Warning

How's my detailing? Dial 1-877-RX-DDMAC

Matthew Arnold May 11, 2010

The FDA is asking healthcare professionals to keep an eye out for violative promotion and to call 1-877-RX-DDMAC or emailing badad@fda.com when they see it. "Recognize and report" is the message of the agency's Bad Ad Program, an educational outreach effort by the Division of Drug Marketing, Advertising and Communications (DDMAC) that will "help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency," according to DDMAC director Tom Abrams.

DDMAC warns J&J on Ultram webcast

Matthew Arnold May 20, 2009

The FDA hit Johnson & Johnson with a warning letter over a webcast promoting pain med Ultram ER, saying it overstated efficacy and underplayed or omitted risks.

DDMAC raps sponsored links for omission of risk info

Matthew Arnold April 06, 2009

The FDA's Division of Drug Marketing, Advertising and Communications slapped 14 drug companies with untitled letters for sponsored links on Google deemed violative because they omitted risk information.

Bayer runs "corrective" Yaz ad, agrees to preclearance

Matthew Arnold February 11, 2009

Bayer is shelling out $20 million to air a rare remedial TV ad campaign for its Yaz birth control pill as part of a settlement with FDA and 27 states over charges of deceptive advertising. Bayer also agreed to submit all ads to FDA for preclearance for the next six years.

Troubled KV cuts 700 jobs amid suspension

Matthew Arnold February 09, 2009

KV Pharmaceutical Company said it is eliminating 700 jobs as part of a cost-cutting program following a suspension of manufacturing and product recalls resulting from an FDA investigation.

DDMAC warning and untitled letters in 2008 total 21

Matthew Arnold December 31, 2008

The FDA's Division of Drug Marketing, Advertising and Communications issued 21 warning and untitled letters in 2008 - scarcely more than the 20 letters the unit sent out in 2007.

FDA raps tiny text in Abbott ad

Matthew Arnold December 29, 2008

Unreadable risk info was at issue in an FDA rebuke of an Abbott ad for Humira.

New study results strengthen hormone therapy, cancer link

Ben Comer December 15, 2008

Results from a large national study may have put the nail in the coffin of hormone replacement therapy (HRT) treatments, the Associated Press reported Saturday.

DDMAC warns Amgen, Bayer on consumer promotions

Matthew Arnold October 30, 2008

The FDA's Division of Drug Marketing, Advertising and Communications issued an "untitled/notice of violation" letter on a patient brochure for Amgen's Sensipar, which is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

DDMAC warns Bayer on YAZ TV ads

Matthew Arnold October 07, 2008

The FDA slapped Bayer HealthCare Pharmaceuticals with a warning letter on two 60-second TV ads for its YAZ contraceptive.

FDA warns Shire on Fosrenol marketing materials

Stephen McGuire May 12, 2008

Shire received a warning letter from the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) asking the drugmaker to halt distribution of specific professional marketing materials for its end stage renal disease treatment Fosrenol (lanthanum carbonate).

FDA warns of Tysabri liver risks

Stephen McGuire February 27, 2008

Biogen Idec and Elan's multiple sclerosis (MS) treatment Tysabri may cause significant liver injury within six days of the first dose, the FDA warned healthcare professionals in a letter posted today on the FDA's website.

Australian regulators issue warning on Novartis' Lamisil

Stephen McGuire February 05, 2008

Australia's drug and medical device regulatory agency, the Therapeutic Goods Administration (TGA), has issued a warning concerning nail fungus treatment Lamisil (terbinafine) tablets following reports of three deaths and severe liver reactions among patients.

FDA issues warning letter to Daytrana manufacturer

Stephen McGuire January 10, 2008

Noven Pharmaceuticals, which manufactures Shire's attention deficit hyperactivity disorder patch Daytrana said it received a warning letter from the FDA related to a prior on-site inspection of its manufacturing facility in Miami.

Roche follows FDA advice to strengthen Tamiflu warning

Stephen McGuire November 28, 2007

Roche has accepted the recommendation of an FDA panel to place a stronger warning on its flu treatment Tamiflu, the Associated Press reports.

FDA issues GSK a warning on Tykerb letters

Matthew Arnold November 27, 2007

The FDA slapped GlaxoSmithKline with a warning letter for a series of Dear Healthcare Practitioner letters promoting Tykerb.

FDA toughens Avandia warnings

Stephen McGuire November 14, 2007

The FDA on Wednesday added a black box warning to GlaxoSmithKline's (GSK) Avandia (rosiglitazone), stating the diabetes treatment was linked to a potential increase in the risk of heart attacks.

Lilly adds weight gain, blood sugar warnings to Zyprexa labeling

Stephen McGuire October 09, 2007

Eli Lilly is strengthening the warning label to its antipsychotic Zyprexa by adding tougher language concerning weight gain and elevated blood sugar.

Cephalon warns docs of Fentora death link

Stephen McGuire September 14, 2007

Drug maker Cephalon this week issued a warning to doctors about deaths linked to its powerful painkiller Fentora, the FDA said.

Timing of FDA notice on diabetes meds leads to confusion

Marc Iskowitz August 15, 2007

Yesterdays FDA notice of black-box warnings for GlaxoSmithKlines Avandia, and drugs like it, for congestive heart failure came as a surprise to many.

Novartis withdraws Prexige in Australia

Marc Iskowitz August 14, 2007

After a number of cases of serious liver damage in Australian patients taking Prexige, Novartis withdrew the drug in that country.

Xolair gets black box labeling

Stephen McGuire July 05, 2007

The FDA has announced new black box labeling for Genentechs Xolair (omalizumab) to address the risk of anaphylaxis in patients using the asthma drug.

Avandia hearings: FDA black-boxes TZD drugs

Matthew Arnold, Stephen McGuire June 06, 2007

FDA has asked GSK and Takeda to place boxed warnings of congestive heart failure risks on the labeling for their type 2 diabetes drugs, Avandia and Actos.

GSK preaches Avandia safety to docs, forgoes new DTC

Marc Iskowitz, Stephen McGuire May 31, 2007

GlaxoSmithKline is stressing Avandia safety with doctors but has no plans for a DTC campaign to address concerns with the diabetes drug.

FDA issues 20 Warning Letters

James G. Dickinson May 01, 2007

The FDA has sent 20 Warning Letters to companies ordering them to stop marketing unapproved products containing ergotamine tartrate, which is used to treat vascular headaches.

DDMAC vows pushback on risk disclosures

Marc Iskowitz April 01, 2007

The FDA has stepped up efforts to combat what it sees as the No. 1 pharmaceutical marketing compliance problem, said Division of Drug Marketing, Advertising and Communication chief Thomas Abrams: ads that omit or downplay risk information.

Torcetrapib's failure raises new questions

Marc Iskowitz, Stephen McGuire January 01, 2007

The halt of Pfizer's torcetrapib program has potentially far-reaching implications for the broader industry and raises questions about safety of other drugs in its class, analysts said.

Merck responds to Arcoxia approvable letter

James G. Dickinson January 01, 2007

Merck has responded to an FDA “approvable” letter for Arcoxia (etoricoxib), an investigational selective Cox-2 inhibitor, with results of the MEDAL program.

FDA still going after unapproved drugs

James G. Dickinson December 01, 2006

The FDA says it is continuing its battle against unapproved drugs with a consent decree signed with one manufacturer of unapproved drugs and Warning Letters sent to four others.

Serotonin warning for users of SSRIs

James G. Dickinson December 01, 2006

The FDA says development of a potentially life-threatening serotonin syndrome may occur in treatment with four selective serotonin reuptake inhibitors.