. Read more.

New postsurgical adhesion reduction solution approved in US August 2, 2006
ST. LOUIS (MD Consult) - Innovata PLC and Baxter Healthcare Corporation announced on August 1, 2006, that the US Food and Drug Administration has approved Adept Adhesion Reduction Solution (4% icodextrin solution) for use in gynecologic laparoscopic procedures in the United States. Because the product is a liquid, it can be delivered directly and rapidly to the site through a laparoscopic port during surgery. Read more.

FDA approves new hyaluronic acid dermal fillers from Allergan August 2, 2006
ST. LOUIS (MD Consult) - Allergan, Inc, announced on June 5, 2006, that the US Food and Drug Administration (FDA) has approved the Juvéderm dermal filler gel products, a collection of hyaluronic acid dermal fillers indicated to correct facial wrinkles and folds. Desired results occur with a single treatment in the majority of patients, and results are sustained for 6 months or longer. Read more.

Eye drop approved for first-line treatment to reduce intraocular pressure in glaucoma August 2, 2006
ST. LOUIS (MD Consult) - On June 23, 2006, Allergan, Inc, announced that the US Food and Drug Administration (FDA) has approved Allergan’s once-daily prescription eye drop Lumigan (bimatoprost ophthalmic solution) 0.03% as a first-line treatment for elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension. Read more.

Abbott’s Humira approved to treat ankylosing spondylitis August 1, 2006
ST. LOUIS (MD Consult) - Illinois-based health care company Abbott announced on July 31, 2006, that the US Food and Drug Administration (FDA) has approved Humira (adalimumab) for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). AS is an autoimmune disease affecting the spine and large peripheral joints that causes inflammatory back pain and stiffness and also can be associated with other inflammatory diseases of the skin, eyes, and intestines. In its severe form, AS can result in complete spinal fusion, causing extreme physical limitation and reduction in health-related quality of life. Read more.

FDA cautions against ingestion of high-strength hydrogen peroxide July 28, 2006
ST. LOUIS (MD Consult) - On July 27, 2006, the US Food and Drug Administration (FDA) warned consumers not to purchase nor to use high-strength hydrogen peroxide products, including a product marketed as "35 Percent Food Grade Hydrogen Peroxide," for medicinal purposes because they can cause serious harm or death when ingested. The FDA recommends that consumers who are currently using high-strength hydrogen peroxide stop immediately and consult a health care provider. Read more.

FDA approves oral contraceptive for 24-day active hormonal therapy July 27, 2006
ST. LOUIS (MD Consult) - Warner Chilcott announced on February 20, 2006, that the US Food and Drug Administration approved its 24-day oral contraceptive, Loestrin 24 Fe (24 norethindrone acetate and ethinyl estradiol tablets, and 4 ferrous fumarate tablets), for the prevention of pregnancy. Read more.

Oncaspar wins new indication, approved for newly diagnosed acute lymphoblastic leukemia July 25, 2006
ST. LOUIS (MD Consult) - On July 24, 2006, the US Food and Drug Administration (FDA) expanded the approved use of Oncaspar (pegaspargase) to include treating newly diagnosed acute lymphoblastic leukemia (ALL) as part of a multiple-drug chemotherapy regimen in children and adults. The FDA approved Oncaspar in 1994 only for patients with ALL who were unable to receive the cancer drug L-asparaginase because of drug allergy. Read more.

First treatment for Hunter syndrome approved in US July 25, 2006
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) announced on July 24, 2006, its approval of Elaprase (idursulfase), the first product for the treatment of Hunter syndrome (ie, mucopolysaccharidosis II), a rare inherited disease that can lead to premature death. Elaprase is a new molecular entity, containing an active ingredient never before marketed in the United States. Read more.

AstraZeneca wins approval in US for new asthma drug July 25, 2006
ST. LOUIS (MD Consult) - Pharmaceutical company AstraZeneca announced on July 22, 2006, that the US Food and Drug Administration (FDA) has approved Symbicort (budesonide/formoterol) for the maintenance treatment of asthma in patients aged 12 years and older. Symbicort is a twice-daily asthma therapy combining budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-acting beta₂-agonist into 1 inhaler. Symbicort will be available in a pressurized metered-dose inhaler in 2 dose strengths: 80/4.5 and 160/4.5 mcg of budesonide and formoterol, respectively. Read more.

Bismacine/chromacine, used to treat Lyme disease, may be dangerous July 24, 2006
ST. LOUIS (MD Consult) - On July 21, 2006, the US Food and Drug Administration (FDA) warned consumers and health care providers not to use a product called bismacine, also known as chromacine. The FDA is investigating 1 report of a death and several reports of injury related to the administration of bismacine. Read more.

Single lot of Ultravist Injection recalled by Berlex July 24, 2006
ST. LOUIS (MD Consult) - On July 21, 2006, Berlex, Inc, and the US Food and Drug Administration (FDA) announced a voluntary nationwide recall of a single lot (No. 41500A; expiration, 1/2007) of Ultravist (iopromide) Injection 370 mgI/mL, 125 mL, an intravenous x-ray contrast agent. The presence of particulate matter in conjunction with crystallization within the agent prompted the recall; the potential for serious safety problems exists if this contaminated Ultravist Injection is administered to patients. These problems may include thrombosis of blood vessels, thromboembolism, and injury or infarction of end organs such as the heart, kidney, and brain. Read more.

Ovation launches second-line treatment for patent ductus arteriosus July 24, 2006
ST. LOUIS (MD Consult) - On July 20, 2006, Ovation Pharmaceuticals announced its launch of NeoProfen (ibuprofen lysine) Injection (10 mg/mL), a new pharmaceutical product indicated as a second-line treatment to close a clinically patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1,500 g who are no more than 32 weeks’ gestational age. It is indicated for use when usual medical management (eg, fluid restriction and respiratory support) is ineffective. Read more.

Triptans taken with certain antidepressants may cause serotonin syndrome, FDA warns July 20, 2006
ST. LOUIS (MD Consult) - On July 19, 2006, the US Food and Drug Administration (FDA) issued a public health advisory announcing new safety information about taking 5-hydroxytryptamine receptor agonists (ie, triptans), commonly used to treat migraine headaches, together with certain types of antidepressant medicines. The antidepressant medicines of concern are selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs), both of which are used to treat depression and other mood disorders. Names of the triptans, SSRIs, and SNRIs are listed at fda.gov/cder/drug/advisory/SSRI_SS200607.htm#drugs. Read more.

Contraceptive implant approved by US FDA July 19, 2006
ST. LOUIS (MD Consult) - On July 18, 2006, biopharmaceutical company Organon announced that the US Food and Drug Administration has approved Implanon (etonogestrel, 68 mg) for contraception in women. The single-rod, subdermal implantable product is effective for up to 3 years. The average hormone release rate is 40 mcg/d. Read more.

FDA approves Lilly drug for treatment of ovarian cancer July 18, 2006
ST. LOUIS (MD Consult) - On July 17, 2006, Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved Gemzar (gemcitabine hydrochloride) for use in the treatment of recurrent ovarian cancer. The approval specifies that Gemzar be used in combination with carboplatin, a widely used platinum-based chemotherapy agent, in women with advanced ovarian cancer that has relapsed at least 6 months after initial therapy. Read more.

Products promoted for sexual enhancement may be dangerous, FDA warns July 17, 2006
ST. LOUIS (MD Consult) - On July 12, 2006, the US Food and Drug Administration (FDA) warned consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. These products are sold on Web sites as "dietary supplements" for treating erectile dysfunction (ED) and enhancing sexual performance, but they are in fact illegal drugs that contain potentially harmful undeclared ingredients. These products have not been approved by the FDA, and there is no guarantee of their safety and effectiveness, nor of the purity of their ingredients. Read more.

Azathioprine tablets possibly switched with methotrexate, recall initiated July 17, 2006
ST. LOUIS (MD Consult) - Roxane Laboratories, Inc, announced on July 13, 2006, that it is conducting a nationwide voluntary recall of a single manufacturing lot of azathioprine tablets, USP 50 mg. Azathioprine is used to help prevent rejection in patients receiving kidney transplant and can also be used to manage severe rheumatoid arthritis. Read more.