Bits of Plastic Found in Vials of Merck Vaccines

merck

Pharmaceutical giant, Merck & Co., recently disclosed that pieces of plastic shrink wrap were found in vials of several of the company’s popular vaccines. The affected vaccines include: Varivax for chicken pox, Gardasil for HPV prevention, Zostavax for shingles MMR II for measles and Pneumovax for pneumococcal disease. Merck claims that they are not aware [...]

FDA Issues Warning for Radioactive Drug Used in Heart Scans

FDA warning

On Tuesday, the U.S. Food and Drug Administration issued a warning to doctors regarding a popular radioactive drug used in heart scans. The agency has asked that doctors stop using the drug CardioGen-82 during heart scan procedures because of the potential risk of increased radiation exposure. CardioGen-82 is manufactured by Bracco Diagnostics and is often [...]

FDA Approves Label Change for Chantix

Chantix Lawyer

The FDA has recently approved updated label changes for the drug, Chantix, otherwise known as varenicline. The anti-smoking drug’s new label now contains information about the efficacy and safety of its use for two particular groups of patients — those with cardiovascular disease and those with chronic obstructive pulmonary disease. The new label also includes [...]

FDA: Updated Safety Information for Oral Bisphosphonate Drugs

fda misc

The FDA recently issued updated information to healthcare professionals and patients about its ongoing review of the use of oral bisphosphonate drugs and their link to an increased risk for esophageal cancer. The agency has not concluded that taking an oral bisphosphonate will, in fact, increase the risk for cancer but announced that it will [...]

FDA Panel Rejects Experimental Diabetes Drug

astrazeneca

A panel convened by the U.S. Food and Drug Administration voted yesterday against approval of the experimental diabetes drug, dapagliflozin, citing safety concerns associated with use of the drug, including increased risk for bladder and breast cancers. The panel concluded that while the drug, which is the first-of-its-kind, had attractive features as a treatment for [...]

Multaq Makes Fifth Appearance on FDA Watch List

multaq

Each quarter, the U.S. Food and Drug Administration releases an updated list of drugs to watch for potential signs of serious side effects or safety issues. For the fifth consecutive time, Sanofi-Aventis’ Multaq (dronedarone) is included. The FDA’s most recent watch list covers the first three months of 2011. During this span of time, the [...]

NSAIDs Can Increase Risk of Heart Attack and Stroke

nsaids

According to new research published in the July edition of the American Journal of Medicine, patients with heart disease and high blood pressure who take a certain class of non-steroidal anti-inflammatory drugs (NSAIDs) are at greater risk of heart attack, stroke and even death. Popular painkillers such as aspirin, Celebrex, Advil, Motrin and Aleve are [...]

FDA Reports Safety Concerns over Transvaginal Surgical Mesh

FDA warning / The Maher Law Firm/ Frank Eidson

The U.S. Food and Drug Administration has issued new warnings regarding the use of transvaginal surgical mesh to treat pelvic organ prolapse. The agency’s warnings are targeted at the placement of the mesh, citing that its use may actually carry greater risk than other surgical options, without any evidence of greater benefit. The number of [...]

Patients Taking Generic Drugs Need More Protection

law

In a recent ruling issued by the U.S. Supreme Court, generic drug companies are not responsible for insufficient warnings to patients regarding the potential dangerous side effects associated with the use of their products, provided that their packaging labels are identical to those of the brand name medications they duplicate. The ruling provides no real [...]

Study Links Use of Antidepressants to Autism

pregnancy and antidepressants

A new study published by the Archives of General Psychology has revealed a link between the use of antidepressants during pregnancy and autism. This news is especially concerning given the fact that use of antidepressants, or SSRIs, during pregnancy has been linked to a variety of other serious birth defects, including life-threatening heart defects and [...]