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Allergan 11 articles

French officials call for ban of Allergan texture breast implants

French health regulators are calling for a ban of Allergan’s textured breast implants, and cautioning doctors and patients about texture implants from other manufacturers. The implants are associated with an increased risk for a type of non-Hodgkin lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Textured implants makeup about 85 percent of the implants used for cosmetic and reconstructive breast surgeries in France. The National Agency for Safety of Medicines and Health Products (ANSM) recommendation comes after two days of testimony during a public hearing about the safety concerns with the breast implants, and days after the U.S. Food ... Read More

Allergen recalls two glaucoma meds

Allergan is recalling two glaucoma medications because laboratory testing found that the products did not meet the regulatory specifications for individual and total impurities. The recall involves seven lots of Combigan (brimoidine tartrate and timolol maleate) and one lot of Lumigan (bimatoprost). Both drugs are ophthalmic solutions used to treat glaucoma and ocular hypertension. Specifically, the recall includes the Combigan 0.2%/0.5%, 5 mL solution with: NDC# 0023-9211-05; Lot# 94715; Expiration date: 1/19 NDC# 0023-9211-05; Lot# 94757; Expiration date: 2/19 NDC# 0023-9211-05; Lot# 94715A; Expiration date: 1/19 NDC# 0023-9211-05; Lot# 95297; Expiration date: 3/19 The 2.5 mL solution with: NDC# 0023-9211-03; ... Read More

IBS-D drug Viberzi linked to cases of serious pancreatitis, death

More than 100 people, most of whom did not have a gallbladder, who were treated with Viberzi, the new drug to treat irritable bowel syndrome with diarrhea (IBS-D), developed serious pancreatitis, 76 of whom were hospitalized and two of whom died, according to the Food and Drug Administration (FDA). As a result, the agency is advising doctors not to prescribe Viberzi to patients who do not have a gallbladder. Pancreatitis is a painful inflammation of the pancreas. People who suffer from this condition may be at increased risk of developing pancreatic cancer. “Pancreatitis may be caused by spasm of a ... Read More

First drug for frequent nighttime urination approved with black box warning

The first drug approved by the Food and Drug Administration (FDA) to reduce nighttime trips to the bathroom will hit the market along with a black box warning for hyponatremia, a potentially fatal condition resulting from dangerously low levels of sodium in the blood. Noctiva, made by Serenity Pharmaceuticals and Allergan, is a nasal spray intended for adults who wake up at least twice a night to urinate, a condition called nocturnal polyuria. It contains the active ingredient desmopressin acetate, a drug that is currently approved to treat other conditions including bleeding disorders. Noctiva is the first FDA-approved product to ... Read More

Testosterone side effects likely to hamper sales

The risk of cardiovascular events has hampered sales of testosterone replacement therapies, and numerous studies providing evidence of adverse events associated with the synthetic hormones are causing many people to look at the products in a negative light. These are just some barriers manufacturers of testosterone treatments face in the near future, an analyst with Transparency Market Research (TMR) predicts. Sales of testosterone replacement therapies have boomed in recent years with new formulations and brands entering the market, each pushing products through heavy direct-to-consumer marketing campaigns. The companies have even coined the phrase “Low T,” and suggested to men that ... Read More

Breast implants linked to serious health risks

After a two-day review, the Food and Drug Administration (FDA) determined that silicone breast implants should not be removed from the market, but they do pose risks and should be removed / replaced after 10 years. The review came after consumer groups, including the National Organization for Women Foundation and the National Research Center for Women and Families, had petitioned the agency to ban Johnson & Johnson’s silicone implants – manufactured by its subsidiary Mentor. The medical device maker was ordered to collect long-term safety data on its device; however, Mentor only collected about 21 percent of three-year follow-up data on ... Read More

Allergan recalls eye ointments

Allergan recalled three types of ointments used to treat various eye conditions because small black particles were found floating in the products. The Allergan recall includes specific lots of Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M. 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. Specific lot numbers can be found here. The recall was initiated after customer complaints about small black particles in the ointments. Allergan says ... Read More

Family files wrongful death lawsuit against Botox maker

The parents of a girl with cerebral palsy who died after undergoing a series of off-label Botox injections have filed a lawsuit against Allergan, Inc., makers of the drug, claiming the injections caused her death. Botox, or botulinum toxin type A, is a therapeutic muscle-relaxing agent that reduces rigidity of muscles or unwanted spasms in a specific muscle. It is used in cosmetic procedures to reduce the appearance of wrinkles, and in recent years has been used to treat muscle spasticity in children with cerebral palsy. Melinda Ann “Mandy” Fortuna of Shelburne, Vt., received a series of Botox injections from ... Read More

FDA approves new silicone breast implant

Johnson & Johnson subsidiary Mentor has won Food and Drug Administration (FDA) approval to market a next-generation silicone breast implant. The MemoryShape breast implant uses a cross-linking gel that is designed to be firmer than previous implants. It is approved for women age 22 years or older. Silicone implants have traveled a rocky road in the medical device industry. In 2006, the FDA approved the first silicone breast implants – made by Mentor and Allergan – since banning silicone implants nearly 20 years earlier due to concerns that they caused illnesses in women who had them. That implant was approved ... Read More

FDA panel reviews safety studies on silicone breast implants

Consumer advocacy groups want the Food and Drug Administration (FDA) to ban the sale of silicone breast implants made by Johnson & Johnson because the safety of the products is in question. The National Organization for Women Foundation and the National Research Center for Women and Families argued their case to an FDA advisory panel, which was convened to review follow-up safety studies for silicone implants currently on the market. Women seeking breast implants for cosmetic reasons have two choices – saline and silicone. Approximately 400,000 breast enlargement or reconstruction procedures using either silicone or saline implants were performed in ... Read More