OTC Cough and Cold Medicines- Product Labels Being Modified To State
" Do Not Use" In Children Under 4 Years Of Age
http://www.fda.gov/medwatch/safety/2008/safety08.htm#CoughCold
FDA notified healthcare professionals and consumers that the
Consumer Healthcare Products Association (CHPA) is voluntarily modifying
the product labels for consumers of over the counter (OTC) cough and cold
medicines to state "do not use" in children under 4 years of age. FDA supports
CHPA members to help prevent and reduce misuse and to better inform
consumers about the safe and effective use of these products for children.
FDA continues to assess the safety and efficacy of these products and to
revise its OTC list of approved ingredients and amounts for these medicines.
Parents and care givers should adhere to the dosage instructions and warnings
on the label that accompanies OTC cough and cold medications before giving
the product to children, and should consult their healthcare professionals
if they have any questions or concerns.
Tiotropium (Spiriva): updated information on risk of stroke and reports of cardiovascular adverse outcomes
Tiotropium (marketed as Spiriva HandiHaler)
http://www.fda.gov/medwatch/safety/2008/safety08.htm#TiotropiumAudience: Pulmonary care health professionals and patients
FDA informed healthcare professionals that FDA has reviewed preliminary data from
UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium),
a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately
6000 patients with chronic obstructive pulmonary disease. The preliminary results
reported by Boehringer Ingelheim to the FDA showed that there was no increased
risk of stroke with tiotropium bromide compared to placebo.
Two recent publications reported increased risk for mortality and/or cardiovascular
events in patients who received tiotropium or inhaled anticholinergics.
Both studies examined cardiovascular outcomes.
FDA expects to receive the complete report for UPLIFT in November 2008.
Results from this trial will also help to address some issues raised about
tiotropium in the two recent publications. Due to the amount of data collected in
UPLIFT, a complete review of the results could take several months, at which time
FDA will update this communication with the final results of the UPLIFT analysis,
as well as all the available data regarding tiotropium and stroke risk.
Dextroamphetamine Sulfate 5mg Tablets- Drug Recall due To The Potential For Oversized Tablets
http://www.fda.gov/medwatch/safety/2008/safety08.htm#DextroamphetamineEthex Corp and FDA notified healthcare professionals of a voluntary recall of three
lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to
the potential presence of oversized tablets that may contain as much as twice the
labeled amount of the active ingredient. Taking a higher than expected dose of
Dextroamphetamine Sulfate may be associated with an increased risk of adverse
effects such as tachycardia, hypertension, tremors, decreased appetite, headache,
insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers
and their caregivers should not use any Dextroamphetamine Sulfate tablets that
appear to be oversized and should consult their healthcare professional with any questions.
Raptiva (efalizumab): Boxed Warning describes risk for life-threatening infections
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Raptiva Raptiva (efalizumab)
Audience: Dermatological healthcare professionals, patients
FDA notified healthcare professionals of extensive labeling changes, including a
Boxed Warning, to highlight the risks of life-threatening infections, including
bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal
leukoencephalopathy and other opportunistic infections with the use of Raptiva.
In addition, the prescribing information will be updated to describe a potential
risk for the permanent suppression of the immune system with repeat administration
of Raptiva in children. Raptiva is not approved for children under 18 years of age.
Doctors and other prescribers should carefully evaluate and weigh the risk/benefit
profile of Raptiva for patients who would be more susceptible to these risks. Health
care professionals should monitor patients treated with Raptiva for the signs and
symptoms of these adverse events and also instruct patients to report any such
signs and symptoms to them without delay. Patients identified to begin therapy
with Raptiva should have received all their age-appropriate vaccinations before starting the drug.
Patients with pre-existing infections or who have a compromised immune system
should notify their health care professional before beginning treatment with Raptiva.